FAQ - 製薬/生命科学（ライフサイエンス）における微粒子測定

質問 Regarding non-viable particle counts in clean area (aseptic processing), does SOP spell out for initial and post operation counts and during filling operation on FMS should not collect data?

回答

The SOP should call for monitoring the environment during the at rest stage, during operations set up and start up of equipment. One product begins to flow then the counting aspect of your environmental monitoring program is turned off. Post filling a period of 15-20 should elapse and then the particle counting turned back on to verify that the environment has reestablished normal baseline conditions. It is also prudent to run a validation exercise at least once but preferably once per year to verify that operations do not contaminate the environment. This would be done by a 30 minute run where glassware and operators perform as per SOP but no product is flowing.

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