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.
70 〈71〉 Sterility Tests / Microbiological Tests USP 35 Fluid Thioglycollate Medium is to be incubated at 30°–35°. Table 1. Strains of the Test Microorganisms Suitable for Use in For products containing a mercurial preservative that cannot the Growth Promotion Test and the Method Suitability be tested by the membrane filtration method, Fluid Thiog-Test (Continued)
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