装备隔离器的冻干粉针车间设计若干问题的探讨

Discussion of Issues about Design of Lyophilized Powder Workshop with Isolator

根据非最终灭菌无菌药品生产的GMP法规要求,对隔离器冻干粉针车间设计若干问题进行了探讨。对瓶子、胶塞、铝盖、配制好的药液进入隔离器,以及轧盖后的产品离开隔离器的方式进行了分析,提出了整体解决方案。并附上具体的平面布局图举例说明。

Based on the requirements in GMP regulation for sterile medicinal products, some issues in the design of lyophilized powder workshop with separator were discussed. The processes that vials, stoppers, aluminum caps and prepared medicinal liquids are put into separator and capped products are put out separator were analyzed. One overall scheme was then presented, and the planar layout was attached.