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The evolving USP Sterility Test.

The USP chapter titled “Sterility Tests” will be almost completely rewritten in USP XXI. Drafts for comment will shortly appear in Pharmacopeial Forum and USP Comment Proofs. “Sterility Tests” is in the Microbiological Tests section of USP under General Tests. The monograph describes in total detail the preferred procedure when the test is employed as a referee test or as a quality control test. The sterility test involves special limitations due in part to sampling in aseptic technique limitations. Fundamental changes have been made in the maintenance of cultures in the Growth Promotion Tests and in the table of quantities for Liquid Articles. The most important change is in the final paragraphs titled “Observation and Interpretation of Sterility Test Results.” Criteria have been established for justifying performance of a ret-est and for determining test validity. The chapter titled “Sterilization and Sterility Assurance of Compendial Articles” is in the informational section of the compendium. The chapter reviews the principal sterilization techniques currently employed in the pharmaceutical industry and also discusses the principles of validation of these sterilization processes. Biological indicators are an important tool in the validation program. The informational chapter also covers the principles of aseptic processing and the sterility tests of lots. An important part of this section reviews the utility of the sterility test and the instances where it is applicable. This paragraph also discusses the need for validating the efficiency of the sterility test facility and procedure.