A
stimulus article entitled "The Development of Compendial Rapid Sterility
Tests" arising from the work of the USP Modern Microbiological
Method Expert Panel, co-chaired between Tony Cundell and Ed Tidswell, has been
published in the Sept-Oct 2017 Pharmacopeial Forum.
The
new paradigm is a risk-based selection of a rapid sterility test for
short-lived sterile products.
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Pharmaceutical Microbiology