The PDA Technical Report on the Validation of Aseptic Processing continued
to advocate a simple 0.1% contamination rate as a Media Fill criterion
despite the EU GMP Annex on Sterile products requiring a 95% confidence limit.
My question is whether US pharmaceuticals company are or have moved to use
of a confidence internal and whether they are using 1 in 4500 or 2 6300 is
the acceptance criterion?
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