洁净室悬浮粒子的监测的研究进展
摘要 目的：依据《药品生产质量管理规范》中无菌药品生产洁净区的要求,空气中的悬浮粒子必须实施监测,以达到药品生产的良好环境.方法：从药品生产洁净室（区）的环境要求到悬浮粒子的监测系统介绍,通过环境监测实例,叙述悬浮粒子在监测中的应用.结果：悬浮粒子监测系统必须按照规定的程序执行,同时采取异常情况处理程序,才能满足生产环境的监测要求,为洁净室生产环境的监测提供可靠的手段.结论：针对悬浮粒子监测系统,讨论在实际应用中的关键因素,对该系统的实际应用有重要的指导意义.
关键词：洁净室；悬浮粒子；监测
Abstract: Objective: according to the 'standard' drug production quality management in the manufacture of sterile products clean area, suspended particles in the air to implement dynamic monitoring, in order to achieve the good environment of drug production. Methods: the production of clean room from the drug (District) environmental requirements introduced to the dynamic monitoring system of suspended particles, through the environment the application of monitoring examples, suspended particles in dynamic monitoring. Results: the suspended particle monitoring system must be carried out in accordance with the provisions of the program, take exception handling procedures at the same time, in order to meet the requirements of monitoring of the production environment, to provide a reliable means for monitoring the production environment of the clean room. Conclusion: for suspended particle dynamic monitoring system, discusses the key the factors in the practical application, has important guiding significance to the application of the system.
Key words: Clean Room，Suspended Particles,， Monitoring
药品生产环境的洁净度对无菌药品生产的质量有着至关重要的作用。在药品生产中产生的污染的主要来源是空气中的活性微粒和非活性微粒，活性微粒和非活性微粒物质间密切关联，其中控制非活性微粒数量是保证产品质量的重要指标，而悬浮粒子的控制就是对非活性微粒数量控制的最直接的保证。
1.洁净室（区）悬浮粒子的来源
