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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.
Measurement – Hold-over
ID
Description
P-13
The test is intended to provide substantiation for the time it takes for the temperature
inside the cabinet to reach the end temperature specified in the appendix.
Ambient temperature and setpoint temperature is specified in P-5.
The temperature inside the cabinet must be stabilized – where all the points in the
working space have reached and maintained the same temperature throughout,
the tolerances are specified in P-6.
When the system is stable, turn off the power to the cabinet.
The measurements, throughout the hold-over test, must be documented and
attached the PQ.
Attachment:
Notes:
P-14
The times it takes the inside of the cabinet to reach the end temperature,
must at least be the time specified in the appendix.
Duration:
Have the criteria been met?
Attachment:
Notes:
Conducted by:
Name:
Inspected / verified by:
Signature:
Model: ________________________
b i o l i n e
Accepted
Yes
Approved
Date:
(Yes / No):
SN: ________________________
No
107
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