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.
It can be viewed free by registering on the USP website at www.usp.org
The new paradigm is a risk-based selection of a Rapid Sterility test for short-lived sterile products.
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