Clean Rooms and Controlled Environments – Free PDF download




Important note regarding FDA Aseptic Guidelines:
–  FDA Aseptic guidelines do not allow averaging at a sampling site!
–  Each discrete sample must be below the class limit.
– This is important, since you can pass ISO and FS 209E, and not meet FDA requirement.
–  FDA aseptic guidelines still reference the FS 209E classes.
–  FDA has no formal position regarding the ISO standards impact on pharmaceutical manufacturers

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