摘要
根据含高活性、高致敏性、高毒性等有害性物料的药品生产GMP规范要求,对在口服固体制剂车间设计方面存在的问题进行了详细探讨,提出了分区化布局的新设计思路。
The problems about the OSD workshop design are diccussed in detail according to the GMP standards for drug production containing hazardous substances with high activity,high sensitization and high toxicity,and a new design idea of partition layout is put forward.
作者
姚玉成
Yao Yucheng(CTTO Pharmaceutical Group Co. Ltd.,Lianyungang 222062)
出处
《化工与医药工程》
2019年第1期28-34,共7页
Chemical and Pharmaceutical Engineering
关键词
高活性物料
高致敏性物料
高毒性物料
有害性物料
口服固体制剂车间设计
分区化布局
highly active substances
highly sensitive substances
highly toxic substances
hazardous substances
OSD workshop design
partition layout
