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Equipment:
Protocol #: U-0018-2009-01
Date: 11/10/09
Location:
9000 Rockville Pike
Building 10 Penthouse
Bethesda, MD 20892
Revision: None
Facility:
National Institute of Health
Title:
Installation Qualification for Compressed Air.
Objective:
The objective of this protocol is to document the proper installation of the Compressed Air
System.
Written By: Narlin Beaty
Title: Consultant
Signature:
Signature:
Date:
Date:
Title: _____________________________
Title: _____________________________
Signature:
Signature:
Date:
Date:
Qualification
Process
Solutions, Inc.
PROPRIETARY INFORMATION:
Unauthorized Duplication Is Prohibited
PAGE: 1 of 24
Installation Qualification
EQUIPMENT NAME: Compressed Air
INSTALLATION QUALIFICATION
FOR THE
COMPRESSED AIR SYSTEM
INSTALLED
AT
TABLE OF CONTENTS
1.0
Objective ....................................................................................................................
........................ 3
2.0
Scope ........................................................................................................................
.......................... 3
3.0
Equipment
Description...................................................................................................................
.... 3
4.0
Responsibilities .............................................................................................................
..................... 3
5.0
Reference
Documents ....................................................................................................................
.... 3
6.0
Definitions ..................................................................................................................
........................ 3
7.0
Test Function Number One: IQ Signature Verification List (Attachment #1) .................................. 3
8.0
Test Function Number Two: Specifications & Purchase List (Attachments #2) .............................. 4
9.0
Test Function Number Three: Test Equipment (Attachment
#3) ...................................................... 4
10.0
Test Function Number Four: Air Compressor System Specification (Attachment #4) ..................... 4
11.0
Test Function Number Five: System Documentation Verification (Attachment #5) ........................ 5
12.0
Test Function Number Six: Drawing Verification List (Attachment #6).......................................... 5
13.0
Test Function Number Seven: Instrumentation and Calibration Verification (Attachment #7) ........ 5
14.0
Test Function Number Eight: Supporting Utility Verification (Attachment #8) .............................. 5
15.0
Test Function Number Nine: Specific Installation Verification (Attachment #9) ............................ 6
16.0
Test Function Number Ten: Safety Review (Attachment
#10) .......................................................... 6
17.0
Deviation Reporting Log (Attachment
#11) ...................................................................................... 6
18.0
Installation Qualification Protocol Review (Attachment
#12) ........................................................... 7
19.0
Summary Report
Requirements ......................................................................................................... 7
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 3 of 24
1.0
Objective
The objective of this protocol is to verify that the Compressed Air System, described in Section 3.0,
has been assembled in accordance to manufacturers specification, and in accordance with Current
Good Manufacturing Practices (cGMPs).
2.0
Scope
This Installation Qualification pertains to the verification of the assembly of the equipment described
in Section 3.0 of this protocol, to be installed in the mechanical room at National Institutes of Health
(NIH), 10 Center Drive, Bethesda, MD 20892-1996. This protocol is specific to the Compressed Air
system and related instrumentation and equipment. This protocol is limited to the aseptic
manufacturing space and the compressed air utility therein.
3.0
Equipment Description
The Air Compressor unit is a Quintaplex, air cooled, two stage, oil free, scroll compressor unit. Unit is
supplied with air receiver. Compressor unit is frame mounted. Unit is pre-piped and wired providing
single point connection for utilities and air piping.
Some of the unit components include:
Model WTR45-A Air Compressor (4 ea.)
Integral 30 diameter , 200 psi ASME coded air receiver
One set of twin tower desiccant dryers , ZEKS Model 160-200 ZPA heatless
One set of cartridge air filters, 5 micron primary and 1 micron final.
Quintaplex Controls
Pressure regulators
4.0
Responsibilities
4.1 Qualification Process Solutions, LLC.
4.1.1 It is the responsibility of QPS to write this protocol.
4.1.2 It is the responsibility of QPS to execute this protocol.
4.2 National Institutes of Health (SI)
4.2.1 Following the execution, NIH will approve the final report associated with this protocol,
indicating the executed protocol was completed correctly and all acceptance criteria were
met.
5.0
Reference Documents
WTR45-A Compressor Manual
Desiccant Dryer Manual
6.0
Definitions
6.1 Critical Instrumentation Critical instruments are defined as those whose performance will
affect the operation of the system and/or the quality attributes of the processed materials.
Critical instruments are calibrated and certified using standards that are traceable to NIST
(National Institutes of Standards and Testing).
6.2 Non-Critical Instrumentation Instrumentation provided for indication or convenience
purposes only.
7.0
7.1
Objective
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 4 of 24
To identify all personnel involved in executing this protocol.
