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
Wyeth-Ayerst
[log in to unmask]


------------------
The PMFList (http://microbiol.org/pmf.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.