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Validation: DataPro 3 software

CLiMET DataPro 3
Supplemental Validation
of Version 1.20

Validation Revision History Software P/N 03000071


Version 1.20 – August 1, 2011 Manual P/N 03036900
Version 1.11 – February 1, 2011 Validation P/N 03036901
Version 1.10 – August 30, 2010
Version 1.02 – June 21, 2010
Version 1.01 – April 21, 2008
Version 1.00 – October 16, 2007
CLiMET Instruments Company
DataPro 3 V1.20, Validation
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Notices
Copyright © 2003-2011 by CLiMET Instruments Company. All rights reserved.

Complying with applicable copyright laws, no part of this document may be reproduced, stored in or introduced to any retrieval system, or
retransmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise), or for any purpose, without the prior
written permission of CLiMET Instruments Company. Contact CLiMET Instruments to request written permission.

Mail: CLiMET Instruments Company Email: Sales@CLiMET.com


1320 West Colton Avenue Phone: 909.793.2788
Redlands, CA 92374
USA Fax: 909.793.1738

CLiMET Instruments Company may make improvements and/or changes in the product(s) and/or the program(s) described in this document at
any time without notice; these improvements and/or changes will be incorporated in new versions of the documentation. Unless otherwise noted,
the example companies, organizations, products, people and events depicted herein are fictitious and no association with any real company,
organization, product, person or event is intended or should be inferred.

Although every precaution has been taken in the preparation of this documentation, the author assumes no responsibility for technical
inaccuracies, typographical errors, or damages resulting from the use of the information contained herein.

The following paragraph does not apply to a country where such provisions are inconsistent with local law:
CLIMET INSTRUMENTS COMPANY PROVIDES THIS DOCUMENTATION “AS IS” WITHOUT WARRANTY OF ANY KIND,
EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF NON-INFRINGEMENT,
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Some states do not allow a disclaimer of express or implied
warranties in certain transactions, therefore, this statement may not apply to you.

Trademarks
CLiMET is a trademark of CLiMET Instruments Company in the United States and/or other countries. Microsoft, Windows, MSDE, SQL
Server 2005 Express, Visual Basic .NET, Visual Studios .NET and Excel are trademarks of Microsoft Corporation in the United States and/or
other countries. VeriSign is a trademark of VeriSign in the United States and/or other countries. RSA and MD5 are trademarks of RSA Security
Inc. in the United States and/or other countries. The names of actual companies and products mentioned herein may be the trademarks of their
respective owners.

Supplementary Features
Note indicates notes related to the nearby text.
Tip indicates tips related to the nearby text.

Typographical Conventions
Bold indicates important words, or names of buttons, menus, and windows.
Italic indicates new terms, or terms in glossary.
 indicates a procedure in the table of contents.
§ indicates reference to a section number.

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Table of Contents
1 Introduction ........................................................................................................................... 5
2 System Requirements & Equipment ................................................................................... 5
3 IQ: Installation Qualification ............................................................................................... 5
3.1 Scope ..................................................................................................................... 5
3.2 Peripherals Test ..................................................................................................... 5

4 OQ: Operational Qualification ............................................................................................ 6


4.1 Scope ..................................................................................................................... 6
4.2 User Requirements ................................................................................................ 6
4.3 Functional Specifications ...................................................................................... 6
4.4 Traceability Matrix ................................................................................................ 8
4.5 Basic Installation Test ........................................................................................... 9
4.6 Product Evaluation Test ...................................................................................... 10
4.7 Activate Product Utility Test ............................................................................... 11
4.8 Individual Computer Installation Test ................................................................. 12
4.9 Overview and View Alarms Tabs Test ............................................................... 13
4.10 Sub controls of Reports Tab Test ..................................................................... 14
4.11 Reports and Graphs Test .................................................................................. 15
4.13 Excel Row Limit Update .................................................................................. 19
4.14 Large Data Limit User Interaction ................................................................... 20
4.15 Alarm Limit Plotting ........................................................................................ 21
4.16 Concentration Limits Test for Alternate EU GMP .......................................... 22
4.17 Uninstalling Test .............................................................................................. 23

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1 Introduction
CLiMET Instruments Company designed, constructed and validated
CLiMET DataPro 3 Version 1.20 at the CLiMET facility in Redlands,
California. The validation method described herein is consistent with
CLiMET’s “SOFTWARE DEVELOPMENT, DOCUMENTATION AND
REVISION STANDARDS” policy (Revision 3.0 – 03/04/1999).
The purpose of this validation document is to provide documented
evidence that DataPro will correctly install and consistently operate in
accordance with the procedures outlined in the DataPro manual. This
protocol describes all of the conditions and tests performed for this
validation.
The manual describes DataPro. The validation system has inputs and
outputs. The inputs to the validation system are particle samples and
the DataPro user interface. The outputs of the system are printouts,
databases and the data recorded in this document.

2 System Requirements &


Equipment
 See requirements in DataPro 3 manual

3 IQ: Installation Qualification


3.1 Scope
The installation process provides a default installation path.

3.2 Peripherals Test


Check that the following items are present:
 One DataPro installation CD
 Three Light Towers

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4 OQ: Operational Qualification


4.1 Scope
The DataPro operational testing utilizes the user interface of DataPro
in conjunction with a particle counter and light tower. The DataPro
software uses Ethernet to communicate with a particle counter.
The Revision History included at the end of the DataPro3 manual
describes in detail the changes of each version. This is a supplemental
validation of DataPro 3 using version 1.20 superseding any prior one
regarding relevant tests. This version is a subsequent version to
DataPro 3 version 1.11 and it’s validation documentation.

4.2 User Requirements


U1.1.0. Change CLiMET DataPro 3 client version number from V1.11
to V1.20 because of new features.
U1.2.0. Add graphing of alarm limits.
U1.3.0. Add alternate EU GMP report style
U2.1.0. Changed supported OS’s and Programs.
U2.1.1. Removed 35000 row cap for Excel 07’ and later
U2.1.2. Allow modification of rows used for large amounts of data.
U3.1.0. Fixed Service issue regarding counters.

4.3 Functional Specifications


The first functional requirement encompass’ both the client and the
service projects.
F1.1.0. Updated version number in DataPro 3 assembly project.
F1.1.1. Updated version number in DataPro3Setup project version
number.
F1.1.2. Updated version number in DataPro3.Info.vb.
F1.2.0. Updated version number in CLiMET_DAS1 project assembly
information.
F1.2.1. Updated version number in CLiMET_DAS1Setup project.
F1.2.2. Updated version number in CLiMet_DAS1.Info.vb

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F1.3.0. Updated CLiMET DataPro3 Manual version numbers in title


and filename.
The following requirements encompass only the service.
F2.1.0. ModbusSensor.vb modified to account for device mainboard
shutdown after reporting no data post startup due to flow never raising
above 90%
The following requirements encompass only the client.
F3.1.0. Update SubTypeIterator to use interval data instead of rolling
count when plotting cubic meter data collected.
F3.2.0. Excelsheet.vb modified to change 32000 row limit to 21 billion.
F3.3.0. RawGraphInfo.vb modified to fix time scale issue of blank area
at start of graph and row limit modification.
F3.4.0. VerifyRowIntegrity.vb modified to allow user to adjust checking
of extreme data amounts.
F3.5.0. TimeScaleArrayBuilder.vb added flag for code reference.
F3.6.0. ExcelArrayDirector.vb added flag changes for code reference.
F3.7.0. SummaryHeader.vb modified to handle alternate EU GMP
reporting.
F3.8.0. RawReportHeader.vb modified to handle row limit modification.
F3.9.0. UCLBody.vb modified to handle alternate EU GMP reporting.
F3.10.0. TimeScaleBody.vb modified to report “Total Count” from the
“Count” data instead of just “rolling count data.” Only impact is on data
collected in CM mode.
F3.11.0. SummaryBody.vb modified to handle alternate EU GMP
reporting.
F3.12.0. RawGraphBody.vb modified to use interval data instead of
rolling count when plotting cubic meter data collected.
F3.13.0. SummaryRow.vb modified to handle alternate EU GMP
reporting.
F3.14.0. GraphRow.vb modified to use interval data instead of rolling
count when plotting cubic meter data collected.
F3.15.0. AlarmGraphing.vb added to handle graphing of alarms.
F3.16.0. Added button, checkbox and status label to DocUI.vb to
handle plotting of alarm limits.
F3.17.0. Added checkbox to DocFooterUI.vb to implement alternate
EU GMP reporting.
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4.4 Traceability Matrix


7. Test or
3. 5.
1. URS 4. GxP 6. Function Verification
CFR11 Other 8.
Reference 2. Description impact? Specification Reference
Impact? Impact Comments
Number (Y/N) Reference (e.g., IQ, OQ,
(Y/N) (Y/N)
PQ)
F1.1.0, F1.1.1,
F1.1.2, F1.2.0, 4.5, 4.6, 4.7,
U1.1.0 Client Package N N N
F1.2.1, F1.2.2, 4.8
F1.3.0
New Feature - Alarm F3.6.0, F3.15,
U1.2.0 N N N 4.1, 4.11, 4.16
Limit Graphing F3.16
F3.7.0, F3.9.0,
New Report - F3.11.0,
U1.3.0 N Y N 4.11, 4.17
Alternate EU GMP F3.13, F3.14,
F3.17
Requirement Update -
4.5, 4.6, 4.7,
U2.1.0 Dropped XP and Excel N N N F3.2.0
4.8
2003
Feature Update - 35k
4.9, 4.10, 4.11,
U2.1.1 Row > 21 Billion Row N Y N F3.2.0
4.13
limit Update
New Excel Handling -
Additional User Limited by
F3.4.0, F3.6.0, 4.9, 4.10, 4.11,
U2.1.2 Options when plotting N Y N hardware
F3.8.0 4.14
massive amounts of memory.
data
U3.1.0 Fix Service N Y N F2.1.0 4.9
Fix CM Total Count F3.1.0,
U4.1.0 N N N 4.9, 4.11
Graphs F3.10.0, F3.12
U5.1.0 Fix Time Scale Graphs N N N F3.3.0, F3.5.0 4.1, 4.11

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4.5 Basic Installation Test

Purpose Test that the DataPro software installation works.

Setup  A personal computer with one of the supported operating systems and,
 One DataPro installation CD.

Procedure 1. Install the entire DataPro system as Administrators or Domain Admins


member.
2. Start the DataPro program as Users member.

A window similar to the following window will appear.

Success Yes  No 

Done by Date 11/21/2011

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4.6 Product Evaluation Test

Purpose Test that the DataPro product evaluation works.

Setup Use virtual machines (VM) as necessary. Disable firewalls as necessary.


 Do Procedure with Windows 7 (preferably x64).

Procedure 3. Install the entire DataPro system as Administrators or Domain Admins


member.
4. Start the DataPro program as Users member.

You will be told that you are not a member of the Administrators or Domain
Admins group.
5. Start the DataPro program as Administrators or Domain Admins member.

You will be told that you have fourteen-days left in your evaluation.

6. Change the date in your PC in increments until the evaluation period expires.

 Make sure that reinstalling the DataPro client on a later day resets the
evaluation period anew.
7. Start the DataPro program as Users member.

 Make sure you can now run the program after the Administrators or Domain
Admins member ran the program once.

Success Yes  No 

Done by Date 11/21/2011

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4.7 Activate Product Utility Test


Purpose This test Validates that the Activation Product utility activates DataPro.

Setup Need LicensePro running.


Use virtual machines (VM) as necessary.

Procedure 1. Install DataPro on computer that hasn’t had DataPro installed.


2. Click the  Start button, point to Programs, point to the CLiMET folder, and
then click the DataPro3 icon.

A window similar to the following window will appear.

3. Enter the activation code from LicensePro


4. Click OK.

“Activation OK” windows appears.

5. Click OK.

 Make sure the product activation works under all user levels.

Success Yes  No 

Done by Date 11/21/11

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4.8 Individual Computer Installation Test

Purpose Test that the system works when installing the system in one computer.

Setup See system requirements. Use virtual machines (VM) as necessary.


Disable firewalls as necessary.
During this test, make sure the SQL Connection Wizard:
 Selects a server that persists throughout sessions.
 Troubleshoots isolated computer problems.
Test:
 Do Procedure with Windows Vista x86.
 Do Procedure with Windows 7 x64.

Procedure 1. Install the entire DataPro system.

 Make sure the client is able to view acquired data.

Success Yes  No 

Done by Date 11/23/2011

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4.9 Overview and View Alarms Tabs Test

Purpose Test that Overview and View Alarms tabs works correctly.
Setup Use CLiMET’s Validation Utility (VU).
Procedure Generate the following events.
 Normal (a.k.a., OK)  Coarse Alert
 Off (a.k.a., Standby)  Coarse Alert Recovery
 Bad Flow  Fine Action
 Bad Flow Recovery  Fine Action Recovery
 Bad Laser  Fine Alert
 Bad Laser Recovery  Fine Alert Recovery
 Bad Sensor  No Response
 Bad Sensor Recovery  No Response Recovery
 Coarse Action  Forced Counts
 Coarse Action Recovery  Forced Counts Recovery
 Service Not Responding  Sample Time Expired
 Not Used (blank)  Sample Time Expired Recovery
 Make sure Overview and View Alarms tabs show the events.
 The Overview tab does not display Recoveries, Forced Counts,
Sample Time Expired, or Alarm Tower No Response.
 The View Alarms tab does not display Service Not Responding, Off,
Not Used or Normal.

 Remove/add sensors removes/adds Overview tab sensor watches.


 Make sure View Alarms tab Auto-refresh check box works correctly.
 Use Manage Databases tab to delete the Alarm Event database.
Return to View Alarms tab. The view will clear.
 Disconnect alarm towers to see View Alarms No Response events.

Success Yes  No 

Done by Date 11/29/11

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4.10 Sub controls of Reports Tab Test

Purpose Test that the sub controls of the Reports tab work as outlined in
Functional Specification (FS).

Setup None

Procedure  Make sure User Fields works as described in FS §7.1.


 Make sure Document Footer works as described in FS §7.2.
 Make sure Sizes works as described in FS §7.3.
 Make sure Tick Period and Label Frequency work properly. Make
sure the default selections make the graph look neat. Try various
combinations of tick periods and label frequencies.
 Make sure Area and Locations works as described in FS §7.5.
 Make sure Template works as described in FS §7.6.
 Make sure Document Sub Type works as described in FS §7.7.
 Make sure Summary Define works as described in FS §7.8.
 Make sure Scale works as described in FS §7.9.
 Make sure Raw Report Define works as described in FS §7.10.

Success Yes  No 

Done by Date 11/28/11

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4.11 Reports and Graphs Test

Purpose Test that the Reports tab creates the documents and verifies the data
integrity.

Setup Use CLiMET’s Validation Utility (VU).


Collect data following the following specifications:
 Locations are labeled "Point #"
 ISO 5: 0.5: CF 70-99 CM 3300-3520,0
 ISO 5: 5.0: CF 0 CM 0-29
 ISO 5: 4 locations: Ampoule Filling Machine 1

To convert from CF to CM use 0.028316847.


To convert from CM to CF use 35.314667.

Procedure For all locations and allowed sizes in Ampoule Filling Machine 1, make
sure the following documents are correct and attach them to the back of
this test:

 Create and print the reports and graphs as listed below.


 Test that there is no truncation on Excel sheet column one when you
have long location names (twenty characters plus).
 Make sure that “Data is intact” is listed at the top of data reports.
The following is a list of graphs and reports attached. The bold items are the actual
printed document for each sub section.

1. Reports
1.1. EU GMP Annex 1
1.1.1. Alternate
1.1.1.1. In Operation
1.1.1.1.1. A
1.1.1.1.2. B
1.1.1.1.3. C
1.1.1.2. At Rest
1.1.1.2.1. A
1.1.1.2.2. B
1.1.1.2.3. C
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1.1.2. Normal
1.1.2.1. In Operation
1.1.2.1.1. A
1.1.2.1.2. B
1.1.2.1.3. C
1.1.2.2. At Rest
1.1.2.2.1. A
1.1.2.2.2. B
1.1.2.2.3. C
1.2. ISO 14644-1 In Operation
1.2.1. C2
1.2.2. C3
1.2.3. C4
1.2.4. C5
1.2.5. C6
1.2.6. C7
1.2.7. C8
1.2.8. C9
1.3. Raw Data
1.3.1. Total Count
1.3.2. Rolling Count
1.4. Summary
1.4.1. CF
1.4.2. CM
1.4.3. Total Count
2. Graphs
2.1. Raw Data
2.1.1. CF Report
2.1.1.1. CM Samples
2.1.1.1.1. “.5”
2.1.1.1.2. “5”
2.1.1.2. CF Samples
2.1.1.2.1. “.5”
2.1.1.2.2. “5”
2.1.2. CM Report
2.1.2.1. CM Samples
2.1.2.1.1. “.5”
2.1.2.1.2. “5”
2.1.2.2. CF Samples

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2.1.2.2.1. “.5”
2.1.2.2.2. “5”
2.1.3. Total Count Report
2.1.3.1. CM Samples
2.1.3.1.1. “.5”
2.1.3.1.2. “5”
2.1.3.2. CF Samples
2.1.3.2.1. “.5”
2.1.3.2.2. “5”
2.1.4. Alarm Test
2.1.4.1. CM Report
2.1.4.1.1. CF + CM + Logarithmic + Alarms
2.1.4.1.1.1. “.5”
2.1.4.1.1.2. “5”
2.1.4.2. CF Report
2.1.4.2.1. CF + CM + Logarithmic + Alarms
2.1.4.2.1.1. “.5”
2.1.4.2.1.2. “5”
2.1.4.3. Total Count
2.1.4.3.1. CF + CM + Logarithmic + Alarms
2.1.4.3.1.1. “.5”
2.1.4.3.1.2. “5”
2.1.4.3.2.
2.2. Time Scale
2.2.1. CF Report
2.2.1.1. CM Samples
2.2.1.1.1. “.5”
2.2.1.1.2. “5”
2.2.1.2. CF Samples
2.2.1.2.1. “.5”
2.2.1.2.2. “5”
2.2.2. CM Report
2.2.2.1. CM Samples
2.2.2.1.1. “.5”
2.2.2.1.2. “5”
2.2.2.2. CF Samples
2.2.2.2.1. “.5”
2.2.2.2.2. “5”
2.2.3. Total Count Report

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2.2.3.1. CM Samples
2.2.3.1.1. “.5”
2.2.3.1.2. “5”
2.2.3.2. CF Samples
2.2.3.2.1. “.5”
2.2.3.2.2. “5”
2.2.4. Alarm Test
2.2.4.1. CM Report
2.2.4.1.1. CF + CM + Logarithmic + Alarms
2.2.4.1.1.1. “.5”
2.2.4.1.1.2. “5”
2.2.4.2. CF Report
2.2.4.2.1. CF + CM + Logarithmic + Alarms
2.2.4.2.1.1. “.5”
2.2.4.2.1.2. “5”
2.2.4.3. Total Count
2.2.4.3.1. CF + CM + Logarithmic + Alarms
2.2.4.3.1.1. “.5”
2.2.4.3.1.2. “5”

NOTE: The Total Count vs CM/CF will not match up for CM sample data as rolling count validation data is created as a static number with the VU
with variable range and not a rolling count of the actual intervals being generated. The data is verifiable as it comes from a counter, but not against
itself.

Success Yes  No 

Done by Date 1/24/2012

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4.13 Excel Row Limit Update

Purpose Verifies that Excel can handle more than 35000 rows. 21 billion hard cap.

Setup  Use Data that has more than 35000 rows.

Procedure  Create a raw data report and make sure it has more than 35000 rows.
 Create a raw graph, timescale graph and make sure the resulting
Excel file contains more than 35000 rows of data.
 Create 1 of each report and more sure resulting files report the proper
range.

Success Yes  No 

Done by Date 1/23/2012

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4.14 Large Data Limit User Interaction

Purpose Verifies that large amounts of data can be handled by user and allows
the user to limit data according to their hardware spec’s.

Setup  Use over 150000 rows of collected data.

Procedure  Create a raw data report and make sure that the program asks for
user input before verifying the data.
 Create a raw data graph and check to make sure that 3 options
appear in a dialog window.
 Check each option to make sure that data is plotted with the
designated number of rows. If an error occurs limit time range and
attempt test again.

Success Yes  No 

Done by Date 1/23/2012

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4.15 Alarm Limit Plotting

Purpose Test that alarm lines show up correctly on graphs.

Setup Use DataPro3.

Procedure 1. Click the “Edit Alarm Lines” button.


2. Create several alarm limits with various names, values, and colors.
3. Add them to the right list to plot.
4. Create a graph after checking the “Plot Alarm Lines” box.
5. Create a few alarm limits using the alarm tab.
6. Click the “Edit Alarm Lines” button.
7. Remove all the custom alarms from the right side.
8. Select the non-custom fields until you see one of the alarm limits you
picked.
9. Add 1 or more of the custom limits to the right side, accept changes,
and plot a graph.

 Check to make sure each line has a different line designation, proper
name, value and color association assigned. Do this for both graphs.

Success Yes  No 

12/1/2011
Done by Date

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4.16 Concentration Limits Test for Alternate EU


GMP

Purpose Test that the alternate EU GMP Annex 1 concentration limits work
correctly. Note: Alternate does not mean that the limits are different just
that the sampling size is now full cubic meters only.

Setup Use CLiMET’s Validation Utility (VU).

Procedure 1. Create cubic meter concentrations that both pass and fail each of the
2. EU GMP Annex 1 concentration limits of the manual.

For example, for a concentration limit of ten, create a location that


averages ten and a second location that averages eleven.

3. Check the “Alternate EU GMP” box at the bottom of the report.


4. Make sure the result of the particulate test is correct.
5. Attach reports to the back of this test.

Success Yes  No 

Done by Date 1/27/2012

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4.17 Uninstalling Test

Purpose Test that the system correctly uninstalls.

Setup None

Procedure Make sure uninstalling works correctly.

Success Yes  No 

Done by Date 1/30/2012

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The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Fail
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:42:25
Author: Kyle Kuehm
Classification: Grade A (2008)
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.1.1.1.1
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 0.5 µm Cubic Meter 204439 204900 2012-01-24 10:39:31 3302 6 CM 0 0 0 Fail
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 5.0 µm Cubic Meter 484 606 2012-01-24 12:59:32 1 6 CM 0 0 0 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00 ≥ 0.5 µm Cubic Meter 204857 205488 2012-01-24 11:14:31 3517 6 CM 0 0 1 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00 ≥ 5.0 µm Cubic Meter 456 551 2012-01-24 11:49:33 13 6 CM 0 0 1 Fail
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 0.5 µm Cubic Meter 2999 3100 2012-01-24 11:53:14 99 6 CM 0 0 1 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6 CM 0 0 1 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00 ≥ 0.5 µm Cubic Meter 2993 3102 2012-01-24 11:53:14 79 6 CM 0 0 0 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00 ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6 CM 0 0 0 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103822 2.4 116424 4 3520 243530.8 Fail
≥ 5.0 µm 235 2.4 271.6 4 20 560.9 Fail

DataPro 3 V1.20, Validation


Completed By: Page 24 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Pass
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:43:38
Author: Kyle Kuehm
Classification: Grade B (2008)
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.1.1.1.2
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 0.5 µm Cubic Meter 204439 204900 2012-01-24 10:39:31 3302 6 CM 0 0 0 Pass
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 5.0 µm Cubic Meter 484 606 2012-01-24 12:59:32 1 6 CM 0 0 0 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00 ≥ 0.5 µm Cubic Meter 204857 205488 2012-01-24 11:14:31 3517 6 CM 0 0 1 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00 ≥ 5.0 µm Cubic Meter 456 551 2012-01-24 11:49:33 13 6 CM 0 0 1 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 0.5 µm Cubic Meter 2999 3100 2012-01-24 11:53:14 99 6 CM 0 0 1 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6 CM 0 0 1 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00 ≥ 0.5 µm Cubic Meter 2993 3102 2012-01-24 11:53:14 79 6 CM 0 0 0 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00 ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6 CM 0 0 0 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103822 2.4 116424 4 352000 243530.8 Pass
≥ 5.0 µm 235 2.4 271.6 4 2900 560.9 Pass

DataPro 3 V1.20, Validation


Completed By: Page 25 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Pass
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:44:04
Author: Kyle Kuehm
Classification: Grade C (2008)
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.1.1.1.3
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 0.5 µm Cubic Meter 204439 204900 2012-01-24 10:39:31 3302 6 CM 0 0 0 Pass
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 5.0 µm Cubic Meter 484 606 2012-01-24 12:59:32 1 6 CM 0 0 0 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00 ≥ 0.5 µm Cubic Meter 204857 205488 2012-01-24 11:14:31 3517 6 CM 0 0 1 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00 ≥ 5.0 µm Cubic Meter 456 551 2012-01-24 11:49:33 13 6 CM 0 0 1 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 0.5 µm Cubic Meter 2999 3100 2012-01-24 11:53:14 99 6 CM 0 0 1 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6 CM 0 0 1 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00 ≥ 0.5 µm Cubic Meter 2993 3102 2012-01-24 11:53:14 79 6 CM 0 0 0 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00 ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6 CM 0 0 0 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103822 2.4 116424 4 3520000 243530.8 Pass
≥ 5.0 µm 235 2.4 271.6 4 29000 560.9 Pass

DataPro 3 V1.20, Validation


Completed By: Page 26 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Fail
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:44:34
Author: Kyle Kuehm
Classification: Grade A (2008)
Occupancy state: At Rest
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.1.1.2.1
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 0.5 µm Cubic Meter 204439 204900 2012-01-24 10:39:31 3302 6 CM 0 0 0 Fail
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 5.0 µm Cubic Meter 484 606 2012-01-24 12:59:32 1 6 CM 0 0 0 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00 ≥ 0.5 µm Cubic Meter 204857 205488 2012-01-24 11:14:31 3517 6 CM 0 0 1 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00 ≥ 5.0 µm Cubic Meter 456 551 2012-01-24 11:49:33 13 6 CM 0 0 1 Fail
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 0.5 µm Cubic Meter 2999 3100 2012-01-24 11:53:14 99 6 CM 0 0 1 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6 CM 0 0 1 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00 ≥ 0.5 µm Cubic Meter 2993 3102 2012-01-24 11:53:14 79 6 CM 0 0 0 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00 ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6 CM 0 0 0 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103822 2.4 116424 4 3520 243530.8 Fail
≥ 5.0 µm 235 2.4 271.6 4 20 560.9 Fail

DataPro 3 V1.20, Validation


Completed By: Page 27 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Fail
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:45:16
Author: Kyle Kuehm
Classification: Grade B (2008)
Occupancy state: At Rest
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.1.1.2.2
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 0.5 µm Cubic Meter 204439 204900 2012-01-24 10:39:31 3302 6 CM 0 0 0 Fail
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 5.0 µm Cubic Meter 484 606 2012-01-24 12:59:32 1 6 CM 0 0 0 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00 ≥ 0.5 µm Cubic Meter 204857 205488 2012-01-24 11:14:31 3517 6 CM 0 0 1 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00 ≥ 5.0 µm Cubic Meter 456 551 2012-01-24 11:49:33 13 6 CM 0 0 1 Fail
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 0.5 µm Cubic Meter 2999 3100 2012-01-24 11:53:14 99 6 CM 0 0 1 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6 CM 0 0 1 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00 ≥ 0.5 µm Cubic Meter 2993 3102 2012-01-24 11:53:14 79 6 CM 0 0 0 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00 ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6 CM 0 0 0 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103822 2.4 116424 4 3520 243530.8 Fail
≥ 5.0 µm 235 2.4 271.6 4 29 560.9 Fail

DataPro 3 V1.20, Validation


Completed By: Page 28 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Pass
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:45:36
Author: Kyle Kuehm
Classification: Grade C (2008)
Occupancy state: At Rest
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.1.1.2.3
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 0.5 µm Cubic Meter 204439 204900 2012-01-24 10:39:31 3302 6 CM 0 0 0 Pass
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 5.0 µm Cubic Meter 484 606 2012-01-24 12:59:32 1 6 CM 0 0 0 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00 ≥ 0.5 µm Cubic Meter 204857 205488 2012-01-24 11:14:31 3517 6 CM 0 0 1 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00 ≥ 5.0 µm Cubic Meter 456 551 2012-01-24 11:49:33 13 6 CM 0 0 1 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 0.5 µm Cubic Meter 2999 3100 2012-01-24 11:53:14 99 6 CM 0 0 1 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00 ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6 CM 0 0 1 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00 ≥ 0.5 µm Cubic Meter 2993 3102 2012-01-24 11:53:14 79 6 CM 0 0 0 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00 ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6 CM 0 0 0 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103822 2.4 116424 4 352000 243530.8 Pass
≥ 5.0 µm 235 2.4 271.6 4 2900 560.9 Pass

DataPro 3 V1.20, Validation


Completed By: Page 29 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Fail
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:47:04
Author: Kyle Kuehm
Classification: Grade A (2008)
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.1.2.1.1
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412 Fail
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 482.2 915 2012-01-24 09:55:08 885 6.9CM 0 0 0 412 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 5.0 µm Cubic Meter 445.2 915 2012-01-24 10:17:58 885 6.9CM 0 0 1 412 Fail
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 1 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 0 240 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103843 2.4 116448 4 3520 243580.7 Fail
≥ 5.0 µm 231.9 2.4 268.1 4 20 553.6 Fail

DataPro 3 V1.20, Validation


Completed By: Page 30 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Pass
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:47:46
Author: Kyle Kuehm
Classification: Grade B (2008)
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.1.2.1.2
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412 Pass
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 482.2 915 2012-01-24 09:55:08 885 6.9CM 0 0 0 412 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 5.0 µm Cubic Meter 445.2 915 2012-01-24 10:17:58 885 6.9CM 0 0 1 412 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 1 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 0 240 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103843 2.4 116448 4 352000 243580.7 Pass
≥ 5.0 µm 231.9 2.4 268.1 4 2900 553.6 Pass

DataPro 3 V1.20, Validation


Completed By: Page 31 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Pass
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:48:08
Author: Kyle Kuehm
Classification: Grade C (2008)
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.1.2.1.3
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412 Pass
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 482.2 915 2012-01-24 09:55:08 885 6.9CM 0 0 0 412 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 5.0 µm Cubic Meter 445.2 915 2012-01-24 10:17:58 885 6.9CM 0 0 1 412 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 1 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 0 240 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103843 2.4 116448 4 3520000 243580.7 Pass
≥ 5.0 µm 231.9 2.4 268.1 4 29000 553.6 Pass

DataPro 3 V1.20, Validation


Completed By: Page 32 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Fail
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:49:06
Author: Kyle Kuehm
Classification: Grade A (2008)
Occupancy state: At Rest
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.1.2.2.1
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412 Fail
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 482.2 915 2012-01-24 09:55:08 885 6.9CM 0 0 0 412 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 5.0 µm Cubic Meter 445.2 915 2012-01-24 10:17:58 885 6.9CM 0 0 1 412 Fail
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 1 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 0 240 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103843 2.4 116448 4 3520 243580.7 Fail
≥ 5.0 µm 231.9 2.4 268.1 4 20 553.6 Fail

DataPro 3 V1.20, Validation


Completed By: Page 33 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Fail
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:49:29
Author: Kyle Kuehm
Classification: Grade B (2008)
Occupancy state: At Rest
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.1.2.2.2
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412 Fail
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 482.2 915 2012-01-24 09:55:08 885 6.9CM 0 0 0 412 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 5.0 µm Cubic Meter 445.2 915 2012-01-24 10:17:58 885 6.9CM 0 0 1 412 Fail
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 1 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 0 240 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103843 2.4 116448 4 3520 243580.7 Fail
≥ 5.0 µm 231.9 2.4 268.1 4 29 553.6 Fail

DataPro 3 V1.20, Validation


Completed By: Page 34 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Pass
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:49:49
Author: Kyle Kuehm
Classification: Grade C (2008)
Occupancy state: At Rest
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.1.2.2.3
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412 Pass
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 482.2 915 2012-01-24 09:55:08 885 6.9CM 0 0 0 412 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 5.0 µm Cubic Meter 445.2 915 2012-01-24 10:17:58 885 6.9CM 0 0 1 412 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 1 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 0 240 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103843 2.4 116448 4 352000 243580.7 Pass
≥ 5.0 µm 231.9 2.4 268.1 4 2900 553.6 Pass

DataPro 3 V1.20, Validation


Completed By: Page 35 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
ISO 14644-1 Report
Result of particulate test: Fail
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:51:04
Author: Kyle Kuehm
Classification: ISO Class 2
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.2.1
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412 Fail
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240 Fail
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240 Fail

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103843 2.4 116448 4 4 243580.7 Fail

DataPro 3 V1.20, Validation


Completed By: Page 36 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
ISO 14644-1 Report
Result of particulate test: Fail
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:51:46
Author: Kyle Kuehm
Classification: ISO Class 3
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.2.2
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412 Fail
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240 Fail
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240 Fail

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103843 2.4 116448 4 35 243580.7 Fail

DataPro 3 V1.20, Validation


Completed By: Page 37 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
ISO 14644-1 Report
Result of particulate test: Fail
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:52:25
Author: Kyle Kuehm
Classification: ISO Class 4
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.2.3
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412 Fail
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240 Fail
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240 Fail

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103843 2.4 116448 4 352 243580.7 Fail

DataPro 3 V1.20, Validation


Completed By: Page 38 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
ISO 14644-1 Report
Result of particulate test: Fail
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:52:45
Author: Kyle Kuehm
Classification: ISO Class 5
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.2.4
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412 Fail
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 482.2 915 2012-01-24 09:55:08 885 6.9CM 0 0 0 412 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 5.0 µm Cubic Meter 445.2 915 2012-01-24 10:17:58 885 6.9CM 0 0 1 412 Fail
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 1 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 0 240 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103843 2.4 116448 4 3520 243580.7 Fail
≥ 5.0 µm 231.9 2.4 268.1 4 29 553.6 Fail

DataPro 3 V1.20, Validation


Completed By: Page 39 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
ISO 14644-1 Report
Result of particulate test: Fail
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:53:00
Author: Kyle Kuehm
Classification: ISO Class 6
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.2.5
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412 Fail
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 482.2 915 2012-01-24 09:55:08 885 6.9CM 0 0 0 412 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412 Fail
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 5.0 µm Cubic Meter 445.2 915 2012-01-24 10:17:58 885 6.9CM 0 0 1 412 Fail
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 1 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 0 240 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103843 2.4 116448 4 35200 243580.7 Fail
≥ 5.0 µm 231.9 2.4 268.1 4 293 553.6 Fail

DataPro 3 V1.20, Validation


Completed By: Page 40 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
ISO 14644-1 Report
Result of particulate test: Pass
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:53:41
Author: Kyle Kuehm
Classification: ISO Class 7
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.2.6
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412 Pass
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 482.2 915 2012-01-24 09:55:08 885 6.9CM 0 0 0 412 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 5.0 µm Cubic Meter 445.2 915 2012-01-24 10:17:58 885 6.9CM 0 0 1 412 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 1 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 0 240 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103843 2.4 116448 4 352000 243580.7 Pass
≥ 5.0 µm 231.9 2.4 268.1 4 2930 553.6 Pass

DataPro 3 V1.20, Validation


Completed By: Page 41 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
ISO 14644-1 Report
Result of particulate test: Pass
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:53:54
Author: Kyle Kuehm
Classification: ISO Class 8
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.2.7
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412 Pass
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 482.2 915 2012-01-24 09:55:08 885 6.9CM 0 0 0 412 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 5.0 µm Cubic Meter 445.2 915 2012-01-24 10:17:58 885 6.9CM 0 0 1 412 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 1 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 0 240 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103843 2.4 116448 4 3520000 243580.7 Pass
≥ 5.0 µm 231.9 2.4 268.1 4 29300 553.6 Pass

DataPro 3 V1.20, Validation


Completed By: Page 42 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
ISO 14644-1 Report
Result of particulate test: Pass
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:54:21
Author: Kyle Kuehm
Classification: ISO Class 9
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.2.8
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples Result
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412 Pass
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 482.2 915 2012-01-24 09:55:08 885 6.9CM 0 0 0 412 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412 Pass
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 5.0 µm Cubic Meter 445.2 915 2012-01-24 10:17:58 885 6.9CM 0 0 1 412 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240 Pass
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 1 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240 Pass
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 0 240 Pass

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 103843 2.4 116448 4 35200000 243580.7 Pass
≥ 5.0 µm 231.9 2.4 268.1 4 293000 553.6 Pass

DataPro 3 V1.20, Validation


Completed By: Page 43 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact

CLiMET Instruments Company


Raw Data Report
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:57:02
Author: Kyle Kuehm
Data count: Total Count
Area: Ampule Filling Machine 1
Point
Location: 1
Number of samples: 412
≥ 0.5 µm, ≥ 5.0
Particle Sizes: µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.3.1