8.0
9.0
10.0
7.2
Procedure
Verify that each person who executes this protocol signs Attachment #1. On this attached form,
each person shall be identified by name, title, company, signature, initials and date.
7.3
Acceptance Criteria
Signatures from all personnel involved in execution of this protocol shall be present.
Test Function Number Two: Specifications & Purchase List (Attachments #2)
8.1
Objective
To verify that the system installed is the intended purchase.
8.2
Procedure
8.2.1 Verify that the attachment model and the installed equipment model are the same.
8.2.2 Complete the applicable attachment identifying the specific system.
8.3
Acceptance Criteria
The equipment was purchased for NIH by Gilbane construction. Verify that the model installed
is the model of the Attachment.
Objective
The objective of this test function is to verify and document all test equipment.
9.2
Procedure
9.2.1 Complete a list of all the instruments required for conducting IQ testing.
9.2.2 Verify that the test equipment/instruments are calibrated and the reference standards are
traceable to National Institute for Standards and Technology (NIST) or other approved
standard.
9.2.3 Complete the applicable attachment, indicating the equipment description, ID/serial
number, calibration date, re-calibration date.
9.3
Acceptance Criteria
All equipment required for execution shall be calibrated with copies of calibration records
attached.
Test Function Number Four: Air Compressor System Specification (Attachment #4)
10.1 Objective:
The objective of this section is to verify the primary equipment components of the compressor.
10.2 Test Method:
10.2.1 Review the as built system and compare it to the specifications on the attachment.
11.0
12.0
13.0
Test Function Number Seven: Instrumentation and Calibration Verification (Attachment #7)
13.1 Objective
The objective of this test function is to verify that all system instruments are installed and, if
applicable, calibrated with a current calibration.
13.2 Procedure
13.2.1 Verify the information of each instrument associated with the system.
13.2.2 Locate and verify calibration data for calibrated instruments.
14.0
14.1 Objective:
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 6 of 24
The objective of this section is to document that all supporting utilities have been certified by
others as having met the minimum specifications for operation of the system and are properly
connected in accordance with engineering design and/or vendor specifications.
14.2 Procedure:
Verify that the following support utility systems are properly connected to the system and are
within specifications:
Electricity
Chilled Water
14.3 Acceptance Criteria:
All supporting utilities meet the specified requirements for the operation of the system.
15.0
The field condition meets or exceeds the installation requirements as designated on the
attachment.
16.0
17.0
17.1 Objective
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 7 of 24
To document any deviation to the stated test procedure or acceptance criteria, and to evaluate
the deviation relative to acceptability of the qualification study.
17.2 Procedure
17.2.1 Document all deviations found during execution using the Deviation Report Form that is
with the Deviation Reporting Log. Make copies of the form for each logged Deviation.
17.2.2 Deviations caused by Out of Specification (OOS) Conditions. If during the evaluation of
equipment parameters against specifications, the equipment fails to meet predetermined
acceptance criteria, a formal deviation report investigates the cause. In these cases, the
cause must be known prior to continuing the protocol execution since a true failure in
equipment performance is likely to affect the completion of the protocol. The protocol
deviation report determines 1) if the acceptance criteria are correct and current with user
requirements and manufacturer's ratings, or 2) if there is an immediate and obvious
explanation for the failure. If a true failure is documented, then appropriate root cause
analysis and corrective actions ensue and are agreed to between the protocol executors
and the department owners and QA. The protocol deviation report documents the
conclusion to this investigation and any appropriate retesting and an impact assessment
on the portions of the protocol executed prior to the documented failure.
17.2.3 Completed Deviation Report Forms are submitted to QA for signature acceptance.
18.0
19.0
19.2 Procedure
19.2.1 Generate a Final Summary on completion of protocol execution.
19.2.2 Attach copies of the completed approved Deviation and Corrective Action Forms where
necessary.
19.2.3 Attach the completed executed protocol attachments to the Summary Report.
19.2.4 Compile a summary of the results obtained, and generate a conclusion, based on these
results, of the acceptability of the qualification results. The conclusion section will
contain a statement(s) of conformance to the specified acceptance criteria, evaluated in
conjunction with the approved Deviations/Variances and Corrective Actions taken, and a
determination of acceptability of the protocol, as executed.
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
Title
Signature
Initials
Date
Company Name
Comments: ________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
Acceptance Criteria: Signatures from all personnel involved in execution of this protocol shall be
present.
Meets Acceptance Criteria? ( ) Yes ( ) No
Reviewed by: ________________________________
Date: ___________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 10 of 24
Attachment #2 Specification and Purchase List
List all applicable specifications, purchase orders and change orders. Note: Make additional copies of this
attachment as necessary. Existing documentation packages, where available, may be included as attachments.
