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?

Tony Cundell
[log in to unmask]

The PMFList ( is operated from
The Microbiology Network ( and supported by
our sponsors ( as a service to
the scientific community.