≥ 0.5 ≥ 5.0
Timestamp µm µm Flow Volume
2012-01-24 09:30:06 3302 1 1.00CFM 1/60 CM
2012-01-24 09:30:41 3458 0 1.00CFM 1/60 CM
2012-01-24 09:31:12 3374 0 1.00CFM 1/60 CM
2012-01-24 09:31:49 3497 0 1.00CFM 1/60 CM
2012-01-24 09:32:25 3352 23 1.00CFM 1/60 CM
2012-01-24 09:32:56 3356 0 1.00CFM 1/60 CM
2012-01-24 09:33:33 3326 0 1.00CFM 1/60 CM
2012-01-24 09:34:09 3338 0 1.00CFM 1/60 CM
2012-01-24 09:34:46 3491 0 1.00CFM 1/60 CM
2012-01-24 09:35:17 3437 24 1.00CFM 1/60 CM
2012-01-24 09:35:54 3462 27 1.00CFM 1/60 CM
2012-01-24 09:36:30 3360 0 1.00CFM 1/60 CM
2012-01-24 09:37:02 3420 0 1.00CFM 1/60 CM
2012-01-24 09:37:40 3327 0 1.00CFM 1/60 CM
2012-01-24 09:38:16 3486 20 1.00CFM 1/60 CM
2012-01-24 09:38:48 3502 15 1.00CFM 1/60 CM
2012-01-24 09:39:24 3394 0 1.00CFM 1/60 CM
2012-01-24 09:40:01 3462 19 1.00CFM 1/60 CM
2012-01-24 09:40:32 3504 7 1.00CFM 1/60 CM
2012-01-24 09:41:09 3460 12 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 44 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 09:41:45 3341 25 1.00CFM 1/60 CM


2012-01-24 09:42:21 3363 0 1.00CFM 1/60 CM
2012-01-24 09:42:53 3395 9 1.00CFM 1/60 CM
2012-01-24 09:43:29 3472 0 1.00CFM 1/60 CM
2012-01-24 09:44:06 3354 12 1.00CFM 1/60 CM
2012-01-24 09:44:37 3368 0 1.00CFM 1/60 CM
2012-01-24 09:45:15 3346 0 1.00CFM 1/60 CM
2012-01-24 09:45:51 3469 0 1.00CFM 1/60 CM
2012-01-24 09:46:22 3473 4 1.00CFM 1/60 CM
2012-01-24 09:47:00 3427 16 1.00CFM 1/60 CM
2012-01-24 09:47:36 3453 22 1.00CFM 1/60 CM
2012-01-24 09:48:08 3478 3 1.00CFM 1/60 CM
2012-01-24 09:48:44 3378 0 1.00CFM 1/60 CM
2012-01-24 09:49:23 3333 0 1.00CFM 1/60 CM
2012-01-24 09:49:54 3339 0 1.00CFM 1/60 CM
2012-01-24 09:50:31 3334 0 1.00CFM 1/60 CM
2012-01-24 09:51:07 3451 21 1.00CFM 1/60 CM
2012-01-24 09:51:38 3430 7 1.00CFM 1/60 CM
2012-01-24 09:52:15 3453 0 1.00CFM 1/60 CM
2012-01-24 09:52:51 3414 25 1.00CFM 1/60 CM
2012-01-24 09:53:24 3506 26 1.00CFM 1/60 CM
2012-01-24 09:54:00 3311 0 1.00CFM 1/60 CM
2012-01-24 09:54:37 3504 16 1.00CFM 1/60 CM
2012-01-24 09:55:08 3442 0 1.00CFM 1/60 CM
2012-01-24 09:55:44 3497 0 1.00CFM 1/60 CM
2012-01-24 09:56:17 3339 17 1.00CFM 1/60 CM
2012-01-24 09:56:54 3365 0 1.00CFM 1/60 CM
2012-01-24 09:57:26 3308 0 1.00CFM 1/60 CM
2012-01-24 09:58:04 3442 8 1.00CFM 1/60 CM
2012-01-24 09:58:40 3443 0 1.00CFM 1/60 CM
2012-01-24 09:59:12 3416 1 1.00CFM 1/60 CM
2012-01-24 09:59:48 3300 0 1.00CFM 1/60 CM
2012-01-24 10:00:25 3407 0 1.00CFM 1/60 CM
2012-01-24 10:00:57 3344 0 1.00CFM 1/60 CM
2012-01-24 10:01:34 3484 0 1.00CFM 1/60 CM
2012-01-24 10:02:10 3443 0 1.00CFM 1/60 CM
2012-01-24 10:02:42 3329 23 1.00CFM 1/60 CM
2012-01-24 10:03:20 3502 1 1.00CFM 1/60 CM
2012-01-24 10:03:51 3327 17 1.00CFM 1/60 CM
2012-01-24 10:04:28 3387 13 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 45 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:05:04 3515 0 1.00CFM 1/60 CM


2012-01-24 10:05:41 3498 0 1.00CFM 1/60 CM
2012-01-24 10:06:12 3460 6 1.00CFM 1/60 CM
2012-01-24 10:06:48 3394 0 1.00CFM 1/60 CM
2012-01-24 10:07:25 3349 11 1.00CFM 1/60 CM
2012-01-24 10:07:56 3358 0 1.00CFM 1/60 CM
2012-01-24 10:08:33 3331 22 1.00CFM 1/60 CM
2012-01-24 10:09:09 3333 21 1.00CFM 1/60 CM
2012-01-24 10:09:43 3451 18 1.00CFM 1/60 CM
2012-01-24 10:10:19 3518 0 1.00CFM 1/60 CM
2012-01-24 10:10:52 3343 0 1.00CFM 1/60 CM
2012-01-24 10:11:28 3450 0 1.00CFM 1/60 CM
2012-01-24 10:12:05 3413 0 1.00CFM 1/60 CM
2012-01-24 10:12:41 3372 9 1.00CFM 1/60 CM
2012-01-24 10:13:14 3354 26 1.00CFM 1/60 CM
2012-01-24 10:13:50 3444 0 1.00CFM 1/60 CM
2012-01-24 10:14:22 3454 26 1.00CFM 1/60 CM
2012-01-24 10:14:59 3340 0 1.00CFM 1/60 CM
2012-01-24 10:15:31 3343 0 1.00CFM 1/60 CM
2012-01-24 10:16:09 3461 27 1.00CFM 1/60 CM
2012-01-24 10:16:46 3492 22 1.00CFM 1/60 CM
2012-01-24 10:17:21 3401 0 1.00CFM 1/60 CM
2012-01-24 10:17:52 3421 12 1.00CFM 1/60 CM
2012-01-24 10:18:29 3519 22 1.00CFM 1/60 CM
2012-01-24 10:19:05 3390 0 1.00CFM 1/60 CM
2012-01-24 10:19:37 3487 12 1.00CFM 1/60 CM
2012-01-24 10:20:13 3356 28 1.00CFM 1/60 CM
2012-01-24 10:20:50 3507 0 1.00CFM 1/60 CM
2012-01-24 10:21:26 3392 15 1.00CFM 1/60 CM
2012-01-24 10:22:00 3470 0 1.00CFM 1/60 CM
2012-01-24 10:22:36 3476 24 1.00CFM 1/60 CM
2012-01-24 10:23:09 3388 29 1.00CFM 1/60 CM
2012-01-24 10:23:45 3369 0 1.00CFM 1/60 CM
2012-01-24 10:24:22 3483 19 1.00CFM 1/60 CM
2012-01-24 10:24:53 3486 13 1.00CFM 1/60 CM
2012-01-24 10:25:30 3300 8 1.00CFM 1/60 CM
2012-01-24 10:26:03 3392 0 1.00CFM 1/60 CM
2012-01-24 10:26:39 3378 24 1.00CFM 1/60 CM
2012-01-24 10:27:16 3300 0 1.00CFM 1/60 CM
2012-01-24 10:27:47 3335 19 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 46 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:28:24 3391 0 1.00CFM 1/60 CM


2012-01-24 10:29:00 3477 18 1.00CFM 1/60 CM
2012-01-24 10:29:37 3339 13 1.00CFM 1/60 CM
2012-01-24 10:30:08 3363 17 1.00CFM 1/60 CM
2012-01-24 10:30:44 3415 2 1.00CFM 1/60 CM
2012-01-24 10:31:22 3345 0 1.00CFM 1/60 CM
2012-01-24 10:31:54 3474 1 1.00CFM 1/60 CM
2012-01-24 10:32:31 3346 0 1.00CFM 1/60 CM
2012-01-24 10:33:02 3491 9 1.00CFM 1/60 CM
2012-01-24 10:33:40 3476 0 1.00CFM 1/60 CM
2012-01-24 10:34:16 3396 17 1.00CFM 1/60 CM
2012-01-24 10:34:47 3451 0 1.00CFM 1/60 CM
2012-01-24 10:35:24 3427 0 1.00CFM 1/60 CM
2012-01-24 10:36:00 3418 0 1.00CFM 1/60 CM
2012-01-24 10:36:37 3380 15 1.00CFM 1/60 CM
2012-01-24 10:37:09 3408 0 1.00CFM 1/60 CM
2012-01-24 10:37:45 3517 0 1.00CFM 1/60 CM
2012-01-24 10:38:17 3513 11 1.00CFM 1/60 CM
2012-01-24 10:38:54 3425 0 1.00CFM 1/60 CM
2012-01-24 10:39:31 3325 11 1.00CFM 1/60 CM
2012-01-24 10:40:02 3466 0 1.00CFM 1/60 CM
2012-01-24 10:40:40 3466 0 1.00CFM 1/60 CM
2012-01-24 10:41:13 3374 10 1.00CFM 1/60 CM
2012-01-24 10:41:49 3403 22 1.00CFM 1/60 CM
2012-01-24 10:42:22 3414 28 1.00CFM 1/60 CM
2012-01-24 10:42:59 3335 0 1.00CFM 1/60 CM
2012-01-24 10:43:36 3385 0 1.00CFM 1/60 CM
2012-01-24 10:44:08 3377 28 1.00CFM 1/60 CM
2012-01-24 10:44:45 3343 22 1.00CFM 1/60 CM
2012-01-24 10:45:17 3499 1 1.00CFM 1/60 CM
2012-01-24 10:45:53 3346 0 1.00CFM 1/60 CM
2012-01-24 10:46:30 3349 0 1.00CFM 1/60 CM
2012-01-24 10:47:06 3485 6 1.00CFM 1/60 CM
2012-01-24 10:47:38 3341 0 1.00CFM 1/60 CM
2012-01-24 10:48:15 3327 0 1.00CFM 1/60 CM
2012-01-24 10:48:52 3311 27 1.00CFM 1/60 CM
2012-01-24 10:49:23 3490 22 1.00CFM 1/60 CM
2012-01-24 10:50:00 3361 0 1.00CFM 1/60 CM
2012-01-24 10:50:33 3350 0 1.00CFM 1/60 CM
2012-01-24 10:51:09 3305 17 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 47 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:51:47 3320 0 1.00CFM 1/60 CM


2012-01-24 10:52:19 3430 25 1.00CFM 1/60 CM
2012-01-24 10:52:56 3483 4 1.00CFM 1/60 CM
2012-01-24 10:53:27 3403 0 1.00CFM 1/60 CM
2012-01-24 10:54:05 3346 0 1.00CFM 1/60 CM
2012-01-24 10:54:36 3441 0 1.00CFM 1/60 CM
2012-01-24 10:55:13 3318 23 1.00CFM 1/60 CM
2012-01-24 10:55:49 3303 24 1.00CFM 1/60 CM
2012-01-24 10:56:26 3425 27 1.00CFM 1/60 CM
2012-01-24 10:56:57 3510 23 1.00CFM 1/60 CM
2012-01-24 10:57:34 3344 9 1.00CFM 1/60 CM
2012-01-24 10:58:11 3388 0 1.00CFM 1/60 CM
2012-01-24 10:58:43 3379 1 1.00CFM 1/60 CM
2012-01-24 10:59:20 3398 0 1.00CFM 1/60 CM
2012-01-24 10:59:56 3337 16 1.00CFM 1/60 CM
2012-01-24 11:00:27 3474 0 1.00CFM 1/60 CM
2012-01-24 11:01:04 3339 0 1.00CFM 1/60 CM
2012-01-24 11:01:40 3316 0 1.00CFM 1/60 CM
2012-01-24 11:02:13 3467 0 1.00CFM 1/60 CM
2012-01-24 11:02:49 3479 0 1.00CFM 1/60 CM
2012-01-24 11:03:22 3503 0 1.00CFM 1/60 CM
2012-01-24 11:03:58 3332 2 1.00CFM 1/60 CM
2012-01-24 11:04:35 3454 0 1.00CFM 1/60 CM
2012-01-24 11:05:11 3446 0 1.00CFM 1/60 CM
2012-01-24 11:05:44 3393 14 1.00CFM 1/60 CM
2012-01-24 11:06:20 3453 0 1.00CFM 1/60 CM
2012-01-24 11:06:57 3511 26 1.00CFM 1/60 CM
2012-01-24 11:07:28 3415 0 1.00CFM 1/60 CM
2012-01-24 11:08:04 3380 0 1.00CFM 1/60 CM
2012-01-24 11:08:37 3444 0 1.00CFM 1/60 CM
2012-01-24 11:09:13 3373 8 1.00CFM 1/60 CM
2012-01-24 11:09:50 3321 2 1.00CFM 1/60 CM
2012-01-24 11:10:26 3396 11 1.00CFM 1/60 CM
2012-01-24 11:10:57 3453 22 1.00CFM 1/60 CM
2012-01-24 11:11:36 3332 0 1.00CFM 1/60 CM
2012-01-24 11:12:07 3381 0 1.00CFM 1/60 CM
2012-01-24 11:12:45 3308 20 1.00CFM 1/60 CM
2012-01-24 11:13:18 3409 0 1.00CFM 1/60 CM
2012-01-24 11:13:55 3327 0 1.00CFM 1/60 CM
2012-01-24 11:14:31 3406 0 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 48 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:15:03 3500 25 1.00CFM 1/60 CM


2012-01-24 11:15:39 3444 0 1.00CFM 1/60 CM
2012-01-24 11:16:16 3396 27 1.00CFM 1/60 CM
2012-01-24 11:16:49 3438 25 1.00CFM 1/60 CM
2012-01-24 11:17:26 3373 11 1.00CFM 1/60 CM
2012-01-24 11:17:57 3445 5 1.00CFM 1/60 CM
2012-01-24 11:18:34 3485 0 1.00CFM 1/60 CM
2012-01-24 11:19:10 3425 0 1.00CFM 1/60 CM
2012-01-24 11:19:47 3322 11 1.00CFM 1/60 CM
2012-01-24 11:20:18 3405 11 1.00CFM 1/60 CM
2012-01-24 11:20:55 3396 0 1.00CFM 1/60 CM
2012-01-24 11:21:27 3322 0 1.00CFM 1/60 CM
2012-01-24 11:22:04 3378 3 1.00CFM 1/60 CM
2012-01-24 11:22:40 3394 14 1.00CFM 1/60 CM
2012-01-24 11:23:11 3421 23 1.00CFM 1/60 CM
2012-01-24 11:23:48 3439 27 1.00CFM 1/60 CM
2012-01-24 11:24:25 3453 9 1.00CFM 1/60 CM
2012-01-24 11:24:57 3459 6 1.00CFM 1/60 CM
2012-01-24 11:25:33 3477 13 1.00CFM 1/60 CM
2012-01-24 11:26:10 3419 21 1.00CFM 1/60 CM
2012-01-24 11:26:46 3385 0 1.00CFM 1/60 CM
2012-01-24 11:27:18 3416 3 1.00CFM 1/60 CM
2012-01-24 11:27:54 3322 0 1.00CFM 1/60 CM
2012-01-24 11:28:31 3309 0 1.00CFM 1/60 CM
2012-01-24 11:29:02 3385 23 1.00CFM 1/60 CM
2012-01-24 11:29:39 3504 0 1.00CFM 1/60 CM
2012-01-24 11:30:15 3373 0 1.00CFM 1/60 CM
2012-01-24 11:30:53 3407 23 1.00CFM 1/60 CM
2012-01-24 11:31:25 3374 0 1.00CFM 1/60 CM
2012-01-24 11:32:01 3404 25 1.00CFM 1/60 CM
2012-01-24 11:32:33 3481 22 1.00CFM 1/60 CM
2012-01-24 11:33:09 3441 0 1.00CFM 1/60 CM
2012-01-24 11:33:46 3354 0 1.00CFM 1/60 CM
2012-01-24 11:34:17 3518 28 1.00CFM 1/60 CM
2012-01-24 11:34:52 3487 0 1.00CFM 1/60 CM
2012-01-24 11:35:30 3371 0 1.00CFM 1/60 CM
2012-01-24 11:36:06 3421 0 1.00CFM 1/60 CM
2012-01-24 11:36:38 3491 0 1.00CFM 1/60 CM
2012-01-24 11:37:12 3492 0 1.00CFM 1/60 CM
2012-01-24 11:37:49 3302 11 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 49 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:38:27 3363 0 1.00CFM 1/60 CM


2012-01-24 11:38:59 3344 0 1.00CFM 1/60 CM
2012-01-24 11:39:36 3318 0 1.00CFM 1/60 CM
2012-01-24 11:40:08 3312 0 1.00CFM 1/60 CM
2012-01-24 11:40:46 3417 0 1.00CFM 1/60 CM
2012-01-24 11:41:17 3387 0 1.00CFM 1/60 CM
2012-01-24 11:41:54 3512 0 1.00CFM 1/60 CM
2012-01-24 11:42:30 3449 9 1.00CFM 1/60 CM
2012-01-24 11:43:02 3351 0 1.00CFM 1/60 CM
2012-01-24 11:43:40 3483 23 1.00CFM 1/60 CM
2012-01-24 11:44:16 3488 0 1.00CFM 1/60 CM
2012-01-24 11:44:48 3309 0 1.00CFM 1/60 CM
2012-01-24 11:45:25 3433 0 1.00CFM 1/60 CM
2012-01-24 11:45:57 3461 0 1.00CFM 1/60 CM
2012-01-24 11:46:35 3420 0 1.00CFM 1/60 CM
2012-01-24 11:47:07 3357 0 1.00CFM 1/60 CM
2012-01-24 11:47:44 3513 0 1.00CFM 1/60 CM
2012-01-24 11:48:20 3508 27 1.00CFM 1/60 CM
2012-01-24 11:48:57 3367 0 1.00CFM 1/60 CM
2012-01-24 11:49:28 3413 0 1.00CFM 1/60 CM
2012-01-24 11:50:05 3446 0 1.00CFM 1/60 CM
2012-01-24 11:50:38 3362 0 1.00CFM 1/60 CM
2012-01-24 11:51:14 3486 0 1.00CFM 1/60 CM
2012-01-24 11:51:51 3481 19 1.00CFM 1/60 CM
2012-01-24 11:52:22 3384 0 1.00CFM 1/60 CM
2012-01-24 11:52:59 3505 0 1.00CFM 1/60 CM
2012-01-24 11:53:35 3467 10 1.00CFM 1/60 CM
2012-01-24 11:54:12 3382 0 1.00CFM 1/60 CM
2012-01-24 11:54:43 3482 0 1.00CFM 1/60 CM
2012-01-24 11:55:19 3492 26 1.00CFM 1/60 CM
2012-01-24 11:55:56 3357 28 1.00CFM 1/60 CM
2012-01-24 11:56:28 3513 13 1.00CFM 1/60 CM
2012-01-24 11:57:05 3393 15 1.00CFM 1/60 CM
2012-01-24 11:57:42 3433 2 1.00CFM 1/60 CM
2012-01-24 11:58:13 3411 0 1.00CFM 1/60 CM
2012-01-24 11:58:49 3438 16 1.00CFM 1/60 CM
2012-01-24 11:59:26 3472 11 1.00CFM 1/60 CM
2012-01-24 11:59:57 3450 7 1.00CFM 1/60 CM
2012-01-24 12:00:34 3314 5 1.00CFM 1/60 CM
2012-01-24 12:01:12 3400 0 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 50 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:01:43 3391 0 1.00CFM 1/60 CM


2012-01-24 12:02:20 3493 11 1.00CFM 1/60 CM
2012-01-24 12:02:51 3328 4 1.00CFM 1/60 CM
2012-01-24 12:03:28 3331 20 1.00CFM 1/60 CM
2012-01-24 12:04:04 3334 0 1.00CFM 1/60 CM
2012-01-24 12:04:41 3504 0 1.00CFM 1/60 CM
2012-01-24 12:05:14 3415 13 1.00CFM 1/60 CM
2012-01-24 12:05:46 3369 7 1.00CFM 1/60 CM
2012-01-24 12:06:23 3306 0 1.00CFM 1/60 CM
2012-01-24 12:07:00 3349 0 1.00CFM 1/60 CM
2012-01-24 12:07:36 3499 0 1.00CFM 1/60 CM
2012-01-24 12:08:07 3494 7 1.00CFM 1/60 CM
2012-01-24 12:08:44 3427 0 1.00CFM 1/60 CM
2012-01-24 12:09:20 3331 29 1.00CFM 1/60 CM
2012-01-24 12:09:52 3444 27 1.00CFM 1/60 CM
2012-01-24 12:10:28 3389 23 1.00CFM 1/60 CM
2012-01-24 12:11:05 3324 2 1.00CFM 1/60 CM
2012-01-24 12:11:41 3353 0 1.00CFM 1/60 CM
2012-01-24 12:12:13 3384 24 1.00CFM 1/60 CM
2012-01-24 12:12:49 3451 19 1.00CFM 1/60 CM
2012-01-24 12:13:27 3350 3 1.00CFM 1/60 CM
2012-01-24 12:13:58 3346 0 1.00CFM 1/60 CM
2012-01-24 12:14:38 3515 0 1.00CFM 1/60 CM
2012-01-24 12:15:09 3460 10 1.00CFM 1/60 CM
2012-01-24 12:15:45 3433 0 1.00CFM 1/60 CM
2012-01-24 12:16:18 3455 0 1.00CFM 1/60 CM
2012-01-24 12:16:54 3477 0 1.00CFM 1/60 CM
2012-01-24 12:17:31 3359 14 1.00CFM 1/60 CM
2012-01-24 12:18:02 3335 18 1.00CFM 1/60 CM
2012-01-24 12:18:39 3496 0 1.00CFM 1/60 CM
2012-01-24 12:19:16 3311 11 1.00CFM 1/60 CM
2012-01-24 12:19:47 3369 0 1.00CFM 1/60 CM
2012-01-24 12:20:24 3351 8 1.00CFM 1/60 CM
2012-01-24 12:20:59 3502 24 1.00CFM 1/60 CM
2012-01-24 12:21:36 3304 29 1.00CFM 1/60 CM
2012-01-24 12:22:07 3350 0 1.00CFM 1/60 CM
2012-01-24 12:22:44 3304 0 1.00CFM 1/60 CM
2012-01-24 12:23:20 3363 9 1.00CFM 1/60 CM
2012-01-24 12:23:57 3455 28 1.00CFM 1/60 CM
2012-01-24 12:24:29 3481 0 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 51 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:25:06 3428 14 1.00CFM 1/60 CM


2012-01-24 12:25:42 3303 0 1.00CFM 1/60 CM
2012-01-24 12:26:14 3364 18 1.00CFM 1/60 CM
2012-01-24 12:26:51 3511 13 1.00CFM 1/60 CM
2012-01-24 12:27:22 3518 19 1.00CFM 1/60 CM
2012-01-24 12:28:00 3326 3 1.00CFM 1/60 CM
2012-01-24 12:28:32 3487 0 1.00CFM 1/60 CM
2012-01-24 12:29:09 3434 0 1.00CFM 1/60 CM
2012-01-24 12:29:45 3370 0 1.00CFM 1/60 CM
2012-01-24 12:30:16 3366 22 1.00CFM 1/60 CM
2012-01-24 12:30:53 3491 0 1.00CFM 1/60 CM
2012-01-24 12:31:29 3504 17 1.00CFM 1/60 CM
2012-01-24 12:32:06 3437 0 1.00CFM 1/60 CM
2012-01-24 12:32:38 3310 6 1.00CFM 1/60 CM
2012-01-24 12:33:16 3346 13 1.00CFM 1/60 CM
2012-01-24 12:33:47 3324 29 1.00CFM 1/60 CM
2012-01-24 12:34:24 3409 0 1.00CFM 1/60 CM
2012-01-24 12:35:00 3401 26 1.00CFM 1/60 CM
2012-01-24 12:35:32 3373 25 1.00CFM 1/60 CM
2012-01-24 12:36:08 3368 2 1.00CFM 1/60 CM
2012-01-24 12:36:46 3441 0 1.00CFM 1/60 CM
2012-01-24 12:37:17 3461 0 1.00CFM 1/60 CM
2012-01-24 12:37:54 3325 0 1.00CFM 1/60 CM
2012-01-24 12:38:31 3391 29 1.00CFM 1/60 CM
2012-01-24 12:39:02 3373 14 1.00CFM 1/60 CM
2012-01-24 12:39:39 3307 24 1.00CFM 1/60 CM
2012-01-24 12:40:16 3499 0 1.00CFM 1/60 CM
2012-01-24 12:40:50 3398 29 1.00CFM 1/60 CM
2012-01-24 12:41:22 3361 0 1.00CFM 1/60 CM
2012-01-24 12:41:59 3391 26 1.00CFM 1/60 CM
2012-01-24 12:42:35 3506 16 1.00CFM 1/60 CM
2012-01-24 12:43:12 3442 9 1.00CFM 1/60 CM
2012-01-24 12:43:43 3492 0 1.00CFM 1/60 CM
2012-01-24 12:44:19 3468 25 1.00CFM 1/60 CM
2012-01-24 12:44:56 3320 21 1.00CFM 1/60 CM
2012-01-24 12:45:27 3374 8 1.00CFM 1/60 CM
2012-01-24 12:46:05 3363 6 1.00CFM 1/60 CM
2012-01-24 12:46:37 3416 0 1.00CFM 1/60 CM
2012-01-24 12:47:13 3378 2 1.00CFM 1/60 CM
2012-01-24 12:47:50 3442 19 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 52 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:48:26 3489 0 1.00CFM 1/60 CM


2012-01-24 12:48:58 3356 25 1.00CFM 1/60 CM
2012-01-24 12:49:34 3469 16 1.00CFM 1/60 CM
2012-01-24 12:50:11 3307 0 1.00CFM 1/60 CM
2012-01-24 12:50:42 3318 0 1.00CFM 1/60 CM
2012-01-24 12:51:18 3492 4 1.00CFM 1/60 CM
2012-01-24 12:51:55 3348 10 1.00CFM 1/60 CM
2012-01-24 12:52:31 3438 0 1.00CFM 1/60 CM
2012-01-24 12:53:03 3488 20 1.00CFM 1/60 CM
2012-01-24 12:53:38 3475 0 1.00CFM 1/60 CM
2012-01-24 12:54:15 3389 2 1.00CFM 1/60 CM
2012-01-24 12:54:53 3447 5 1.00CFM 1/60 CM
2012-01-24 12:55:24 3351 0 1.00CFM 1/60 CM
2012-01-24 12:56:02 3409 8 1.00CFM 1/60 CM
2012-01-24 12:56:33 3518 23 1.00CFM 1/60 CM
2012-01-24 12:57:10 3338 27 1.00CFM 1/60 CM
2012-01-24 12:57:47 3313 2 1.00CFM 1/60 CM
2012-01-24 12:58:18 3303 0 1.00CFM 1/60 CM
2012-01-24 12:58:54 3356 3 1.00CFM 1/60 CM
2012-01-24 12:59:32 3341 26 1.00CFM 1/60 CM
2012-01-24 13:00:03 3501 0 1.00CFM 1/60 CM
2012-01-24 13:00:40 3382 0 1.00CFM 1/60 CM
2012-01-24 13:01:17 3349 0 1.00CFM 1/60 CM
2012-01-24 13:01:49 3507 6 1.00CFM 1/60 CM
2012-01-24 13:02:25 3380 0 1.00CFM 1/60 CM
2012-01-24 13:03:01 3452 0 1.00CFM 1/60 CM
2012-01-24 13:03:33 3344 0 1.00CFM 1/60 CM
2012-01-24 13:04:11 3302 28 1.00CFM 1/60 CM
2012-01-24 13:04:43 3462 0 1.00CFM 1/60 CM
2012-01-24 13:05:19 3390 5 1.00CFM 1/60 CM
2012-01-24 13:05:57 3518 0 1.00CFM 1/60 CM
2012-01-24 13:06:28 3436 13 1.00CFM 1/60 CM
2012-01-24 13:07:04 3306 25 1.00CFM 1/60 CM
2012-01-24 13:07:41 3341 0 1.00CFM 1/60 CM
2012-01-24 13:08:12 3449 0 1.00CFM 1/60 CM
2012-01-24 13:08:51 3362 28 1.00CFM 1/60 CM
2012-01-24 13:09:22 3427 0 1.00CFM 1/60 CM
2012-01-24 13:09:59 3350 26 1.00CFM 1/60 CM
2012-01-24 13:10:35 3313 0 1.00CFM 1/60 CM
2012-01-24 13:11:07 3455 21 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 53 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 13:11:44 3443 0 1.00CFM 1/60 CM


2012-01-24 13:12:20 3518 17 1.00CFM 1/60 CM
2012-01-24 13:12:52 3408 0 1.00CFM 1/60 CM
2012-01-24 13:13:28 3328 0 1.00CFM 1/60 CM
2012-01-24 13:14:05 3445 5 1.00CFM 1/60 CM
2012-01-24 13:14:37 3401 0 1.00CFM 1/60 CM
2012-01-24 13:15:15 3404 19 1.00CFM 1/60 CM
2012-01-24 13:15:47 3387 0 1.00CFM 1/60 CM
2012-01-24 13:16:23 3300 0 1.00CFM 1/60 CM
2012-01-24 13:17:01 3502 17 1.00CFM 1/60 CM
2012-01-24 13:17:32 3519 0 1.00CFM 1/60 CM
2012-01-24 13:18:10 3495 24 1.00CFM 1/60 CM
2012-01-24 13:18:42 3313 0 1.00CFM 1/60 CM
2012-01-24 13:19:19 3340 3 1.00CFM 1/60 CM
2012-01-24 13:19:55 3383 9 1.00CFM 1/60 CM
2012-01-24 13:20:32 3321 6 1.00CFM 1/60 CM
2012-01-24 13:21:03 3491 15 1.00CFM 1/60 CM
2012-01-24 13:21:40 3340 10 1.00CFM 1/60 CM
2012-01-24 13:22:16 3513 27 1.00CFM 1/60 CM
2012-01-24 13:22:48 3478 0 1.00CFM 1/60 CM
2012-01-24 13:23:25 3506 0 1.00CFM 1/60 CM
2012-01-24 13:24:02 3414 15 1.00CFM 1/60 CM
2012-01-24 13:24:33 3386 1 1.00CFM 1/60 CM
2012-01-24 13:25:10 3418 22 1.00CFM 1/60 CM
2012-01-24 13:25:47 3441 15 1.00CFM 1/60 CM
2012-01-24 13:26:18 3402 9 1.00CFM 1/60 CM
2012-01-24 13:26:55 3481 0 1.00CFM 1/60 CM
2012-01-24 13:27:31 3515 23 1.00CFM 1/60 CM
2012-01-24 13:28:03 3426 0 1.00CFM 1/60 CM
2012-01-24 13:28:39 3379 18 1.00CFM 1/60 CM
2012-01-24 13:29:18 3480 0 1.00CFM 1/60 CM
2012-01-24 13:29:49 3460 0 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 54 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact

CLiMET Instruments Company


Raw Data Report
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:57:02
Author: Kyle Kuehm
Data count: Total Count
Area: Ampule Filling Machine 1
Point
Location: 2
Number of samples: 412
≥ 0.5 µm, ≥ 5.0
Particle Sizes: µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.3.1

≥ 0.5 ≥ 5.0
Timestamp µm µm Flow Volume
2012-01-24 09:30:06 3517 13 1.00CFM 1/60 CM
2012-01-24 09:30:41 3499 0 1.00CFM 1/60 CM
2012-01-24 09:31:17 3382 14 1.00CFM 1/60 CM
2012-01-24 09:31:49 3462 5 1.00CFM 1/60 CM
2012-01-24 09:32:25 3459 0 1.00CFM 1/60 CM
2012-01-24 09:33:02 3394 0 1.00CFM 1/60 CM
2012-01-24 09:33:33 3366 0 1.00CFM 1/60 CM
2012-01-24 09:34:09 3454 26 1.00CFM 1/60 CM
2012-01-24 09:34:46 3370 18 1.00CFM 1/60 CM
2012-01-24 09:35:22 3408 9 1.00CFM 1/60 CM
2012-01-24 09:35:54 3503 0 1.00CFM 1/60 CM
2012-01-24 09:36:30 3331 0 1.00CFM 1/60 CM
2012-01-24 09:37:08 3358 0 1.00CFM 1/60 CM
2012-01-24 09:37:40 3432 0 1.00CFM 1/60 CM
2012-01-24 09:38:16 3448 0 1.00CFM 1/60 CM
2012-01-24 09:38:53 3452 15 1.00CFM 1/60 CM
2012-01-24 09:39:24 3391 18 1.00CFM 1/60 CM
2012-01-24 09:40:01 3464 16 1.00CFM 1/60 CM
2012-01-24 09:40:37 3407 22 1.00CFM 1/60 CM
2012-01-24 09:41:09 3348 11 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 55 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 09:41:45 3403 0 1.00CFM 1/60 CM


2012-01-24 09:42:21 3462 0 1.00CFM 1/60 CM
2012-01-24 09:42:58 3423 0 1.00CFM 1/60 CM
2012-01-24 09:43:29 3381 0 1.00CFM 1/60 CM
2012-01-24 09:44:06 3336 5 1.00CFM 1/60 CM
2012-01-24 09:44:42 3436 0 1.00CFM 1/60 CM
2012-01-24 09:45:15 3357 3 1.00CFM 1/60 CM
2012-01-24 09:45:51 3459 25 1.00CFM 1/60 CM
2012-01-24 09:46:28 3484 6 1.00CFM 1/60 CM
2012-01-24 09:47:00 3394 22 1.00CFM 1/60 CM
2012-01-24 09:47:37 3330 0 1.00CFM 1/60 CM
2012-01-24 09:48:13 3400 19 1.00CFM 1/60 CM
2012-01-24 09:48:44 3428 0 1.00CFM 1/60 CM
2012-01-24 09:49:23 3314 25 1.00CFM 1/60 CM
2012-01-24 09:49:54 3484 0 1.00CFM 1/60 CM
2012-01-24 09:50:31 3433 0 1.00CFM 1/60 CM
2012-01-24 09:51:07 3321 0 1.00CFM 1/60 CM
2012-01-24 09:51:38 3433 0 1.00CFM 1/60 CM
2012-01-24 09:52:15 3388 8 1.00CFM 1/60 CM
2012-01-24 09:52:51 3319 27 1.00CFM 1/60 CM
2012-01-24 09:53:24 3499 0 1.00CFM 1/60 CM
2012-01-24 09:54:00 3373 11 1.00CFM 1/60 CM
2012-01-24 09:54:37 3402 0 1.00CFM 1/60 CM
2012-01-24 09:55:13 3501 0 1.00CFM 1/60 CM
2012-01-24 09:55:44 3518 19 1.00CFM 1/60 CM
2012-01-24 09:56:22 3517 2 1.00CFM 1/60 CM
2012-01-24 09:56:54 3438 0 1.00CFM 1/60 CM
2012-01-24 09:57:32 3409 21 1.00CFM 1/60 CM
2012-01-24 09:58:04 3372 0 1.00CFM 1/60 CM
2012-01-24 09:58:40 3493 17 1.00CFM 1/60 CM
2012-01-24 09:59:17 3519 0 1.00CFM 1/60 CM
2012-01-24 09:59:48 3486 0 1.00CFM 1/60 CM
2012-01-24 10:00:25 3388 25 1.00CFM 1/60 CM
2012-01-24 10:01:02 3393 0 1.00CFM 1/60 CM
2012-01-24 10:01:34 3398 17 1.00CFM 1/60 CM
2012-01-24 10:02:10 3389 0 1.00CFM 1/60 CM
2012-01-24 10:02:48 3451 24 1.00CFM 1/60 CM
2012-01-24 10:03:20 3325 8 1.00CFM 1/60 CM
2012-01-24 10:03:56 3320 27 1.00CFM 1/60 CM
2012-01-24 10:04:33 3394 10 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 56 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:05:04 3505 0 1.00CFM 1/60 CM


