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Deviations from the specifications dictated in the PQ are to be reported in the deviation report.
The PQ is concluded if all criteria of acceptance are approved and the possible deviations are rectified or accepted.
Measurements – Door opening test
ID
Description
P-9
The test is intended to provide substantiation for the temperature recovery time
inside the cabinet subsequently after a door opening.
The temperature inside the cabinet must be stabilised – Where all the points in
the working space have reached and maintained the same temperature, the
setpoint temperature is specified in P-5.
When the system is stable, open the door at 90° for 60 seconds.
The measurements, throughout the door opening test, must be documented
and attached the PQ.
Duration:
Attachment:
Notes:
P-10
Has the setpoint temperature specified in P-5, measured in the absolute centre of
the cabinet, been achieved within the set time-frame specified in the appendix?
Attachment:
Notes:
Name:
Conducted by:
Inspected/verified by:
Signature:
Model: ________________________
b i o l i n e
Accepted
Yes
Approved
Date:
(Yes/No):
SN: ________________________
No
151
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