F0大于12的湿热灭菌生物指示剂

ning_zilv

该生物指示剂含菌量国内标准是10的5次方到10的6次方。现在要过FDA该标准能不能符合美国标准。
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来自安卓APP客户端

剑魔

Microbiological validation studies should be submitted that
demonstrate the efficacy of the minimum cycle to provide a sterility
assurance of 10 or better to the product under the most difficult to
-6
sterilize conditions (e.g., the most difficult to sterilize load with
biological indicators at microbiological master sites or in master
product or both). Use of a microbiological master product or site
should be supported by scientific data. Microbiological master
sites or solutions are those sites or solutions in which it is most
difficult to kill the biological indicator under sterilization cycles that
simulate production conditions.

剑魔

Microbiological validation studies should be submitted that
demonstrate the efficacy of the minimum cycle to provide a sterility
assurance of 10^6 or better to the product under the most difficult to
sterilize conditions (e.g., the most difficult to sterilize load with
biological indicators at microbiological master sites or in master
product or both). Use of a microbiological master product or site
should be supported by scientific data. Microbiological master
sites or solutions are those sites or solutions in which it is most
difficult to kill the biological indicator under sterilization cycles that
simulate production conditions.