N.44

Environmental Microbial Data interpretation in aseptic processing.

We report what USP 38 – USP Pharmacopeial Conventions says at page1199 in the Chapter “Further considerations about data interpretation” of the document “Overall Management of a microbiological control program”. ZERO CONTAMINATION “In the high quality environments required for aseptic processing, detection frequency typically is low. As can be seen from the rates recommended in the enclosed table.

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