CNC级车间与D级车间的区别
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2018-12-20 15:04 莫邪小仙     
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对洁净级别进行比较，可以从标准上比较，例如微粒和微生物数量方面评价两者的区别。你可以找一下对CNC车间洁净级别要求，然后跟“附录一：无菌药品“中对级别的定义进行比较。

2018-12-20 23:02 奕瞳     
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Jwj1 2018-12-21 11:23

Controlled/Not Classified

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奕瞳 2018-12-21 14:43

ISPE Baseline Guide,Vol.3:Sterile Product Manufacturing Facilities (Second Edition):

Controlled Not Classified (CNC)

A non-classified room environment where closed processes and their immediate support systerms may be located.CNC space is cleanable,access controlled and served with filtered ventilation air;procedural controls and personnel garment upgrades may be applied at the owner's discreton .in the biopharmaceutical industry CNC is replacing the term "gray space".

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