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USP Sterility Test Proposal

Dr. Michael J. Miller mignatz at mjmiller.roc.servtech.com
Sat Jul 1 12:09:29 EST 1995

In the May-June PF, the USP has proposed radical changes to the Sterility
Test procedure <71>.  This includes: no retests when barrier isolators are
used, 20 containers when using the membrane filtration, 40 containers
during a retest (and other requirements associated with invalidating an
initial test), and a 14 day incubation period.  Please respond with your
comments, as we are preparing replies to the USP.  You may post your
comments here or e-mail me directly.  Thanks for you time.


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