悬浮粒子在线监测系统设计实例

摘要

按照中国《药品生产质量管理规范》（2010修订的新版GMP）附录1的要求，对于洁净区A级区，在关键工艺（包括设备的组装）的全过程中，应当对悬浮粒子进行连续的监测，同时在B级区采用相似的系统。为此，我公司在新建车间的分装线A级区，安装了悬浮粒子的在线监测系统，对A级洁净区的悬浮粒子进行了有效的监控。%The continuos monitoring to the whole procedures of key process, including equipment installation, in clean area of Grade A, with similar system for Grade B, are required in Annex 1, the new version of Chinese GMP-2010. The airborne particle on-line monitoring system was intalled in an assembly line in area of Grade A of new cleanroom, having effective monitoring results.