某些药品制剂企业洁净区现状及改进策略  

Current Situation of Cleaning Area in Some Pharmaceutical Enterprises and Improvement Measures

作　　者：吴则栋 

机构地区：[1]三普药业股份有限公司,青海西宁810007

出　　处：《医药工程设计》2007年第5期30-33,共4页Pharmaceutical Engineering Design

摘　　要：根据GMP改造和运行管理的实践,从使用者的角度,以厂房建设和洁净区的运行实际为基础,总结、分析了目前一些中小企业药品制剂生产的洁净工程建设和运行管理的现状,找出其设计和运行中存在的差距和不足,提出了适合制剂中小药品制剂企业建造和运行的建议。Based on the experience of GMP reform and administration, with the stand point of the users, in this article, the current situations of cleaning engineering construction and operation administration in some small and middle scale enterprises were summarized and analyzed with respects to workshop construction and the operation of cleaning area. The shortages existed in the design and the operation were found, and the proposals appropriate to small and middle scale pharmaceutical enterprises were presented.

关 键 词：口服制剂 洁净区 平面布局 空调净化系统 消毒 再验证 

分 类 号：TQ460.8[化学工程—制药化工]