USP 62 非无菌产品微生物限度检查(控制菌) USP38.pdf

62 MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS 非无菌产品微生物限度检查:控制菌 （USP38 ） 1. 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. 控制菌检查法系用于在规定的试验条件下，检查供试品中是否存在特定的微生物。 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. 当本法用于检查非无菌制剂及其原辅料是否符合相应的微生物限度标准时,应按下列规定进行检验，,包括样品的取 样量,结果的判断. Alternative microbiological procedures, including automated methods, may be used, provided that their equivalence to the Pharmacopeial method has been demonstrated. 可以使用包括自动化法在内的方法,需确认与药典方法的等同性. 2. GENERAL PROCEDURES通用规程 The preparation of samples is carried out as described in Microbiological Examination of Non sterile Products: Microbial Enumeration Tests 61. 供试品制备,同USP61 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. 若供试品有抗菌活性,应尽可能中和或去除,中和或去除的方法同USP61 If surface-active substances are used for sample preparation, their absence of toxicity for microorganisms and their compatibility with any inactivators used must be demonstrated as described in Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests 61. 若供试品制备过程中使用了表面活性剂,应确认其对微生物的无毒性以及与所用的中和剂/ 灭活