Transcription of 2.6. BIOLOGICAL TESTS - uspbpep.com
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EUROPEAN PHARMACOPOEIA BIOLOGICAL TESTS01/2008 STERILITYThe test is applied to substances, preparations or articleswhich, according to the Pharmacopoeia, are required to besterile. However, a satisfactory result only indicates thatno contaminating micro-organism has been found in thesample examined in the conditions of the test. Guidancefor using the test for sterility is given at the end of this AGAINST MICROBIAL CONTAMINATIONThe test for sterility is carried out under aseptic order to achieve such conditions, the test environmenthas to be adapted to the way in which the sterility test isperformed.
Fluid thioglycollate medium is primarily intended for the culture of anaerobic bacteria; however, it will also detect aerobic bacteria. Soya-bean casein digest medium is suitable for the culture of both fungi and aerobic bacteria. Other media may be used provided that they pass the growth promotion and the validation tests. Fluid thioglycollate ...
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