USP 61 微生物限度检测——计数法.pdf

61MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS 非无菌产品微生物限度检查：微生物计数法 1. INTRODUCTION导言 The tests described hereafter will allow quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions. 微生物计数法系用于能在有氧条件下生长的嗜温细菌和霉菌的定量计数。 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、辅料等是否符合相应的微生物限度标准时，应按照下述规定 进行检验，包括样品的取样量，结果的判断。 The methods are not applicable to products containing viable microorganisms as active ingredients. 本法不适用于活菌制剂的检查。 Alternative microbiological procedures, including automated methods, may be used, provided that their equivalence to the Pharmacopeial method has been demonstrated. 可使用包括自动化法在内的替代方法，需确认其与药典方法的等同性。 2. GENERAL PROCEDURES通用规程 Carry out the determination under conditions designed to avoid extrinsic microbial contamination of the product to be examined. The precautions taken to avoid contamination must be such that they do not affect any microorganisms that are to be revealed in the test. 微生物计数环境应能防止外来微生物对供试品的污染。防止污染的措施不能影响供试品中微生物 的检出。 备注：检验全过程必须严格遵守无菌操作，防止再污染。单向气流区域、工作台面及环境应定期 进行监测。 If the product to be examined has antimicrobial activity, this is, insofar as possible, removed or neutralized. If inactivators are used for this purpose, their efficacy and their absence of toxicity for microorganisms must be demonstrated. 如果供试品有抗菌活性，应尽可能去除或中和。若使用了中和剂或灭活剂，需确认其有效性及对 微生物无毒性。