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Sterilization or Depyrogenation Validation - Non Product
Sterilization or Depyrogenation Validation - Non Product
Prepared by:
Date:
Supersedes:
Checked by:
Date:
Date Issued:
Approved by:
Date:
Review Date:
Preventive Maintenance (PM) Measures should include, and not be limited to,
the following:
For Steam
Calibrate I/Es;
Calibrate I/Es;
Clean chamber;
2.
Critical Process Parameters (e.g., temperature, exposure time) for each type of
9.
10.
All BIs Used in Validation Studies should be accounted for, before and after
processing.
11.
For Steam Sterilization Processes, BIs are available in four (4) forms:
12.
13.
Steam Sterilization OQ/PQ Studies should be performed and include, and not
be limited to, the following:
14.