Vendor
Equipment Specification
Initials/Date
Gardner Denver*
Model WTR45-A
User Requirement Specification
Gilbane Spec.
15360 Laboratory Compressed Air and
Gas Systems
*There is only one document for these two listing.
Comments: *Equipment was purchased through Gilbane as part of the PDS Atrium infill project.
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Acceptance Criteria: The specification of model is as listed and the user requirements document is attached.
Meets Acceptance Criteria? ( ) Yes ( ) No
Reviewed by: __________________________________
Date: __________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 11 of 24
Attachment #3 Test Equipment
This attachment identifies the instruments, equipment, and materials that are not part of the equipment or
system being qualified, but are used in this qualification.
Equipment
Manufacturer
Description
AC/DC True
RMS Clamp
Meter
Pressure
Calibrator
FLUKE
FLUKE
ID#
102526
ALID11
G23LAB
H4
Certified/
Cal.
Cal
Calibrated
Yes
Date
11 May
2009
Due Date
11 May
2010
Yes
26 Oct
2009
26 Oct
2010
Initials/
Serial #
92402293
9466060
Date
Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Acceptance Criteria: All test equipment required for execution shall be calibrated with copies of calibration
records attached.
Meets Acceptance Criteria? ( ) Yes ( ) No
Reviewed by: _____________________________________
Date: __________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 12 of 24
Attachment #4 Air Compressor Systems Specification
Review the as built system and compare to the specifications on this attachment.
Verification Items
Manufacturer
Model Number
Serial Number
Quantity of Modules
Rating
Compressors
Mounting
Specified
Gardner Denver
WTR45-A
as found
1
48 CFM @ 175 psi
5-15 HP
Frame Mounted
Actual
Initial/Date
Electrical Service
Air Receiver
Dimensions
Pressure Regulators
Dessicant Dryers
Dimensions
Connections
Control Panel
1
30 X 84 , LOA 95.75
as found
1 twin tower
32x45x60 (LxWxH)
1 NPT
NEMA 4 Quintaplex
Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Description
Document Location
Date
Air Receiver
ASME
Certification
Certification Report
System Manual
WTR45-A
Maintenance Instructions
Compressor
Equipment Specification
System Manual
Desiccant Dryer
Maintenance Instructions
Sequence of Operations (or
Control Panel
Operating Manual)
Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Acceptance Criteria: The documents have been located and are either attached here, or if too large to attach,
then their location elsewhere is clearly specified.
Meets Acceptance Criteria? ( ) Yes ( ) No
Reviewed by: __________________________________
Date: __________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 14 of 24
Attachment #6 Drawing Verification List
Obtain a copy of the current or approved revision for each drawing listed below. Record the revision number
and date of each drawing. Visually compare the drawings to the installed equipment/system.
Drawing
Rev. No./
Date
Location of
Initials / Date
Drawing Description
Number
Drawing
Acceptance Criteria: All drawings pertaining to the equipment are listed above and the information is
complete.
Meets Acceptance Criteria? ( ) Yes
( ) No
Instrument
Description
Calibration
(Due Date or
N/A)
Initial / Date
Air Compressor
High Temp Switches 1-5
Panel Mounted
Panel Mounted
Panel Mounted
As Found
As Found
Desiccant Dryer
Tower Pressure Gage
Tower mount
Tower mount
N/A
Tank Mounted
Wall mounted
sensor.
Wall mounted
sensor.
N/A
Air Receiver
Safety Relief Valve
Differential Pressure Monitor
(DPM)
Remote Pressure Transmitter
(RPT)
Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Acceptance Criteria: Instruments listed above have been located and calibration status noted.
Meets Acceptance Criteria? ( ) Yes ( ) No
Reviewed by: ________________________________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Date: ______________
Page 16 of 24
Attachment #8 Supporting Utility Verification
Measure/Verify the support utility parameters to assure that they match with system requirements.
Verification Items
Specified (nominal)
Electrical Power
460/3/60
Actual
Air Compressor
As-Found
Verification Method
Direct Measurement
Vendor Start-Up
Direct Measurement
Vendor Start-Up
Initial/Date
Chilled Water
(Temp/Flow)
Desiccant Dryers
Direct Measurement
Electrical Power
115/1/60
Vendor Start-Up
Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Date: ______________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 17 of 24
Attachment #9 Specific Installation Requirements
As Found Condition
Field Condition
Meets Requirement
Installation Requirement
Y/N
Equipment is properly leveled and
adequately secured in place.
Vibration isolators properly installed
and adjusted
Drain pans sloped. One outlet drain
per cooling section.
The filters are installed and are
orientated to match the flow direction.
Shipping braces removed
All piping is supported. (No visible
sag.)
Equipment has been cleaned prior to
start-up.
