摘要
最终灭菌注射剂灌装生产线中灌装头的清洗及灭菌采用手工清洗及灭菌,存在诸多隐患。为更好地满足新版《药品生产质量管理规范》(GMP)的要求,灌装头的在线清洗(CIP)及灭菌(SIP)是亟待解决的问题之一。针对应用最广泛的陶瓷计量泵灌装法,初步讨论灌装泵的在线清洗及灭菌方法。根据所选方法仅通过改进原有设备的灌装系统结构以适应新技术,并确定了过程操作的基本参数、可编程逻辑控制器(PLC)控制过程以及相应仪表的形式。
There are many potential perils in hand cleaning of filling head in injection filling production line.To meet the requirements in new version GMP,cleaning in place（CIP） and sterilization in process（SIP） are two of the most urgent problems to be solved.In this paper,with respect to the filling method by using ceramic volume meter,the methods of CIP and SIP were discussed.With selected method,the structure of filling system in original equipment was reformed to adapt new technique,the basic parameters used in process,the control process in PLC and relevant instrument were determined.
出处
《医药工程设计》
2012年第1期40-44,共5页
Pharmaceutical Engineering Design
关键词
最终灭菌注射剂
陶瓷灌装泵
在线清洗
在线灭菌
系统研究
final sterilized injection agent
ceramic filling pump
cleaning in place
sterilization in process
system research
