无菌药品生产车间灭菌系统设计探讨

灭菌是无菌药品生产的关键环节,根据《药品生产质量管理规范》(2010年修订)的要求,结合本人的设计实例,对无菌药品生产车间灭菌系统的设计做简单的探讨和归纳。阐述了干热灭菌、湿热灭菌、过滤除菌三种方法的工作原理及影响灭菌效果的主要因素,并对灭菌设备的选用情况作简要说明。

A Discussion of Sterilization Systems in Production Plants for Aseptic Pharmaceuticals

Sterilization was a critical unit operation in production of aseptic pharmaceuticals. Complying with the re- quirements by cGMP （2010 Version） and integrating design examples, a brief discussion and induction on the design of the sterilization systems in production plants for aseptic pharmaceuticals were presented. The operating principle and fac- tors reducing sterilization efficiency of 3 methods including dry -heat sterilization, moist -heat sterilization, and filtration sterilization were summed up, and the sterilization equipment selection was discribed briefly.