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.