2012-01-24 10:05:41 3494 8 1.00CFM 1/60 CM
2012-01-24 10:06:17 3353 4 1.00CFM 1/60 CM
2012-01-24 10:06:49 3436 0 1.00CFM 1/60 CM
2012-01-24 10:07:25 3420 0 1.00CFM 1/60 CM
2012-01-24 10:08:02 3437 24 1.00CFM 1/60 CM
2012-01-24 10:08:38 3407 0 1.00CFM 1/60 CM
2012-01-24 10:09:09 3335 0 1.00CFM 1/60 CM
2012-01-24 10:09:48 3423 19 1.00CFM 1/60 CM
2012-01-24 10:10:19 3312 9 1.00CFM 1/60 CM
2012-01-24 10:10:57 3329 0 1.00CFM 1/60 CM
2012-01-24 10:11:33 3445 0 1.00CFM 1/60 CM
2012-01-24 10:12:05 3431 0 1.00CFM 1/60 CM
2012-01-24 10:12:41 3340 24 1.00CFM 1/60 CM
2012-01-24 10:13:14 3439 5 1.00CFM 1/60 CM
2012-01-24 10:13:50 3371 0 1.00CFM 1/60 CM
2012-01-24 10:14:27 3508 2 1.00CFM 1/60 CM
2012-01-24 10:14:59 3481 11 1.00CFM 1/60 CM
2012-01-24 10:15:37 3305 24 1.00CFM 1/60 CM
2012-01-24 10:16:09 3332 17 1.00CFM 1/60 CM
2012-01-24 10:16:46 3340 23 1.00CFM 1/60 CM
2012-01-24 10:17:21 3388 9 1.00CFM 1/60 CM
2012-01-24 10:17:58 3437 0 1.00CFM 1/60 CM
2012-01-24 10:18:29 3382 0 1.00CFM 1/60 CM
2012-01-24 10:19:06 3394 0 1.00CFM 1/60 CM
2012-01-24 10:19:42 3356 0 1.00CFM 1/60 CM
2012-01-24 10:20:13 3301 0 1.00CFM 1/60 CM
2012-01-24 10:20:50 3421 0 1.00CFM 1/60 CM
2012-01-24 10:21:26 3480 29 1.00CFM 1/60 CM
2012-01-24 10:22:00 3509 0 1.00CFM 1/60 CM
2012-01-24 10:22:36 3457 0 1.00CFM 1/60 CM
2012-01-24 10:23:09 3370 0 1.00CFM 1/60 CM
2012-01-24 10:23:45 3516 16 1.00CFM 1/60 CM
2012-01-24 10:24:22 3367 0 1.00CFM 1/60 CM
2012-01-24 10:24:53 3483 0 1.00CFM 1/60 CM
2012-01-24 10:25:30 3501 0 1.00CFM 1/60 CM
2012-01-24 10:26:03 3386 7 1.00CFM 1/60 CM
2012-01-24 10:26:39 3467 0 1.00CFM 1/60 CM
2012-01-24 10:27:16 3460 27 1.00CFM 1/60 CM
2012-01-24 10:27:52 3402 0 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 57 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:28:24 3506 7 1.00CFM 1/60 CM


2012-01-24 10:29:00 3453 0 1.00CFM 1/60 CM
2012-01-24 10:29:37 3460 24 1.00CFM 1/60 CM
2012-01-24 10:30:08 3419 0 1.00CFM 1/60 CM
2012-01-24 10:30:44 3398 23 1.00CFM 1/60 CM
2012-01-24 10:31:22 3320 28 1.00CFM 1/60 CM
2012-01-24 10:31:54 3366 0 1.00CFM 1/60 CM
2012-01-24 10:32:31 3437 0 1.00CFM 1/60 CM
2012-01-24 10:33:07 3500 0 1.00CFM 1/60 CM
2012-01-24 10:33:40 3359 0 1.00CFM 1/60 CM
2012-01-24 10:34:16 3316 11 1.00CFM 1/60 CM
2012-01-24 10:34:53 3301 0 1.00CFM 1/60 CM
2012-01-24 10:35:24 3444 27 1.00CFM 1/60 CM
2012-01-24 10:36:01 3348 9 1.00CFM 1/60 CM
2012-01-24 10:36:37 3365 28 1.00CFM 1/60 CM
2012-01-24 10:37:09 3311 0 1.00CFM 1/60 CM
2012-01-24 10:37:45 3465 0 1.00CFM 1/60 CM
2012-01-24 10:38:23 3458 0 1.00CFM 1/60 CM
2012-01-24 10:38:54 3473 4 1.00CFM 1/60 CM
2012-01-24 10:39:31 3342 0 1.00CFM 1/60 CM
2012-01-24 10:40:07 3300 6 1.00CFM 1/60 CM
2012-01-24 10:40:40 3406 4 1.00CFM 1/60 CM
2012-01-24 10:41:13 3460 0 1.00CFM 1/60 CM
2012-01-24 10:41:50 3391 21 1.00CFM 1/60 CM
2012-01-24 10:42:27 3429 29 1.00CFM 1/60 CM
2012-01-24 10:43:00 3449 0 1.00CFM 1/60 CM
2012-01-24 10:43:36 3454 0 1.00CFM 1/60 CM
2012-01-24 10:44:08 3334 16 1.00CFM 1/60 CM
2012-01-24 10:44:45 3438 0 1.00CFM 1/60 CM
2012-01-24 10:45:22 3414 29 1.00CFM 1/60 CM
2012-01-24 10:45:53 3471 0 1.00CFM 1/60 CM
2012-01-24 10:46:30 3460 0 1.00CFM 1/60 CM
2012-01-24 10:47:07 3430 12 1.00CFM 1/60 CM
2012-01-24 10:47:43 3418 26 1.00CFM 1/60 CM
2012-01-24 10:48:15 3320 0 1.00CFM 1/60 CM
2012-01-24 10:48:52 3449 3 1.00CFM 1/60 CM
2012-01-24 10:49:23 3373 0 1.00CFM 1/60 CM
2012-01-24 10:50:00 3449 0 1.00CFM 1/60 CM
2012-01-24 10:50:38 3411 23 1.00CFM 1/60 CM
2012-01-24 10:51:09 3483 22 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 58 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:51:47 3441 12 1.00CFM 1/60 CM


2012-01-24 10:52:19 3393 21 1.00CFM 1/60 CM
2012-01-24 10:52:56 3431 8 1.00CFM 1/60 CM
2012-01-24 10:53:32 3443 0 1.00CFM 1/60 CM
2012-01-24 10:54:05 3438 0 1.00CFM 1/60 CM
2012-01-24 10:54:41 3428 0 1.00CFM 1/60 CM
2012-01-24 10:55:18 3429 0 1.00CFM 1/60 CM
2012-01-24 10:55:49 3456 0 1.00CFM 1/60 CM
2012-01-24 10:56:26 3428 0 1.00CFM 1/60 CM
2012-01-24 10:57:03 3478 19 1.00CFM 1/60 CM
2012-01-24 10:57:34 3324 9 1.00CFM 1/60 CM
2012-01-24 10:58:11 3396 0 1.00CFM 1/60 CM
2012-01-24 10:58:43 3494 0 1.00CFM 1/60 CM
2012-01-24 10:59:20 3470 0 1.00CFM 1/60 CM
2012-01-24 10:59:56 3449 0 1.00CFM 1/60 CM
2012-01-24 11:00:33 3364 10 1.00CFM 1/60 CM
2012-01-24 11:01:04 3346 0 1.00CFM 1/60 CM
2012-01-24 11:01:41 3495 0 1.00CFM 1/60 CM
2012-01-24 11:02:13 3423 10 1.00CFM 1/60 CM
2012-01-24 11:02:49 3445 0 1.00CFM 1/60 CM
2012-01-24 11:03:27 3421 0 1.00CFM 1/60 CM
2012-01-24 11:03:58 3409 14 1.00CFM 1/60 CM
2012-01-24 11:04:35 3496 5 1.00CFM 1/60 CM
2012-01-24 11:05:11 3483 6 1.00CFM 1/60 CM
2012-01-24 11:05:44 3512 15 1.00CFM 1/60 CM
2012-01-24 11:06:20 3474 0 1.00CFM 1/60 CM
2012-01-24 11:06:57 3414 0 1.00CFM 1/60 CM
2012-01-24 11:07:28 3409 0 1.00CFM 1/60 CM
2012-01-24 11:08:04 3310 0 1.00CFM 1/60 CM
2012-01-24 11:08:42 3354 0 1.00CFM 1/60 CM
2012-01-24 11:09:13 3352 0 1.00CFM 1/60 CM
2012-01-24 11:09:50 3459 0 1.00CFM 1/60 CM
2012-01-24 11:10:26 3417 0 1.00CFM 1/60 CM
2012-01-24 11:11:03 3363 0 1.00CFM 1/60 CM
2012-01-24 11:11:36 3502 0 1.00CFM 1/60 CM
2012-01-24 11:12:13 3505 20 1.00CFM 1/60 CM
2012-01-24 11:12:45 3483 28 1.00CFM 1/60 CM
2012-01-24 11:13:23 3314 0 1.00CFM 1/60 CM
2012-01-24 11:13:55 3436 4 1.00CFM 1/60 CM
2012-01-24 11:14:31 3465 29 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 59 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:15:08 3378 0 1.00CFM 1/60 CM


2012-01-24 11:15:39 3502 19 1.00CFM 1/60 CM
2012-01-24 11:16:16 3319 0 1.00CFM 1/60 CM
2012-01-24 11:16:49 3459 0 1.00CFM 1/60 CM
2012-01-24 11:17:26 3505 28 1.00CFM 1/60 CM
2012-01-24 11:18:02 3422 1 1.00CFM 1/60 CM
2012-01-24 11:18:34 3393 0 1.00CFM 1/60 CM
2012-01-24 11:19:10 3446 16 1.00CFM 1/60 CM
2012-01-24 11:19:47 3454 18 1.00CFM 1/60 CM
2012-01-24 11:20:23 3321 0 1.00CFM 1/60 CM
2012-01-24 11:20:55 3319 21 1.00CFM 1/60 CM
2012-01-24 11:21:32 3316 0 1.00CFM 1/60 CM
2012-01-24 11:22:04 3315 0 1.00CFM 1/60 CM
2012-01-24 11:22:40 3326 0 1.00CFM 1/60 CM
2012-01-24 11:23:17 3375 0 1.00CFM 1/60 CM
2012-01-24 11:23:48 3399 14 1.00CFM 1/60 CM
2012-01-24 11:24:25 3444 5 1.00CFM 1/60 CM
2012-01-24 11:25:02 3481 19 1.00CFM 1/60 CM
2012-01-24 11:25:33 3328 12 1.00CFM 1/60 CM
2012-01-24 11:26:10 3497 20 1.00CFM 1/60 CM
2012-01-24 11:26:46 3331 10 1.00CFM 1/60 CM
2012-01-24 11:27:18 3464 19 1.00CFM 1/60 CM
2012-01-24 11:27:54 3460 0 1.00CFM 1/60 CM
2012-01-24 11:28:31 3460 17 1.00CFM 1/60 CM
2012-01-24 11:29:07 3456 8 1.00CFM 1/60 CM
2012-01-24 11:29:39 3460 0 1.00CFM 1/60 CM
2012-01-24 11:30:15 3325 0 1.00CFM 1/60 CM
2012-01-24 11:30:53 3507 27 1.00CFM 1/60 CM
2012-01-24 11:31:25 3475 0 1.00CFM 1/60 CM
2012-01-24 11:32:01 3473 2 1.00CFM 1/60 CM
2012-01-24 11:32:33 3381 0 1.00CFM 1/60 CM
2012-01-24 11:33:09 3408 25 1.00CFM 1/60 CM
2012-01-24 11:33:46 3406 0 1.00CFM 1/60 CM
2012-01-24 11:34:22 3323 28 1.00CFM 1/60 CM
2012-01-24 11:34:57 3421 29 1.00CFM 1/60 CM
2012-01-24 11:35:30 3360 29 1.00CFM 1/60 CM
2012-01-24 11:36:06 3430 0 1.00CFM 1/60 CM
2012-01-24 11:36:38 3473 18 1.00CFM 1/60 CM
2012-01-24 11:37:18 3374 0 1.00CFM 1/60 CM
2012-01-24 11:37:49 3327 0 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 60 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:38:27 3469 2 1.00CFM 1/60 CM


2012-01-24 11:38:59 3389 8 1.00CFM 1/60 CM
2012-01-24 11:39:36 3504 0 1.00CFM 1/60 CM
2012-01-24 11:40:13 3367 15 1.00CFM 1/60 CM
2012-01-24 11:40:46 3305 0 1.00CFM 1/60 CM
2012-01-24 11:41:22 3345 13 1.00CFM 1/60 CM
2012-01-24 11:41:54 3367 0 1.00CFM 1/60 CM
2012-01-24 11:42:30 3507 21 1.00CFM 1/60 CM
2012-01-24 11:43:09 3410 24 1.00CFM 1/60 CM
2012-01-24 11:43:40 3480 19 1.00CFM 1/60 CM
2012-01-24 11:44:16 3520 0 1.00CFM 1/60 CM
2012-01-24 11:44:53 3428 0 1.00CFM 1/60 CM
2012-01-24 11:45:25 3314 0 1.00CFM 1/60 CM
2012-01-24 11:46:03 3346 8 1.00CFM 1/60 CM
2012-01-24 11:46:35 3468 2 1.00CFM 1/60 CM
2012-01-24 11:47:13 3488 17 1.00CFM 1/60 CM
2012-01-24 11:47:44 3403 14 1.00CFM 1/60 CM
2012-01-24 11:48:20 3478 0 1.00CFM 1/60 CM
2012-01-24 11:48:57 3327 12 1.00CFM 1/60 CM
2012-01-24 11:49:33 3459 11 1.00CFM 1/60 CM
2012-01-24 11:50:05 3374 0 1.00CFM 1/60 CM
2012-01-24 11:50:43 3478 18 1.00CFM 1/60 CM
2012-01-24 11:51:14 3349 0 1.00CFM 1/60 CM
2012-01-24 11:51:51 3477 0 1.00CFM 1/60 CM
2012-01-24 11:52:28 3378 14 1.00CFM 1/60 CM
2012-01-24 11:52:59 3413 0 1.00CFM 1/60 CM
2012-01-24 11:53:35 3424 0 1.00CFM 1/60 CM
2012-01-24 11:54:12 3496 25 1.00CFM 1/60 CM
2012-01-24 11:54:48 3472 11 1.00CFM 1/60 CM
2012-01-24 11:55:20 3503 22 1.00CFM 1/60 CM
2012-01-24 11:55:56 3390 3 1.00CFM 1/60 CM
2012-01-24 11:56:28 3378 0 1.00CFM 1/60 CM
2012-01-24 11:57:05 3462 29 1.00CFM 1/60 CM
2012-01-24 11:57:42 3421 0 1.00CFM 1/60 CM
2012-01-24 11:58:13 3303 7 1.00CFM 1/60 CM
2012-01-24 11:58:49 3375 10 1.00CFM 1/60 CM
2012-01-24 11:59:26 3329 0 1.00CFM 1/60 CM
2012-01-24 12:00:03 3308 0 1.00CFM 1/60 CM
2012-01-24 12:00:34 3442 29 1.00CFM 1/60 CM
2012-01-24 12:01:12 3479 0 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 61 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:01:43 3448 0 1.00CFM 1/60 CM


2012-01-24 12:02:20 3420 17 1.00CFM 1/60 CM
2012-01-24 12:02:56 3451 0 1.00CFM 1/60 CM
2012-01-24 12:03:33 3345 0 1.00CFM 1/60 CM
2012-01-24 12:04:04 3422 3 1.00CFM 1/60 CM
2012-01-24 12:04:41 3514 12 1.00CFM 1/60 CM
2012-01-24 12:05:14 3480 1 1.00CFM 1/60 CM
2012-01-24 12:05:52 3437 0 1.00CFM 1/60 CM
2012-01-24 12:06:23 3354 0 1.00CFM 1/60 CM
2012-01-24 12:07:00 3461 19 1.00CFM 1/60 CM
2012-01-24 12:07:36 3300 0 1.00CFM 1/60 CM
2012-01-24 12:08:13 3346 0 1.00CFM 1/60 CM
2012-01-24 12:08:44 3339 1 1.00CFM 1/60 CM
2012-01-24 12:09:20 3314 0 1.00CFM 1/60 CM
2012-01-24 12:09:57 3428 14 1.00CFM 1/60 CM
2012-01-24 12:10:28 3325 18 1.00CFM 1/60 CM
2012-01-24 12:11:05 3422 0 1.00CFM 1/60 CM
2012-01-24 12:11:42 3361 14 1.00CFM 1/60 CM
2012-01-24 12:12:18 3495 28 1.00CFM 1/60 CM
2012-01-24 12:12:49 3437 0 1.00CFM 1/60 CM
2012-01-24 12:13:27 3422 5 1.00CFM 1/60 CM
2012-01-24 12:13:58 3444 0 1.00CFM 1/60 CM
2012-01-24 12:14:38 3460 0 1.00CFM 1/60 CM
2012-01-24 12:15:09 3444 0 1.00CFM 1/60 CM
2012-01-24 12:15:45 3519 10 1.00CFM 1/60 CM
2012-01-24 12:16:23 3360 0 1.00CFM 1/60 CM
2012-01-24 12:16:54 3320 0 1.00CFM 1/60 CM
2012-01-24 12:17:31 3350 26 1.00CFM 1/60 CM
2012-01-24 12:18:07 3437 0 1.00CFM 1/60 CM
2012-01-24 12:18:39 3327 0 1.00CFM 1/60 CM
2012-01-24 12:19:16 3382 0 1.00CFM 1/60 CM
2012-01-24 12:19:53 3441 0 1.00CFM 1/60 CM
2012-01-24 12:20:24 3350 0 1.00CFM 1/60 CM
2012-01-24 12:20:59 3475 0 1.00CFM 1/60 CM
2012-01-24 12:21:36 3338 3 1.00CFM 1/60 CM
2012-01-24 12:22:12 3509 28 1.00CFM 1/60 CM
2012-01-24 12:22:44 3461 25 1.00CFM 1/60 CM
2012-01-24 12:23:20 3421 5 1.00CFM 1/60 CM
2012-01-24 12:23:57 3465 22 1.00CFM 1/60 CM
2012-01-24 12:24:29 3409 19 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 62 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:25:06 3434 0 1.00CFM 1/60 CM


2012-01-24 12:25:42 3413 0 1.00CFM 1/60 CM
2012-01-24 12:26:14 3419 0 1.00CFM 1/60 CM
2012-01-24 12:26:51 3377 14 1.00CFM 1/60 CM
2012-01-24 12:27:28 3392 0 1.00CFM 1/60 CM
2012-01-24 12:28:00 3339 14 1.00CFM 1/60 CM
2012-01-24 12:28:37 3486 19 1.00CFM 1/60 CM
2012-01-24 12:29:09 3444 0 1.00CFM 1/60 CM
2012-01-24 12:29:45 3370 0 1.00CFM 1/60 CM
2012-01-24 12:30:22 3478 18 1.00CFM 1/60 CM
2012-01-24 12:30:58 3398 15 1.00CFM 1/60 CM
2012-01-24 12:31:29 3408 11 1.00CFM 1/60 CM
2012-01-24 12:32:06 3453 0 1.00CFM 1/60 CM
2012-01-24 12:32:45 3460 0 1.00CFM 1/60 CM
2012-01-24 12:33:16 3310 23 1.00CFM 1/60 CM
2012-01-24 12:33:52 3421 16 1.00CFM 1/60 CM
2012-01-24 12:34:24 3371 27 1.00CFM 1/60 CM
2012-01-24 12:35:00 3397 10 1.00CFM 1/60 CM
2012-01-24 12:35:37 3445 0 1.00CFM 1/60 CM
2012-01-24 12:36:08 3477 0 1.00CFM 1/60 CM
2012-01-24 12:36:46 3337 0 1.00CFM 1/60 CM
2012-01-24 12:37:22 3356 0 1.00CFM 1/60 CM
2012-01-24 12:37:54 3460 0 1.00CFM 1/60 CM
2012-01-24 12:38:31 3466 0 1.00CFM 1/60 CM
2012-01-24 12:39:08 3481 0 1.00CFM 1/60 CM
2012-01-24 12:39:39 3486 1 1.00CFM 1/60 CM
2012-01-24 12:40:16 3308 5 1.00CFM 1/60 CM
2012-01-24 12:40:50 3405 0 1.00CFM 1/60 CM
2012-01-24 12:41:27 3307 0 1.00CFM 1/60 CM
2012-01-24 12:41:59 3467 0 1.00CFM 1/60 CM
2012-01-24 12:42:35 3388 0 1.00CFM 1/60 CM
2012-01-24 12:43:12 3424 7 1.00CFM 1/60 CM
2012-01-24 12:43:43 3318 29 1.00CFM 1/60 CM
2012-01-24 12:44:19 3492 19 1.00CFM 1/60 CM
2012-01-24 12:44:56 3344 0 1.00CFM 1/60 CM
2012-01-24 12:45:32 3473 14 1.00CFM 1/60 CM
2012-01-24 12:46:05 3388 0 1.00CFM 1/60 CM
2012-01-24 12:46:42 3480 2 1.00CFM 1/60 CM
2012-01-24 12:47:13 3310 19 1.00CFM 1/60 CM
2012-01-24 12:47:50 3340 21 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 63 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:48:26 3514 19 1.00CFM 1/60 CM


2012-01-24 12:49:03 3400 11 1.00CFM 1/60 CM
2012-01-24 12:49:34 3317 0 1.00CFM 1/60 CM
2012-01-24 12:50:11 3366 13 1.00CFM 1/60 CM
2012-01-24 12:50:47 3438 0 1.00CFM 1/60 CM
2012-01-24 12:51:19 3511 6 1.00CFM 1/60 CM
2012-01-24 12:51:55 3325 0 1.00CFM 1/60 CM
2012-01-24 12:52:31 3341 0 1.00CFM 1/60 CM
2012-01-24 12:53:08 3495 19 1.00CFM 1/60 CM
2012-01-24 12:53:43 3389 23 1.00CFM 1/60 CM
2012-01-24 12:54:15 3361 0 1.00CFM 1/60 CM
2012-01-24 12:54:53 3342 11 1.00CFM 1/60 CM
2012-01-24 12:55:25 3364 0 1.00CFM 1/60 CM
2012-01-24 12:56:02 3513 0 1.00CFM 1/60 CM
2012-01-24 12:56:33 3457 11 1.00CFM 1/60 CM
2012-01-24 12:57:10 3445 10 1.00CFM 1/60 CM
2012-01-24 12:57:47 3484 13 1.00CFM 1/60 CM
2012-01-24 12:58:23 3489 13 1.00CFM 1/60 CM
2012-01-24 12:58:55 3452 9 1.00CFM 1/60 CM
2012-01-24 12:59:32 3380 0 1.00CFM 1/60 CM
2012-01-24 13:00:03 3441 0 1.00CFM 1/60 CM
2012-01-24 13:00:40 3515 27 1.00CFM 1/60 CM
2012-01-24 13:01:17 3342 0 1.00CFM 1/60 CM
2012-01-24 13:01:49 3344 4 1.00CFM 1/60 CM
2012-01-24 13:02:25 3491 5 1.00CFM 1/60 CM
2012-01-24 13:03:02 3410 0 1.00CFM 1/60 CM
2012-01-24 13:03:38 3473 0 1.00CFM 1/60 CM
2012-01-24 13:04:11 3497 0 1.00CFM 1/60 CM
2012-01-24 13:04:48 3332 0 1.00CFM 1/60 CM
2012-01-24 13:05:19 3359 0 1.00CFM 1/60 CM
2012-01-24 13:05:57 3437 0 1.00CFM 1/60 CM
2012-01-24 13:06:33 3516 0 1.00CFM 1/60 CM
2012-01-24 13:07:04 3406 13 1.00CFM 1/60 CM
2012-01-24 13:07:41 3320 11 1.00CFM 1/60 CM
2012-01-24 13:08:18 3484 0 1.00CFM 1/60 CM
2012-01-24 13:08:51 3466 0 1.00CFM 1/60 CM
2012-01-24 13:09:27 3429 0 1.00CFM 1/60 CM
2012-01-24 13:09:59 3340 0 1.00CFM 1/60 CM
2012-01-24 13:10:35 3458 3 1.00CFM 1/60 CM
2012-01-24 13:11:13 3508 0 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 64 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 13:11:44 3493 2 1.00CFM 1/60 CM


2012-01-24 13:12:20 3476 0 1.00CFM 1/60 CM
2012-01-24 13:12:57 3351 19 1.00CFM 1/60 CM
2012-01-24 13:13:28 3347 0 1.00CFM 1/60 CM
2012-01-24 13:14:05 3307 0 1.00CFM 1/60 CM
2012-01-24 13:14:42 3484 0 1.00CFM 1/60 CM
2012-01-24 13:15:15 3313 12 1.00CFM 1/60 CM
2012-01-24 13:15:52 3374 0 1.00CFM 1/60 CM
2012-01-24 13:16:24 3334 19 1.00CFM 1/60 CM
2012-01-24 13:17:01 3462 10 1.00CFM 1/60 CM
2012-01-24 13:17:38 3375 28 1.00CFM 1/60 CM
2012-01-24 13:18:10 3493 24 1.00CFM 1/60 CM
2012-01-24 13:18:47 3392 0 1.00CFM 1/60 CM
2012-01-24 13:19:19 3345 9 1.00CFM 1/60 CM
2012-01-24 13:19:55 3322 0 1.00CFM 1/60 CM
2012-01-24 13:20:32 3452 0 1.00CFM 1/60 CM
2012-01-24 13:21:03 3455 0 1.00CFM 1/60 CM
2012-01-24 13:21:40 3376 28 1.00CFM 1/60 CM
2012-01-24 13:22:16 3367 10 1.00CFM 1/60 CM
2012-01-24 13:22:49 3435 1 1.00CFM 1/60 CM
2012-01-24 13:23:25 3471 26 1.00CFM 1/60 CM
2012-01-24 13:24:02 3414 1 1.00CFM 1/60 CM
2012-01-24 13:24:38 3348 0 1.00CFM 1/60 CM
2012-01-24 13:25:10 3464 13 1.00CFM 1/60 CM
2012-01-24 13:25:52 3365 22 1.00CFM 1/60 CM
2012-01-24 13:26:18 3411 0 1.00CFM 1/60 CM
2012-01-24 13:26:55 3427 0 1.00CFM 1/60 CM
2012-01-24 13:27:31 3388 7 1.00CFM 1/60 CM
2012-01-24 13:28:08 3373 12 1.00CFM 1/60 CM
2012-01-24 13:28:39 3489 0 1.00CFM 1/60 CM
2012-01-24 13:29:18 3450 4 1.00CFM 1/60 CM
2012-01-24 13:29:49 3516 8 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 65 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact

CLiMET Instruments Company


Raw Data Report
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:57:02
Author: Kyle Kuehm
Data count: Total Count
Area: Ampule Filling Machine 1
Point
Location: 3
Number of samples: 240
≥ 0.5 µm, ≥ 5.0
Particle Sizes: µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.3.1

≥ 0.5 ≥ 5.0
Timestamp µm µm Flow Volume
2012-01-24 09:30:11 99 0 1.00CFM 1CF
2012-01-24 09:31:12 91 0 1.00CFM 1CF
2012-01-24 09:32:09 84 0 1.00CFM 1CF
2012-01-24 09:33:12 85 0 1.00CFM 1CF
2012-01-24 09:34:09 74 0 1.00CFM 1CF
2012-01-24 09:35:12 86 0 1.00CFM 1CF
2012-01-24 09:36:15 86 0 1.00CFM 1CF
2012-01-24 09:37:13 95 0 1.00CFM 1CF
2012-01-24 09:38:11 85 0 1.00CFM 1CF
2012-01-24 09:39:14 78 0 1.00CFM 1CF
2012-01-24 09:40:11 74 0 1.00CFM 1CF
2012-01-24 09:41:14 87 0 1.00CFM 1CF
2012-01-24 09:42:11 97 0 1.00CFM 1CF
2012-01-24 09:43:14 74 0 1.00CFM 1CF
2012-01-24 09:44:11 93 0 1.00CFM 1CF
2012-01-24 09:45:09 81 0 1.00CFM 1CF
2012-01-24 09:46:12 84 0 1.00CFM 1CF
2012-01-24 09:47:11 86 0 1.00CFM 1CF
2012-01-24 09:48:13 92 0 1.00CFM 1CF
2012-01-24 09:49:11 90 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 66 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 09:50:10 83 0 1.00CFM 1CF


2012-01-24 09:51:12 95 0 1.00CFM 1CF
2012-01-24 09:52:15 89 0 1.00CFM 1CF
2012-01-24 09:53:13 94 0 1.00CFM 1CF
2012-01-24 09:54:10 93 0 1.00CFM 1CF
2012-01-24 09:55:13 72 0 1.00CFM 1CF
2012-01-24 09:56:11 83 0 1.00CFM 1CF
2012-01-24 09:57:11 91 0 1.00CFM 1CF
2012-01-24 09:58:14 91 0 1.00CFM 1CF
2012-01-24 09:59:12 74 0 1.00CFM 1CF
2012-01-24 10:00:14 86 0 1.00CFM 1CF
2012-01-24 10:01:13 85 0 1.00CFM 1CF
2012-01-24 10:02:10 90 0 1.00CFM 1CF
2012-01-24 10:03:14 82 0 1.00CFM 1CF
2012-01-24 10:04:12 78 0 1.00CFM 1CF
2012-01-24 10:05:10 90 0 1.00CFM 1CF
2012-01-24 10:06:12 72 0 1.00CFM 1CF
2012-01-24 10:07:10 83 0 1.00CFM 1CF
2012-01-24 10:08:12 88 0 1.00CFM 1CF
2012-01-24 10:09:09 74 0 1.00CFM 1CF
2012-01-24 10:10:14 81 0 1.00CFM 1CF
2012-01-24 10:11:12 84 0 1.00CFM 1CF
2012-01-24 10:12:10 77 0 1.00CFM 1CF
2012-01-24 10:13:14 87 0 1.00CFM 1CF
2012-01-24 10:14:11 82 0 1.00CFM 1CF
2012-01-24 10:15:10 78 0 1.00CFM 1CF
2012-01-24 10:16:14 75 0 1.00CFM 1CF
2012-01-24 10:17:11 74 0 1.00CFM 1CF
2012-01-24 10:18:13 95 0 1.00CFM 1CF
2012-01-24 10:19:11 99 0 1.00CFM 1CF
2012-01-24 10:20:13 92 0 1.00CFM 1CF
2012-01-24 10:21:11 81 0 1.00CFM 1CF
2012-01-24 10:22:10 92 0 1.00CFM 1CF
2012-01-24 10:23:14 98 0 1.00CFM 1CF
2012-01-24 10:24:11 77 0 1.00CFM 1CF
2012-01-24 10:25:15 79 0 1.00CFM 1CF
2012-01-24 10:26:13 83 0 1.00CFM 1CF
2012-01-24 10:27:11 71 0 1.00CFM 1CF
2012-01-24 10:28:13 74 0 1.00CFM 1CF
2012-01-24 10:29:10 89 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 67 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:30:13 90 0 1.00CFM 1CF


2012-01-24 10:31:11 79 0 1.00CFM 1CF
2012-01-24 10:32:10 96 0 1.00CFM 1CF
2012-01-24 10:33:13 83 0 1.00CFM 1CF
2012-01-24 10:34:11 82 0 1.00CFM 1CF
2012-01-24 10:35:14 76 0 1.00CFM 1CF
2012-01-24 10:36:11 80 0 1.00CFM 1CF
2012-01-24 10:37:19 95 0 1.00CFM 1CF
2012-01-24 10:38:12 77 0 1.00CFM 1CF
2012-01-24 10:39:15 85 0 1.00CFM 1CF
2012-01-24 10:40:13 89 0 1.00CFM 1CF
2012-01-24 10:41:13 87 0 1.00CFM 1CF
2012-01-24 10:42:11 91 0 1.00CFM 1CF
2012-01-24 10:43:15 94 0 1.00CFM 1CF
2012-01-24 10:44:14 75 0 1.00CFM 1CF
2012-01-24 10:45:12 90 0 1.00CFM 1CF
2012-01-24 10:46:14 96 0 1.00CFM 1CF
2012-01-24 10:47:12 93 0 1.00CFM 1CF
2012-01-24 10:48:10 71 0 1.00CFM 1CF
2012-01-24 10:49:13 83 0 1.00CFM 1CF
2012-01-24 10:50:11 94 0 1.00CFM 1CF
2012-01-24 10:51:10 84 0 1.00CFM 1CF
2012-01-24 10:52:14 86 0 1.00CFM 1CF
2012-01-24 10:53:11 80 0 1.00CFM 1CF
2012-01-24 10:54:10 85 0 1.00CFM 1CF
2012-01-24 10:55:13 85 0 1.00CFM 1CF
2012-01-24 10:56:10 91 0 1.00CFM 1CF
2012-01-24 10:57:14 97 0 1.00CFM 1CF
2012-01-24 10:58:11 94 0 1.00CFM 1CF
2012-01-24 10:59:15 95 0 1.00CFM 1CF
2012-01-24 11:00:12 97 0 1.00CFM 1CF
2012-01-24 11:01:14 71 0 1.00CFM 1CF
2012-01-24 11:02:13 88 0 1.00CFM 1CF
2012-01-24 11:03:10 90 0 1.00CFM 1CF
2012-01-24 11:04:14 85 0 1.00CFM 1CF
2012-01-24 11:05:11 86 0 1.00CFM 1CF
2012-01-24 11:06:10 98 0 1.00CFM 1CF
2012-01-24 11:07:12 86 0 1.00CFM 1CF
2012-01-24 11:08:16 79 0 1.00CFM 1CF
2012-01-24 11:09:13 96 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 68 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:10:11 77 0 1.00CFM 1CF


2012-01-24 11:11:13 79 0 1.00CFM 1CF
2012-01-24 11:12:13 72 0 1.00CFM 1CF
2012-01-24 11:13:13 79 0 1.00CFM 1CF
2012-01-24 11:14:10 74 0 1.00CFM 1CF
2012-01-24 11:15:13 81 0 1.00CFM 1CF
2012-01-24 11:16:11 72 0 1.00CFM 1CF
2012-01-24 11:17:10 71 0 1.00CFM 1CF
2012-01-24 11:18:13 82 0 1.00CFM 1CF
2012-01-24 11:19:10 76 0 1.00CFM 1CF
2012-01-24 11:20:13 77 0 1.00CFM 1CF
2012-01-24 11:21:11 72 0 1.00CFM 1CF
2012-01-24 11:22:14 79 0 1.00CFM 1CF
2012-01-24 11:23:11 93 0 1.00CFM 1CF
2012-01-24 11:24:10 79 0 1.00CFM 1CF
2012-01-24 11:25:12 88 0 1.00CFM 1CF
2012-01-24 11:26:10 89 0 1.00CFM 1CF
2012-01-24 11:27:13 79 0 1.00CFM 1CF
2012-01-24 11:28:10 83 0 1.00CFM 1CF
2012-01-24 11:29:13 85 0 1.00CFM 1CF
2012-01-24 11:30:10 91 0 1.00CFM 1CF
2012-01-24 11:31:13 93 0 1.00CFM 1CF
2012-01-24 11:32:12 90 0 1.00CFM 1CF
2012-01-24 11:33:15 84 0 1.00CFM 1CF
2012-01-24 11:34:12 86 0 1.00CFM 1CF
2012-01-24 11:35:14 76 0 1.00CFM 1CF
2012-01-24 11:36:11 90 0 1.00CFM 1CF
2012-01-24 11:37:12 73 0 1.00CFM 1CF
2012-01-24 11:38:11 85 0 1.00CFM 1CF
2012-01-24 11:39:15 74 0 1.00CFM 1CF
2012-01-24 11:40:13 93 0 1.00CFM 1CF
2012-01-24 11:41:12 98 0 1.00CFM 1CF
2012-01-24 11:42:14 98 0 1.00CFM 1CF
2012-01-24 11:43:14 97 0 1.00CFM 1CF
2012-01-24 11:44:11 98 0 1.00CFM 1CF
2012-01-24 11:45:14 99 0 1.00CFM 1CF
2012-01-24 11:46:14 85 0 1.00CFM 1CF
2012-01-24 11:47:13 94 0 1.00CFM 1CF
2012-01-24 11:48:15 93 0 1.00CFM 1CF
2012-01-24 11:49:13 91 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 69 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:50:11 94 0 1.00CFM 1CF


2012-01-24 11:51:14 72 0 1.00CFM 1CF
2012-01-24 11:52:12 79 0 1.00CFM 1CF
2012-01-24 11:53:14 85 0 1.00CFM 1CF
2012-01-24 11:54:12 99 0 1.00CFM 1CF
2012-01-24 11:55:14 72 0 1.00CFM 1CF
2012-01-24 11:56:12 80 0 1.00CFM 1CF
2012-01-24 11:57:10 80 0 1.00CFM 1CF
2012-01-24 11:58:13 71 0 1.00CFM 1CF
2012-01-24 11:59:10 84 0 1.00CFM 1CF
2012-01-24 12:00:14 81 0 1.00CFM 1CF
2012-01-24 12:01:12 97 0 1.00CFM 1CF
2012-01-24 12:02:09 82 0 1.00CFM 1CF
2012-01-24 12:03:12 79 0 1.00CFM 1CF
2012-01-24 12:04:15 96 0 1.00CFM 1CF
2012-01-24 12:05:14 83 0 1.00CFM 1CF
2012-01-24 12:06:13 75 0 1.00CFM 1CF
2012-01-24 12:07:10 76 0 1.00CFM 1CF
2012-01-24 12:08:13 94 0 1.00CFM 1CF
2012-01-24 12:09:10 73 0 1.00CFM 1CF
2012-01-24 12:10:13 98 0 1.00CFM 1CF
2012-01-24 12:11:10 87 0 1.00CFM 1CF
2012-01-24 12:12:13 75 0 1.00CFM 1CF
2012-01-24 12:13:10 92 0 1.00CFM 1CF
2012-01-24 12:14:14 89 0 1.00CFM 1CF
2012-01-24 12:15:14 72 0 1.00CFM 1CF
2012-01-24 12:16:12 83 0 1.00CFM 1CF
2012-01-24 12:17:15 74 0 1.00CFM 1CF
2012-01-24 12:18:13 84 0 1.00CFM 1CF
2012-01-24 12:19:16 79 0 1.00CFM 1CF
2012-01-24 12:20:14 84 0 1.00CFM 1CF
2012-01-24 12:21:15 90 0 1.00CFM 1CF
2012-01-24 12:22:12 83 0 1.00CFM 1CF
2012-01-24 12:23:15 87 0 1.00CFM 1CF
2012-01-24 12:24:14 73 0 1.00CFM 1CF
2012-01-24 12:25:11 76 0 1.00CFM 1CF
2012-01-24 12:26:09 73 0 1.00CFM 1CF
2012-01-24 12:27:12 82 0 1.00CFM 1CF
2012-01-24 12:28:10 95 0 1.00CFM 1CF
2012-01-24 12:29:14 95 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 70 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:30:11 84 0 1.00CFM 1CF


2012-01-24 12:31:14 81 0 1.00CFM 1CF
2012-01-24 12:32:11 93 0 1.00CFM 1CF
2012-01-24 12:33:11 75 0 1.00CFM 1CF
2012-01-24 12:34:13 73 0 1.00CFM 1CF
2012-01-24 12:35:11 99 0 1.00CFM 1CF
2012-01-24 12:36:13 92 0 1.00CFM 1CF
2012-01-24 12:37:12 91 0 1.00CFM 1CF
2012-01-24 12:38:14 98 0 1.00CFM 1CF
2012-01-24 12:39:13 83 0 1.00CFM 1CF
2012-01-24 12:40:11 80 0 1.00CFM 1CF
2012-01-24 12:41:12 95 0 1.00CFM 1CF
2012-01-24 12:42:14 79 0 1.00CFM 1CF
2012-01-24 12:43:12 88 0 1.00CFM 1CF
2012-01-24 12:44:14 82 0 1.00CFM 1CF
2012-01-24 12:45:12 77 0 1.00CFM 1CF
2012-01-24 12:46:10 96 0 1.00CFM 1CF
2012-01-24 12:47:13 96 0 1.00CFM 1CF
2012-01-24 12:48:11 77 0 1.00CFM 1CF
2012-01-24 12:49:14 72 0 1.00CFM 1CF
2012-01-24 12:50:11 96 0 1.00CFM 1CF
2012-01-24 12:51:13 91 0 1.00CFM 1CF
2012-01-24 12:52:11 93 0 1.00CFM 1CF
2012-01-24 12:53:13 86 0 1.00CFM 1CF
2012-01-24 12:54:15 78 0 1.00CFM 1CF
2012-01-24 12:55:14 77 0 1.00CFM 1CF
2012-01-24 12:56:13 73 0 1.00CFM 1CF
2012-01-24 12:57:16 72 0 1.00CFM 1CF
2012-01-24 12:58:13 89 0 1.00CFM 1CF
2012-01-24 12:59:10 96 0 1.00CFM 1CF
2012-01-24 13:00:14 98 0 1.00CFM 1CF
2012-01-24 13:01:11 86 0 1.00CFM 1CF
2012-01-24 13:02:15 85 0 1.00CFM 1CF
2012-01-24 13:03:12 90 0 1.00CFM 1CF
2012-01-24 13:04:11 94 0 1.00CFM 1CF
2012-01-24 13:05:14 78 0 1.00CFM 1CF
2012-01-24 13:06:12 95 0 1.00CFM 1CF
2012-01-24 13:07:15 75 0 1.00CFM 1CF
2012-01-24 13:08:12 85 0 1.00CFM 1CF
2012-01-24 13:09:12 89 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 71 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 13:10:14 96 0 1.00CFM 1CF


2012-01-24 13:11:13 74 0 1.00CFM 1CF
2012-01-24 13:12:10 90 0 1.00CFM 1CF
2012-01-24 13:13:13 99 0 1.00CFM 1CF
2012-01-24 13:14:10 87 0 1.00CFM 1CF
2012-01-24 13:15:15 77 0 1.00CFM 1CF
2012-01-24 13:16:13 74 0 1.00CFM 1CF
2012-01-24 13:17:11 77 0 1.00CFM 1CF
2012-01-24 13:18:10 93 0 1.00CFM 1CF
2012-01-24 13:19:13 80 0 1.00CFM 1CF
2012-01-24 13:20:11 94 0 1.00CFM 1CF
2012-01-24 13:21:14 87 0 1.00CFM 1CF
2012-01-24 13:22:11 79 0 1.00CFM 1CF
2012-01-24 13:23:09 80 0 1.00CFM 1CF
2012-01-24 13:24:12 84 0 1.00CFM 1CF
2012-01-24 13:25:10 87 0 1.00CFM 1CF
2012-01-24 13:26:13 71 0 1.00CFM 1CF
2012-01-24 13:27:11 74 0 1.00CFM 1CF
2012-01-24 13:28:13 89 0 1.00CFM 1CF
2012-01-24 13:29:12 87 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 72 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact

CLiMET Instruments Company


Raw Data Report
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:57:02
Author: Kyle Kuehm
Data count: Total Count
Area: Ampule Filling Machine 1
Location: Point 4
Number of samples: 240
≥ 0.5 µm, ≥ 5.0
Particle Sizes: µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.3.1

≥ 0.5 ≥ 5.0
Timestamp µm µm Flow Volume
2012-01-24 09:30:11 79 0 1.00CFM 1CF
2012-01-24 09:31:12 71 0 1.00CFM 1CF
2012-01-24 09:32:15 90 0 1.00CFM 1CF
2012-01-24 09:33:12 79 0 1.00CFM 1CF
2012-01-24 09:34:15 71 0 1.00CFM 1CF
2012-01-24 09:35:12 74 0 1.00CFM 1CF
2012-01-24 09:36:15 98 0 1.00CFM 1CF
2012-01-24 09:37:13 71 0 1.00CFM 1CF
2012-01-24 09:38:11 80 0 1.00CFM 1CF
2012-01-24 09:39:14 84 0 1.00CFM 1CF
2012-01-24 09:40:11 79 0 1.00CFM 1CF
2012-01-24 09:41:14 94 0 1.00CFM 1CF
2012-01-24 09:42:11 98 0 1.00CFM 1CF
2012-01-24 09:43:14 75 0 1.00CFM 1CF
2012-01-24 09:44:11 86 0 1.00CFM 1CF
2012-01-24 09:45:15 89 0 1.00CFM 1CF
2012-01-24 09:46:12 79 0 1.00CFM 1CF
2012-01-24 09:47:16 74 0 1.00CFM 1CF
2012-01-24 09:48:13 81 0 1.00CFM 1CF
2012-01-24 09:49:12 90 0 1.00CFM 1CF
2012-01-24 09:50:15 88 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 73 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 09:51:12 86 0 1.00CFM 1CF


2012-01-24 09:52:15 76 0 1.00CFM 1CF
2012-01-24 09:53:13 75 0 1.00CFM 1CF
2012-01-24 09:54:16 88 0 1.00CFM 1CF
2012-01-24 09:55:13 82 0 1.00CFM 1CF
2012-01-24 09:56:12 71 0 1.00CFM 1CF
2012-01-24 09:57:16 90 0 1.00CFM 1CF
2012-01-24 09:58:14 96 0 1.00CFM 1CF
2012-01-24 09:59:12 86 0 1.00CFM 1CF
2012-01-24 10:00:14 81 0 1.00CFM 1CF
2012-01-24 10:01:13 88 0 1.00CFM 1CF
2012-01-24 10:02:16 78 0 1.00CFM 1CF
2012-01-24 10:03:14 91 0 1.00CFM 1CF
2012-01-24 10:04:12 75 0 1.00CFM 1CF
2012-01-24 10:05:15 87 0 1.00CFM 1CF
2012-01-24 10:06:12 85 0 1.00CFM 1CF
2012-01-24 10:07:15 72 0 1.00CFM 1CF
2012-01-24 10:08:12 79 0 1.00CFM 1CF
2012-01-24 10:09:15 99 0 1.00CFM 1CF
2012-01-24 10:10:14 76 0 1.00CFM 1CF
2012-01-24 10:11:12 98 0 1.00CFM 1CF
2012-01-24 10:12:15 84 0 1.00CFM 1CF
2012-01-24 10:13:14 96 0 1.00CFM 1CF
2012-01-24 10:14:11 95 0 1.00CFM 1CF
2012-01-24 10:15:15 74 0 1.00CFM 1CF
2012-01-24 10:16:15 72 0 1.00CFM 1CF
2012-01-24 10:17:16 78 0 1.00CFM 1CF
2012-01-24 10:18:13 80 0 1.00CFM 1CF
2012-01-24 10:19:16 87 0 1.00CFM 1CF
2012-01-24 10:20:13 73 0 1.00CFM 1CF
2012-01-24 10:21:16 97 0 1.00CFM 1CF
2012-01-24 10:22:15 95 0 1.00CFM 1CF
2012-01-24 10:23:14 77 0 1.00CFM 1CF
2012-01-24 10:24:11 90 0 1.00CFM 1CF
2012-01-24 10:25:15 95 0 1.00CFM 1CF
2012-01-24 10:26:13 87 0 1.00CFM 1CF
2012-01-24 10:27:16 80 0 1.00CFM 1CF
2012-01-24 10:28:13 91 0 1.00CFM 1CF
2012-01-24 10:29:16 76 0 1.00CFM 1CF
2012-01-24 10:30:13 86 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 74 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:31:12 82 0 1.00CFM 1CF


2012-01-24 10:32:15 86 0 1.00CFM 1CF
2012-01-24 10:33:14 99 0 1.00CFM 1CF
2012-01-24 10:34:11 76 0 1.00CFM 1CF
2012-01-24 10:35:14 79 0 1.00CFM 1CF
2012-01-24 10:36:11 87 0 1.00CFM 1CF
2012-01-24 10:37:19 86 0 1.00CFM 1CF
2012-01-24 10:38:12 82 0 1.00CFM 1CF
2012-01-24 10:39:15 81 0 1.00CFM 1CF
2012-01-24 10:40:13 92 0 1.00CFM 1CF
2012-01-24 10:41:13 82 0 1.00CFM 1CF
2012-01-24 10:42:16 87 0 1.00CFM 1CF
2012-01-24 10:43:15 72 0 1.00CFM 1CF
2012-01-24 10:44:14 74 0 1.00CFM 1CF
2012-01-24 10:45:12 93 0 1.00CFM 1CF
2012-01-24 10:46:15 77 0 1.00CFM 1CF
2012-01-24 10:47:12 98 0 1.00CFM 1CF
2012-01-24 10:48:15 76 0 1.00CFM 1CF
2012-01-24 10:49:13 99 0 1.00CFM 1CF
2012-01-24 10:50:11 72 0 1.00CFM 1CF
2012-01-24 10:51:15 99 0 1.00CFM 1CF
2012-01-24 10:52:14 95 0 1.00CFM 1CF
2012-01-24 10:53:11 92 0 1.00CFM 1CF
2012-01-24 10:54:15 87 0 1.00CFM 1CF
2012-01-24 10:55:13 78 0 1.00CFM 1CF
2012-01-24 10:56:15 80 0 1.00CFM 1CF
2012-01-24 10:57:14 87 0 1.00CFM 1CF
2012-01-24 10:58:16 84 0 1.00CFM 1CF
2012-01-24 10:59:15 95 0 1.00CFM 1CF
2012-01-24 11:00:12 88 0 1.00CFM 1CF
2012-01-24 11:01:15 72 0 1.00CFM 1CF
2012-01-24 11:02:13 86 0 1.00CFM 1CF
2012-01-24 11:03:17 71 0 1.00CFM 1CF
2012-01-24 11:04:14 96 0 1.00CFM 1CF
2012-01-24 11:05:12 72 0 1.00CFM 1CF
2012-01-24 11:06:15 86 0 1.00CFM 1CF
2012-01-24 11:07:13 87 0 1.00CFM 1CF
2012-01-24 11:08:16 87 0 1.00CFM 1CF
2012-01-24 11:09:13 95 0 1.00CFM 1CF
2012-01-24 11:10:16 80 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 75 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:11:13 87 0 1.00CFM 1CF


2012-01-24 11:12:13 87 0 1.00CFM 1CF
2012-01-24 11:13:13 77 0 1.00CFM 1CF
2012-01-24 11:14:16 86 0 1.00CFM 1CF
2012-01-24 11:15:13 87 0 1.00CFM 1CF
2012-01-24 11:16:16 77 0 1.00CFM 1CF
2012-01-24 11:17:15 82 0 1.00CFM 1CF
2012-01-24 11:18:13 99 0 1.00CFM 1CF
2012-01-24 11:19:16 80 0 1.00CFM 1CF
2012-01-24 11:20:13 88 0 1.00CFM 1CF
2012-01-24 11:21:11 84 0 1.00CFM 1CF
2012-01-24 11:22:14 76 0 1.00CFM 1CF
2012-01-24 11:23:12 80 0 1.00CFM 1CF
2012-01-24 11:24:15 78 0 1.00CFM 1CF
2012-01-24 11:25:13 99 0 1.00CFM 1CF
2012-01-24 11:26:15 88 0 1.00CFM 1CF
2012-01-24 11:27:13 84 0 1.00CFM 1CF
2012-01-24 11:28:15 76 0 1.00CFM 1CF
2012-01-24 11:29:13 74 0 1.00CFM 1CF
2012-01-24 11:30:15 78 0 1.00CFM 1CF
2012-01-24 11:31:14 99 0 1.00CFM 1CF
2012-01-24 11:32:12 82 0 1.00CFM 1CF
2012-01-24 11:33:15 79 0 1.00CFM 1CF
2012-01-24 11:34:12 96 0 1.00CFM 1CF
2012-01-24 11:35:14 97 0 1.00CFM 1CF
2012-01-24 11:36:11 97 0 1.00CFM 1CF
2012-01-24 11:37:12 91 0 1.00CFM 1CF
2012-01-24 11:38:11 76 0 1.00CFM 1CF
2012-01-24 11:39:15 96 0 1.00CFM 1CF
2012-01-24 11:40:13 99 0 1.00CFM 1CF
2012-01-24 11:41:12 96 0 1.00CFM 1CF
2012-01-24 11:42:14 82 0 1.00CFM 1CF
2012-01-24 11:43:14 84 0 1.00CFM 1CF
2012-01-24 11:44:11 87 0 1.00CFM 1CF
2012-01-24 11:45:14 77 0 1.00CFM 1CF
2012-01-24 11:46:14 73 0 1.00CFM 1CF
2012-01-24 11:47:13 73 0 1.00CFM 1CF
2012-01-24 11:48:15 97 0 1.00CFM 1CF
2012-01-24 11:49:13 85 0 1.00CFM 1CF
2012-01-24 11:50:16 82 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 76 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:51:15 91 0 1.00CFM 1CF


2012-01-24 11:52:12 92 0 1.00CFM 1CF
2012-01-24 11:53:14 87 0 1.00CFM 1CF
2012-01-24 11:54:12 77 0 1.00CFM 1CF
2012-01-24 11:55:14 88 0 1.00CFM 1CF
2012-01-24 11:56:12 92 0 1.00CFM 1CF
2012-01-24 11:57:15 97 0 1.00CFM 1CF
2012-01-24 11:58:13 79 0 1.00CFM 1CF
2012-01-24 11:59:15 71 0 1.00CFM 1CF
2012-01-24 12:00:14 99 0 1.00CFM 1CF
2012-01-24 12:01:12 99 0 1.00CFM 1CF
2012-01-24 12:02:15 88 0 1.00CFM 1CF
2012-01-24 12:03:12 74 0 1.00CFM 1CF
2012-01-24 12:04:15 82 0 1.00CFM 1CF
2012-01-24 12:05:14 77 0 1.00CFM 1CF
2012-01-24 12:06:13 79 0 1.00CFM 1CF
2012-01-24 12:07:15 86 0 1.00CFM 1CF
2012-01-24 12:08:13 78 0 1.00CFM 1CF
2012-01-24 12:09:15 76 0 1.00CFM 1CF
2012-01-24 12:10:13 81 0 1.00CFM 1CF
2012-01-24 12:11:16 92 0 1.00CFM 1CF
2012-01-24 12:12:13 96 0 1.00CFM 1CF
2012-01-24 12:13:16 96 0 1.00CFM 1CF
2012-01-24 12:14:14 97 0 1.00CFM 1CF
2012-01-24 12:15:14 85 0 1.00CFM 1CF
2012-01-24 12:16:12 90 0 1.00CFM 1CF
2012-01-24 12:17:15 94 0 1.00CFM 1CF
2012-01-24 12:18:13 72 0 1.00CFM 1CF
2012-01-24 12:19:16 91 0 1.00CFM 1CF
2012-01-24 12:20:14 81 0 1.00CFM 1CF
2012-01-24 12:21:15 87 0 1.00CFM 1CF
2012-01-24 12:22:13 72 0 1.00CFM 1CF
2012-01-24 12:23:15 93 0 1.00CFM 1CF
2012-01-24 12:24:14 93 0 1.00CFM 1CF
2012-01-24 12:25:16 78 0 1.00CFM 1CF
2012-01-24 12:26:15 99 0 1.00CFM 1CF
2012-01-24 12:27:12 75 0 1.00CFM 1CF
2012-01-24 12:28:17 86 0 1.00CFM 1CF
2012-01-24 12:29:14 82 0 1.00CFM 1CF
2012-01-24 12:30:16 99 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 77 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:31:14 97 0 1.00CFM 1CF


2012-01-24 12:32:11 84 0 1.00CFM 1CF
2012-01-24 12:33:16 81 0 1.00CFM 1CF
2012-01-24 12:34:14 93 0 1.00CFM 1CF
2012-01-24 12:35:16 81 0 1.00CFM 1CF
2012-01-24 12:36:14 87 0 1.00CFM 1CF
2012-01-24 12:37:12 71 0 1.00CFM 1CF
2012-01-24 12:38:14 79 0 1.00CFM 1CF
2012-01-24 12:39:13 91 0 1.00CFM 1CF
2012-01-24 12:40:11 96 0 1.00CFM 1CF
2012-01-24 12:41:12 79 0 1.00CFM 1CF
2012-01-24 12:42:14 75 0 1.00CFM 1CF
2012-01-24 12:43:12 75 0 1.00CFM 1CF
2012-01-24 12:44:14 80 0 1.00CFM 1CF
2012-01-24 12:45:12 92 0 1.00CFM 1CF
2012-01-24 12:46:16 72 0 1.00CFM 1CF
2012-01-24 12:47:13 91 0 1.00CFM 1CF
2012-01-24 12:48:11 96 0 1.00CFM 1CF
2012-01-24 12:49:14 99 0 1.00CFM 1CF
2012-01-24 12:50:11 76 0 1.00CFM 1CF
2012-01-24 12:51:13 80 0 1.00CFM 1CF
2012-01-24 12:52:16 95 0 1.00CFM 1CF
2012-01-24 12:53:13 85 0 1.00CFM 1CF
2012-01-24 12:54:15 82 0 1.00CFM 1CF
2012-01-24 12:55:14 86 0 1.00CFM 1CF
2012-01-24 12:56:13 75 0 1.00CFM 1CF
2012-01-24 12:57:16 75 0 1.00CFM 1CF
2012-01-24 12:58:13 89 0 1.00CFM 1CF
2012-01-24 12:59:16 71 0 1.00CFM 1CF
2012-01-24 13:00:14 92 0 1.00CFM 1CF
2012-01-24 13:01:17 77 0 1.00CFM 1CF
2012-01-24 13:02:15 90 0 1.00CFM 1CF
2012-01-24 13:03:12 71 0 1.00CFM 1CF
2012-01-24 13:04:11 73 0 1.00CFM 1CF
2012-01-24 13:05:14 84 0 1.00CFM 1CF
2012-01-24 13:06:12 74 0 1.00CFM 1CF
2012-01-24 13:07:15 86 0 1.00CFM 1CF
2012-01-24 13:08:12 83 0 1.00CFM 1CF
2012-01-24 13:09:12 74 0 1.00CFM 1CF
2012-01-24 13:10:14 71 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 78 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 13:11:13 91 0 1.00CFM 1CF


2012-01-24 13:12:15 91 0 1.00CFM 1CF
2012-01-24 13:13:13 79 0 1.00CFM 1CF
2012-01-24 13:14:15 75 0 1.00CFM 1CF
2012-01-24 13:15:15 82 0 1.00CFM 1CF
2012-01-24 13:16:13 96 0 1.00CFM 1CF
2012-01-24 13:17:12 98 0 1.00CFM 1CF
2012-01-24 13:18:15 87 0 1.00CFM 1CF
2012-01-24 13:19:14 95 0 1.00CFM 1CF
2012-01-24 13:20:16 78 0 1.00CFM 1CF
2012-01-24 13:21:14 75 0 1.00CFM 1CF
2012-01-24 13:22:16 89 0 1.00CFM 1CF
2012-01-24 13:23:15 98 0 1.00CFM 1CF
2012-01-24 13:24:12 88 0 1.00CFM 1CF
2012-01-24 13:25:15 76 0 1.00CFM 1CF
2012-01-24 13:26:13 92 0 1.00CFM 1CF
2012-01-24 13:27:16 98 0 1.00CFM 1CF
2012-01-24 13:28:13 95 0 1.00CFM 1CF
2012-01-24 13:29:12 93 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 79 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact

CLiMET Instruments Company


Raw Data Report
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:57:45
Author: Kyle Kuehm
Data count: Rolling Count
Area: Ampule Filling Machine 1
Location: Point 1
Number of samples: 412
Particle Sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.3.2

≥ 0.5 ≥ 5.0
Timestamp µm µm Flow Volume
2012-01-24 09:30:06 204678 898 1.00CFM 1/60 CM
2012-01-24 09:30:41 204608 893 1.00CFM 1/60 CM
2012-01-24 09:31:12 204642 886 1.00CFM 1/60 CM
2012-01-24 09:31:49 204660 914 1.00CFM 1/60 CM
2012-01-24 09:32:25 204655 889 1.00CFM 1/60 CM
2012-01-24 09:32:56 204614 887 1.00CFM 1/60 CM
2012-01-24 09:33:33 204638 890 1.00CFM 1/60 CM
2012-01-24 09:34:09 204676 903 1.00CFM 1/60 CM
2012-01-24 09:34:46 204499 902 1.00CFM 1/60 CM
2012-01-24 09:35:17 204689 886 1.00CFM 1/60 CM
2012-01-24 09:35:54 204692 901 1.00CFM 1/60 CM
2012-01-24 09:36:30 204584 903 1.00CFM 1/60 CM
2012-01-24 09:37:02 204630 904 1.00CFM 1/60 CM
2012-01-24 09:37:40 204529 887 1.00CFM 1/60 CM
2012-01-24 09:38:16 204602 905 1.00CFM 1/60 CM
2012-01-24 09:38:48 204519 911 1.00CFM 1/60 CM
2012-01-24 09:39:24 204681 900 1.00CFM 1/60 CM
2012-01-24 09:40:01 204521 901 1.00CFM 1/60 CM
2012-01-24 09:40:32 204672 902 1.00CFM 1/60 CM
2012-01-24 09:41:09 204672 908 1.00CFM 1/60 CM
2012-01-24 09:41:45 204663 907 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 80 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 09:42:21 204613 891 1.00CFM 1/60 CM


2012-01-24 09:42:53 204587 905 1.00CFM 1/60 CM
2012-01-24 09:43:29 204557 894 1.00CFM 1/60 CM
2012-01-24 09:44:06 204541 906 1.00CFM 1/60 CM
2012-01-24 09:44:37 204631 885 1.00CFM 1/60 CM
2012-01-24 09:45:15 204652 911 1.00CFM 1/60 CM
2012-01-24 09:45:51 204623 896 1.00CFM 1/60 CM
2012-01-24 09:46:22 204603 898 1.00CFM 1/60 CM
2012-01-24 09:47:00 204582 890 1.00CFM 1/60 CM
2012-01-24 09:47:36 204568 891 1.00CFM 1/60 CM
2012-01-24 09:48:08 204649 885 1.00CFM 1/60 CM
2012-01-24 09:48:44 204566 903 1.00CFM 1/60 CM
2012-01-24 09:49:23 204578 912 1.00CFM 1/60 CM
2012-01-24 09:49:54 204595 891 1.00CFM 1/60 CM
2012-01-24 09:50:31 204667 887 1.00CFM 1/60 CM
2012-01-24 09:51:07 204655 912 1.00CFM 1/60 CM
2012-01-24 09:51:38 204601 902 1.00CFM 1/60 CM
2012-01-24 09:52:15 204498 899 1.00CFM 1/60 CM
2012-01-24 09:52:51 204574 911 1.00CFM 1/60 CM
2012-01-24 09:53:24 204575 905 1.00CFM 1/60 CM
2012-01-24 09:54:00 204658 912 1.00CFM 1/60 CM
2012-01-24 09:54:37 204685 907 1.00CFM 1/60 CM
2012-01-24 09:55:08 204674 915 1.00CFM 1/60 CM
2012-01-24 09:55:44 204504 887 1.00CFM 1/60 CM
2012-01-24 09:56:17 204589 913 1.00CFM 1/60 CM
2012-01-24 09:56:54 204499 912 1.00CFM 1/60 CM
2012-01-24 09:57:26 204508 889 1.00CFM 1/60 CM
2012-01-24 09:58:04 204698 893 1.00CFM 1/60 CM
2012-01-24 09:58:40 204678 912 1.00CFM 1/60 CM
2012-01-24 09:59:12 204646 904 1.00CFM 1/60 CM
2012-01-24 09:59:48 204588 888 1.00CFM 1/60 CM
2012-01-24 10:00:25 204693 913 1.00CFM 1/60 CM
2012-01-24 10:00:57 204635 913 1.00CFM 1/60 CM
2012-01-24 10:01:34 204596 903 1.00CFM 1/60 CM
2012-01-24 10:02:10 204577 897 1.00CFM 1/60 CM
2012-01-24 10:02:42 204565 900 1.00CFM 1/60 CM
2012-01-24 10:03:20 204555 891 1.00CFM 1/60 CM
2012-01-24 10:03:51 204508 893 1.00CFM 1/60 CM
2012-01-24 10:04:28 204568 906 1.00CFM 1/60 CM
2012-01-24 10:05:04 204674 914 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 81 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:05:41 204555 891 1.00CFM 1/60 CM


2012-01-24 10:06:12 204586 914 1.00CFM 1/60 CM
2012-01-24 10:06:48 204703 897 1.00CFM 1/60 CM
2012-01-24 10:07:25 204654 898 1.00CFM 1/60 CM
2012-01-24 10:07:56 204676 904 1.00CFM 1/60 CM
2012-01-24 10:08:33 204641 905 1.00CFM 1/60 CM
2012-01-24 10:09:09 204701 892 1.00CFM 1/60 CM
2012-01-24 10:09:43 204639 894 1.00CFM 1/60 CM
2012-01-24 10:10:19 204655 886 1.00CFM 1/60 CM
2012-01-24 10:10:52 204509 887 1.00CFM 1/60 CM
2012-01-24 10:11:28 204520 894 1.00CFM 1/60 CM
2012-01-24 10:12:05 204642 899 1.00CFM 1/60 CM
2012-01-24 10:12:41 204621 893 1.00CFM 1/60 CM
2012-01-24 10:13:14 204651 890 1.00CFM 1/60 CM
2012-01-24 10:13:50 204646 898 1.00CFM 1/60 CM
2012-01-24 10:14:22 204545 891 1.00CFM 1/60 CM
2012-01-24 10:14:59 204645 905 1.00CFM 1/60 CM
2012-01-24 10:15:31 204679 904 1.00CFM 1/60 CM
2012-01-24 10:16:09 204673 885 1.00CFM 1/60 CM
2012-01-24 10:16:46 204625 892 1.00CFM 1/60 CM
2012-01-24 10:17:21 204612 897 1.00CFM 1/60 CM
2012-01-24 10:17:52 204608 891 1.00CFM 1/60 CM
2012-01-24 10:18:29 204522 898 1.00CFM 1/60 CM
2012-01-24 10:19:05 204627 891 1.00CFM 1/60 CM
2012-01-24 10:19:37 204650 904 1.00CFM 1/60 CM
2012-01-24 10:20:13 204601 887 1.00CFM 1/60 CM
2012-01-24 10:20:50 204703 897 1.00CFM 1/60 CM
2012-01-24 10:21:26 204570 907 1.00CFM 1/60 CM
2012-01-24 10:22:00 204628 904 1.00CFM 1/60 CM
2012-01-24 10:22:36 204648 896 1.00CFM 1/60 CM
2012-01-24 10:23:09 204494 909 1.00CFM 1/60 CM
2012-01-24 10:23:45 204491 893 1.00CFM 1/60 CM
2012-01-24 10:24:22 204571 887 1.00CFM 1/60 CM
2012-01-24 10:24:53 204635 889 1.00CFM 1/60 CM
2012-01-24 10:25:30 204667 886 1.00CFM 1/60 CM
2012-01-24 10:26:03 204544 913 1.00CFM 1/60 CM
2012-01-24 10:26:39 204616 885 1.00CFM 1/60 CM
2012-01-24 10:27:16 204593 886 1.00CFM 1/60 CM
2012-01-24 10:27:47 204492 892 1.00CFM 1/60 CM
2012-01-24 10:28:24 204495 907 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 82 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:29:00 204548 901 1.00CFM 1/60 CM


2012-01-24 10:29:37 204602 897 1.00CFM 1/60 CM
2012-01-24 10:30:08 204701 889 1.00CFM 1/60 CM
2012-01-24 10:30:44 204557 898 1.00CFM 1/60 CM
2012-01-24 10:31:22 204516 914 1.00CFM 1/60 CM
2012-01-24 10:31:54 204666 885 1.00CFM 1/60 CM
2012-01-24 10:32:31 204624 893 1.00CFM 1/60 CM
2012-01-24 10:33:02 204706 891 1.00CFM 1/60 CM
2012-01-24 10:33:40 204707 897 1.00CFM 1/60 CM
2012-01-24 10:34:16 204619 895 1.00CFM 1/60 CM
2012-01-24 10:34:47 204515 906 1.00CFM 1/60 CM
2012-01-24 10:35:24 204501 897 1.00CFM 1/60 CM
2012-01-24 10:36:00 204628 906 1.00CFM 1/60 CM
2012-01-24 10:36:37 204526 905 1.00CFM 1/60 CM
2012-01-24 10:37:09 204637 908 1.00CFM 1/60 CM
2012-01-24 10:37:45 204587 908 1.00CFM 1/60 CM
2012-01-24 10:38:17 204493 891 1.00CFM 1/60 CM
2012-01-24 10:38:54 204566 897 1.00CFM 1/60 CM
2012-01-24 10:39:31 204545 908 1.00CFM 1/60 CM
2012-01-24 10:40:02 204623 901 1.00CFM 1/60 CM
2012-01-24 10:40:40 204691 897 1.00CFM 1/60 CM
2012-01-24 10:41:13 204693 899 1.00CFM 1/60 CM
2012-01-24 10:41:49 204698 903 1.00CFM 1/60 CM
2012-01-24 10:42:22 204511 893 1.00CFM 1/60 CM
2012-01-24 10:42:59 204553 890 1.00CFM 1/60 CM
2012-01-24 10:43:36 204545 911 1.00CFM 1/60 CM
2012-01-24 10:44:08 204630 904 1.00CFM 1/60 CM
2012-01-24 10:44:45 204689 891 1.00CFM 1/60 CM
2012-01-24 10:45:17 204570 908 1.00CFM 1/60 CM
2012-01-24 10:45:53 204692 885 1.00CFM 1/60 CM
2012-01-24 10:46:30 204637 885 1.00CFM 1/60 CM
2012-01-24 10:47:06 204681 888 1.00CFM 1/60 CM
2012-01-24 10:47:38 204622 911 1.00CFM 1/60 CM
2012-01-24 10:48:15 204691 900 1.00CFM 1/60 CM
2012-01-24 10:48:52 204491 898 1.00CFM 1/60 CM
2012-01-24 10:49:23 204527 901 1.00CFM 1/60 CM
2012-01-24 10:50:00 204509 913 1.00CFM 1/60 CM
2012-01-24 10:50:33 204553 905 1.00CFM 1/60 CM
2012-01-24 10:51:09 204629 887 1.00CFM 1/60 CM
2012-01-24 10:51:47 204562 893 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 83 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:52:19 204511 906 1.00CFM 1/60 CM


2012-01-24 10:52:56 204672 902 1.00CFM 1/60 CM
2012-01-24 10:53:27 204663 915 1.00CFM 1/60 CM
2012-01-24 10:54:05 204494 907 1.00CFM 1/60 CM
2012-01-24 10:54:36 204553 907 1.00CFM 1/60 CM
2012-01-24 10:55:13 204541 899 1.00CFM 1/60 CM
2012-01-24 10:55:49 204644 908 1.00CFM 1/60 CM
2012-01-24 10:56:26 204587 897 1.00CFM 1/60 CM
2012-01-24 10:56:57 204568 887 1.00CFM 1/60 CM
2012-01-24 10:57:34 204553 906 1.00CFM 1/60 CM
2012-01-24 10:58:11 204543 904 1.00CFM 1/60 CM
2012-01-24 10:58:43 204610 888 1.00CFM 1/60 CM
2012-01-24 10:59:20 204657 901 1.00CFM 1/60 CM
2012-01-24 10:59:56 204515 908 1.00CFM 1/60 CM
2012-01-24 11:00:27 204500 896 1.00CFM 1/60 CM
2012-01-24 11:01:04 204531 892 1.00CFM 1/60 CM
2012-01-24 11:01:40 204520 891 1.00CFM 1/60 CM
2012-01-24 11:02:13 204502 885 1.00CFM 1/60 CM
2012-01-24 11:02:49 204532 893 1.00CFM 1/60 CM
2012-01-24 11:03:22 204627 904 1.00CFM 1/60 CM
2012-01-24 11:03:58 204549 903 1.00CFM 1/60 CM
2012-01-24 11:04:35 204649 899 1.00CFM 1/60 CM
2012-01-24 11:05:11 204656 892 1.00CFM 1/60 CM
2012-01-24 11:05:44 204606 894 1.00CFM 1/60 CM
2012-01-24 11:06:20 204582 896 1.00CFM 1/60 CM
2012-01-24 11:06:57 204615 892 1.00CFM 1/60 CM
2012-01-24 11:07:28 204530 902 1.00CFM 1/60 CM
2012-01-24 11:08:04 204674 913 1.00CFM 1/60 CM
2012-01-24 11:08:37 204510 895 1.00CFM 1/60 CM
2012-01-24 11:09:13 204624 908 1.00CFM 1/60 CM
2012-01-24 11:09:50 204655 911 1.00CFM 1/60 CM
2012-01-24 11:10:26 204562 904 1.00CFM 1/60 CM
2012-01-24 11:10:57 204661 897 1.00CFM 1/60 CM
2012-01-24 11:11:36 204580 894 1.00CFM 1/60 CM
2012-01-24 11:12:07 204691 914 1.00CFM 1/60 CM
2012-01-24 11:12:45 204546 914 1.00CFM 1/60 CM
2012-01-24 11:13:18 204697 901 1.00CFM 1/60 CM
2012-01-24 11:13:55 204663 906 1.00CFM 1/60 CM
2012-01-24 11:14:31 204614 901 1.00CFM 1/60 CM
2012-01-24 11:15:03 204561 904 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 84 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:15:39 204513 904 1.00CFM 1/60 CM


2012-01-24 11:16:16 204600 915 1.00CFM 1/60 CM
2012-01-24 11:16:49 204567 909 1.00CFM 1/60 CM
2012-01-24 11:17:26 204619 894 1.00CFM 1/60 CM
2012-01-24 11:17:57 204565 913 1.00CFM 1/60 CM
2012-01-24 11:18:34 204593 912 1.00CFM 1/60 CM
2012-01-24 11:19:10 204599 912 1.00CFM 1/60 CM
2012-01-24 11:19:47 204579 895 1.00CFM 1/60 CM
2012-01-24 11:20:18 204648 894 1.00CFM 1/60 CM
2012-01-24 11:20:55 204649 888 1.00CFM 1/60 CM
2012-01-24 11:21:27 204562 911 1.00CFM 1/60 CM
2012-01-24 11:22:04 204665 908 1.00CFM 1/60 CM
2012-01-24 11:22:40 204651 912 1.00CFM 1/60 CM
2012-01-24 11:23:11 204639 899 1.00CFM 1/60 CM
2012-01-24 11:23:48 204553 893 1.00CFM 1/60 CM
2012-01-24 11:24:25 204519 896 1.00CFM 1/60 CM
2012-01-24 11:24:57 204681 905 1.00CFM 1/60 CM
2012-01-24 11:25:33 204682 908 1.00CFM 1/60 CM
2012-01-24 11:26:10 204542 906 1.00CFM 1/60 CM
2012-01-24 11:26:46 204549 895 1.00CFM 1/60 CM
2012-01-24 11:27:18 204590 885 1.00CFM 1/60 CM
2012-01-24 11:27:54 204570 892 1.00CFM 1/60 CM
2012-01-24 11:28:31 204611 890 1.00CFM 1/60 CM
2012-01-24 11:29:02 204609 899 1.00CFM 1/60 CM
2012-01-24 11:29:39 204631 891 1.00CFM 1/60 CM
2012-01-24 11:30:15 204688 887 1.00CFM 1/60 CM
2012-01-24 11:30:53 204612 898 1.00CFM 1/60 CM
2012-01-24 11:31:25 204547 898 1.00CFM 1/60 CM
2012-01-24 11:32:01 204565 911 1.00CFM 1/60 CM
2012-01-24 11:32:33 204573 905 1.00CFM 1/60 CM
2012-01-24 11:33:09 204683 887 1.00CFM 1/60 CM
2012-01-24 11:33:46 204703 897 1.00CFM 1/60 CM
2012-01-24 11:34:17 204698 898 1.00CFM 1/60 CM
2012-01-24 11:34:52 204591 897 1.00CFM 1/60 CM
2012-01-24 11:35:30 204552 913 1.00CFM 1/60 CM
2012-01-24 11:36:06 204670 899 1.00CFM 1/60 CM
2012-01-24 11:36:38 204669 909 1.00CFM 1/60 CM
2012-01-24 11:37:12 204610 915 1.00CFM 1/60 CM
2012-01-24 11:37:49 204512 907 1.00CFM 1/60 CM
2012-01-24 11:38:27 204599 915 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 85 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:38:59 204657 900 1.00CFM 1/60 CM


2012-01-24 11:39:36 204552 906 1.00CFM 1/60 CM
2012-01-24 11:40:08 204698 894 1.00CFM 1/60 CM
2012-01-24 11:40:46 204593 904 1.00CFM 1/60 CM
2012-01-24 11:41:17 204633 911 1.00CFM 1/60 CM
2012-01-24 11:41:54 204547 900 1.00CFM 1/60 CM
2012-01-24 11:42:30 204649 905 1.00CFM 1/60 CM
2012-01-24 11:43:02 204563 914 1.00CFM 1/60 CM
2012-01-24 11:43:40 204583 890 1.00CFM 1/60 CM
2012-01-24 11:44:16 204614 895 1.00CFM 1/60 CM
2012-01-24 11:44:48 204622 909 1.00CFM 1/60 CM
2012-01-24 11:45:25 204564 897 1.00CFM 1/60 CM
2012-01-24 11:45:57 204506 902 1.00CFM 1/60 CM
2012-01-24 11:46:35 204512 909 1.00CFM 1/60 CM
2012-01-24 11:47:07 204691 885 1.00CFM 1/60 CM
2012-01-24 11:47:44 204704 898 1.00CFM 1/60 CM
2012-01-24 11:48:20 204499 900 1.00CFM 1/60 CM
2012-01-24 11:48:57 204677 906 1.00CFM 1/60 CM
2012-01-24 11:49:28 204518 902 1.00CFM 1/60 CM
2012-01-24 11:50:05 204674 889 1.00CFM 1/60 CM
2012-01-24 11:50:38 204694 886 1.00CFM 1/60 CM
2012-01-24 11:51:14 204522 914 1.00CFM 1/60 CM
2012-01-24 11:51:51 204525 900 1.00CFM 1/60 CM
2012-01-24 11:52:22 204623 913 1.00CFM 1/60 CM
2012-01-24 11:52:59 204642 913 1.00CFM 1/60 CM
2012-01-24 11:53:35 204506 894 1.00CFM 1/60 CM
2012-01-24 11:54:12 204524 910 1.00CFM 1/60 CM
2012-01-24 11:54:43 204632 897 1.00CFM 1/60 CM
2012-01-24 11:55:19 204701 899 1.00CFM 1/60 CM
2012-01-24 11:55:56 204588 886 1.00CFM 1/60 CM
2012-01-24 11:56:28 204580 898 1.00CFM 1/60 CM
2012-01-24 11:57:05 204596 894 1.00CFM 1/60 CM
2012-01-24 11:57:42 204532 895 1.00CFM 1/60 CM
2012-01-24 11:58:13 204588 912 1.00CFM 1/60 CM
2012-01-24 11:58:49 204661 895 1.00CFM 1/60 CM
2012-01-24 11:59:26 204679 907 1.00CFM 1/60 CM
2012-01-24 11:59:57 204679 891 1.00CFM 1/60 CM
2012-01-24 12:00:34 204654 913 1.00CFM 1/60 CM
2012-01-24 12:01:12 204547 910 1.00CFM 1/60 CM
2012-01-24 12:01:43 204496 900 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 86 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:02:20 204676 890 1.00CFM 1/60 CM


2012-01-24 12:02:51 204634 910 1.00CFM 1/60 CM
2012-01-24 12:03:28 204703 908 1.00CFM 1/60 CM
2012-01-24 12:04:04 204653 888 1.00CFM 1/60 CM
2012-01-24 12:04:41 204578 885 1.00CFM 1/60 CM
2012-01-24 12:05:14 204595 891 1.00CFM 1/60 CM
2012-01-24 12:05:46 204623 908 1.00CFM 1/60 CM
2012-01-24 12:06:23 204500 885 1.00CFM 1/60 CM
2012-01-24 12:07:00 204681 899 1.00CFM 1/60 CM
2012-01-24 12:07:36 204560 914 1.00CFM 1/60 CM
2012-01-24 12:08:07 204614 914 1.00CFM 1/60 CM
2012-01-24 12:08:44 204562 892 1.00CFM 1/60 CM
2012-01-24 12:09:20 204691 896 1.00CFM 1/60 CM
2012-01-24 12:09:52 204696 888 1.00CFM 1/60 CM
2012-01-24 12:10:28 204652 886 1.00CFM 1/60 CM
2012-01-24 12:11:05 204551 888 1.00CFM 1/60 CM
2012-01-24 12:11:41 204644 893 1.00CFM 1/60 CM
2012-01-24 12:12:13 204673 888 1.00CFM 1/60 CM
2012-01-24 12:12:49 204541 887 1.00CFM 1/60 CM
2012-01-24 12:13:27 204627 908 1.00CFM 1/60 CM
2012-01-24 12:13:58 204636 911 1.00CFM 1/60 CM
2012-01-24 12:14:38 204694 906 1.00CFM 1/60 CM
2012-01-24 12:15:09 204538 898 1.00CFM 1/60 CM
2012-01-24 12:15:45 204559 889 1.00CFM 1/60 CM
2012-01-24 12:16:18 204555 903 1.00CFM 1/60 CM
2012-01-24 12:16:54 204647 915 1.00CFM 1/60 CM
2012-01-24 12:17:31 204625 913 1.00CFM 1/60 CM
2012-01-24 12:18:02 204672 889 1.00CFM 1/60 CM
2012-01-24 12:18:39 204517 906 1.00CFM 1/60 CM
2012-01-24 12:19:16 204525 892 1.00CFM 1/60 CM
2012-01-24 12:19:47 204500 885 1.00CFM 1/60 CM
2012-01-24 12:20:24 204650 912 1.00CFM 1/60 CM
2012-01-24 12:20:59 204622 892 1.00CFM 1/60 CM
2012-01-24 12:21:36 204692 898 1.00CFM 1/60 CM
2012-01-24 12:22:07 204563 915 1.00CFM 1/60 CM
2012-01-24 12:22:44 204576 885 1.00CFM 1/60 CM
2012-01-24 12:23:20 204638 895 1.00CFM 1/60 CM
2012-01-24 12:23:57 204642 914 1.00CFM 1/60 CM
2012-01-24 12:24:29 204668 891 1.00CFM 1/60 CM
2012-01-24 12:25:06 204537 886 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 87 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:25:42 204579 885 1.00CFM 1/60 CM


2012-01-24 12:26:14 204707 905 1.00CFM 1/60 CM
2012-01-24 12:26:51 204550 896 1.00CFM 1/60 CM
2012-01-24 12:27:22 204671 892 1.00CFM 1/60 CM
2012-01-24 12:28:00 204558 905 1.00CFM 1/60 CM
2012-01-24 12:28:32 204498 905 1.00CFM 1/60 CM
2012-01-24 12:29:09 204588 905 1.00CFM 1/60 CM
2012-01-24 12:29:45 204490 885 1.00CFM 1/60 CM
2012-01-24 12:30:16 204642 902 1.00CFM 1/60 CM
2012-01-24 12:30:53 204628 911 1.00CFM 1/60 CM
2012-01-24 12:31:29 204507 896 1.00CFM 1/60 CM
2012-01-24 12:32:06 204511 915 1.00CFM 1/60 CM
2012-01-24 12:32:38 204700 901 1.00CFM 1/60 CM
2012-01-24 12:33:16 204513 890 1.00CFM 1/60 CM
2012-01-24 12:33:47 204639 893 1.00CFM 1/60 CM
2012-01-24 12:34:24 204665 900 1.00CFM 1/60 CM
2012-01-24 12:35:00 204567 912 1.00CFM 1/60 CM
2012-01-24 12:35:32 204575 914 1.00CFM 1/60 CM
2012-01-24 12:36:08 204505 913 1.00CFM 1/60 CM
2012-01-24 12:36:46 204544 902 1.00CFM 1/60 CM
2012-01-24 12:37:17 204558 913 1.00CFM 1/60 CM
2012-01-24 12:37:54 204690 903 1.00CFM 1/60 CM
2012-01-24 12:38:31 204594 885 1.00CFM 1/60 CM
2012-01-24 12:39:02 204631 897 1.00CFM 1/60 CM
2012-01-24 12:39:39 204550 885 1.00CFM 1/60 CM
2012-01-24 12:40:16 204558 915 1.00CFM 1/60 CM
2012-01-24 12:40:50 204566 913 1.00CFM 1/60 CM
2012-01-24 12:41:22 204704 892 1.00CFM 1/60 CM
2012-01-24 12:41:59 204686 906 1.00CFM 1/60 CM
2012-01-24 12:42:35 204521 912 1.00CFM 1/60 CM
2012-01-24 12:43:12 204537 914 1.00CFM 1/60 CM
2012-01-24 12:43:43 204597 899 1.00CFM 1/60 CM
2012-01-24 12:44:19 204626 911 1.00CFM 1/60 CM
2012-01-24 12:44:56 204556 914 1.00CFM 1/60 CM
2012-01-24 12:45:27 204580 890 1.00CFM 1/60 CM
2012-01-24 12:46:05 204494 915 1.00CFM 1/60 CM
2012-01-24 12:46:37 204637 899 1.00CFM 1/60 CM
2012-01-24 12:47:13 204519 898 1.00CFM 1/60 CM
2012-01-24 12:47:50 204564 890 1.00CFM 1/60 CM
2012-01-24 12:48:26 204614 905 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 88 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:48:58 204660 890 1.00CFM 1/60 CM


2012-01-24 12:49:34 204579 887 1.00CFM 1/60 CM
2012-01-24 12:50:11 204600 912 1.00CFM 1/60 CM
2012-01-24 12:50:42 204694 898 1.00CFM 1/60 CM
2012-01-24 12:51:18 204495 904 1.00CFM 1/60 CM
2012-01-24 12:51:55 204646 913 1.00CFM 1/60 CM
2012-01-24 12:52:31 204500 893 1.00CFM 1/60 CM
2012-01-24 12:53:03 204693 911 1.00CFM 1/60 CM
2012-01-24 12:53:38 204648 890 1.00CFM 1/60 CM
2012-01-24 12:54:15 204532 913 1.00CFM 1/60 CM
2012-01-24 12:54:53 204546 896 1.00CFM 1/60 CM
2012-01-24 12:55:24 204589 913 1.00CFM 1/60 CM
2012-01-24 12:56:02 204544 885 1.00CFM 1/60 CM
2012-01-24 12:56:33 204550 901 1.00CFM 1/60 CM
2012-01-24 12:57:10 204686 910 1.00CFM 1/60 CM
2012-01-24 12:57:47 204643 911 1.00CFM 1/60 CM
2012-01-24 12:58:18 204519 901 1.00CFM 1/60 CM
2012-01-24 12:58:54 204533 885 1.00CFM 1/60 CM
2012-01-24 12:59:32 204657 892 1.00CFM 1/60 CM
2012-01-24 13:00:03 204673 907 1.00CFM 1/60 CM
2012-01-24 13:00:40 204539 887 1.00CFM 1/60 CM
2012-01-24 13:01:17 204548 891 1.00CFM 1/60 CM
2012-01-24 13:01:49 204561 909 1.00CFM 1/60 CM
2012-01-24 13:02:25 204509 904 1.00CFM 1/60 CM
2012-01-24 13:03:01 204530 912 1.00CFM 1/60 CM
2012-01-24 13:03:33 204696 913 1.00CFM 1/60 CM
2012-01-24 13:04:11 204520 886 1.00CFM 1/60 CM
2012-01-24 13:04:43 204638 894 1.00CFM 1/60 CM
2012-01-24 13:05:19 204491 912 1.00CFM 1/60 CM
2012-01-24 13:05:57 204561 911 1.00CFM 1/60 CM
2012-01-24 13:06:28 204538 885 1.00CFM 1/60 CM
2012-01-24 13:07:04 204683 911 1.00CFM 1/60 CM
2012-01-24 13:07:41 204694 913 1.00CFM 1/60 CM
2012-01-24 13:08:12 204497 902 1.00CFM 1/60 CM
2012-01-24 13:08:51 204622 888 1.00CFM 1/60 CM
2012-01-24 13:09:22 204559 896 1.00CFM 1/60 CM
2012-01-24 13:09:59 204699 909 1.00CFM 1/60 CM
2012-01-24 13:10:35 204548 912 1.00CFM 1/60 CM
2012-01-24 13:11:07 204661 912 1.00CFM 1/60 CM
2012-01-24 13:11:44 204663 902 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 89 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 13:12:20 204565 899 1.00CFM 1/60 CM


2012-01-24 13:12:52 204585 910 1.00CFM 1/60 CM
2012-01-24 13:13:28 204531 915 1.00CFM 1/60 CM
2012-01-24 13:14:05 204530 911 1.00CFM 1/60 CM
2012-01-24 13:14:37 204636 913 1.00CFM 1/60 CM
2012-01-24 13:15:15 204678 885 1.00CFM 1/60 CM
2012-01-24 13:15:47 204704 893 1.00CFM 1/60 CM
2012-01-24 13:16:23 204610 892 1.00CFM 1/60 CM
2012-01-24 13:17:01 204573 885 1.00CFM 1/60 CM
2012-01-24 13:17:32 204581 913 1.00CFM 1/60 CM
2012-01-24 13:18:10 204604 891 1.00CFM 1/60 CM
2012-01-24 13:18:42 204563 912 1.00CFM 1/60 CM
2012-01-24 13:19:19 204629 908 1.00CFM 1/60 CM
2012-01-24 13:19:55 204647 894 1.00CFM 1/60 CM
2012-01-24 13:20:32 204647 897 1.00CFM 1/60 CM
2012-01-24 13:21:03 204648 890 1.00CFM 1/60 CM
2012-01-24 13:21:40 204663 899 1.00CFM 1/60 CM
2012-01-24 13:22:16 204512 885 1.00CFM 1/60 CM
2012-01-24 13:22:48 204611 885 1.00CFM 1/60 CM
2012-01-24 13:23:25 204619 887 1.00CFM 1/60 CM
2012-01-24 13:24:02 204690 914 1.00CFM 1/60 CM
2012-01-24 13:24:33 204662 907 1.00CFM 1/60 CM
2012-01-24 13:25:10 204659 915 1.00CFM 1/60 CM
2012-01-24 13:25:47 204561 903 1.00CFM 1/60 CM
2012-01-24 13:26:18 204497 913 1.00CFM 1/60 CM
2012-01-24 13:26:55 204513 895 1.00CFM 1/60 CM
2012-01-24 13:27:31 204506 914 1.00CFM 1/60 CM
2012-01-24 13:28:03 204706 913 1.00CFM 1/60 CM
2012-01-24 13:28:39 204553 908 1.00CFM 1/60 CM
2012-01-24 13:29:18 204691 892 1.00CFM 1/60 CM
2012-01-24 13:29:49 204599 888 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 90 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact

CLiMET Instruments Company


Raw Data Report
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:57:45
Author: Kyle Kuehm
Data count: Rolling Count
Area: Ampule Filling Machine 1
Location: Point 2
Number of samples: 412
Particle Sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.3.2

≥ 0.5 ≥ 5.0
Timestamp µm µm Flow Volume
2012-01-24 09:30:06 204573 897 1.00CFM 1/60 CM
2012-01-24 09:30:41 204527 914 1.00CFM 1/60 CM
2012-01-24 09:31:17 204657 898 1.00CFM 1/60 CM
2012-01-24 09:31:49 204564 912 1.00CFM 1/60 CM
2012-01-24 09:32:25 204604 912 1.00CFM 1/60 CM
2012-01-24 09:33:02 204490 912 1.00CFM 1/60 CM
2012-01-24 09:33:33 204562 913 1.00CFM 1/60 CM
2012-01-24 09:34:09 204508 889 1.00CFM 1/60 CM
2012-01-24 09:34:46 204655 885 1.00CFM 1/60 CM
2012-01-24 09:35:22 204525 900 1.00CFM 1/60 CM
2012-01-24 09:35:54 204700 903 1.00CFM 1/60 CM
2012-01-24 09:36:30 204497 899 1.00CFM 1/60 CM
2012-01-24 09:37:08 204694 905 1.00CFM 1/60 CM
2012-01-24 09:37:40 204605 901 1.00CFM 1/60 CM
2012-01-24 09:38:16 204542 907 1.00CFM 1/60 CM
2012-01-24 09:38:53 204678 910 1.00CFM 1/60 CM
2012-01-24 09:39:24 204613 896 1.00CFM 1/60 CM
2012-01-24 09:40:01 204652 893 1.00CFM 1/60 CM
2012-01-24 09:40:37 204564 909 1.00CFM 1/60 CM
2012-01-24 09:41:09 204681 885 1.00CFM 1/60 CM
2012-01-24 09:41:45 204708 889 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 91 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 09:42:21 204595 895 1.00CFM 1/60 CM


2012-01-24 09:42:58 204513 894 1.00CFM 1/60 CM
2012-01-24 09:43:29 204563 895 1.00CFM 1/60 CM
2012-01-24 09:44:06 204667 913 1.00CFM 1/60 CM
2012-01-24 09:44:42 204629 895 1.00CFM 1/60 CM
2012-01-24 09:45:15 204499 914 1.00CFM 1/60 CM
2012-01-24 09:45:51 204678 900 1.00CFM 1/60 CM
2012-01-24 09:46:28 204548 894 1.00CFM 1/60 CM
2012-01-24 09:47:00 204576 895 1.00CFM 1/60 CM
2012-01-24 09:47:37 204588 905 1.00CFM 1/60 CM
2012-01-24 09:48:13 204710 887 1.00CFM 1/60 CM
2012-01-24 09:48:44 204584 888 1.00CFM 1/60 CM
2012-01-24 09:49:23 204556 901 1.00CFM 1/60 CM
2012-01-24 09:49:54 204666 891 1.00CFM 1/60 CM
2012-01-24 09:50:31 204563 894 1.00CFM 1/60 CM
2012-01-24 09:51:07 204686 909 1.00CFM 1/60 CM
2012-01-24 09:51:38 204663 890 1.00CFM 1/60 CM
2012-01-24 09:52:15 204662 910 1.00CFM 1/60 CM
2012-01-24 09:52:51 204670 910 1.00CFM 1/60 CM
2012-01-24 09:53:24 204653 890 1.00CFM 1/60 CM
2012-01-24 09:54:00 204600 908 1.00CFM 1/60 CM
2012-01-24 09:54:37 204709 886 1.00CFM 1/60 CM
2012-01-24 09:55:13 204511 902 1.00CFM 1/60 CM
2012-01-24 09:55:44 204501 911 1.00CFM 1/60 CM
2012-01-24 09:56:22 204490 901 1.00CFM 1/60 CM
2012-01-24 09:56:54 204680 890 1.00CFM 1/60 CM
2012-01-24 09:57:32 204635 898 1.00CFM 1/60 CM
2012-01-24 09:58:04 204642 901 1.00CFM 1/60 CM
2012-01-24 09:58:40 204696 910 1.00CFM 1/60 CM
2012-01-24 09:59:17 204594 889 1.00CFM 1/60 CM
2012-01-24 09:59:48 204634 890 1.00CFM 1/60 CM
2012-01-24 10:00:25 204558 912 1.00CFM 1/60 CM
2012-01-24 10:01:02 204521 907 1.00CFM 1/60 CM
2012-01-24 10:01:34 204643 913 1.00CFM 1/60 CM
2012-01-24 10:02:10 204605 897 1.00CFM 1/60 CM
2012-01-24 10:02:48 204689 885 1.00CFM 1/60 CM
2012-01-24 10:03:20 204537 906 1.00CFM 1/60 CM
2012-01-24 10:03:56 204593 889 1.00CFM 1/60 CM
2012-01-24 10:04:33 204523 886 1.00CFM 1/60 CM
2012-01-24 10:05:04 204527 895 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 92 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:05:41 204580 912 1.00CFM 1/60 CM


2012-01-24 10:06:17 204564 904 1.00CFM 1/60 CM
2012-01-24 10:06:49 204542 894 1.00CFM 1/60 CM
2012-01-24 10:07:25 204704 902 1.00CFM 1/60 CM
2012-01-24 10:08:02 204648 898 1.00CFM 1/60 CM
2012-01-24 10:08:38 204525 914 1.00CFM 1/60 CM
2012-01-24 10:09:09 204492 893 1.00CFM 1/60 CM
2012-01-24 10:09:48 204508 902 1.00CFM 1/60 CM
2012-01-24 10:10:19 204637 899 1.00CFM 1/60 CM
2012-01-24 10:10:57 204492 898 1.00CFM 1/60 CM
2012-01-24 10:11:33 204626 905 1.00CFM 1/60 CM
2012-01-24 10:12:05 204628 898 1.00CFM 1/60 CM
2012-01-24 10:12:41 204641 905 1.00CFM 1/60 CM
2012-01-24 10:13:14 204645 904 1.00CFM 1/60 CM
2012-01-24 10:13:50 204665 913 1.00CFM 1/60 CM
2012-01-24 10:14:27 204523 904 1.00CFM 1/60 CM
2012-01-24 10:14:59 204628 887 1.00CFM 1/60 CM
2012-01-24 10:15:37 204692 911 1.00CFM 1/60 CM
2012-01-24 10:16:09 204560 911 1.00CFM 1/60 CM
2012-01-24 10:16:46 204594 885 1.00CFM 1/60 CM
2012-01-24 10:17:21 204606 891 1.00CFM 1/60 CM
2012-01-24 10:17:58 204597 915 1.00CFM 1/60 CM
2012-01-24 10:18:29 204631 909 1.00CFM 1/60 CM
2012-01-24 10:19:06 204585 902 1.00CFM 1/60 CM
2012-01-24 10:19:42 204641 904 1.00CFM 1/60 CM
2012-01-24 10:20:13 204627 912 1.00CFM 1/60 CM
2012-01-24 10:20:50 204557 896 1.00CFM 1/60 CM
2012-01-24 10:21:26 204613 896 1.00CFM 1/60 CM
2012-01-24 10:22:00 204634 902 1.00CFM 1/60 CM
2012-01-24 10:22:36 204508 894 1.00CFM 1/60 CM
2012-01-24 10:23:09 204696 914 1.00CFM 1/60 CM
2012-01-24 10:23:45 204655 889 1.00CFM 1/60 CM
2012-01-24 10:24:22 204700 903 1.00CFM 1/60 CM
2012-01-24 10:24:53 204655 885 1.00CFM 1/60 CM
2012-01-24 10:25:30 204688 889 1.00CFM 1/60 CM
2012-01-24 10:26:03 204570 888 1.00CFM 1/60 CM
2012-01-24 10:26:39 204582 897 1.00CFM 1/60 CM
2012-01-24 10:27:16 204640 913 1.00CFM 1/60 CM
2012-01-24 10:27:52 204662 897 1.00CFM 1/60 CM
2012-01-24 10:28:24 204643 900 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 93 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:29:00 204701 903 1.00CFM 1/60 CM


2012-01-24 10:29:37 204694 885 1.00CFM 1/60 CM
2012-01-24 10:30:08 204561 886 1.00CFM 1/60 CM
2012-01-24 10:30:44 204603 898 1.00CFM 1/60 CM
2012-01-24 10:31:22 204603 906 1.00CFM 1/60 CM
2012-01-24 10:31:54 204625 892 1.00CFM 1/60 CM
2012-01-24 10:32:31 204563 898 1.00CFM 1/60 CM
2012-01-24 10:33:07 204648 891 1.00CFM 1/60 CM
2012-01-24 10:33:40 204514 893 1.00CFM 1/60 CM
2012-01-24 10:34:16 204545 893 1.00CFM 1/60 CM
2012-01-24 10:34:53 204709 908 1.00CFM 1/60 CM
2012-01-24 10:35:24 204621 913 1.00CFM 1/60 CM
2012-01-24 10:36:01 204553 890 1.00CFM 1/60 CM
2012-01-24 10:36:37 204613 904 1.00CFM 1/60 CM
2012-01-24 10:37:09 204599 904 1.00CFM 1/60 CM
2012-01-24 10:37:45 204624 911 1.00CFM 1/60 CM
2012-01-24 10:38:23 204620 912 1.00CFM 1/60 CM
2012-01-24 10:38:54 204566 911 1.00CFM 1/60 CM
2012-01-24 10:39:31 204629 907 1.00CFM 1/60 CM
2012-01-24 10:40:07 204628 913 1.00CFM 1/60 CM
2012-01-24 10:40:40 204707 910 1.00CFM 1/60 CM
2012-01-24 10:41:13 204491 899 1.00CFM 1/60 CM
2012-01-24 10:41:50 204654 901 1.00CFM 1/60 CM
2012-01-24 10:42:27 204671 888 1.00CFM 1/60 CM
2012-01-24 10:43:00 204503 906 1.00CFM 1/60 CM
2012-01-24 10:43:36 204504 905 1.00CFM 1/60 CM
2012-01-24 10:44:08 204649 902 1.00CFM 1/60 CM
2012-01-24 10:44:45 204680 912 1.00CFM 1/60 CM
2012-01-24 10:45:22 204630 886 1.00CFM 1/60 CM
2012-01-24 10:45:53 204611 894 1.00CFM 1/60 CM
2012-01-24 10:46:30 204631 909 1.00CFM 1/60 CM
2012-01-24 10:47:07 204578 888 1.00CFM 1/60 CM
2012-01-24 10:47:43 204500 906 1.00CFM 1/60 CM
2012-01-24 10:48:15 204654 913 1.00CFM 1/60 CM
2012-01-24 10:48:52 204630 901 1.00CFM 1/60 CM
2012-01-24 10:49:23 204585 913 1.00CFM 1/60 CM
2012-01-24 10:50:00 204516 914 1.00CFM 1/60 CM
2012-01-24 10:50:38 204544 908 1.00CFM 1/60 CM
2012-01-24 10:51:09 204520 885 1.00CFM 1/60 CM
2012-01-24 10:51:47 204645 892 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 94 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:52:19 204623 898 1.00CFM 1/60 CM


2012-01-24 10:52:56 204655 891 1.00CFM 1/60 CM
2012-01-24 10:53:32 204532 898 1.00CFM 1/60 CM
2012-01-24 10:54:05 204524 895 1.00CFM 1/60 CM
2012-01-24 10:54:41 204534 901 1.00CFM 1/60 CM
2012-01-24 10:55:18 204600 886 1.00CFM 1/60 CM
2012-01-24 10:55:49 204612 886 1.00CFM 1/60 CM
2012-01-24 10:56:26 204667 888 1.00CFM 1/60 CM
2012-01-24 10:57:03 204536 901 1.00CFM 1/60 CM
2012-01-24 10:57:34 204583 894 1.00CFM 1/60 CM
2012-01-24 10:58:11 204494 887 1.00CFM 1/60 CM
2012-01-24 10:58:43 204587 909 1.00CFM 1/60 CM
2012-01-24 10:59:20 204555 913 1.00CFM 1/60 CM
2012-01-24 10:59:56 204545 897 1.00CFM 1/60 CM
2012-01-24 11:00:33 204705 885 1.00CFM 1/60 CM
2012-01-24 11:01:04 204589 911 1.00CFM 1/60 CM
2012-01-24 11:01:41 204635 890 1.00CFM 1/60 CM
2012-01-24 11:02:13 204702 896 1.00CFM 1/60 CM
2012-01-24 11:02:49 204491 901 1.00CFM 1/60 CM
2012-01-24 11:03:27 204668 888 1.00CFM 1/60 CM
2012-01-24 11:03:58 204508 901 1.00CFM 1/60 CM
2012-01-24 11:04:35 204620 914 1.00CFM 1/60 CM
2012-01-24 11:05:11 204606 914 1.00CFM 1/60 CM
2012-01-24 11:05:44 204641 904 1.00CFM 1/60 CM
2012-01-24 11:06:20 204556 903 1.00CFM 1/60 CM
2012-01-24 11:06:57 204581 913 1.00CFM 1/60 CM
2012-01-24 11:07:28 204708 913 1.00CFM 1/60 CM
2012-01-24 11:08:04 204660 905 1.00CFM 1/60 CM
2012-01-24 11:08:42 204687 907 1.00CFM 1/60 CM
2012-01-24 11:09:13 204697 913 1.00CFM 1/60 CM
2012-01-24 11:09:50 204680 906 1.00CFM 1/60 CM
2012-01-24 11:10:26 204710 910 1.00CFM 1/60 CM
2012-01-24 11:11:03 204586 900 1.00CFM 1/60 CM
2012-01-24 11:11:36 204710 901 1.00CFM 1/60 CM
2012-01-24 11:12:13 204538 915 1.00CFM 1/60 CM
2012-01-24 11:12:45 204515 888 1.00CFM 1/60 CM
2012-01-24 11:13:23 204543 912 1.00CFM 1/60 CM
2012-01-24 11:13:55 204619 902 1.00CFM 1/60 CM
2012-01-24 11:14:31 204605 896 1.00CFM 1/60 CM
2012-01-24 11:15:08 204611 895 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 95 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:15:39 204559 885 1.00CFM 1/60 CM


2012-01-24 11:16:16 204709 901 1.00CFM 1/60 CM
2012-01-24 11:16:49 204584 913 1.00CFM 1/60 CM
2012-01-24 11:17:26 204648 911 1.00CFM 1/60 CM
2012-01-24 11:18:02 204588 899 1.00CFM 1/60 CM
2012-01-24 11:18:34 204647 895 1.00CFM 1/60 CM
2012-01-24 11:19:10 204567 904 1.00CFM 1/60 CM
2012-01-24 11:19:47 204600 891 1.00CFM 1/60 CM
2012-01-24 11:20:23 204590 915 1.00CFM 1/60 CM
2012-01-24 11:20:55 204548 898 1.00CFM 1/60 CM
2012-01-24 11:21:32 204522 904 1.00CFM 1/60 CM
2012-01-24 11:22:04 204600 902 1.00CFM 1/60 CM
2012-01-24 11:22:40 204544 908 1.00CFM 1/60 CM
2012-01-24 11:23:17 204574 906 1.00CFM 1/60 CM
2012-01-24 11:23:48 204513 887 1.00CFM 1/60 CM
2012-01-24 11:24:25 204635 887 1.00CFM 1/60 CM
2012-01-24 11:25:02 204663 909 1.00CFM 1/60 CM
2012-01-24 11:25:33 204665 886 1.00CFM 1/60 CM
2012-01-24 11:26:10 204588 888 1.00CFM 1/60 CM
2012-01-24 11:26:46 204636 898 1.00CFM 1/60 CM
2012-01-24 11:27:18 204525 886 1.00CFM 1/60 CM
2012-01-24 11:27:54 204512 892 1.00CFM 1/60 CM
2012-01-24 11:28:31 204632 907 1.00CFM 1/60 CM
2012-01-24 11:29:07 204492 893 1.00CFM 1/60 CM
2012-01-24 11:29:39 204591 889 1.00CFM 1/60 CM
2012-01-24 11:30:15 204607 888 1.00CFM 1/60 CM
2012-01-24 11:30:53 204641 910 1.00CFM 1/60 CM
2012-01-24 11:31:25 204613 914 1.00CFM 1/60 CM
2012-01-24 11:32:01 204661 885 1.00CFM 1/60 CM
2012-01-24 11:32:33 204532 888 1.00CFM 1/60 CM
2012-01-24 11:33:09 204622 915 1.00CFM 1/60 CM
2012-01-24 11:33:46 204629 891 1.00CFM 1/60 CM
2012-01-24 11:34:22 204509 899 1.00CFM 1/60 CM
2012-01-24 11:34:57 204658 887 1.00CFM 1/60 CM
2012-01-24 11:35:30 204578 886 1.00CFM 1/60 CM
2012-01-24 11:36:06 204632 892 1.00CFM 1/60 CM
2012-01-24 11:36:38 204623 906 1.00CFM 1/60 CM
2012-01-24 11:37:18 204691 904 1.00CFM 1/60 CM
2012-01-24 11:37:49 204535 909 1.00CFM 1/60 CM
2012-01-24 11:38:27 204590 896 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 96 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:38:59 204645 894 1.00CFM 1/60 CM


2012-01-24 11:39:36 204594 888 1.00CFM 1/60 CM
2012-01-24 11:40:13 204683 886 1.00CFM 1/60 CM
2012-01-24 11:40:46 204561 891 1.00CFM 1/60 CM
2012-01-24 11:41:22 204701 887 1.00CFM 1/60 CM
2012-01-24 11:41:54 204605 911 1.00CFM 1/60 CM
2012-01-24 11:42:30 204694 911 1.00CFM 1/60 CM
2012-01-24 11:43:09 204683 888 1.00CFM 1/60 CM
2012-01-24 11:43:40 204528 915 1.00CFM 1/60 CM
2012-01-24 11:44:16 204667 897 1.00CFM 1/60 CM
2012-01-24 11:44:53 204678 904 1.00CFM 1/60 CM
2012-01-24 11:45:25 204643 896 1.00CFM 1/60 CM
2012-01-24 11:46:03 204662 898 1.00CFM 1/60 CM
2012-01-24 11:46:35 204631 915 1.00CFM 1/60 CM
2012-01-24 11:47:13 204550 885 1.00CFM 1/60 CM
2012-01-24 11:47:44 204655 896 1.00CFM 1/60 CM
2012-01-24 11:48:20 204636 908 1.00CFM 1/60 CM
2012-01-24 11:48:57 204515 906 1.00CFM 1/60 CM
2012-01-24 11:49:33 204620 904 1.00CFM 1/60 CM
2012-01-24 11:50:05 204629 887 1.00CFM 1/60 CM
2012-01-24 11:50:43 204561 902 1.00CFM 1/60 CM
2012-01-24 11:51:14 204554 908 1.00CFM 1/60 CM
2012-01-24 11:51:51 204504 891 1.00CFM 1/60 CM
2012-01-24 11:52:28 204589 893 1.00CFM 1/60 CM
2012-01-24 11:52:59 204695 898 1.00CFM 1/60 CM
2012-01-24 11:53:35 204580 902 1.00CFM 1/60 CM
2012-01-24 11:54:12 204527 887 1.00CFM 1/60 CM
2012-01-24 11:54:48 204612 902 1.00CFM 1/60 CM
2012-01-24 11:55:20 204579 903 1.00CFM 1/60 CM
2012-01-24 11:55:56 204613 888 1.00CFM 1/60 CM
2012-01-24 11:56:28 204495 891 1.00CFM 1/60 CM
2012-01-24 11:57:05 204698 887 1.00CFM 1/60 CM
2012-01-24 11:57:42 204600 898 1.00CFM 1/60 CM
2012-01-24 11:58:13 204653 915 1.00CFM 1/60 CM
2012-01-24 11:58:49 204527 903 1.00CFM 1/60 CM
2012-01-24 11:59:26 204515 900 1.00CFM 1/60 CM
2012-01-24 12:00:03 204602 885 1.00CFM 1/60 CM
2012-01-24 12:00:34 204559 910 1.00CFM 1/60 CM
2012-01-24 12:01:12 204672 890 1.00CFM 1/60 CM
2012-01-24 12:01:43 204603 909 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 97 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:02:20 204680 898 1.00CFM 1/60 CM


2012-01-24 12:02:56 204590 905 1.00CFM 1/60 CM
2012-01-24 12:03:33 204566 913 1.00CFM 1/60 CM
2012-01-24 12:04:04 204598 900 1.00CFM 1/60 CM
2012-01-24 12:04:41 204639 886 1.00CFM 1/60 CM
2012-01-24 12:05:14 204522 906 1.00CFM 1/60 CM
2012-01-24 12:05:52 204655 888 1.00CFM 1/60 CM
2012-01-24 12:06:23 204627 913 1.00CFM 1/60 CM
2012-01-24 12:07:00 204523 886 1.00CFM 1/60 CM
2012-01-24 12:07:36 204703 897 1.00CFM 1/60 CM
2012-01-24 12:08:13 204534 890 1.00CFM 1/60 CM
2012-01-24 12:08:44 204676 895 1.00CFM 1/60 CM
2012-01-24 12:09:20 204649 887 1.00CFM 1/60 CM
2012-01-24 12:09:57 204591 890 1.00CFM 1/60 CM
2012-01-24 12:10:28 204704 892 1.00CFM 1/60 CM
2012-01-24 12:11:05 204665 909 1.00CFM 1/60 CM
2012-01-24 12:11:42 204705 887 1.00CFM 1/60 CM
2012-01-24 12:12:18 204532 889 1.00CFM 1/60 CM
2012-01-24 12:12:49 204541 906 1.00CFM 1/60 CM
2012-01-24 12:13:27 204674 907 1.00CFM 1/60 CM
2012-01-24 12:13:58 204580 909 1.00CFM 1/60 CM
2012-01-24 12:14:38 204663 903 1.00CFM 1/60 CM
2012-01-24 12:15:09 204566 885 1.00CFM 1/60 CM
2012-01-24 12:15:45 204622 915 1.00CFM 1/60 CM
2012-01-24 12:16:23 204577 894 1.00CFM 1/60 CM
2012-01-24 12:16:54 204692 888 1.00CFM 1/60 CM
2012-01-24 12:17:31 204610 888 1.00CFM 1/60 CM
2012-01-24 12:18:07 204584 902 1.00CFM 1/60 CM
2012-01-24 12:18:39 204584 900 1.00CFM 1/60 CM
2012-01-24 12:19:16 204602 887 1.00CFM 1/60 CM
2012-01-24 12:19:53 204564 902 1.00CFM 1/60 CM
2012-01-24 12:20:24 204492 892 1.00CFM 1/60 CM
2012-01-24 12:20:59 204645 899 1.00CFM 1/60 CM
2012-01-24 12:21:36 204687 913 1.00CFM 1/60 CM
2012-01-24 12:22:12 204508 901 1.00CFM 1/60 CM
2012-01-24 12:22:44 204674 899 1.00CFM 1/60 CM
2012-01-24 12:23:20 204654 890 1.00CFM 1/60 CM
2012-01-24 12:23:57 204567 890 1.00CFM 1/60 CM
2012-01-24 12:24:29 204665 915 1.00CFM 1/60 CM
2012-01-24 12:25:06 204509 908 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 98 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:25:42 204640 893 1.00CFM 1/60 CM


2012-01-24 12:26:14 204531 915 1.00CFM 1/60 CM
2012-01-24 12:26:51 204659 914 1.00CFM 1/60 CM
2012-01-24 12:27:28 204507 910 1.00CFM 1/60 CM
2012-01-24 12:28:00 204568 910 1.00CFM 1/60 CM
2012-01-24 12:28:37 204562 902 1.00CFM 1/60 CM
2012-01-24 12:29:09 204581 914 1.00CFM 1/60 CM
2012-01-24 12:29:45 204581 893 1.00CFM 1/60 CM
2012-01-24 12:30:22 204628 891 1.00CFM 1/60 CM
2012-01-24 12:30:58 204567 891 1.00CFM 1/60 CM
2012-01-24 12:31:29 204568 888 1.00CFM 1/60 CM
2012-01-24 12:32:06 204643 895 1.00CFM 1/60 CM
2012-01-24 12:32:45 204634 893 1.00CFM 1/60 CM
2012-01-24 12:33:16 204699 910 1.00CFM 1/60 CM
2012-01-24 12:33:52 204513 886 1.00CFM 1/60 CM
2012-01-24 12:34:24 204504 910 1.00CFM 1/60 CM
2012-01-24 12:35:00 204690 897 1.00CFM 1/60 CM
2012-01-24 12:35:37 204582 885 1.00CFM 1/60 CM
2012-01-24 12:36:08 204563 894 1.00CFM 1/60 CM
2012-01-24 12:36:46 204663 893 1.00CFM 1/60 CM
2012-01-24 12:37:22 204627 894 1.00CFM 1/60 CM
2012-01-24 12:37:54 204492 896 1.00CFM 1/60 CM
2012-01-24 12:38:31 204657 895 1.00CFM 1/60 CM
2012-01-24 12:39:08 204683 902 1.00CFM 1/60 CM
2012-01-24 12:39:39 204563 893 1.00CFM 1/60 CM
2012-01-24 12:40:16 204597 910 1.00CFM 1/60 CM
2012-01-24 12:40:50 204545 891 1.00CFM 1/60 CM
2012-01-24 12:41:27 204570 911 1.00CFM 1/60 CM
2012-01-24 12:41:59 204640 885 1.00CFM 1/60 CM
2012-01-24 12:42:35 204638 888 1.00CFM 1/60 CM
2012-01-24 12:43:12 204529 898 1.00CFM 1/60 CM
2012-01-24 12:43:43 204601 906 1.00CFM 1/60 CM
2012-01-24 12:44:19 204648 907 1.00CFM 1/60 CM
2012-01-24 12:44:56 204649 905 1.00CFM 1/60 CM
2012-01-24 12:45:32 204549 899 1.00CFM 1/60 CM
2012-01-24 12:46:05 204645 892 1.00CFM 1/60 CM
2012-01-24 12:46:42 204492 904 1.00CFM 1/60 CM
2012-01-24 12:47:13 204586 900 1.00CFM 1/60 CM
2012-01-24 12:47:50 204667 890 1.00CFM 1/60 CM
2012-01-24 12:48:26 204707 910 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 99 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:49:03 204617 908 1.00CFM 1/60 CM


2012-01-24 12:49:34 204516 891 1.00CFM 1/60 CM
2012-01-24 12:50:11 204653 898 1.00CFM 1/60 CM
2012-01-24 12:50:47 204583 890 1.00CFM 1/60 CM
2012-01-24 12:51:19 204518 890 1.00CFM 1/60 CM
2012-01-24 12:51:55 204491 896 1.00CFM 1/60 CM
2012-01-24 12:52:31 204582 899 1.00CFM 1/60 CM
2012-01-24 12:53:08 204635 906 1.00CFM 1/60 CM
2012-01-24 12:53:43 204490 890 1.00CFM 1/60 CM
2012-01-24 12:54:15 204502 899 1.00CFM 1/60 CM
2012-01-24 12:54:53 204633 913 1.00CFM 1/60 CM
2012-01-24 12:55:25 204640 894 1.00CFM 1/60 CM
2012-01-24 12:56:02 204601 915 1.00CFM 1/60 CM
2012-01-24 12:56:33 204562 915 1.00CFM 1/60 CM
2012-01-24 12:57:10 204505 896 1.00CFM 1/60 CM
2012-01-24 12:57:47 204686 907 1.00CFM 1/60 CM
2012-01-24 12:58:23 204665 906 1.00CFM 1/60 CM
2012-01-24 12:58:55 204658 890 1.00CFM 1/60 CM
2012-01-24 12:59:32 204675 909 1.00CFM 1/60 CM
2012-01-24 13:00:03 204619 911 1.00CFM 1/60 CM
2012-01-24 13:00:40 204703 899 1.00CFM 1/60 CM
2012-01-24 13:01:17 204622 903 1.00CFM 1/60 CM
2012-01-24 13:01:49 204495 899 1.00CFM 1/60 CM
2012-01-24 13:02:25 204622 899 1.00CFM 1/60 CM
2012-01-24 13:03:02 204595 906 1.00CFM 1/60 CM
2012-01-24 13:03:38 204571 886 1.00CFM 1/60 CM
2012-01-24 13:04:11 204630 885 1.00CFM 1/60 CM
2012-01-24 13:04:48 204673 891 1.00CFM 1/60 CM
2012-01-24 13:05:19 204685 894 1.00CFM 1/60 CM
2012-01-24 13:05:57 204650 907 1.00CFM 1/60 CM
2012-01-24 13:06:33 204640 889 1.00CFM 1/60 CM
2012-01-24 13:07:04 204696 914 1.00CFM 1/60 CM
2012-01-24 13:07:41 204669 902 1.00CFM 1/60 CM
2012-01-24 13:08:18 204674 894 1.00CFM 1/60 CM
2012-01-24 13:08:51 204693 908 1.00CFM 1/60 CM
2012-01-24 13:09:27 204508 912 1.00CFM 1/60 CM
2012-01-24 13:09:59 204516 892 1.00CFM 1/60 CM
2012-01-24 13:10:35 204695 905 1.00CFM 1/60 CM
2012-01-24 13:11:13 204541 887 1.00CFM 1/60 CM
2012-01-24 13:11:44 204686 901 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 100 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 13:12:20 204625 910 1.00CFM 1/60 CM


2012-01-24 13:12:57 204543 910 1.00CFM 1/60 CM
2012-01-24 13:13:28 204547 885 1.00CFM 1/60 CM
2012-01-24 13:14:05 204526 887 1.00CFM 1/60 CM
2012-01-24 13:14:42 204621 908 1.00CFM 1/60 CM
2012-01-24 13:15:15 204563 910 1.00CFM 1/60 CM
2012-01-24 13:15:52 204642 897 1.00CFM 1/60 CM
2012-01-24 13:16:24 204595 899 1.00CFM 1/60 CM
2012-01-24 13:17:01 204628 903 1.00CFM 1/60 CM
2012-01-24 13:17:38 204534 897 1.00CFM 1/60 CM
2012-01-24 13:18:10 204627 909 1.00CFM 1/60 CM
2012-01-24 13:18:47 204576 907 1.00CFM 1/60 CM
2012-01-24 13:19:19 204519 903 1.00CFM 1/60 CM
2012-01-24 13:19:55 204498 910 1.00CFM 1/60 CM
2012-01-24 13:20:32 204614 910 1.00CFM 1/60 CM
2012-01-24 13:21:03 204617 907 1.00CFM 1/60 CM
2012-01-24 13:21:40 204525 896 1.00CFM 1/60 CM
2012-01-24 13:22:16 204490 901 1.00CFM 1/60 CM
2012-01-24 13:22:49 204625 885 1.00CFM 1/60 CM
2012-01-24 13:23:25 204706 886 1.00CFM 1/60 CM
2012-01-24 13:24:02 204535 911 1.00CFM 1/60 CM
2012-01-24 13:24:38 204564 886 1.00CFM 1/60 CM
2012-01-24 13:25:10 204645 906 1.00CFM 1/60 CM
2012-01-24 13:25:52 204505 892 1.00CFM 1/60 CM
2012-01-24 13:26:18 204671 909 1.00CFM 1/60 CM
2012-01-24 13:26:55 204630 906 1.00CFM 1/60 CM
2012-01-24 13:27:31 204531 885 1.00CFM 1/60 CM
2012-01-24 13:28:08 204632 911 1.00CFM 1/60 CM
2012-01-24 13:28:39 204537 894 1.00CFM 1/60 CM
2012-01-24 13:29:18 204633 886 1.00CFM 1/60 CM
2012-01-24 13:29:49 204495 905 1.00CFM 1/60 CM

DataPro 3 V1.20, Validation


Completed By: Page 101 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact

CLiMET Instruments Company


Raw Data Report
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:57:45
Author: Kyle Kuehm
Data count: Rolling Count
Area: Ampule Filling Machine 1
Location: Point 3
Number of samples: 240
≥ 0.5 µm, ≥ 5.0
Particle Sizes: µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.3.2

≥ 0.5 ≥ 5.0
Timestamp µm µm Flow Volume
2012-01-24 09:30:11 99 0 1.00CFM 1CF
2012-01-24 09:31:12 91 0 1.00CFM 1CF
2012-01-24 09:32:09 84 0 1.00CFM 1CF
2012-01-24 09:33:12 85 0 1.00CFM 1CF
2012-01-24 09:34:09 74 0 1.00CFM 1CF
2012-01-24 09:35:12 86 0 1.00CFM 1CF
2012-01-24 09:36:15 86 0 1.00CFM 1CF
2012-01-24 09:37:13 95 0 1.00CFM 1CF
2012-01-24 09:38:11 85 0 1.00CFM 1CF
2012-01-24 09:39:14 78 0 1.00CFM 1CF
2012-01-24 09:40:11 74 0 1.00CFM 1CF
2012-01-24 09:41:14 87 0 1.00CFM 1CF
2012-01-24 09:42:11 97 0 1.00CFM 1CF
2012-01-24 09:43:14 74 0 1.00CFM 1CF
2012-01-24 09:44:11 93 0 1.00CFM 1CF
2012-01-24 09:45:09 81 0 1.00CFM 1CF
2012-01-24 09:46:12 84 0 1.00CFM 1CF
2012-01-24 09:47:11 86 0 1.00CFM 1CF
2012-01-24 09:48:13 92 0 1.00CFM 1CF
2012-01-24 09:49:11 90 0 1.00CFM 1CF
2012-01-24 09:50:10 83 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 102 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 09:51:12 95 0 1.00CFM 1CF


2012-01-24 09:52:15 89 0 1.00CFM 1CF
2012-01-24 09:53:13 94 0 1.00CFM 1CF
2012-01-24 09:54:10 93 0 1.00CFM 1CF
2012-01-24 09:55:13 72 0 1.00CFM 1CF
2012-01-24 09:56:11 83 0 1.00CFM 1CF
2012-01-24 09:57:11 91 0 1.00CFM 1CF
2012-01-24 09:58:14 91 0 1.00CFM 1CF
2012-01-24 09:59:12 74 0 1.00CFM 1CF
2012-01-24 10:00:14 86 0 1.00CFM 1CF
2012-01-24 10:01:13 85 0 1.00CFM 1CF
2012-01-24 10:02:10 90 0 1.00CFM 1CF
2012-01-24 10:03:14 82 0 1.00CFM 1CF
2012-01-24 10:04:12 78 0 1.00CFM 1CF
2012-01-24 10:05:10 90 0 1.00CFM 1CF
2012-01-24 10:06:12 72 0 1.00CFM 1CF
2012-01-24 10:07:10 83 0 1.00CFM 1CF
2012-01-24 10:08:12 88 0 1.00CFM 1CF
2012-01-24 10:09:09 74 0 1.00CFM 1CF
2012-01-24 10:10:14 81 0 1.00CFM 1CF
2012-01-24 10:11:12 84 0 1.00CFM 1CF
2012-01-24 10:12:10 77 0 1.00CFM 1CF
2012-01-24 10:13:14 87 0 1.00CFM 1CF
2012-01-24 10:14:11 82 0 1.00CFM 1CF
2012-01-24 10:15:10 78 0 1.00CFM 1CF
2012-01-24 10:16:14 75 0 1.00CFM 1CF
2012-01-24 10:17:11 74 0 1.00CFM 1CF
2012-01-24 10:18:13 95 0 1.00CFM 1CF
2012-01-24 10:19:11 99 0 1.00CFM 1CF
2012-01-24 10:20:13 92 0 1.00CFM 1CF
2012-01-24 10:21:11 81 0 1.00CFM 1CF
2012-01-24 10:22:10 92 0 1.00CFM 1CF
2012-01-24 10:23:14 98 0 1.00CFM 1CF
2012-01-24 10:24:11 77 0 1.00CFM 1CF
2012-01-24 10:25:15 79 0 1.00CFM 1CF
2012-01-24 10:26:13 83 0 1.00CFM 1CF
2012-01-24 10:27:11 71 0 1.00CFM 1CF
2012-01-24 10:28:13 74 0 1.00CFM 1CF
2012-01-24 10:29:10 89 0 1.00CFM 1CF
2012-01-24 10:30:13 90 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 103 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:31:11 79 0 1.00CFM 1CF


2012-01-24 10:32:10 96 0 1.00CFM 1CF
2012-01-24 10:33:13 83 0 1.00CFM 1CF
2012-01-24 10:34:11 82 0 1.00CFM 1CF
2012-01-24 10:35:14 76 0 1.00CFM 1CF
2012-01-24 10:36:11 80 0 1.00CFM 1CF
2012-01-24 10:37:19 95 0 1.00CFM 1CF
2012-01-24 10:38:12 77 0 1.00CFM 1CF
2012-01-24 10:39:15 85 0 1.00CFM 1CF
2012-01-24 10:40:13 89 0 1.00CFM 1CF
2012-01-24 10:41:13 87 0 1.00CFM 1CF
2012-01-24 10:42:11 91 0 1.00CFM 1CF
2012-01-24 10:43:15 94 0 1.00CFM 1CF
2012-01-24 10:44:14 75 0 1.00CFM 1CF
2012-01-24 10:45:12 90 0 1.00CFM 1CF
2012-01-24 10:46:14 96 0 1.00CFM 1CF
2012-01-24 10:47:12 93 0 1.00CFM 1CF
2012-01-24 10:48:10 71 0 1.00CFM 1CF
2012-01-24 10:49:13 83 0 1.00CFM 1CF
2012-01-24 10:50:11 94 0 1.00CFM 1CF
2012-01-24 10:51:10 84 0 1.00CFM 1CF
2012-01-24 10:52:14 86 0 1.00CFM 1CF
2012-01-24 10:53:11 80 0 1.00CFM 1CF
2012-01-24 10:54:10 85 0 1.00CFM 1CF
2012-01-24 10:55:13 85 0 1.00CFM 1CF
2012-01-24 10:56:10 91 0 1.00CFM 1CF
2012-01-24 10:57:14 97 0 1.00CFM 1CF
2012-01-24 10:58:11 94 0 1.00CFM 1CF
2012-01-24 10:59:15 95 0 1.00CFM 1CF
2012-01-24 11:00:12 97 0 1.00CFM 1CF
2012-01-24 11:01:14 71 0 1.00CFM 1CF
2012-01-24 11:02:13 88 0 1.00CFM 1CF
2012-01-24 11:03:10 90 0 1.00CFM 1CF
2012-01-24 11:04:14 85 0 1.00CFM 1CF
2012-01-24 11:05:11 86 0 1.00CFM 1CF
2012-01-24 11:06:10 98 0 1.00CFM 1CF
2012-01-24 11:07:12 86 0 1.00CFM 1CF
2012-01-24 11:08:16 79 0 1.00CFM 1CF
2012-01-24 11:09:13 96 0 1.00CFM 1CF
2012-01-24 11:10:11 77 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 104 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:11:13 79 0 1.00CFM 1CF


2012-01-24 11:12:13 72 0 1.00CFM 1CF
2012-01-24 11:13:13 79 0 1.00CFM 1CF
2012-01-24 11:14:10 74 0 1.00CFM 1CF
2012-01-24 11:15:13 81 0 1.00CFM 1CF
2012-01-24 11:16:11 72 0 1.00CFM 1CF
2012-01-24 11:17:10 71 0 1.00CFM 1CF
2012-01-24 11:18:13 82 0 1.00CFM 1CF
2012-01-24 11:19:10 76 0 1.00CFM 1CF
2012-01-24 11:20:13 77 0 1.00CFM 1CF
2012-01-24 11:21:11 72 0 1.00CFM 1CF
2012-01-24 11:22:14 79 0 1.00CFM 1CF
2012-01-24 11:23:11 93 0 1.00CFM 1CF
2012-01-24 11:24:10 79 0 1.00CFM 1CF
2012-01-24 11:25:12 88 0 1.00CFM 1CF
2012-01-24 11:26:10 89 0 1.00CFM 1CF
2012-01-24 11:27:13 79 0 1.00CFM 1CF
2012-01-24 11:28:10 83 0 1.00CFM 1CF
2012-01-24 11:29:13 85 0 1.00CFM 1CF
2012-01-24 11:30:10 91 0 1.00CFM 1CF
2012-01-24 11:31:13 93 0 1.00CFM 1CF
2012-01-24 11:32:12 90 0 1.00CFM 1CF
2012-01-24 11:33:15 84 0 1.00CFM 1CF
2012-01-24 11:34:12 86 0 1.00CFM 1CF
2012-01-24 11:35:14 76 0 1.00CFM 1CF
2012-01-24 11:36:11 90 0 1.00CFM 1CF
2012-01-24 11:37:12 73 0 1.00CFM 1CF
2012-01-24 11:38:11 85 0 1.00CFM 1CF
2012-01-24 11:39:15 74 0 1.00CFM 1CF
2012-01-24 11:40:13 93 0 1.00CFM 1CF
2012-01-24 11:41:12 98 0 1.00CFM 1CF
2012-01-24 11:42:14 98 0 1.00CFM 1CF
2012-01-24 11:43:14 97 0 1.00CFM 1CF
2012-01-24 11:44:11 98 0 1.00CFM 1CF
2012-01-24 11:45:14 99 0 1.00CFM 1CF
2012-01-24 11:46:14 85 0 1.00CFM 1CF
2012-01-24 11:47:13 94 0 1.00CFM 1CF
2012-01-24 11:48:15 93 0 1.00CFM 1CF
2012-01-24 11:49:13 91 0 1.00CFM 1CF
2012-01-24 11:50:11 94 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 105 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:51:14 72 0 1.00CFM 1CF


2012-01-24 11:52:12 79 0 1.00CFM 1CF
2012-01-24 11:53:14 85 0 1.00CFM 1CF
2012-01-24 11:54:12 99 0 1.00CFM 1CF
2012-01-24 11:55:14 72 0 1.00CFM 1CF
2012-01-24 11:56:12 80 0 1.00CFM 1CF
2012-01-24 11:57:10 80 0 1.00CFM 1CF
2012-01-24 11:58:13 71 0 1.00CFM 1CF
2012-01-24 11:59:10 84 0 1.00CFM 1CF
2012-01-24 12:00:14 81 0 1.00CFM 1CF
2012-01-24 12:01:12 97 0 1.00CFM 1CF
2012-01-24 12:02:09 82 0 1.00CFM 1CF
2012-01-24 12:03:12 79 0 1.00CFM 1CF
2012-01-24 12:04:15 96 0 1.00CFM 1CF
2012-01-24 12:05:14 83 0 1.00CFM 1CF
2012-01-24 12:06:13 75 0 1.00CFM 1CF
2012-01-24 12:07:10 76 0 1.00CFM 1CF
2012-01-24 12:08:13 94 0 1.00CFM 1CF
2012-01-24 12:09:10 73 0 1.00CFM 1CF
2012-01-24 12:10:13 98 0 1.00CFM 1CF
2012-01-24 12:11:10 87 0 1.00CFM 1CF
2012-01-24 12:12:13 75 0 1.00CFM 1CF
2012-01-24 12:13:10 92 0 1.00CFM 1CF
2012-01-24 12:14:14 89 0 1.00CFM 1CF
2012-01-24 12:15:14 72 0 1.00CFM 1CF
2012-01-24 12:16:12 83 0 1.00CFM 1CF
2012-01-24 12:17:15 74 0 1.00CFM 1CF
2012-01-24 12:18:13 84 0 1.00CFM 1CF
2012-01-24 12:19:16 79 0 1.00CFM 1CF
2012-01-24 12:20:14 84 0 1.00CFM 1CF
2012-01-24 12:21:15 90 0 1.00CFM 1CF
2012-01-24 12:22:12 83 0 1.00CFM 1CF
2012-01-24 12:23:15 87 0 1.00CFM 1CF
2012-01-24 12:24:14 73 0 1.00CFM 1CF
2012-01-24 12:25:11 76 0 1.00CFM 1CF
2012-01-24 12:26:09 73 0 1.00CFM 1CF
2012-01-24 12:27:12 82 0 1.00CFM 1CF
2012-01-24 12:28:10 95 0 1.00CFM 1CF
2012-01-24 12:29:14 95 0 1.00CFM 1CF
2012-01-24 12:30:11 84 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 106 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:31:14 81 0 1.00CFM 1CF


2012-01-24 12:32:11 93 0 1.00CFM 1CF
2012-01-24 12:33:11 75 0 1.00CFM 1CF
2012-01-24 12:34:13 73 0 1.00CFM 1CF
2012-01-24 12:35:11 99 0 1.00CFM 1CF
2012-01-24 12:36:13 92 0 1.00CFM 1CF
2012-01-24 12:37:12 91 0 1.00CFM 1CF
2012-01-24 12:38:14 98 0 1.00CFM 1CF
2012-01-24 12:39:13 83 0 1.00CFM 1CF
2012-01-24 12:40:11 80 0 1.00CFM 1CF
2012-01-24 12:41:12 95 0 1.00CFM 1CF
2012-01-24 12:42:14 79 0 1.00CFM 1CF
2012-01-24 12:43:12 88 0 1.00CFM 1CF
2012-01-24 12:44:14 82 0 1.00CFM 1CF
2012-01-24 12:45:12 77 0 1.00CFM 1CF
2012-01-24 12:46:10 96 0 1.00CFM 1CF
2012-01-24 12:47:13 96 0 1.00CFM 1CF
2012-01-24 12:48:11 77 0 1.00CFM 1CF
2012-01-24 12:49:14 72 0 1.00CFM 1CF
2012-01-24 12:50:11 96 0 1.00CFM 1CF
2012-01-24 12:51:13 91 0 1.00CFM 1CF
2012-01-24 12:52:11 93 0 1.00CFM 1CF
2012-01-24 12:53:13 86 0 1.00CFM 1CF
2012-01-24 12:54:15 78 0 1.00CFM 1CF
2012-01-24 12:55:14 77 0 1.00CFM 1CF
2012-01-24 12:56:13 73 0 1.00CFM 1CF
2012-01-24 12:57:16 72 0 1.00CFM 1CF
2012-01-24 12:58:13 89 0 1.00CFM 1CF
2012-01-24 12:59:10 96 0 1.00CFM 1CF
2012-01-24 13:00:14 98 0 1.00CFM 1CF
2012-01-24 13:01:11 86 0 1.00CFM 1CF
2012-01-24 13:02:15 85 0 1.00CFM 1CF
2012-01-24 13:03:12 90 0 1.00CFM 1CF
2012-01-24 13:04:11 94 0 1.00CFM 1CF
2012-01-24 13:05:14 78 0 1.00CFM 1CF
2012-01-24 13:06:12 95 0 1.00CFM 1CF
2012-01-24 13:07:15 75 0 1.00CFM 1CF
2012-01-24 13:08:12 85 0 1.00CFM 1CF
2012-01-24 13:09:12 89 0 1.00CFM 1CF
2012-01-24 13:10:14 96 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 107 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 13:11:13 74 0 1.00CFM 1CF


2012-01-24 13:12:10 90 0 1.00CFM 1CF
2012-01-24 13:13:13 99 0 1.00CFM 1CF
2012-01-24 13:14:10 87 0 1.00CFM 1CF
2012-01-24 13:15:15 77 0 1.00CFM 1CF
2012-01-24 13:16:13 74 0 1.00CFM 1CF
2012-01-24 13:17:11 77 0 1.00CFM 1CF
2012-01-24 13:18:10 93 0 1.00CFM 1CF
2012-01-24 13:19:13 80 0 1.00CFM 1CF
2012-01-24 13:20:11 94 0 1.00CFM 1CF
2012-01-24 13:21:14 87 0 1.00CFM 1CF
2012-01-24 13:22:11 79 0 1.00CFM 1CF
2012-01-24 13:23:09 80 0 1.00CFM 1CF
2012-01-24 13:24:12 84 0 1.00CFM 1CF
2012-01-24 13:25:10 87 0 1.00CFM 1CF
2012-01-24 13:26:13 71 0 1.00CFM 1CF
2012-01-24 13:27:11 74 0 1.00CFM 1CF
2012-01-24 13:28:13 89 0 1.00CFM 1CF
2012-01-24 13:29:12 87 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 108 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact

CLiMET Instruments Company


Raw Data Report
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 11:57:45
Author: Kyle Kuehm
Data count: Rolling Count
Area: Ampule Filling Machine 1
Point
Location: 4
Number of samples: 240
≥ 0.5 µm, ≥ 5.0
Particle Sizes: µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.3.2

≥ 0.5 ≥ 5.0
Timestamp µm µm Flow Volume
2012-01-24 09:30:11 79 0 1.00CFM 1CF
2012-01-24 09:31:12 71 0 1.00CFM 1CF
2012-01-24 09:32:15 90 0 1.00CFM 1CF
2012-01-24 09:33:12 79 0 1.00CFM 1CF
2012-01-24 09:34:15 71 0 1.00CFM 1CF
2012-01-24 09:35:12 74 0 1.00CFM 1CF
2012-01-24 09:36:15 98 0 1.00CFM 1CF
2012-01-24 09:37:13 71 0 1.00CFM 1CF
2012-01-24 09:38:11 80 0 1.00CFM 1CF
2012-01-24 09:39:14 84 0 1.00CFM 1CF
2012-01-24 09:40:11 79 0 1.00CFM 1CF
2012-01-24 09:41:14 94 0 1.00CFM 1CF
2012-01-24 09:42:11 98 0 1.00CFM 1CF
2012-01-24 09:43:14 75 0 1.00CFM 1CF
2012-01-24 09:44:11 86 0 1.00CFM 1CF
2012-01-24 09:45:15 89 0 1.00CFM 1CF
2012-01-24 09:46:12 79 0 1.00CFM 1CF
2012-01-24 09:47:16 74 0 1.00CFM 1CF
2012-01-24 09:48:13 81 0 1.00CFM 1CF
2012-01-24 09:49:12 90 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 109 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 09:50:15 88 0 1.00CFM 1CF


2012-01-24 09:51:12 86 0 1.00CFM 1CF
2012-01-24 09:52:15 76 0 1.00CFM 1CF
2012-01-24 09:53:13 75 0 1.00CFM 1CF
2012-01-24 09:54:16 88 0 1.00CFM 1CF
2012-01-24 09:55:13 82 0 1.00CFM 1CF
2012-01-24 09:56:12 71 0 1.00CFM 1CF
2012-01-24 09:57:16 90 0 1.00CFM 1CF
2012-01-24 09:58:14 96 0 1.00CFM 1CF
2012-01-24 09:59:12 86 0 1.00CFM 1CF
2012-01-24 10:00:14 81 0 1.00CFM 1CF
2012-01-24 10:01:13 88 0 1.00CFM 1CF
2012-01-24 10:02:16 78 0 1.00CFM 1CF
2012-01-24 10:03:14 91 0 1.00CFM 1CF
2012-01-24 10:04:12 75 0 1.00CFM 1CF
2012-01-24 10:05:15 87 0 1.00CFM 1CF
2012-01-24 10:06:12 85 0 1.00CFM 1CF
2012-01-24 10:07:15 72 0 1.00CFM 1CF
2012-01-24 10:08:12 79 0 1.00CFM 1CF
2012-01-24 10:09:15 99 0 1.00CFM 1CF
2012-01-24 10:10:14 76 0 1.00CFM 1CF
2012-01-24 10:11:12 98 0 1.00CFM 1CF
2012-01-24 10:12:15 84 0 1.00CFM 1CF
2012-01-24 10:13:14 96 0 1.00CFM 1CF
2012-01-24 10:14:11 95 0 1.00CFM 1CF
2012-01-24 10:15:15 74 0 1.00CFM 1CF
2012-01-24 10:16:15 72 0 1.00CFM 1CF
2012-01-24 10:17:16 78 0 1.00CFM 1CF
2012-01-24 10:18:13 80 0 1.00CFM 1CF
2012-01-24 10:19:16 87 0 1.00CFM 1CF
2012-01-24 10:20:13 73 0 1.00CFM 1CF
2012-01-24 10:21:16 97 0 1.00CFM 1CF
2012-01-24 10:22:15 95 0 1.00CFM 1CF
2012-01-24 10:23:14 77 0 1.00CFM 1CF
2012-01-24 10:24:11 90 0 1.00CFM 1CF
2012-01-24 10:25:15 95 0 1.00CFM 1CF
2012-01-24 10:26:13 87 0 1.00CFM 1CF
2012-01-24 10:27:16 80 0 1.00CFM 1CF
2012-01-24 10:28:13 91 0 1.00CFM 1CF
2012-01-24 10:29:16 76 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 110 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 10:30:13 86 0 1.00CFM 1CF


2012-01-24 10:31:12 82 0 1.00CFM 1CF
2012-01-24 10:32:15 86 0 1.00CFM 1CF
2012-01-24 10:33:14 99 0 1.00CFM 1CF
2012-01-24 10:34:11 76 0 1.00CFM 1CF
2012-01-24 10:35:14 79 0 1.00CFM 1CF
2012-01-24 10:36:11 87 0 1.00CFM 1CF
2012-01-24 10:37:19 86 0 1.00CFM 1CF
2012-01-24 10:38:12 82 0 1.00CFM 1CF
2012-01-24 10:39:15 81 0 1.00CFM 1CF
2012-01-24 10:40:13 92 0 1.00CFM 1CF
2012-01-24 10:41:13 82 0 1.00CFM 1CF
2012-01-24 10:42:16 87 0 1.00CFM 1CF
2012-01-24 10:43:15 72 0 1.00CFM 1CF
2012-01-24 10:44:14 74 0 1.00CFM 1CF
2012-01-24 10:45:12 93 0 1.00CFM 1CF
2012-01-24 10:46:15 77 0 1.00CFM 1CF
2012-01-24 10:47:12 98 0 1.00CFM 1CF
2012-01-24 10:48:15 76 0 1.00CFM 1CF
2012-01-24 10:49:13 99 0 1.00CFM 1CF
2012-01-24 10:50:11 72 0 1.00CFM 1CF
2012-01-24 10:51:15 99 0 1.00CFM 1CF
2012-01-24 10:52:14 95 0 1.00CFM 1CF
2012-01-24 10:53:11 92 0 1.00CFM 1CF
2012-01-24 10:54:15 87 0 1.00CFM 1CF
2012-01-24 10:55:13 78 0 1.00CFM 1CF
2012-01-24 10:56:15 80 0 1.00CFM 1CF
2012-01-24 10:57:14 87 0 1.00CFM 1CF
2012-01-24 10:58:16 84 0 1.00CFM 1CF
2012-01-24 10:59:15 95 0 1.00CFM 1CF
2012-01-24 11:00:12 88 0 1.00CFM 1CF
2012-01-24 11:01:15 72 0 1.00CFM 1CF
2012-01-24 11:02:13 86 0 1.00CFM 1CF
2012-01-24 11:03:17 71 0 1.00CFM 1CF
2012-01-24 11:04:14 96 0 1.00CFM 1CF
2012-01-24 11:05:12 72 0 1.00CFM 1CF
2012-01-24 11:06:15 86 0 1.00CFM 1CF
2012-01-24 11:07:13 87 0 1.00CFM 1CF
2012-01-24 11:08:16 87 0 1.00CFM 1CF
2012-01-24 11:09:13 95 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 111 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:10:16 80 0 1.00CFM 1CF


2012-01-24 11:11:13 87 0 1.00CFM 1CF
2012-01-24 11:12:13 87 0 1.00CFM 1CF
2012-01-24 11:13:13 77 0 1.00CFM 1CF
2012-01-24 11:14:16 86 0 1.00CFM 1CF
2012-01-24 11:15:13 87 0 1.00CFM 1CF
2012-01-24 11:16:16 77 0 1.00CFM 1CF
2012-01-24 11:17:15 82 0 1.00CFM 1CF
2012-01-24 11:18:13 99 0 1.00CFM 1CF
2012-01-24 11:19:16 80 0 1.00CFM 1CF
2012-01-24 11:20:13 88 0 1.00CFM 1CF
2012-01-24 11:21:11 84 0 1.00CFM 1CF
2012-01-24 11:22:14 76 0 1.00CFM 1CF
2012-01-24 11:23:12 80 0 1.00CFM 1CF
2012-01-24 11:24:15 78 0 1.00CFM 1CF
2012-01-24 11:25:13 99 0 1.00CFM 1CF
2012-01-24 11:26:15 88 0 1.00CFM 1CF
2012-01-24 11:27:13 84 0 1.00CFM 1CF
2012-01-24 11:28:15 76 0 1.00CFM 1CF
2012-01-24 11:29:13 74 0 1.00CFM 1CF
2012-01-24 11:30:15 78 0 1.00CFM 1CF
2012-01-24 11:31:14 99 0 1.00CFM 1CF
2012-01-24 11:32:12 82 0 1.00CFM 1CF
2012-01-24 11:33:15 79 0 1.00CFM 1CF
2012-01-24 11:34:12 96 0 1.00CFM 1CF
2012-01-24 11:35:14 97 0 1.00CFM 1CF
2012-01-24 11:36:11 97 0 1.00CFM 1CF
2012-01-24 11:37:12 91 0 1.00CFM 1CF
2012-01-24 11:38:11 76 0 1.00CFM 1CF
2012-01-24 11:39:15 96 0 1.00CFM 1CF
2012-01-24 11:40:13 99 0 1.00CFM 1CF
2012-01-24 11:41:12 96 0 1.00CFM 1CF
2012-01-24 11:42:14 82 0 1.00CFM 1CF
2012-01-24 11:43:14 84 0 1.00CFM 1CF
2012-01-24 11:44:11 87 0 1.00CFM 1CF
2012-01-24 11:45:14 77 0 1.00CFM 1CF
2012-01-24 11:46:14 73 0 1.00CFM 1CF
2012-01-24 11:47:13 73 0 1.00CFM 1CF
2012-01-24 11:48:15 97 0 1.00CFM 1CF
2012-01-24 11:49:13 85 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 112 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 11:50:16 82 0 1.00CFM 1CF


2012-01-24 11:51:15 91 0 1.00CFM 1CF
2012-01-24 11:52:12 92 0 1.00CFM 1CF
2012-01-24 11:53:14 87 0 1.00CFM 1CF
2012-01-24 11:54:12 77 0 1.00CFM 1CF
2012-01-24 11:55:14 88 0 1.00CFM 1CF
2012-01-24 11:56:12 92 0 1.00CFM 1CF
2012-01-24 11:57:15 97 0 1.00CFM 1CF
2012-01-24 11:58:13 79 0 1.00CFM 1CF
2012-01-24 11:59:15 71 0 1.00CFM 1CF
2012-01-24 12:00:14 99 0 1.00CFM 1CF
2012-01-24 12:01:12 99 0 1.00CFM 1CF
2012-01-24 12:02:15 88 0 1.00CFM 1CF
2012-01-24 12:03:12 74 0 1.00CFM 1CF
2012-01-24 12:04:15 82 0 1.00CFM 1CF
2012-01-24 12:05:14 77 0 1.00CFM 1CF
2012-01-24 12:06:13 79 0 1.00CFM 1CF
2012-01-24 12:07:15 86 0 1.00CFM 1CF
2012-01-24 12:08:13 78 0 1.00CFM 1CF
2012-01-24 12:09:15 76 0 1.00CFM 1CF
2012-01-24 12:10:13 81 0 1.00CFM 1CF
2012-01-24 12:11:16 92 0 1.00CFM 1CF
2012-01-24 12:12:13 96 0 1.00CFM 1CF
2012-01-24 12:13:16 96 0 1.00CFM 1CF
2012-01-24 12:14:14 97 0 1.00CFM 1CF
2012-01-24 12:15:14 85 0 1.00CFM 1CF
2012-01-24 12:16:12 90 0 1.00CFM 1CF
2012-01-24 12:17:15 94 0 1.00CFM 1CF
2012-01-24 12:18:13 72 0 1.00CFM 1CF
2012-01-24 12:19:16 91 0 1.00CFM 1CF
2012-01-24 12:20:14 81 0 1.00CFM 1CF
2012-01-24 12:21:15 87 0 1.00CFM 1CF
2012-01-24 12:22:13 72 0 1.00CFM 1CF
2012-01-24 12:23:15 93 0 1.00CFM 1CF
2012-01-24 12:24:14 93 0 1.00CFM 1CF
2012-01-24 12:25:16 78 0 1.00CFM 1CF
2012-01-24 12:26:15 99 0 1.00CFM 1CF
2012-01-24 12:27:12 75 0 1.00CFM 1CF
2012-01-24 12:28:17 86 0 1.00CFM 1CF
2012-01-24 12:29:14 82 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 113 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 12:30:16 99 0 1.00CFM 1CF


2012-01-24 12:31:14 97 0 1.00CFM 1CF
2012-01-24 12:32:11 84 0 1.00CFM 1CF
2012-01-24 12:33:16 81 0 1.00CFM 1CF
2012-01-24 12:34:14 93 0 1.00CFM 1CF
2012-01-24 12:35:16 81 0 1.00CFM 1CF
2012-01-24 12:36:14 87 0 1.00CFM 1CF
2012-01-24 12:37:12 71 0 1.00CFM 1CF
2012-01-24 12:38:14 79 0 1.00CFM 1CF
2012-01-24 12:39:13 91 0 1.00CFM 1CF
2012-01-24 12:40:11 96 0 1.00CFM 1CF
2012-01-24 12:41:12 79 0 1.00CFM 1CF
2012-01-24 12:42:14 75 0 1.00CFM 1CF
2012-01-24 12:43:12 75 0 1.00CFM 1CF
2012-01-24 12:44:14 80 0 1.00CFM 1CF
2012-01-24 12:45:12 92 0 1.00CFM 1CF
2012-01-24 12:46:16 72 0 1.00CFM 1CF
2012-01-24 12:47:13 91 0 1.00CFM 1CF
2012-01-24 12:48:11 96 0 1.00CFM 1CF
2012-01-24 12:49:14 99 0 1.00CFM 1CF
2012-01-24 12:50:11 76 0 1.00CFM 1CF
2012-01-24 12:51:13 80 0 1.00CFM 1CF
2012-01-24 12:52:16 95 0 1.00CFM 1CF
2012-01-24 12:53:13 85 0 1.00CFM 1CF
2012-01-24 12:54:15 82 0 1.00CFM 1CF
2012-01-24 12:55:14 86 0 1.00CFM 1CF
2012-01-24 12:56:13 75 0 1.00CFM 1CF
2012-01-24 12:57:16 75 0 1.00CFM 1CF
2012-01-24 12:58:13 89 0 1.00CFM 1CF
2012-01-24 12:59:16 71 0 1.00CFM 1CF
2012-01-24 13:00:14 92 0 1.00CFM 1CF
2012-01-24 13:01:17 77 0 1.00CFM 1CF
2012-01-24 13:02:15 90 0 1.00CFM 1CF
2012-01-24 13:03:12 71 0 1.00CFM 1CF
2012-01-24 13:04:11 73 0 1.00CFM 1CF
2012-01-24 13:05:14 84 0 1.00CFM 1CF
2012-01-24 13:06:12 74 0 1.00CFM 1CF
2012-01-24 13:07:15 86 0 1.00CFM 1CF
2012-01-24 13:08:12 83 0 1.00CFM 1CF
2012-01-24 13:09:12 74 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 114 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

2012-01-24 13:10:14 71 0 1.00CFM 1CF


2012-01-24 13:11:13 91 0 1.00CFM 1CF
2012-01-24 13:12:15 91 0 1.00CFM 1CF
2012-01-24 13:13:13 79 0 1.00CFM 1CF
2012-01-24 13:14:15 75 0 1.00CFM 1CF
2012-01-24 13:15:15 82 0 1.00CFM 1CF
2012-01-24 13:16:13 96 0 1.00CFM 1CF
2012-01-24 13:17:12 98 0 1.00CFM 1CF
2012-01-24 13:18:15 87 0 1.00CFM 1CF
2012-01-24 13:19:14 95 0 1.00CFM 1CF
2012-01-24 13:20:16 78 0 1.00CFM 1CF
2012-01-24 13:21:14 75 0 1.00CFM 1CF
2012-01-24 13:22:16 89 0 1.00CFM 1CF
2012-01-24 13:23:15 98 0 1.00CFM 1CF
2012-01-24 13:24:12 88 0 1.00CFM 1CF
2012-01-24 13:25:15 76 0 1.00CFM 1CF
2012-01-24 13:26:13 92 0 1.00CFM 1CF
2012-01-24 13:27:16 98 0 1.00CFM 1CF
2012-01-24 13:28:13 95 0 1.00CFM 1CF
2012-01-24 13:29:12 93 0 1.00CFM 1CF

DataPro 3 V1.20, Validation


Completed By: Page 115 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
Summary Report
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 12:00:31
Author: Kyle Kuehm
Count mode: Cubic Foot
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.4.1
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CF Maximum /CF Time of Maximum Minimum /CF Volume Alert Action Events # of samples
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Foot 5791.1 5796.7 2012-01-24 10:33:40 5790.5 242.5CF 0 0 0 412
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Foot 13.7 25.9 2012-01-24 09:55:08 25.1 242.5CF 0 0 0 412
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Foot 5801.3 5796.7 2012-01-24 09:48:13 5790.5 242.5CF 0 0 1 412
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 5.0 µm Cubic Foot 12.6 25.9 2012-01-24 10:17:58 25.1 242.5CF 0 0 1 412
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Foot 84.9 99 2012-01-24 09:30:11 71 240CF 0 0 1 240
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Foot 0 0 2012-01-24 09:30:11 0 240CF 0 0 1 240
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Foot 84.8 99 2012-01-24 10:09:15 71 240CF 0 0 0 240
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 5.0 µm Cubic Foot 0 0 2012-01-24 09:30:11 0 240CF 0 0 0 240

DataPro 3 V1.20, Validation


Completed By: Page 116 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
Summary Report
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 12:00:56
Author: Kyle Kuehm
Count mode: Cubic Meter
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.4.2
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events # of samples
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 204509.4 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 482.2 915 2012-01-24 09:55:08 885 6.9CM 0 0 0 412
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Cubic Meter 204870.4 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 5.0 µm Cubic Meter 445.2 915 2012-01-24 10:17:58 885 6.9CM 0 0 1 412
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Cubic Meter 2998.1 3496.2 2012-01-24 09:30:11 2507.3 6.8CM 0 0 1 240
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 1 240
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Cubic Meter 2994.2 3496.2 2012-01-24 10:09:15 2507.3 6.8CM 0 0 0 240
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 5.0 µm Cubic Meter 0 0 2012-01-24 09:30:11 0 6.8CM 0 0 0 240

DataPro 3 V1.20, Validation


Completed By: Page 117 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
Summary Report
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-26 12:01:33
Author: Kyle Kuehm
Count mode: Total Count
Area: Ampule Filling Machine 1
Number of locations: 4
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-24 09:30:00
End of report: 2012-01-24 13:30:00
Purpose of test: Validation 1.4.3
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average Maximum Time of Maximum Minimum Volume Alert Action Events # of samples
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Total Count 204509 204707 2012-01-24 10:33:40 204490 6.9CM 0 0 0 412
Point 1 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Total Count 482.2 915 2012-01-24 09:55:08 885 6.9CM 0 0 0 412
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 0.5 µm Total Count 204870 204710 2012-01-24 09:48:13 204490 6.9CM 0 0 1 412
Point 2 CI-3100-21 CI-3100-21-1-4-6 Mystic Pharma 1.00CFM ≥ 5.0 µm Total Count 445.2 915 2012-01-24 10:17:58 885 6.9CM 0 0 1 412
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 0.5 µm Total Count 84.9 99 2012-01-24 09:30:11 71 240CF 0 0 1 240
Point 3 CI-3100-21 CI-3100-21-1-4-6 1.00CFM ≥ 5.0 µm Total Count 0 0 2012-01-24 09:30:11 0 240CF 0 0 1 240
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 0.5 µm Total Count 84.8 99 2012-01-24 10:09:15 71 240CF 0 0 0 240
Point 4 CI-3100-21 CI-3100 -21 S/N 079090 1.00CFM ≥ 5.0 µm Total Count 0 0 2012-01-24 09:30:11 0 240CF 0 0 0 240

DataPro 3 V1.20, Validation


Completed By: Page 118 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

All graphs have the graph type and date created at the top, as well as the start and end times at the bottom of the printed graphs. These are headers and footers respectively but will
not appear on the following graphs due to the way the data is converted for this document. The graph types can be referenced in the validation documents “Reports and Graphs”
section using the Validation number on each graph. The start and end times for all graphs are the same as this example. EXAMPLE:

DataPro 3 V1.20, Validation


Completed By: Page 119 of 156 P/N 03036901

Date: 1/26/12 .
Cubic Foot

Date:
5787
5788
5789
5790
5791
5792
5793
5794
5795
5796
5797
5798
2012-01-24 09:30:41
2012-01-24 09:33:33
2012-01-24 09:37:02
2012-01-24 09:40:01

Completed By:
2012-01-24 09:42:58
2012-01-24 09:46:22
2012-01-24 09:48:44

1/26/12
2012-01-24 09:52:51
2012-01-24 09:56:17

.
2012-01-24 09:59:12
2012-01-24 10:02:10
2012-01-24 10:04:33
2012-01-24 10:07:25
2012-01-24 10:09:48
2012-01-24 10:12:41
2012-01-24 10:15:37
2012-01-24 10:19:05
2012-01-24 10:22:00
2012-01-24 10:26:03
2012-01-24 10:29:37
2012-01-24 10:33:07
2012-01-24 10:36:01
2012-01-24 10:39:31
2012-01-24 10:42:22
2012-01-24 10:45:17
2012-01-24 10:47:43
2012-01-24 10:51:09
2012-01-24 10:54:36
2012-01-24 10:57:03
2012-01-24 11:00:33

Page 120 of 156


2012-01-24 11:03:27
2012-01-24 11:07:28
2012-01-24 11:10:57
2012-01-24 11:13:23
2012-01-24 11:16:49
2012-01-24 11:20:18
2012-01-24 11:23:11
2012-01-24 11:26:10
2012-01-24 11:29:39
2012-01-24 11:33:46
2012-01-24 11:36:38
2012-01-24 11:40:08
2012-01-24 11:43:02
2012-01-24 11:45:57
2012-01-24 11:48:57
2012-01-24 11:51:51
2012-01-24 11:54:48
Ampule Filling Machine 1

2012-01-24 11:58:13
2012-01-24 12:01:43
2012-01-24 12:04:41
2012-01-24 12:08:07

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:11:05
2012-01-24 12:13:58
2012-01-24 12:17:31
2012-01-24 12:20:24
2012-01-24 12:23:57
2012-01-24 12:27:28
2012-01-24 12:30:22
2012-01-24 12:33:16
2012-01-24 12:36:08
2012-01-24 12:39:08
2012-01-24 12:42:35
2012-01-24 12:46:05
2012-01-24 12:49:03
2012-01-24 12:51:55
2012-01-24 12:54:53
2012-01-24 12:58:18
2012-01-24 13:01:17
2012-01-24 13:04:11
2012-01-24 13:07:04
2012-01-24 13:09:59
2012-01-24 13:12:57
2012-01-24 13:15:52
2012-01-24 13:18:42
2012-01-24 13:22:16
2012-01-24 13:25:10
2012-01-24 13:28:08
2.1.1.1.1
Validation
Point 2 ≥ 0.5 µm
Point 1 ≥ 0.5 µm
Cubic Foot

Date:
24.6
24.8
25.2
25.4
25.6
25.8

25
26
2012-01-24 09:30:41
2012-01-24 09:34:09
2012-01-24 09:37:40
2012-01-24 09:41:09

Completed By:
2012-01-24 09:44:42
2012-01-24 09:48:08

1/26/12
2012-01-24 09:52:15
2012-01-24 09:56:17

.
2012-01-24 09:59:17
2012-01-24 10:02:48
2012-01-24 10:06:12
2012-01-24 10:08:38
2012-01-24 10:11:33
2012-01-24 10:15:31
2012-01-24 10:19:05
2012-01-24 10:22:36
2012-01-24 10:27:16
2012-01-24 10:31:22
2012-01-24 10:34:53
2012-01-24 10:38:23
2012-01-24 10:41:50
2012-01-24 10:45:17
2012-01-24 10:48:15
2012-01-24 10:52:19
2012-01-24 10:55:18
2012-01-24 10:59:20

Page 121 of 156


2012-01-24 11:02:49
2012-01-24 11:06:57
2012-01-24 11:10:57
2012-01-24 11:13:55
2012-01-24 11:17:57
2012-01-24 11:21:27
2012-01-24 11:24:57
2012-01-24 11:29:02
2012-01-24 11:33:09
2012-01-24 11:36:38
2012-01-24 11:40:13
2012-01-24 11:43:40
2012-01-24 11:47:07
2012-01-24 11:50:38
2012-01-24 11:54:12
2012-01-24 11:57:42
Ampule Filling Machine 1

2012-01-24 12:01:43
2012-01-24 12:05:14
2012-01-24 12:08:44
2012-01-24 12:12:13

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:16:18
2012-01-24 12:19:47
2012-01-24 12:23:20
2012-01-24 12:27:28
2012-01-24 12:30:53
2012-01-24 12:33:52
2012-01-24 12:37:22
2012-01-24 12:41:22
2012-01-24 12:45:27
2012-01-24 12:48:58
2012-01-24 12:51:55
2012-01-24 12:55:24
2012-01-24 12:58:54
2012-01-24 13:03:01
2012-01-24 13:05:57
2012-01-24 13:09:22
2012-01-24 13:12:52
2012-01-24 13:15:52
2012-01-24 13:18:47
2012-01-24 13:22:49
2012-01-24 13:26:18
2012-01-24 13:29:49
2.1.1.1.2
Validation
Point 2 ≥ 5.0 µm
Point 1 ≥ 5.0 µm
Cubic Foot

Date:
0
20
40
60
80
100
120
2012-01-24 09:31:12
2012-01-24 09:34:15
2012-01-24 09:39:14
2012-01-24 09:44:11

Completed By:
2012-01-24 09:47:16
2012-01-24 09:50:15

1/26/12
2012-01-24 09:54:16
2012-01-24 09:57:16

.
2012-01-24 10:02:10
2012-01-24 10:05:15
2012-01-24 10:09:09
2012-01-24 10:12:15
2012-01-24 10:16:14
2012-01-24 10:19:11
2012-01-24 10:22:10
2012-01-24 10:26:13
2012-01-24 10:29:16
2012-01-24 10:32:15
2012-01-24 10:36:11
2012-01-24 10:41:13
2012-01-24 10:45:12
2012-01-24 10:48:15
2012-01-24 10:52:14
2012-01-24 10:56:10
2012-01-24 10:59:15

Page 122 of 156


2012-01-24 11:03:10
2012-01-24 11:06:10
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2012-01-24 11:13:13
2012-01-24 11:16:16
2012-01-24 11:19:16
2012-01-24 11:23:12
2012-01-24 11:26:10
2012-01-24 11:29:13
2012-01-24 11:32:12
2012-01-24 11:37:12
2012-01-24 11:42:14
2012-01-24 11:47:13
2012-01-24 11:51:14
2012-01-24 11:55:14
Ampule Filling Machine 1

2012-01-24 11:59:10
2012-01-24 12:02:15
2012-01-24 12:07:10
2012-01-24 12:10:13

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:13:16
2012-01-24 12:18:13
2012-01-24 12:22:13
2012-01-24 12:26:09
2012-01-24 12:29:14
2012-01-24 12:33:11
2012-01-24 12:35:16
2012-01-24 12:39:13
2012-01-24 12:44:14
2012-01-24 12:48:11
2012-01-24 12:52:16
2012-01-24 12:57:16
2012-01-24 13:01:11
2012-01-24 13:05:14
2012-01-24 13:10:14
2012-01-24 13:14:10
2012-01-24 13:17:12
2012-01-24 13:20:11
2012-01-24 13:23:09
2012-01-24 13:26:13
2012-01-24 13:29:12
2.1.1.2.1
Validation
Point 4 ≥ 0.5 µm
Point 3 ≥ 0.5 µm
Cubic Foot

Date:
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9

0
1
2012-01-24 09:31:12
2012-01-24 09:34:09
2012-01-24 09:37:13
2012-01-24 09:41:14
2012-01-24 09:45:09

Completed By:
2012-01-24 09:47:16
2012-01-24 09:50:10
2012-01-24 09:53:13

1/26/12
2012-01-24 09:56:11
2012-01-24 09:58:14

.
2012-01-24 10:02:10
2012-01-24 10:05:10
2012-01-24 10:07:15
2012-01-24 10:10:14
2012-01-24 10:13:14
2012-01-24 10:16:14
2012-01-24 10:18:13
2012-01-24 10:21:11
2012-01-24 10:23:14
2012-01-24 10:27:11
2012-01-24 10:29:16
2012-01-24 10:32:10
2012-01-24 10:34:11
2012-01-24 10:38:12
2012-01-24 10:42:11
2012-01-24 10:45:12
2012-01-24 10:48:10
2012-01-24 10:51:10
2012-01-24 10:54:10
2012-01-24 10:56:15
2012-01-24 10:59:15

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2012-01-24 11:02:13
2012-01-24 11:05:11
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2012-01-24 11:13:13
2012-01-24 11:16:11
2012-01-24 11:18:13
2012-01-24 11:21:11
2012-01-24 11:24:10
2012-01-24 11:26:10
2012-01-24 11:28:15
2012-01-24 11:31:13
2012-01-24 11:34:12
2012-01-24 11:38:11
2012-01-24 11:42:14
2012-01-24 11:46:14
2012-01-24 11:50:11
2012-01-24 11:52:12
Ampule Filling Machine 1

2012-01-24 11:56:12
2012-01-24 11:59:10
2012-01-24 12:02:09
2012-01-24 12:05:14
2012-01-24 12:08:13

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:11:10
2012-01-24 12:13:16
2012-01-24 12:17:15
2012-01-24 12:21:15
2012-01-24 12:24:14
2012-01-24 12:26:15
2012-01-24 12:29:14
2012-01-24 12:32:11
2012-01-24 12:34:14
2012-01-24 12:36:14
2012-01-24 12:40:11
2012-01-24 12:44:14
2012-01-24 12:47:13
2012-01-24 12:51:13
2012-01-24 12:54:15
2012-01-24 12:58:13
2012-01-24 13:01:11
2012-01-24 13:04:11
2012-01-24 13:08:12
2012-01-24 13:12:10
2012-01-24 13:14:15
2012-01-24 13:17:12
2012-01-24 13:19:14
2012-01-24 13:22:11
2012-01-24 13:24:12
2012-01-24 13:27:11
2012-01-24 13:29:12
2.1.1.2.2
Validation
Point 4 ≥ 5.0 µm
Point 3 ≥ 5.0 µm
Cubic Meter

Date:
204350
204400
204450
204500
204550
204600
204650
204700
204750
2012-01-24 09:30:41
2012-01-24 09:34:09
2012-01-24 09:37:40

Completed By:
2012-01-24 09:41:09
2012-01-24 09:44:42
2012-01-24 09:48:08

1/26/12
2012-01-24 09:52:15

.
2012-01-24 09:56:17
2012-01-24 09:59:17
2012-01-24 10:02:48
2012-01-24 10:06:12
2012-01-24 10:08:38
2012-01-24 10:11:33
2012-01-24 10:15:31
2012-01-24 10:19:05
2012-01-24 10:22:36
2012-01-24 10:27:16
2012-01-24 10:31:22
2012-01-24 10:34:53
2012-01-24 10:38:23
2012-01-24 10:41:50
2012-01-24 10:45:17
2012-01-24 10:48:15
2012-01-24 10:52:19
2012-01-24 10:55:18
2012-01-24 10:59:20

Page 124 of 156


2012-01-24 11:02:49
2012-01-24 11:06:57
2012-01-24 11:10:57
2012-01-24 11:13:55
2012-01-24 11:17:57
2012-01-24 11:21:27
2012-01-24 11:24:57
2012-01-24 11:29:02
2012-01-24 11:33:09
2012-01-24 11:36:38
2012-01-24 11:40:13
2012-01-24 11:43:40
2012-01-24 11:47:07
2012-01-24 11:50:38
2012-01-24 11:54:12
2012-01-24 11:57:42
Ampule Filling Machine 1

2012-01-24 12:01:43
2012-01-24 12:05:14
2012-01-24 12:08:44
2012-01-24 12:12:13

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:16:18
2012-01-24 12:19:47
2012-01-24 12:23:20
2012-01-24 12:27:28
2012-01-24 12:30:53
2012-01-24 12:33:52
2012-01-24 12:37:22
2012-01-24 12:41:22
2012-01-24 12:45:27
2012-01-24 12:48:58
2012-01-24 12:51:55
2012-01-24 12:55:24
2012-01-24 12:58:54
2012-01-24 13:03:01
2012-01-24 13:05:57
2012-01-24 13:09:22
2012-01-24 13:12:52
2012-01-24 13:15:52
2012-01-24 13:18:47
2012-01-24 13:22:49
2012-01-24 13:26:18
2012-01-24 13:29:49
2.1.2.1.1
Validation
Point 2 ≥ 0.5 µm
Point 1 ≥ 0.5 µm
Cubic Meter

Date:
870
875
880
885
890
895
900
905
910
915
920
2012-01-24 09:30:41
2012-01-24 09:34:09
2012-01-24 09:37:40
2012-01-24 09:41:09

Completed By:
2012-01-24 09:44:42
2012-01-24 09:48:08
2012-01-24 09:52:15

1/26/12
2012-01-24 09:56:17

.
2012-01-24 09:59:17
2012-01-24 10:02:48
2012-01-24 10:06:12
2012-01-24 10:08:38
2012-01-24 10:11:33
2012-01-24 10:15:31
2012-01-24 10:19:05
2012-01-24 10:22:36
2012-01-24 10:27:16
2012-01-24 10:31:22
2012-01-24 10:34:53
2012-01-24 10:38:23
2012-01-24 10:41:50
2012-01-24 10:45:17
2012-01-24 10:48:15
2012-01-24 10:52:19
2012-01-24 10:55:18
2012-01-24 10:59:20
2012-01-24 11:02:49

Page 125 of 156


2012-01-24 11:06:57
2012-01-24 11:10:57
2012-01-24 11:13:55
2012-01-24 11:17:57
2012-01-24 11:21:27
2012-01-24 11:24:57
2012-01-24 11:29:02
2012-01-24 11:33:09
2012-01-24 11:36:38
2012-01-24 11:40:13
2012-01-24 11:43:40
2012-01-24 11:47:07
2012-01-24 11:50:38
2012-01-24 11:54:12
2012-01-24 11:57:42
Ampule Filling Machine 1

2012-01-24 12:01:43
2012-01-24 12:05:14
2012-01-24 12:08:44
2012-01-24 12:12:13

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:16:18
2012-01-24 12:19:47
2012-01-24 12:23:20
2012-01-24 12:27:28
2012-01-24 12:30:53
2012-01-24 12:33:52
2012-01-24 12:37:22
2012-01-24 12:41:22
2012-01-24 12:45:27
2012-01-24 12:48:58
2012-01-24 12:51:55
2012-01-24 12:55:24
2012-01-24 12:58:54
2012-01-24 13:03:01
2012-01-24 13:05:57
2012-01-24 13:09:22
2012-01-24 13:12:52
2012-01-24 13:15:52
2012-01-24 13:18:47
2012-01-24 13:22:49
2012-01-24 13:26:18
2012-01-24 13:29:49
2.1.2.1.2
Validation
Point 2 ≥ 5.0 µm
Point 1 ≥ 5.0 µm
Cubic Meter

Date:
1000
1500
2000
2500
3000
3500
4000

0
500
2012-01-24 09:31:12
2012-01-24 09:34:15
2012-01-24 09:39:14

Completed By:
2012-01-24 09:44:11
2012-01-24 09:47:16
2012-01-24 09:50:15

1/26/12
2012-01-24 09:54:16

.
2012-01-24 09:57:16
2012-01-24 10:02:10
2012-01-24 10:05:15
2012-01-24 10:09:09
2012-01-24 10:12:15
2012-01-24 10:16:14
2012-01-24 10:19:11
2012-01-24 10:22:10
2012-01-24 10:26:13
2012-01-24 10:29:16
2012-01-24 10:32:15
2012-01-24 10:36:11
2012-01-24 10:41:13
2012-01-24 10:45:12
2012-01-24 10:48:15
2012-01-24 10:52:14
2012-01-24 10:56:10
2012-01-24 10:59:15

Page 126 of 156


2012-01-24 11:03:10
2012-01-24 11:06:10
2012-01-24 11:09:13
2012-01-24 11:13:13
2012-01-24 11:16:16
2012-01-24 11:19:16
2012-01-24 11:23:12
2012-01-24 11:26:10
2012-01-24 11:29:13
2012-01-24 11:32:12
2012-01-24 11:37:12
2012-01-24 11:42:14
2012-01-24 11:47:13
2012-01-24 11:51:14
2012-01-24 11:55:14
Ampule Filling Machine 1

2012-01-24 11:59:10
2012-01-24 12:02:15
2012-01-24 12:07:10
2012-01-24 12:10:13

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:13:16
2012-01-24 12:18:13
2012-01-24 12:22:13
2012-01-24 12:26:09
2012-01-24 12:29:14
2012-01-24 12:33:11
2012-01-24 12:35:16
2012-01-24 12:39:13
2012-01-24 12:44:14
2012-01-24 12:48:11
2012-01-24 12:52:16
2012-01-24 12:57:16
2012-01-24 13:01:11
2012-01-24 13:05:14
2012-01-24 13:10:14
2012-01-24 13:14:10
2012-01-24 13:17:12
2012-01-24 13:20:11
2012-01-24 13:23:09
2012-01-24 13:26:13
2012-01-24 13:29:12
2.1.2.2.1
Validation
Point 4 ≥ 0.5 µm
Point 3 ≥ 0.5 µm
Cubic Meter

Date:
0.1
0.2
0.3
0.4
0.5
0.6
0.8
0.9

0.7

0
1
2012-01-24 09:31:12
2012-01-24 09:34:15
2012-01-24 09:39:14
2012-01-24 09:44:11

Completed By:
2012-01-24 09:47:16
2012-01-24 09:50:15

1/26/12
2012-01-24 09:54:16
2012-01-24 09:57:16

.
2012-01-24 10:02:10
2012-01-24 10:05:15
2012-01-24 10:09:09
2012-01-24 10:12:15
2012-01-24 10:16:14
2012-01-24 10:19:11
2012-01-24 10:22:10
2012-01-24 10:26:13
2012-01-24 10:29:16
2012-01-24 10:32:15
2012-01-24 10:36:11
2012-01-24 10:41:13
2012-01-24 10:45:12
2012-01-24 10:48:15
2012-01-24 10:52:14
2012-01-24 10:56:10
2012-01-24 10:59:15
2012-01-24 11:03:10

Page 127 of 156


2012-01-24 11:06:10
2012-01-24 11:09:13
2012-01-24 11:13:13
2012-01-24 11:16:16
2012-01-24 11:19:16
2012-01-24 11:23:12
2012-01-24 11:26:10
2012-01-24 11:29:13
2012-01-24 11:32:12
2012-01-24 11:37:12
2012-01-24 11:42:14
2012-01-24 11:47:13
2012-01-24 11:51:14
2012-01-24 11:55:14
Ampule Filling Machine 1

2012-01-24 11:59:10
2012-01-24 12:02:15
2012-01-24 12:07:10
2012-01-24 12:10:13

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:13:16
2012-01-24 12:18:13
2012-01-24 12:22:13
2012-01-24 12:26:09
2012-01-24 12:29:14
2012-01-24 12:33:11
2012-01-24 12:35:16
2012-01-24 12:39:13
2012-01-24 12:44:14
2012-01-24 12:48:11
2012-01-24 12:52:16
2012-01-24 12:57:16
2012-01-24 13:01:11
2012-01-24 13:05:14
2012-01-24 13:10:14
2012-01-24 13:14:10
2012-01-24 13:17:12
2012-01-24 13:20:11
2012-01-24 13:23:09
2012-01-24 13:26:13
2012-01-24 13:29:12
2.1.2.2.2
Validation
Point 4 ≥ 5.0 µm
Point 3 ≥ 5.0 µm
Total Count

Date:
3150
3200
3250
3300
3350
3400
3450
3500
3550
2012-01-24 09:30:41
2012-01-24 09:34:09
2012-01-24 09:37:40

Completed By:
2012-01-24 09:41:09
2012-01-24 09:44:42
2012-01-24 09:48:08

1/26/12
2012-01-24 09:52:15
2012-01-24 09:56:17

.
2012-01-24 09:59:17
2012-01-24 10:02:48
2012-01-24 10:06:12
2012-01-24 10:08:38
2012-01-24 10:11:33
2012-01-24 10:15:31
2012-01-24 10:19:05
2012-01-24 10:22:36
2012-01-24 10:27:16
2012-01-24 10:31:22
2012-01-24 10:34:53
2012-01-24 10:38:23
2012-01-24 10:41:50
2012-01-24 10:45:17
2012-01-24 10:48:15
2012-01-24 10:52:19
2012-01-24 10:55:18
2012-01-24 10:59:20

Page 128 of 156


2012-01-24 11:02:49
2012-01-24 11:06:57
2012-01-24 11:10:57
2012-01-24 11:13:55
2012-01-24 11:17:57
2012-01-24 11:21:27
2012-01-24 11:24:57
2012-01-24 11:29:02
2012-01-24 11:33:09
2012-01-24 11:36:38
2012-01-24 11:40:13
2012-01-24 11:43:40
2012-01-24 11:47:07
2012-01-24 11:50:38
2012-01-24 11:54:12
2012-01-24 11:57:42
Ampule Filling Machine 1

2012-01-24 12:01:43
2012-01-24 12:05:14
2012-01-24 12:08:44
2012-01-24 12:12:13

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:16:18
2012-01-24 12:19:47
2012-01-24 12:23:20
2012-01-24 12:27:28
2012-01-24 12:30:53
2012-01-24 12:33:52
2012-01-24 12:37:22
2012-01-24 12:41:22
2012-01-24 12:45:27
2012-01-24 12:48:58
2012-01-24 12:51:55
2012-01-24 12:55:24
2012-01-24 12:58:54
2012-01-24 13:03:01
2012-01-24 13:05:57
2012-01-24 13:09:22
2012-01-24 13:12:52
2012-01-24 13:15:52
2012-01-24 13:18:47
2012-01-24 13:22:49
2012-01-24 13:26:18
2012-01-24 13:29:49
2.1.3.1.1
Validation
Point 2 ≥ 0.5 µm
Point 1 ≥ 0.5 µm
Total Count

Date:
0
5
10
15
20
25
30
35
2012-01-24 09:30:41
2012-01-24 09:34:09
2012-01-24 09:37:40
2012-01-24 09:41:09

Completed By:
2012-01-24 09:44:42
2012-01-24 09:48:08
2012-01-24 09:52:15

1/26/12
2012-01-24 09:56:17

.
2012-01-24 09:59:17
2012-01-24 10:02:48
2012-01-24 10:06:12
2012-01-24 10:08:38
2012-01-24 10:11:33
2012-01-24 10:15:31
2012-01-24 10:19:05
2012-01-24 10:22:36
2012-01-24 10:27:16
2012-01-24 10:31:22
2012-01-24 10:34:53
2012-01-24 10:38:23
2012-01-24 10:41:50
2012-01-24 10:45:17
2012-01-24 10:48:15
2012-01-24 10:52:19
2012-01-24 10:55:18
2012-01-24 10:59:20
2012-01-24 11:02:49

