吹灌封车间设计若干问题的探讨  

Discussion on Several Problems of BFS Workshop Design

作　　者：姚玉成 李敏 Yao Yucheng;Li Min(CTTQ Pharmaceutical Group Co.Ltd.,Lianyungang,Jiangsu 222062,China)

机构地区：[1]正大天晴药业集团股份有限公司,江苏连云港222062

出　　处：《化工与医药工程》2024年第5期16-21,共6页Chemical and Pharmaceutical Engineering

摘　　要：根据吹灌封药品生产的工艺技术特点及GMP法规等要求,对吹灌封车间设计方面的无菌产品生产工艺选择、设备选型、环境洁净度设置、塑料颗粒选材等问题进行了探讨。并附上具体的示意图举例说明。according to the characteristics of BFS processes and GMP regulations,several problems such as production processes of sterile products,BFS equipment selection,environmental cleanliness assignments,plastic pellets are discussed in the design of BFS workshop.And specific example schematic diagrams are attached for illustration.

关 键 词：GMP规范 吹灌封 无菌产品 环境洁净度设置 塑料颗粒 

分 类 号：TQ460.8[化学工程—制药化工]