培养基无菌灌装模拟试验验证方案——以盐酸赖氨酸注射剂为例  

Proof Scheme of Simulation Test for Medium Aseptic Filling——Taking Example of Lysine Hydrochloride Injection

作　　者：覃淑宁 

机构地区：[1]广西南宁邕江药业有限公司,广西南宁530031

出　　处：《企业科技与发展》2013年第6期59-61,共3页Sci-Tech & Development of Enterprise

摘　　要：通过培养基无菌灌装模拟试验,明确针剂车间进行盐酸赖氨酸注射液灌装作业的控制要求,为今后针剂车间进行灌装作业管理提供依据。本厂区无菌操作生产线,按《药品生产质量管理规范(2010版)》及其附录要求进行设计,是专用于小容量注射剂非最终灭菌产品生产使用。Througb simulation test of the medium aseptic filling, the paper points out the control requirements of filling oper- ations to lysine hydrochloride injection in injection workshop, providing the basis for the field. The production line with aseptic operation designed according to ＂Drug production quality management norms＂ （2010 edition）and its appendix requirements, which is dedicated to production use of small volume injection products that are not terminally sterilized products.

关 键 词：培养基 无菌灌装 小容量注射液 

分 类 号：TQ460[化学工程—制药化工]