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 FMS continue monitoring during production where powder filling is done?

回答

An installed monitoring system should be turned off when powder is flowing, if you are using a portable device then this can also be disabled. The rationale behind this is that you are looking for extraneous contamination and the product here is likely to be confused with contamination levels and as such is superfluous. It is required that you maintain the integrity of the environment and have proof of that integrity, as such you must continue to monitor the air velocity from the laminar flow hoods and differential pressures in the filling suite. Microbial monitoring remains a high priority however given the nature of many dry powder products you will need to select media carefully.

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