环境监测风险分析(翻译初稿).doc

Environmental Monitoring Risk Assessment 环境监测风险评估Wednesday, August 30, 2006 - Journal of GXP Compliance, January 2006, Volume 10, Number 2 星期三，8月30日，2006 - Journal of GXP Compliance，2006年1月，10卷，2号 INTRODUCTION 引言Environmental Monitoring describes the microbiological testing undertaken in order to detect changing trends of microbial counts and micro-flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations. 环境监测描述了在洁净室或受控环境下，为了监测微生物数量和微生物群落繁殖的变化趋势而进行的微生物测试。所测结果提供关于房间结构，空调系统性能，人员卫生，更衣行为，设备和清洁操作的信息。 Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring. 在过去十年里，环境监测愈发复杂，从任意取样，按照假想的房间网格进行测试，到现阶段注重风险评估并使用风险评估工具确定环境监测的最佳方法。 This paper explores current trends in the application of risk assessment to the practice of environmental monitoring by examining the following key areas: 本文从以下几个重要方面探讨了将风险分析应用于环境监测的现有趋势： Determining the Frequency of Monitoring: Using the concept（理念、观念） of risk assessment to decide how often to monitor different types of cleanrooms 确定监测频率：按照风险分析理念，确定不同类型洁净室的监测周期。 Risk Assessment Tools（工具）: Applying risk assessment tools to establish methods for environmental monitoring 。 风险评估工具：运用风险分析工具确定环境监测方法。 Numerical（数字的、数值的） Approaches: Considering a numerical approach to assess risk data using a case study of an aseptic（无菌的） filling operation 数值法：使用无菌灌装操作案例分析考虑采用数值法评估风险数据 The examples used are from a sterile drug manufacturing facility and focus mostly on aseptic filling; however, the concepts and tools are applicable to the environmental monitoring of