Transcription of <71> STERILITY TESTS
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<71> STERILITY TESTS
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. In order to achieve such conditions, the test environ-surface (for example, chambered slides) suitable forment has to be adapted to the way in which the sterilitythe test procedure.
Fluid Thioglycollate Medium is 6. Remove the stain and rinse the monolayer with Puri-primarily intended for the culture of anaerobic bacteria. fied Water. However, it will also detect aerobic bacteria. Soybean–Casein 7. Mount each coverslip, where applicable (a mixture ofDigest Medium is suitable for the culture of both fungi and
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