Product qualification

Performance
Qualification

Manufacturer: MEMMERT GmbH + Co.KG, 91107 Schwabach, Germany

Designation: Constant Climate Chambers

Type: HPP 749

Voltage: 230 V, 50 / 60 HZ

Serial No: X 512-0018

Examined by Date Signature

Checked by Date Signature

by MEMMERT GmbH + Co. KG, Qualification report is valid only if initial data are entered (page 2, Section 3)
Product qualification
Performance Ref.: PQ_HPP_108-749 Date: 20.02.2012
qualification
Document: PQ_HPP Version:
2010_001
PQ examination plan / Page 1 of 7
report

1. Purpose of qualification
The purpose of this qualification is to ensure the function of the product
designated as examination object and that it is show reproductive results.
The following are tested on site
- all alarm and switching functions relevant for quality and / or process
- all control functions relevant for quality and / or process
- temperature distribution inside the chamber
-
a. Alteration history (to be completed by user)

Version Date Reason for alteration Signature

01 New product / First installation
02 Installation after repair
03 New application of product
(cross out items which do not apply)

b. Distribution (to be completed by user)

Main department Function Number /

Department / Copies
Laboratory
Engineering Original
User 1 Copy

Examined by Date Signature

Checked by Date Signature

by MEMMERT GmbH + Co. KG, Qualification report is valid only if initial data are entered (page 2, Section 3)
Product qualification
Performance Ref.: PQ_HPP_108-749 Date: 20.02.2012
qualification
Document: PQ_HPP Version:
2010_001
PQ examination plan / Page 2 of 7
report

2. Examination object (to be completed by user)

Manufacturer: MEMMERT GmbH + Co.KG, 91107 Schwabach, Germany

Designation: Constant Climate Chamber

Type: HPP 749 Yes No

Voltage: 230 V, 50 / 60 HZ Yes No

Nom. Temperature 70.0 C Yes No

Serial No.: X - - -. - - - - Yes No

Examined by Date Signature

Checked by Date Signature

by MEMMERT GmbH + Co. KG, Qualification report is valid only if initial data are entered (page 2, Section 3)
Product qualification
Performance Ref.: PQ_HPP_108-749 Date: 20.02.2012
qualification
Document: PQ_HPP Version:
2010_001
PQ examination plan / Page 3 of 7
report

3. Performance qualification procedure (to be completed by

manufacturer)
a. Power ON

Power ON the switch, the regulator red light lit shows that the equipment is
ready for operation.

b. Setting of temperature

Set the temperature : 30 C

c. Position of logger monitors

Five temperature / humidity logger monitors are placed in tray No. 1 to 5 from
top to bottom.

Position 1: Sr. # ___________

Position 2: Sr. # ___________
Position 3: Sr. # ___________
Position 4: Sr. # ___________
Position 5: Sr. # ___________

To be completed by user

Examined by Date Signature

Checked by Date Signature

by MEMMERT GmbH + Co. KG, Qualification report is valid only if initial data are entered (page 2, Section 3)
Product qualification
Performance Ref.: PQ_HPP_108-749 Date: 20.02.2012
qualification
Document: PQ_HPP Version:
2010_001
PQ examination plan / Page 4 of 7
report

d. Temperature distribution test

Determines the distribution of the temperature at 5 points inside the chamber.

In addition to establishing the lowest and the highest temperature inside the
chamber (temperature distribution), the maximum temperature fluctuations
must also be evaluated.
For this purpose, after reaching stable conditions, the lowest and
subsequently the highest temperature at one point (ideally center of chamber)
are measured and documented.

The measured temperature has to be entered in the table below.

The temperature probes for determining the temperature distribution have to

be positioned according to DIN 12880: 2007 05 (see appendix).
Relative humidity measured in accordance to the Guideline DKD R 5 7
and DIN EN 60068 3 5 or DIN 50011 12.
To be completed by responsible personnel

e. Procedure

Set the logger monitors to magnetic start.

Place the placebo product in each shelf.
Adjust stability chamber to required temperature & humidity.
Place the five logger monitors after activating with magnet at respective
positions, when temperature is achieved.
During prescribed period all the variations are recorded.
Remove the logger monitors and get the readings of each place.

Examined by Date Signature

Checked by Date Signature

by MEMMERT GmbH + Co. KG, Qualification report is valid only if initial data are entered (page 2, Section 3)
Product qualification
Performance Ref.: PQ_HPP_108-749 Date: 20.02.2012
qualification
Document: PQ_HPP Version:
2010_001
PQ examination plan / Page 5 of 7
report

f. Acceptance Criteria
For Temperature : ________ C 2 C

g. Results

Setpoint temperature _ _ _ C
Indicated temperature (controller display) _ _ _ C
Setpoint relative humidity rh __%
Indicated actual relative humidity rh (controller display) __%
Time interval between each level reading _ _ _ Hours

Sensor
Level 0 Level 1 Level 2 Level 3 Level 4
numbering
Sensor # 1 _ _ _ C _ _ _ C _ _ _ C _ _ _ C _ _ _ C
Sensor # 2 _ _ _ C _ _ _ C _ _ _ C _ _ _ C _ _ _ C
Sensor # 3 _ _ _ C _ _ _ C _ _ _ C _ _ _ C _ _ _ C
Sensor # 4 _ _ _ C _ _ _ C _ _ _ C _ _ _ C _ _ _ C
Sensor # 5 _ _ _ C _ _ _ C _ _ _ C _ _ _ C _ _ _ C
Maximum temperature difference _ _ _ C
Acceptance criteria for temperature measurement referred to +/___
DIN 50011 C
Measurement values acceptable in accordance to DIN50011 Yes No
To be completed by user
Examined by Date Signature

Checked by Date Signature

by MEMMERT GmbH + Co. KG, Qualification report is valid only if initial data are entered (page 2, Section 3)
Product qualification
Performance Ref.: PQ_HPP_108-749 Date: 20.02.2012
qualification
Document: PQ_HPP Version:
2010_001
PQ examination plan / Page 6 of 7
report

Test result was successfully achieved Yes No *

Examiner Date Signature

Verified by Date Signature

Remarks (if any)

* If test result shows NO then see Deviation Sheet No.: ________________

The answer to all questions must be yes in order to move on to the next
qualification stage, otherwise rectify the fault!!
To be completed by user

4. Test of temperature distribution accorded to DIN 12880: 2007 05

The original documentation for the measured temperatures and
humidity values as entered in the qualification.

Examined by Date Signature

Checked by Date Signature

by MEMMERT GmbH + Co. KG, Qualification report is valid only if initial data are entered (page 2, Section 3)
Product qualification
Performance Ref.: PQ_HPP_108-749 Date: 20.02.2012
qualification
Document: PQ_HPP Version:
2010_001
PQ examination plan / Page 7 of 7
report

5. Release of the examined product for testing purpose

The release of the product for the intended application is authorised by

Name Company / department Date Signature

Examined by Date Signature

Checked by Date Signature

by MEMMERT GmbH + Co. KG, Qualification report is valid only if initial data are entered (page 2, Section 3)