Adequate clearance provided to
equipment.
Drive belts aligned and tensioned.
Belt guards in place and secure.
Equipment appears to be clean and
not damaged.
125psi SS flex connectors are
installed at compressor inlet and
outlets. air piping provides supply air
Supply
Initials / Date
Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Acceptance Criteria: The field condition meets or exceeds the installation requirements as designated on the
attachment.
Meets Acceptance Criteria? ( ) Yes ( ) No
Reviewed by: ________________________________
Date: ______________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 18 of 24
[ ] YES [ ] NO [ ] N/A
Applicable
Location: ______________________
[ ] YES [ ] NO
Applicable
[
[
[
[
]
]
]
]
YES
YES
YES
YES
[
[
[
[
]
]
]
]
NO
NO
NO
NO
[
[
[
[
]
]
]
]
N/A
N/A
N/A
N/A
[ ] YES [ ] NO
YES [ ] NO
procedures
YES [ ] NO
state
YES [ ] NO
[
[
[
[
[
]
]
]
]
]
N/A
YES [ ] NO [ ] N/A
N/A
YES [ ] NO [ ] N/A
N/A
Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Date: _____________________
Date: _____________________
Applicable
[ ] YES [ ] NO
If hazardous materials are applicable, attach Material Safety Data Sheet(s) to this report.
MSDS attached
[ ] YES [ ] NO [ ] N/A
Applicable
[ ] YES [ ] NO [ ] N/A
[ ] YES [ ] NO
[ ] YES [ ] NO
[ ] YES [ ] NO
[ ] YES [ ] NO
Applicable
[ ] N/A
[ ] N/A
[ ] N/A
NO
NO
NO
[ ] N/A
[ ] N/A
[ ] N/A
NO
[ ] N/A
[ ] YES [ ] NO
[
[
[
[
]
]
]
]
YES
YES
YES
YES
[
[
[
[
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]
]
NO
NO
NO
NO
[
[
[
[
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]
]
]
N/A
N/A
N/A
N/A
Comments: _____________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Performed by: _______________________________
Date: _____________________
Date: _____________________
Applicable
[ ] YES [ ] NO
Applicable
[
[
[
[
[
[
[
[
[
]
]
]
]
]
]
]
]
]
YES
YES
YES
YES
YES
YES
YES
YES
YES
[
[
[
[
[
[
[
[
[
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]
]
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]
NO
NO
NO
NO
NO
NO
NO
NO
NO
[
[
[
[
[
[
[
[
[
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]
]
]
]
]
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
[ ] YES [ ] NO
[ ] YES [ ] NO [ ] N/A
Location: ____________________________________________________
Respiratory equipment/device in place, if required
Noise Levels:
Applicable
[ ] YES [ ] NO [ ] N/A
[ ] YES [ ] NO
[ ] YES [ ] NO [ ] N/A
Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Date: _____________________
Date: _____________________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 21 of 24
Attachment #10 Safety Review
Hazop Review and Checklist
Ergonomic Design:
Applicable
[ ] YES [ ] NO
Ergonomic risks evaluated, operators can access all areas of machine [ ] YES [ ] NO [ ] N/A
Adequate operator visibility
[ ] YES [ ] NO [ ] N/A
Emergency stop buttons visible, accessible, labeled, and operational [ ] YES [ ] NO [ ] N/A
Warning bells and lights visible and functional
[ ] YES [ ] NO [ ] N/A
[ ] YES [ ] NO [ ] N/A
[ ] YES [ ] NO [ ] N/A
Excessive reaching, body bending, weight pushing and pulling eliminated or minimized
[ ] YES [ ] NO [ ] N/A
Personnel protective equipment to be worn while operating is indicated. Include requirements.
[ ] YES [ ] NO [ ] N/A
This equipment can be safely operated if it is maintained properly and appropriate procedures are followed.
Safety Personnel Signature: _________________________
Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Performed by: _______________________________
Date: _____________________
Date: _____________________
Resolved (Y/N)
Number
Yes / No
Yes / No
Yes / No
Comments: _______________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
Acceptance Criteria: A list of deviations resulting from the execution of this protocol shall be recorded.
Protocol Section
Date Encountered:
Page
Executor/Discovered By
Step
Description of Deviation
Investigation / Findings
Statement of Impact
Resolution
Approvals
Role
Executor
Name (Print)
Signature
Date
Reviewer
NIH QA Officer
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 24 of 24
Attachment #12 Installation Qualification Protocol Review
I attest that this document has been reviewed and found satisfactory.
Name (print):____________________________________________________________________
Title: ________________________________
Signature: ____________________________________________
Date: ___________________
Title: _____________________________
Title: _____________________________
Signature:
Signature:
Date:
Date: