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). However, the basicstructure of the test was test has generated controversy as to its role in productquality testing for decades. While this is understandable, ithighlights a significant problem in Quality Control (QC)pharmaceutical Microbiology .
Pharmacopeia, National Formulary,AOAC INTERNATIONAL, Book of Methods,{1} or in other recognized standard references, or is detailed in an approved new drug application and the referenced method is not modified, a statement indicating the method and reference will suffice). The suitability of all testing methods used shall
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