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無菌操作台放置環境有規定可以參考嗎?

#1
Daniel 發表於 2018 / 04 / 20
請問,無菌操作台放置環境是否有相關規範?例如:無塵室(等級)、無菌室? 無菌操作台欲進行無菌試驗,所以想要問,放置的環境有沒有相關規定可以參考?
管理員回覆

請參考PI 012 “ STERILITY TESTING  ”
8.1.1.1 The sterility test should be conducted within a class A laminar airflow cabinet located within a class B clean room, or in an isolator that need not be located within a controlled environment. The test may also be performed within a class A clean room, if available. Sterility testing should be carried out in a work zone that offers sufficient space and material should be placed in such a way that it does not disrupt the laminar airflow.

FROM TPDA
2018/5/3

 

 

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