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药品生产质量管理规范(2010年版)对无菌药品生产的洁净度级别提出了具体要求,增加了在线监测的要求,特别提出了对洁净区的空气悬浮粒子要进行静态和动态监测。文章介绍了洁净区洁净度在线监测系统安装确认方案,为药品生产企业提供有益借鉴。
The quality standards of pharmaceutical production (2010 edition) put forward specific requirements on the cleanliness level of the aseptic drug production and increased the requirement of on-line monitoring. In particular, it proposes to conduct static and dynamic monitoring of airborne particles in a clean area. This article introduces the clean zone cleanliness online monitoring system installation confirmation program for pharmaceutical manufacturers to provide useful reference.