Sterility testing United States Pharmacopeia

The United States Pharmacopeia 31 (USP)/The National Formulary 26. Section (71) Sterility Tests. Rockville, MD U.S. Pharmacopeial Convention, 2008. 

After several years of negotiation the sterility tests of the European Pharmacopoeia, The United States Pharmacopeia and the Japanese Pharmacopoeia are harmonised [59]. In the next sections the five steps of this harmonised test, as described in Ph. Eur. 2.6.1 will be discussed sampling, sample preparation, inoculation, incubation, and interpretation. Prior to the routine application of the test, a suitability test with a range of specified test organisms shall demonstrate that growth of these organisms is not inhibited due to residual antimicrobial activity of the product. 

Sterility tests appeared in the British Pharmacopoeia for the first time in 1932 and in the United States Pharmacopeia in 1936 [59]. Currently sterility testing is a legally binding... 

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