滴眼剂无菌生产工艺过程控制中的几点思考

目的:为医药企业无菌生产滴眼剂提供参考。方法:参考2010年版《中国药典》和2010年版《药品生产质量管理规范》(GMP)相关要求,基于滴眼剂生产现状,就非最终灭菌滴眼剂的无菌生产工艺,从生产车间洁净度、设备设施、物料、无菌操作等方面进行探讨。结果与结论:现行法规要求所有眼用制剂必须是无菌制剂,2010年版GMP就此要求作出明确规定,如提高了生产车间洁净度要求,设备设施清洗后必须对清洗效果和残留进行验证,与无菌药液接触的设备设施表面必须进行灭菌处理,灌封等关键部位可采用隔离技术,直接接触药液的气体应除菌过滤并定期进行微粒和无菌性检测,原辅料应符合微生物限度标准等。建立并维持良好的无菌环境,对无菌生产工艺过程各个环节进行严格控制,可为生产符合无菌制剂要求的滴眼剂提供有力的技术保障。

Reflections for Aseptic Production Process Control of Eye Drops

OBJECTIVE： To provide reference for aseptic production process of eye drops. METHODS ： According to requirements of Chinese Pharmacopeia （2010 edition） and Good Manufacturing Practice （GMP） 2010 edition, based on the situation of eye drops production, aseptic production technology of non-terminally sterilized products was investigated in terms of production workshop cleanliness, equipment and facilities, material, sterile operation, etc. RESULTS ＆ CONCLUSIONS： Present regulations require that all eye drops are sterile preparation; GMP 2010 edition clearly defines that as follows： improving the requirements of production workshop cleanliness; validating cleaning effect and residual after cleaning equipment and facilities; sterilizing the surface of equipment and facilities which interacts with sterile liquid; adopting isolation technique in key parts as embedment; adopting aseptic filtration and regular particle detection and sterility test for gas that contacted with the solution directly. Establishment of sterile environment and the strict control of aseptic production process can provide technical support for the production to meet the requirements of sterile eye drops.