Page 129 of 156


2012-01-24 11:06:57
2012-01-24 11:10:57
2012-01-24 11:13:55
2012-01-24 11:17:57
2012-01-24 11:21:27
2012-01-24 11:24:57
2012-01-24 11:29:02
2012-01-24 11:33:09
2012-01-24 11:36:38
2012-01-24 11:40:13
2012-01-24 11:43:40
2012-01-24 11:47:07
2012-01-24 11:50:38
2012-01-24 11:54:12
2012-01-24 11:57:42
Ampule Filling Machine 1

2012-01-24 12:01:43
2012-01-24 12:05:14
2012-01-24 12:08:44
2012-01-24 12:12:13

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:16:18
2012-01-24 12:19:47
2012-01-24 12:23:20
2012-01-24 12:27:28
2012-01-24 12:30:53
2012-01-24 12:33:52
2012-01-24 12:37:22
2012-01-24 12:41:22
2012-01-24 12:45:27
2012-01-24 12:48:58
2012-01-24 12:51:55
2012-01-24 12:55:24
2012-01-24 12:58:54
2012-01-24 13:03:01
2012-01-24 13:05:57
2012-01-24 13:09:22
2012-01-24 13:12:52
2012-01-24 13:15:52
2012-01-24 13:18:47
2012-01-24 13:22:49
2012-01-24 13:26:18
2012-01-24 13:29:49
2.1.3.1.2
Validation
Point 2 ≥ 5.0 µm
Point 1 ≥ 5.0 µm
Total Count

Date:
0
20
40
60
80
100
120
2012-01-24 09:31:12
2012-01-24 09:34:15
2012-01-24 09:39:14
2012-01-24 09:44:11

Completed By:
2012-01-24 09:47:16
2012-01-24 09:50:15

1/26/12
2012-01-24 09:54:16
2012-01-24 09:57:16

.
2012-01-24 10:02:10
2012-01-24 10:05:15
2012-01-24 10:09:09
2012-01-24 10:12:15
2012-01-24 10:16:14
2012-01-24 10:19:11
2012-01-24 10:22:10
2012-01-24 10:26:13
2012-01-24 10:29:16
2012-01-24 10:32:15
2012-01-24 10:36:11
2012-01-24 10:41:13
2012-01-24 10:45:12
2012-01-24 10:48:15
2012-01-24 10:52:14
2012-01-24 10:56:10
2012-01-24 10:59:15

Page 130 of 156


2012-01-24 11:03:10
2012-01-24 11:06:10
2012-01-24 11:09:13
2012-01-24 11:13:13
2012-01-24 11:16:16
2012-01-24 11:19:16
2012-01-24 11:23:12
2012-01-24 11:26:10
2012-01-24 11:29:13
2012-01-24 11:32:12
2012-01-24 11:37:12
2012-01-24 11:42:14
2012-01-24 11:47:13
2012-01-24 11:51:14
2012-01-24 11:55:14
Ampule Filling Machine 1

2012-01-24 11:59:10
2012-01-24 12:02:15
2012-01-24 12:07:10
2012-01-24 12:10:13

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:13:16
2012-01-24 12:18:13
2012-01-24 12:22:13
2012-01-24 12:26:09
2012-01-24 12:29:14
2012-01-24 12:33:11
2012-01-24 12:35:16
2012-01-24 12:39:13
2012-01-24 12:44:14
2012-01-24 12:48:11
2012-01-24 12:52:16
2012-01-24 12:57:16
2012-01-24 13:01:11
2012-01-24 13:05:14
2012-01-24 13:10:14
2012-01-24 13:14:10
2012-01-24 13:17:12
2012-01-24 13:20:11
2012-01-24 13:23:09
2012-01-24 13:26:13
2012-01-24 13:29:12
2.1.3.2.1
Validation
Point 4 ≥ 0.5 µm
Point 3 ≥ 0.5 µm
Total Count

Date:
0.1
0.2
0.3
0.4
0.5
0.6
0.8
0.9

0.7

0
1
2012-01-24 09:31:12
2012-01-24 09:34:15
2012-01-24 09:39:14
2012-01-24 09:44:11

Completed By:
2012-01-24 09:47:16
2012-01-24 09:50:15

1/26/12
2012-01-24 09:54:16
2012-01-24 09:57:16

.
2012-01-24 10:02:10
2012-01-24 10:05:15
2012-01-24 10:09:09
2012-01-24 10:12:15
2012-01-24 10:16:14
2012-01-24 10:19:11
2012-01-24 10:22:10
2012-01-24 10:26:13
2012-01-24 10:29:16
2012-01-24 10:32:15
2012-01-24 10:36:11
2012-01-24 10:41:13
2012-01-24 10:45:12
2012-01-24 10:48:15
2012-01-24 10:52:14
2012-01-24 10:56:10
2012-01-24 10:59:15
2012-01-24 11:03:10

Page 131 of 156


2012-01-24 11:06:10
2012-01-24 11:09:13
2012-01-24 11:13:13
2012-01-24 11:16:16
2012-01-24 11:19:16
2012-01-24 11:23:12
2012-01-24 11:26:10
2012-01-24 11:29:13
2012-01-24 11:32:12
2012-01-24 11:37:12
2012-01-24 11:42:14
2012-01-24 11:47:13
2012-01-24 11:51:14
2012-01-24 11:55:14
Ampule Filling Machine 1

2012-01-24 11:59:10
2012-01-24 12:02:15
2012-01-24 12:07:10
2012-01-24 12:10:13

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:13:16
2012-01-24 12:18:13
2012-01-24 12:22:13
2012-01-24 12:26:09
2012-01-24 12:29:14
2012-01-24 12:33:11
2012-01-24 12:35:16
2012-01-24 12:39:13
2012-01-24 12:44:14
2012-01-24 12:48:11
2012-01-24 12:52:16
2012-01-24 12:57:16
2012-01-24 13:01:11
2012-01-24 13:05:14
2012-01-24 13:10:14
2012-01-24 13:14:10
2012-01-24 13:17:12
2012-01-24 13:20:11
2012-01-24 13:23:09
2012-01-24 13:26:13
2012-01-24 13:29:12
2.1.3.2.2
Validation
Point 4 ≥ 5.0 µm
Point 3 ≥ 5.0 µm
Cubic Meter

Date:
1000
10000

1
100000

10
1000000

100
2012-01-24 09:30:11
2012-01-24 09:34:09

Completed By:
2012-01-24 09:37:40
2012-01-24 09:41:14
2012-01-24 09:45:09

1/26/12
2012-01-24 09:48:13
2012-01-24 09:52:15

.
2012-01-24 09:56:12
2012-01-24 09:59:17
2012-01-24 10:03:14
2012-01-24 10:06:17
2012-01-24 10:09:15
2012-01-24 10:12:15
2012-01-24 10:16:09
2012-01-24 10:19:06
2012-01-24 10:22:15
2012-01-24 10:26:39
2012-01-24 10:30:13
2012-01-24 10:33:14
2012-01-24 10:37:09
2012-01-24 10:40:40
2012-01-24 10:44:08
2012-01-24 10:47:12
2012-01-24 10:51:09
2012-01-24 10:54:15
2012-01-24 10:57:34

Page 132 of 156


2012-01-24 11:01:15
2012-01-24 11:05:11
2012-01-24 11:08:37
2012-01-24 11:12:13
2012-01-24 11:15:39
2012-01-24 11:19:16
2012-01-24 11:23:11
2012-01-24 11:26:10
2012-01-24 11:29:39
2012-01-24 11:33:46
2012-01-24 11:37:18
2012-01-24 11:41:22
2012-01-24 11:45:14
2012-01-24 11:49:13
2012-01-24 11:52:22
2012-01-24 11:56:12
2012-01-24 12:00:03
Ampule Filling Machine 1

2012-01-24 12:03:33
2012-01-24 12:07:36
2012-01-24 12:11:10
2012-01-24 12:14:38

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:18:13
2012-01-24 12:22:13
2012-01-24 12:26:14
2012-01-24 12:29:14
2012-01-24 12:32:45
2012-01-24 12:35:37
2012-01-24 12:39:08
2012-01-24 12:43:12
2012-01-24 12:46:42
2012-01-24 12:51:13
2012-01-24 12:54:15
2012-01-24 12:58:18
2012-01-24 13:01:49
2012-01-24 13:05:19
2012-01-24 13:09:22
2012-01-24 13:12:57
2012-01-24 13:16:23
2012-01-24 13:19:14
2012-01-24 13:22:49
2012-01-24 13:26:13
2.1.4.1.1.1
Validation

2012-01-24 13:29:49
*Alert
*Alarm
Point 4 ≥ 0.5 µm
Point 3 ≥ 0.5 µm
Point 2 ≥ 0.5 µm
Point 1 ≥ 0.5 µm
Cubic Meter

Date:
1000
10000

1
10
100
2012-01-24 09:30:11
2012-01-24 09:34:09
2012-01-24 09:37:40

Completed By:
2012-01-24 09:41:14
2012-01-24 09:45:09
2012-01-24 09:48:13

1/26/12
2012-01-24 09:52:15
2012-01-24 09:56:12

.
2012-01-24 09:59:17
2012-01-24 10:03:14
2012-01-24 10:06:17
2012-01-24 10:09:15
2012-01-24 10:12:15
2012-01-24 10:16:09
2012-01-24 10:19:06
2012-01-24 10:22:15
2012-01-24 10:26:39
2012-01-24 10:30:13
2012-01-24 10:33:14
2012-01-24 10:37:09
2012-01-24 10:40:40
2012-01-24 10:44:08
2012-01-24 10:47:12
2012-01-24 10:51:09
2012-01-24 10:54:15
2012-01-24 10:57:34
2012-01-24 11:01:15

Page 133 of 156


2012-01-24 11:05:11
2012-01-24 11:08:37
2012-01-24 11:12:13
2012-01-24 11:15:39
2012-01-24 11:19:16
2012-01-24 11:23:11
2012-01-24 11:26:10
2012-01-24 11:29:39
2012-01-24 11:33:46
2012-01-24 11:37:18
2012-01-24 11:41:22
2012-01-24 11:45:14
2012-01-24 11:49:13
2012-01-24 11:52:22
2012-01-24 11:56:12
2012-01-24 12:00:03
Ampule Filling Machine 1

2012-01-24 12:03:33
2012-01-24 12:07:36
2012-01-24 12:11:10
2012-01-24 12:14:38

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:18:13
2012-01-24 12:22:13
2012-01-24 12:26:14
2012-01-24 12:29:14
2012-01-24 12:32:45
2012-01-24 12:35:37
2012-01-24 12:39:08
2012-01-24 12:43:12
2012-01-24 12:46:42
2012-01-24 12:51:13
2012-01-24 12:54:15
2012-01-24 12:58:18
2012-01-24 13:01:49
2012-01-24 13:05:19
2012-01-24 13:09:22
2012-01-24 13:12:57
2012-01-24 13:16:23
2012-01-24 13:19:14
2012-01-24 13:22:49
2012-01-24 13:26:13
2.1.4.1.1.2
Validation

2012-01-24 13:29:49
*Alert
*Alarm
Point 4 ≥ 5.0 µm
Point 3 ≥ 5.0 µm
Point 2 ≥ 5.0 µm
Point 1 ≥ 5.0 µm
Total Count

Date:
1000
10000

1
10
100
2012-01-24 09:30:11
2012-01-24 09:33:33
2012-01-24 09:37:08
2012-01-24 09:40:32

Completed By:
2012-01-24 09:44:06
2012-01-24 09:47:11
2012-01-24 09:50:10

1/26/12
2012-01-24 09:54:10

.
2012-01-24 09:57:11
2012-01-24 10:00:25
2012-01-24 10:03:51
2012-01-24 10:06:48
2012-01-24 10:09:15
2012-01-24 10:12:10
2012-01-24 10:15:31
2012-01-24 10:18:13
2012-01-24 10:21:16
2012-01-24 10:24:53
2012-01-24 10:28:24
2012-01-24 10:31:54
2012-01-24 10:34:47
2012-01-24 10:38:12
2012-01-24 10:41:49
2012-01-24 10:44:14
2012-01-24 10:47:12
2012-01-24 10:50:38
2012-01-24 10:54:05
2012-01-24 10:56:57
2012-01-24 11:00:27

Page 134 of 156


2012-01-24 11:03:22
2012-01-24 11:06:57
2012-01-24 11:10:16
2012-01-24 11:13:23
2012-01-24 11:16:49
2012-01-24 11:20:13
2012-01-24 11:23:12
2012-01-24 11:26:10
2012-01-24 11:29:13
2012-01-24 11:33:09
2012-01-24 11:36:11
2012-01-24 11:40:13
2012-01-24 11:43:40
2012-01-24 11:47:07
2012-01-24 11:50:16
2012-01-24 11:53:35
2012-01-24 11:57:10
Ampule Filling Machine 1

2012-01-24 12:00:34
2012-01-24 12:04:04
2012-01-24 12:07:36
2012-01-24 12:11:05

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:13:58
2012-01-24 12:17:31
2012-01-24 12:21:15
2012-01-24 12:25:06
2012-01-24 12:28:00
2012-01-24 12:30:53
2012-01-24 12:33:52
2012-01-24 12:36:14
2012-01-24 12:39:39
2012-01-24 12:43:43
2012-01-24 12:46:42
2012-01-24 12:50:47
2012-01-24 12:53:38
2012-01-24 12:57:16
2012-01-24 13:00:14
2012-01-24 13:03:38
2012-01-24 13:07:15
2012-01-24 13:11:07
2012-01-24 13:14:10
2012-01-24 13:17:11
2012-01-24 13:19:55
2012-01-24 13:23:09
2012-01-24 13:26:13
2.1.4.3.1.1
Validation

2012-01-24 13:29:18
*Alert
*Alarm
Point 4 ≥ 0.5 µm
Point 3 ≥ 0.5 µm
Point 2 ≥ 0.5 µm
Point 1 ≥ 0.5 µm
Total Count

Date:
1000
10000

1
10
100
2012-01-24 09:30:11
2012-01-24 09:33:33
2012-01-24 09:37:08
2012-01-24 09:40:32

Completed By:
2012-01-24 09:44:06
2012-01-24 09:47:11
2012-01-24 09:50:10

1/26/12
2012-01-24 09:54:10

.
2012-01-24 09:57:11
2012-01-24 10:00:25
2012-01-24 10:03:51
2012-01-24 10:06:48
2012-01-24 10:09:15
2012-01-24 10:12:10
2012-01-24 10:15:31
2012-01-24 10:18:13
2012-01-24 10:21:16
2012-01-24 10:24:53
2012-01-24 10:28:24
2012-01-24 10:31:54
2012-01-24 10:34:47
2012-01-24 10:38:12
2012-01-24 10:41:49
2012-01-24 10:44:14
2012-01-24 10:47:12
2012-01-24 10:50:38
2012-01-24 10:54:05
2012-01-24 10:56:57
2012-01-24 11:00:27

Page 135 of 156


2012-01-24 11:03:22
2012-01-24 11:06:57
2012-01-24 11:10:16
2012-01-24 11:13:23
2012-01-24 11:16:49
2012-01-24 11:20:13
2012-01-24 11:23:12
2012-01-24 11:26:10
2012-01-24 11:29:13
2012-01-24 11:33:09
2012-01-24 11:36:11
2012-01-24 11:40:13
2012-01-24 11:43:40
2012-01-24 11:47:07
2012-01-24 11:50:16
2012-01-24 11:53:35
2012-01-24 11:57:10
Ampule Filling Machine 1

2012-01-24 12:00:34
2012-01-24 12:04:04
2012-01-24 12:07:36
2012-01-24 12:11:05

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:13:58
2012-01-24 12:17:31
2012-01-24 12:21:15
2012-01-24 12:25:06
2012-01-24 12:28:00
2012-01-24 12:30:53
2012-01-24 12:33:52
2012-01-24 12:36:14
2012-01-24 12:39:39
2012-01-24 12:43:43
2012-01-24 12:46:42
2012-01-24 12:50:47
2012-01-24 12:53:38
2012-01-24 12:57:16
2012-01-24 13:00:14
2012-01-24 13:03:38
2012-01-24 13:07:15
2012-01-24 13:11:07
2012-01-24 13:14:10
2012-01-24 13:17:11
2012-01-24 13:19:55
2012-01-24 13:23:09
2012-01-24 13:26:13
2.1.4.3.1.2
Validation

2012-01-24 13:29:18
*Alert
*Alarm
Point 4 ≥ 5.0 µm
Point 3 ≥ 5.0 µm
Point 2 ≥ 5.0 µm
Point 1 ≥ 5.0 µm
Cubic Foot

Date:
5792.5
5793.5
5794.5
5795.5
5796.5

5793
5795
5796
5797

5794
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

1/26/12
2012-01-24 09:55:00

.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

Page 136 of 156


2012-01-24 11:05:00

2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:15:00

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.1.1.1
Validation
Point 2 ≥ 0.5 µm
Point 1 ≥ 0.5 µm
Cubic Foot

Date:
25.3
25.4
25.5
25.6
25.7
25.8
25.9
26
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

1/26/12
2012-01-24 09:55:00

.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

2012-01-24 11:05:00

Page 137 of 156


2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

P/N 03036901
DataPro 3 V1.20, Validation
2012-01-24 12:15:00
Validation: DataPro 3 software

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.1.1.2
Validation
Point 2 ≥ 5.0 µm
Point 1 ≥ 5.0 µm
Cubic Foot

Date:
0
20
40
60
80
100
120
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

1/26/12
2012-01-24 09:55:00

.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

2012-01-24 11:05:00

Page 138 of 156


2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

2012-01-24 12:15:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.1.2.1
Validation
Point 4 ≥ 0.5 µm
Point 3 ≥ 0.5 µm
Cubic Foot

Date:
0.1
0.2
0.3
0.4
0.5
0.6
0.8
0.9

0.7

0
1
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

2012-01-24 09:55:00

1/26/12
.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

2012-01-24 11:05:00

Page 139 of 156


2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

2012-01-24 12:15:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.1.2.2
Validation
Point 4 ≥ 5.0 µm
Point 3 ≥ 5.0 µm
Cubic Meter

Date:
204560
204580
204600
204620
204640
204660
204680
204700
204720
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

1/26/12
2012-01-24 09:55:00

.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

Page 140 of 156


2012-01-24 11:05:00

2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:15:00

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.2.1.1
Validation
Point 2 ≥ 0.5 µm
Point 1 ≥ 0.5 µm
Cubic Meter

Date:
895
900
905
910
915
920
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

1/26/12
2012-01-24 09:55:00

.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

2012-01-24 11:05:00

Page 141 of 156


2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

2012-01-24 12:15:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.2.1.2
Validation
Point 2 ≥ 5.0 µm
Point 1 ≥ 5.0 µm
Cubic Meter

Date:
1000
1500
2000
2500
3000
3500
4000

0
500
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

1/26/12
2012-01-24 09:55:00

.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

2012-01-24 11:05:00

Page 142 of 156


2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:15:00

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.2.2.1
Validation
Point 4 ≥ 0.5 µm
Point 3 ≥ 0.5 µm
Cubic Meter

Date:
0.1
0.2
0.3
0.4
0.5
0.6
0.8
0.9

0.7

0
1
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

2012-01-24 09:55:00

1/26/12
.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

2012-01-24 11:05:00

Page 143 of 156


2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

2012-01-24 12:15:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.2.2.2
Validation
Point 4 ≥ 5.0 µm
Point 3 ≥ 5.0 µm
Total Count

Date:
3380
3400
3420
3440
3460
3480
3500
3520
3540
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

1/26/12
2012-01-24 09:55:00

.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

2012-01-24 11:05:00

Page 144 of 156


2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:15:00

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.3.1.1
Validation
Point 2 ≥ 0.5 µm
Point 1 ≥ 0.5 µm
Total Count

Date:
0
5
10
15
20
25
30
35
2012-01-24 09:35:00

2012-01-24 09:45:00

Completed By:
2012-01-24 09:55:00

1/26/12
.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

2012-01-24 11:05:00

Page 145 of 156


2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

2012-01-24 12:15:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.3.1.2
Validation
Point 2 ≥ 5.0 µm
Point 1 ≥ 5.0 µm
Total Count

Date:
0
20
40
60
80
100
120
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

1/26/12
2012-01-24 09:55:00

.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

2012-01-24 11:05:00

Page 146 of 156


2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

2012-01-24 12:15:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.3.2.1
Validation
Point 4 ≥ 0.5 µm
Point 3 ≥ 0.5 µm
Total Count

Date:
0.1
0.2
0.3
0.4
0.5
0.6
0.8
0.9

0.7

0
1
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

2012-01-24 09:55:00

1/26/12
.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

2012-01-24 11:05:00

Page 147 of 156


2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

2012-01-24 12:15:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.3.2.2
Validation
Point 4 ≥ 5.0 µm
Point 3 ≥ 5.0 µm
Cubic Meter

Date:
1000
10000

1
100000

10
1000000

100
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

1/26/12
2012-01-24 09:55:00

.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

Page 148 of 156


2012-01-24 11:05:00

2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

2012-01-24 12:15:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.4.1.1.1
Validation
*Alert
*Alarm
Point 4 ≥ 0.5 µm
Point 3 ≥ 0.5 µm
Point 2 ≥ 0.5 µm
Point 1 ≥ 0.5 µm
Cubic Meter

Date:
1000
10000

1
10
100
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

1/26/12
2012-01-24 09:55:00

.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

2012-01-24 11:05:00

Page 149 of 156


2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

2012-01-24 12:15:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.4.1.1.2
Validation
*Alert
*Alarm
Point 4 ≥ 5.0 µm
Point 3 ≥ 5.0 µm
Point 2 ≥ 5.0 µm
Point 1 ≥ 5.0 µm
Cubic Foot

Date:
1000
10000

1
10
100
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

1/26/12
2012-01-24 09:55:00

.
2012-01-24 10:05:00

2012-01-24 10:15:00

2012-01-24 10:25:00

2012-01-24 10:35:00

2012-01-24 10:45:00

2012-01-24 10:55:00

2012-01-24 11:05:00

Page 150 of 156


2012-01-24 11:15:00

2012-01-24 11:25:00

2012-01-24 11:35:00

2012-01-24 11:45:00

2012-01-24 11:55:00
Ampule Filling Machine 1

2012-01-24 12:05:00

2012-01-24 12:15:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.4.2.1.1
Validation
*Alert
*Alarm
Point 4 ≥ 0.5 µm
Point 3 ≥ 0.5 µm
Point 2 ≥ 0.5 µm
Point 1 ≥ 0.5 µm
Cubic Foot

Date:
1000
10000

1
10
100
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1/26/12
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Ampule Filling Machine 1

2012-01-24 12:05:00

2012-01-24 12:15:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.4.2.1.2
Validation
*Alert
*Alarm
Point 4 ≥ 5.0 µm
Point 3 ≥ 5.0 µm
Point 2 ≥ 5.0 µm
Point 1 ≥ 5.0 µm
Total Count

Date:
1000
10000

1
10
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2012-01-24 09:35:00

Completed By:
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1/26/12
2012-01-24 09:55:00

.
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Ampule Filling Machine 1

2012-01-24 12:05:00

2012-01-24 12:15:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.4.3.1.1
Validation
*Alert
*Alarm
Point 4 ≥ 0.5 µm
Point 3 ≥ 0.5 µm
Point 2 ≥ 0.5 µm
Point 1 ≥ 0.5 µm
Total Count

Date:
1000
10000

1
10
100
2012-01-24 09:35:00

Completed By:
2012-01-24 09:45:00

1/26/12
2012-01-24 09:55:00

.
2012-01-24 10:05:00

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Ampule Filling Machine 1

2012-01-24 12:05:00

2012-01-24 12:15:00

P/N 03036901
DataPro 3 V1.20, Validation
Validation: DataPro 3 software

2012-01-24 12:25:00

2012-01-24 12:35:00

2012-01-24 12:45:00

2012-01-24 12:55:00

2012-01-24 13:05:00

2012-01-24 13:15:00

2012-01-24 13:25:00
2.2.4.3.1.2
Validation
*Alert
*Alarm
Point 4 ≥ 5.0 µm
Point 3 ≥ 5.0 µm
Point 2 ≥ 5.0 µm
Point 1 ≥ 5.0 µm
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Fail
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-27 10:00:26
Author: Kyle Kuehm
Classification: Grade A (2008)
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 2
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-27 09:15:00
End of report: 2012-01-27 10:00:09
Purpose of test: Validation
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events Result
Point 5 CI-3100-21 CI-3100-21-2-4-6 S/N 000186 1.00 ≥ 0.5 µm Cubic Meter 60 60 2012-01-27 09:50:52 1 1 CM 0 0 2 Pass
Point 5 CI-3100-21 CI-3100-21-2-4-6 S/N 000186 1.00 ≥ 5.0 µm Cubic Meter 0 0 2012-01-27 09:16:47 0 1 CM 0 0 2 Pass
Point 6 CI-3100-21 CI-3100-21-2-4-6 S/N 000196 1.00 ≥ 0.5 µm Cubic Meter 3540 3540 2012-01-27 09:51:36 59 1 CM 0 0 0 Fail
Point 6 CI-3100-21 CI-3100-21-2-4-6 S/N 000196 1.00 ≥ 5.0 µm Cubic Meter 60 60 2012-01-27 09:51:36 1 1 CM 0 0 0 Fail

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 1800 6.3 2460.7 2 3520 12762 Fail
≥ 5.0 µm 30 6.3 42.4 2 20 219 Fail

DataPro 3 V1.20, Validation


Completed By: Page 154 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Fail
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-27 12:34:45
Author: Kyle Kuehm
Classification: Grade B (2008)
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 2
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-27 11:40:00
End of report: 2012-01-27 13:00:09
Purpose of test: Validation
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events Result
Point 5 CI-3100-21 CI-3100-21-2-4-6 S/N 000186 1.00 ≥ 0.5 µm Cubic Meter 342000 342000 2012-01-27 12:14:48 5700 1 CM 0 0 0 Pass
Point 5 CI-3100-21 CI-3100-21-2-4-6 S/N 000186 1.00 ≥ 5.0 µm Cubic Meter 2820 2820 2012-01-27 12:14:48 47 1 CM 0 0 0 Pass
Point 6 CI-3100-21 CI-3100-21-2-4-6 S/N 000196 1.00 ≥ 0.5 µm Cubic Meter 354000 354000 2012-01-27 12:14:48 5900 1 CM 0 0 0 Fail
Point 6 CI-3100-21 CI-3100-21-2-4-6 S/N 000196 1.00 ≥ 5.0 µm Cubic Meter 2940 2940 2012-01-27 12:14:48 49 1 CM 0 0 0 Fail

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 348000 6.3 8485.3 2 352000 385800 Fail
≥ 5.0 µm 2880 6.3 84.9 2 2900 3258 Fail

DataPro 3 V1.20, Validation


Completed By: Page 155 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

The data in this report is intact


CLiMET Instruments Company
EU GMP Annex 1 Report
Result of particulate test: Fail
Reporting software: CLiMET DataPro 3 V1.20
File created on: 2012-01-27 13:30:41
Author: Kyle Kuehm
Classification: Grade C (2008)
Occupancy state: In Operation
Area: Ampule Filling Machine 1
Number of locations: 2
Particle sizes: ≥ 0.5 µm, ≥ 5.0 µm
Start of report: 2012-01-27 12:39:00
End of report: 2012-01-27 13:30:09
Purpose of test: Validation
Company Address: 1320 W. Colton Ave
Redlands, CA 92374
Telephone: (909) 793-2788

Location Sensor Unit Id Flow Average Size Count Mode Average /CM Maximum /CM Time of Maximum Minimum /CM Volume Alert Action Events Result
Point 5 CI-3100-21 CI-3100-21-2-4-6 S/N 000186 1.00 ≥ 0.5 µm Cubic Meter 342000 342000 2012-01-27 13:13:42 5700 1 CM 0 0 0 Pass
Point 5 CI-3100-21 CI-3100-21-2-4-6 S/N 000186 1.00 ≥ 5.0 µm Cubic Meter 28200 28200 2012-01-27 13:13:42 470 1 CM 0 0 0 Pass
Point 6 CI-3100-21 CI-3100-21-2-4-6 S/N 000196 1.00 ≥ 0.5 µm Cubic Meter 3540000 3540000 2012-01-27 13:13:42 59000 1 CM 0 0 0 Fail
Point 6 CI-3100-21 CI-3100-21-2-4-6 S/N 000196 1.00 ≥ 5.0 µm Cubic Meter 29400 29400 2012-01-27 13:13:42 490 1 CM 0 0 0 Fail

95% Upper Confidence Limit (UCL)


Size Mean of Averages UCL Factor Standard Deviation # of Locations Class Limit 95% UCL Result
≥ 0.5 µm 1941000 6.3 2261327.5 2 3520000 12014700 Fail
≥ 5.0 µm 28800 6.3 848.5 2 29000 32580 Fail

DataPro 3 V1.20, Validation


Completed By: Page 156 of 156 P/N 03036901

Date: 1/26/12 .
Validation: DataPro 3 software

CLiMET DataPro 3
Supplemental Validation
of Version 1.21

Validation Revision History


Version 1.21 – September 14, 2012
CLiMET Instruments Company

DataPro 3 V1.21, Validation


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DataPro 3 V1.21, Validation


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Notices
Copyright © 2003-2012 by CLiMET Instruments Company. All rights reserved.

Complying with applicable copyright laws, no part of this document may be reproduced, stored in or introduced to any retrieval system, or
retransmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise), or for any purpose, without the prior
written permission of CLiMET Instruments Company. Contact CLiMET Instruments to request written permission.

Mail: CLiMET Instruments Company Email: Sales@CLiMET.com


1320 West Colton Avenue Phone: 909.793.2788
Redlands, CA 92374
USA Fax: 909.793.1738

CLiMET Instruments Company may make improvements and/or changes in the product(s) and/or the program(s) described in this document at
any time without notice; these improvements and/or changes will be incorporated in new versions of the documentation. Unless otherwise noted,
the example companies, organizations, products, people and events depicted herein are fictitious and no association with any real company,
organization, product, person or event is intended or should be inferred.

Although every precaution has been taken in the preparation of this documentation, the author assumes no responsibility for technical
inaccuracies, typographical errors, or damages resulting from the use of the information contained herein.

The following paragraph does not apply to a country where such provisions are inconsistent with local law:
CLIMET INSTRUMENTS COMPANY PROVIDES THIS DOCUMENTATION “AS IS” WITHOUT WARRANTY OF ANY KIND,
EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF NON -INFRINGEMENT,
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Some states do not allow a disclaimer of express or implied
warranties in certain transactions, therefore, this statement may not apply to you.

Trademarks
CLiMET is a trademark of CLiMET Instruments Company in the United States and/or other countries. Microsoft, Windows, MSDE, SQL
Server 2005 Express, Visual Basic .NET, Visual Studios .NET and Excel are trademarks of Microsoft Corporation in the United States and/or
other countries. VeriSign is a trademark of VeriSign in the United States and/or other countries. RSA and MD5 are trademarks of RSA Security
Inc. in the United States and/or other countries. The names of actual companies and products mentioned herein may be the tra demarks of their
respective owners.

Supplementary Features
Note indicates notes related to the nearby text.
Tip indicates tips related to the nearby text.

Typographical Conventions
Bold indicates important words, or names of buttons, menus, and windows.
Italic indicates new terms, or terms in glossary.
 indicates a procedure in the table of contents.
§ indicates reference to a section number.

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Validation: DataPro 3 software

Table of Contents
1 Introduction ....................................................................................................................... 5
2 System Requirements & Equipment ................................................................................. 5
3 IQ: Installation Qualification ............................................................................................ 5
3.1 Scope ................................................................................................................. 5
3.2 Peripherals Test .................................................................................................. 5

4 OQ: Operational Qualification ......................................................................................... 6


4.1 Scope ................................................................................................................. 6
4.2 User Requirements ............................................................................................. 6
4.3 Functional Specifications ................................................................................... 6
4.4 Traceability Matrix ............................................................................................ 7
4.5 Text Changes ..................................................................................................... 8
4.6 Blocked Sensor at Startup Test ........................................................................... 9

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Validation: DataPro 3 software

1 Introduction
CLiMET Instruments Company designed, constructed and validated
CLiMET DataPro 3 Version 1.21 at the CLiMET facility in Redlands,
California. The validation method described herein is consistent with
CLiMET’s “SOFTWARE DEVELOPMENT, DOCUMENTATION AND
REVISION STANDARDS” policy (Revision 3.0 – 03/04/1999).
The purpose of this validation document is to provide documented
evidence that DataPro will correctly install and consistently operate in
accordance with the procedures outlined in the DataPro manual. This
protocol describes all of the conditions and tests performed for this
validation.
The manual describes DataPro. The validation system has inputs and
outputs. The inputs to the validation system are particle samples and
the DataPro user interface. The outputs of the system are printouts,
databases and the data recorded in this document.

2 System Requirements &


Equipment
 See requirements in DataPro 3 v1.21 manual

3 IQ: Installation Qualification


3.1 Scope
The installation process provides a default installation path.

3.2 Peripherals Test


Check that the following items are present:
 One DataPro installation CD

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Validation: DataPro 3 software

4 OQ: Operational Qualification


4.1 Scope
The DataPro operational testing utilizes the user interface of DataPro
in conjunction with a particle. The DataPro software uses Ethernet to
communicate with a particle counter.
The Revision History included at the end of the DataPro3 manual
describes in detail the changes of each version. This is a supplemental
validation of DataPro 3 using version 1.21 superseding any prior one
regarding relevant tests. This version is a subsequent version to
DataPro 3 version 1.20 and it’s validation documentation.

4.2 User Requirements


U1.1.0. Split the version of the DataPro3 software package as a whole
off from the Client version number. The software package is now v1.21
from v1.20, the client remains unchanged, and the DAS has been
changed from v1.0.5 to 1.0.6
U1.2.0. Removed Windows XP from the minimum requirements of
DataPro3. It does functionally work on XP but is no longer validated on
this End of Life operating system as of v1.20.
U1.3.0. After patching the blocked sensor issue in v1.20, some users
on older systems using XP reported problems with blocked counters
on start up. This issue has been resolved.

4.3 Functional Specifications


The first functional requirement encompass’ both the client and the
service projects.
F1.1.0. Updated version number in DAS assembly project.
F1.1.1. Updated version number in DASSetup project version number.
F1.2.0. Updated CLiMET DataPro3 Manual version numbers in title
and filename.
F1.4.0. Removed XP from minimum requirements in manual.
The following requirements encompass only the service.
F2.1.0. ModbusSensor.vb modified to be more compatible with older
systems.

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Validation: DataPro 3 software

4.4 Traceability Matrix


7. Test or
3. 5.
1. URS 4. GxP 6. Function Verification
CFR11 Other 8.
Reference 2. Description impact? Specification Reference
Impact? Impact Comments
Number (Y/N) Reference (e.g., IQ, OQ,
(Y/N) (Y/N)
PQ)

F1.1.0, F1.1.1,
U1.1.0 Software Package N N N 4.5
F1.2.0

Dropped XP from
U1.2.0 minimum N N N F1.4.0 4.5
requirements

U1.3.0 Service Fix N Y N F1.3.0 4.6

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Validation: DataPro 3 software

4.5 Text Changes

Purpose Observe that versions have been updated and that XP is removed from
minimum requirements.

Setup Use the manual to determine the correct version numbering for the
software package, the client and DAS.

Procedure Check various places for correct version numbers.


 Manual
 Client Installation (About
DataPro Help Menu)
 DAS Installation (Windows
Installed Programs area)
 Check to make sure minimum
requirements no longer list XP

Success  Yes  No

Done by Date 9/14/2012

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Validation: DataPro 3 software

4.6 Blocked Sensor at Startup Test

Purpose Test that Overview correctly shows “Bad Sensor” when blocked at start
up.

Setup Use One Sensor.

Procedure Generate the following events by blocking the air flow and starting the
unit. Leave the air flow blocked for 2 minutes.
 Bad Sensor

 Make sure Overview and View Alarms tabs show the Bad Sensor
event.
 Test on XP
 Text on Vista
 Test on Windows 7
 Once a Bad Sensor alarm is thrown, put the counter into standby,
remove the restricted airflow, and start the counter again.
 The Overview and View Alarms tab does not display Bad Sensor
recovery. This type of error must be manually resolved by the
operator at the physical location to prevent unit damage. Cycling the
unit into a Standby state and then Active again forces this interaction.
 The unit will resume counting if powered off and on after a flow
obstruction is cleared however it will take a few minutes to show on
the over view. To expedite this process put the counter into Standby
state and only setting it to Active after the obstruction is cleared.

Success  Yes  No

Done by Date 9/14/2012

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September 14, 2012 Page 9 of 9 P/N 03036901