USP30_1208-无菌实验----隔离系统的验证(摘译).docVIP

USP30-NF25 （1208） STERILITY TESTING— VALIDATION OF ISOLATOR SYSTEMS 无菌实验----隔离系统的验证 （摘译可供全自动无菌检查系统参考的部分） Performance Qualifications (PQ) 性能确认 The PQ phase verifies that the system is functioning in compliance with its operator requirement specifications. At the completion of the PQ phase, the efficacy of the decontamination cycle and, if appropriate, the adequacy of decontaminating chemical venting are verified. All PQ data are adequately summarized, reviewed, and archived. PQ阶段要确认的是系统的运行功能符合操作人员所要求的标准。PQ完成时，净化循环的效验以及在适当的情况下化学物品通风净化的适用性被确认。所有的PQ数据应该进行充分地总结、回顾及归档。 Cleaning Verification— In general, cleaning is not critical for sterility testing applications. However, residual products are a concern in multiproduct testing, particularly for aggressive antimicrobial agents, because these materials could interfere with the ability of subsequent tests to detect low levels of contamination in the product. 清洁确认—一般而言，清洁对于无菌检测的实施并不关键。然而，在多批产品检测中残留产品是一个值得注意的问题，特别是具有强烈抑菌性的试剂，这些物质可能影响到后续检测实验对产品中低水平污染的检测能力。 Concerns about contamination with the product are heightened when it is an inherently antimicrobial powder, because powders are more readily disseminated. Cleaning to a level at which no visible contamination is present is adequate for sterility test isolator systems and is a suitable operator requirement specification. The cleaning method, frequency, equipment, and materials used to clean the isolator are documented. 如果产品本身是一种抑菌性的粉末，由于粉末容易散布，那么应该提高对产品带来的污染的关注。清洁程度达到无肉眼可见污染物的水平，对于无菌检测隔离系统是足够的，也适合于操作规范要求。应用于隔离系统的清洁方法、清洁频次、所使用的设备和材料都应有文件记录。 Decontamination Validation — The interior surfaces of the isolator, the equipment within the isolator, and the materials brought into the isolator are treated to eliminate all bioburden. 净化验证—对隔离器内表面、隔离器内部设备以及被携带入隔离器的物质都 应进行处理以清除所有的生物负载。 The decontamination methods used to treat isolators, test articles, and sterility testing supplies are capable of reproducibly yielding greater than a three-log reduction against highly resistant b