从设计角度略论制剂设备的GMP达标

The designing of pharmaceuticals equipment on reaching GMP standards

从设计角度论证我国制剂设备的 GMP达标问题 ,对保证 GMP达标的先进隔离技术与建立就地清洗和就地灭菌系统进行了阐述 ,提出制剂设备设计应坚持标准化、通用化、系列化、机电一体化发展方向 ,向机械化、自动化、程控化。

In order to recah GMP standards, the designing of pharmaceuticals equipment must be based on standardization, generalization, seriation and mechatronics.Mechanization, automation, procedure controlling and intelligence are the future trend of its development. This article reasons the problem concerning the pharmaceutical equipment attaining the standards of GMP, and explains the isolating technology, the clean in place and the sterilization in place.