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<62> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS：TESTS FOR SPECIFIED MICROORGANISMS 非无菌产品的微生物学检查：指定微生物检查 INTRODUCTION 导言 The tests described hereafter will allow determination of the absence of, or limited occurrence of, specified microorganisms that may be detected under the conditions described. 以下描述的这些检测将使确定特定微生物不存在或数量在限度内的测定得以进行，这些微生物可以在描述的条件下进行检测。 The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When used for such purposes, follow the instructions given below, including the number of samples to be taken, and interpret the results as stated below. 这些测试主要设计用于测定某种物质或制备品是否符合已确立的微生物质量标准。当用于此目的时，遵循以下所给的说明，包括待取样品的数量，并按照以下所述来解释结果。 Alternative microbiological procedures, including automated methods, may be used, provided that their equivalence to the Pharmacopeial method has been demonstrated. 可以使用替代的微生物规程，包括自动化方法，只要它们与药典方法的同等性得到论证。 GENERAL PROCEDURES 通用规程 The preparation of samples is carried out as described in Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests <61>. 按照在非无菌产品微生物学检查：微生物计数检查法<61>中的描述进行样品制备。 If the product to be examined has antimicrobial activity, this is insofar as possible removed or neutralized as described in Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests <61>. 如果供试品具有抗菌活性，则按照非无菌产品微生物学检查：微生物计数检查法<61>中的描述尽可能将其去除或中和。 If surface-active substances are used for sample preparation, their absence of toxicity for microorganisms and their...