摘要
根据药品生产的水质特点及GMP法规等要求,对纯化水和注射用水系统设计方面的制水、储存与分配、用水点设置等问题进行了探讨。并附上具体的示意图举例说明。
according to the characteristics of pharmaceutical water and GMP regulations,several problems such as water generation,storage&distribution,POU settings are discussed in the design of PW and WFI system.And specific example schematic diagrams are attached for illustration.
作者
姚玉成
李敏
Yao Yucheng;Li Min(CTTQ Pharmaceutical Group Co.,Ltd.,Lianyungang,Jiangsu 222062,China)
出处
《化工与医药工程》
CAS
2024年第1期23-31,共9页
Chemical and Pharmaceutical Engineering
关键词
GMP规范
纯化水
注射用水
制药用水
制水
储存与分配
用水点
GMP regulations
purified water
water for injection
pharmaceutical water
water generation
water storage&distribution
points of use
