CAJ | 학술논문

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、智能化的更高目标迈进.
종설계각도론증아국제제설비적GMP체표문제,대보증GMP체표적선진격리기술여건립취지청세화취지멸균계통진행료천술,제출제제설비설계응견지표준화、통용화、계렬화、궤전일체화발전방향,향궤계화、자동화、정공화、지능화적경고목표매진.
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.