Transcription of <71> STERILITY TESTS
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USP 35 Microbiological TESTS / 71 STERILITY Tests69 The test is applied to substances, preparations, or articlesMETHOD which, according to the Pharmacopeia, are required to be ster-ile. However, a satisfactory result only indicates that no the indicator cell culture at a suitable densitytaminating microorganism has been found in the sample ex-(for example, 2 104 to 2 105 cells/mL, 4 103 toamined under the conditions of the 104 cells/cm2) that will yield confluence after 3days of growth. Inoculate 1 mL of the product to beexamined into the cell culture vessel, and incubate atPRECAUTIONS AGAINST MICROBIAL36 1 . at least 3 days of incubation, when the cellshave grown to confluence, make a subculture onThe test for STERILITY is carried out under aseptic condi-cover slips in suitable containers or on some othertions.
5. Add a suitable DNA stain and allow standing for a Test of Aerobes, Anaerobes, and Fungi. suitable time (bisbenzimide working solution and a The following culture media have been found to be suita-standing time of 10 minutes are suitable). ble for the test for sterility. Fluid Thioglycollate Medium is 6.
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