USP1231翻译关于微生物增菌培养的考虑.docVIP

USP -- 1231 WATER FOR PHARMACEUTICAL PURPOSES MICROBIAL ENUMERATION CONSIDERATIONS 关于微生物增菌培养的考虑 The objective of a water system microbiological monitoring program is to provide sufficient information to control and assess the microbiological quality of the water produced. Product quality requirements should dictate water quality specifications. An appropriate level of control may be maintained by using data trending techniques and, if necessary, limiting specific contraindicated microorganisms. Consequently, it may not be necessary to detect all of the microorganisms species present in a given sample. 水系统微生物监测的目的是为控制、评定水的微生物质量提供充足的信息。产品质量要求应规定水的质量规格。可以通过数据趋势技术，或有必要的话,通过限制特定的控制菌来进行适当程度的控制。因此不必检测样品中的所有微生物种类。 The monitoring program and methodology should indicate adverse trends and detect microorganisms that are potentially harmful to the finished product, process, or consumer. Final selection of method variables should be based on the individual requirements of the system being monitored. 监测程序和方法应显示不利的趋势并检测那些对终产品、加工过程或消费者有潜在伤害的微生物。方法变量的最终选择应基于所监测系统的要求。 It should be recognized that there is no single method that is capable of detecting all of the potential microbial contaminants of a water system. The methods used for microbial monitoring should be capable of isolating the numbers and types of organisms that have been deemed significant relative to in-process system control and product impact for each individual system. 应该清楚的是没有一种方法可以检测水系统中所有的潜在微生物污染。用于微生物监测的方法应可以区分那些被认为与现行系统控制密切相关及对各系统的产品有影响的微生物的种类和数量。 Several criteria should be considered when selecting a method to monitor the microbial content of a pharmaceutical water system. These include method sensitivity, range of organisms types or species recovered, sample processing throughput, incubation period, cost, and methodological complexity. 当选择监测制药用水系统微生物含量的方法时应考虑几个标准。包括方法的灵敏度，微生物的种类及其回收率，样品处理能力，培养时长，费用和方法学适用性。An alternative consideration to the use of the classical “culture” approaches is a sophisticated instrum