Transcription of The Sterility Tests - Microbiology Network
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The Sterility Tests - Microbiology Network
2 THE Sterility TESTSS cott SuttonMicrobiology Network , , NYUSABACKGROUNDThe compendial Sterility Test is not a test for product Sterility . This isnot a new, nor a particularly insightful observation. It has beenfrequently presented as a flawed test for its stated purpose in theliterature over the past 80 years. The test first appeared in 1932 ( , 1932) and included the basic features of the modern test two media, prescribed dilution scheme (for Bacteriostasis/Fungistasis or method suitability) and a defined incubation time. Theoriginal test had the media incubated for five days and allowed tworetests (all three had to fail to fail the test).
test as finished product QC release tests, but this is neither its design nor intent. Those chapters in United States Pharmacopeia (USP) numbered less than 1000 (for example, the Sterility Test is 7. Sutton, S. 2011. Sterility Tests IN Rapid Sterility Testing J. …
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