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Web of Proceedings - Francis Academic Press
Web of Proceedings - Francis Academic Press

Pre-test and Method Validation of Microbial Limit Test for Drugs Based on Predictive Microbiology

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DOI: 10.25236/icbcme.2019.023


Hong Xiaoming

Corresponding Author

Hong Xiaoming


Microbial limit test of drugs is an important inspection item to control the quality of drugs. The microbial limit validation method has been greatly revised, and all the drugs that need microbial limit test should be re-validated in accordance with the requirements of the current Pharmacopoeia. The special role of specific spoilage bacteria in microbial prediction, the application of traceability technology, temperature synthesis function and biological indicators in microbial prediction. Select the method of predictive microbiology to improve the microbiological detection rate of the drug, and ensure the correctness and credibility of the test results. The operating environment, standards, cleanliness test and other indicators for microbiological limit inspection and verification are clarified to ensure the inspection method, Verify the reliability of the results. the feasibility of application in predictive microbiology and molecular prediction were also studied in order to provide theoretical reference for promoting the progress of microbial limit test of drugs in an all-round way.


Predictive microorganisms, Drugs, Microbial limit