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71 〉〉〉〉 STERILITY TESTS

Printed on: Mon Mar 30 2020, 16:39:24 pmPrinted by: Deborah NishikawaOfficial Status: Currently Official on 30-Mar-2020 Official Date: Official Prior to 2013 Document Type: GENERAL CHAPTERDocId: 1_GUID-481C30EA-8A49-4A77-9E81-D0CD7C533 498_1_en-USPrinted from: 2020 USPC 71 STERILITY TESTS Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopeia and/or the Japanese Pharmacopeia. Those portions that are not harmonized are marked with symbols ( ) to specify this Pharmacopeial procedures are not by themselves designed to ensure that a batch of product is sterile or has been sterilized. This is accomplished primarily by validation of the sterilization process or of the aseptic processing procedures.

Fluid Thioglycollate Medium is to be incubated at 30°–35°. For products containing a mercurial preservative that cannot be tested by the membrane filtration method, Fluid Thioglycollate Medium incubated at 20°–25° may be used instead of Soybean–Casein Digest Medium provided that it has been validated as described in Growth Promotion Test of Aerobes, Anaerobes, and …

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Transcription of 71 〉〉〉〉 STERILITY TESTS

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