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发表于 2013-12-16 15:14:37
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小李飞刀 发表于 2013-12-16 13:14 
啥内容的?
借用一下tsingsea的翻译:
This Technical Report is intended to provide guidance for the successful evaluation, validation, and implementation of alternative and rapid microbiological methods needed by the pharmaceutical, biotechnology and medical device industries to assure product quality. Applications for these methods include, but are not limited to, the testing of microbial limits, sterility, and antimicrobial effectiveness; microbiological monitoring of clean rooms and other controlled environments and water for pharmaceutical purposes; microbial characterization and identification; and microbiological in-process control testing.
本技术报告的目的是为那些被制药、生物技术、医疗器械保证产品质量所需要的非传统或快速微生物检测方法的成功评估、验证和实施提供指南。这些方法的应用包括但不限于微生物限度测试、无菌测试、抗菌效力测试,洁净室和其他受控环境的微生物监测、制药用水监测,以及微生物的识别、鉴定和过程控制检测。
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