滴眼剂包装材料灭菌方法介绍与思考

Introduction and Thought of Sterilization Methods for Packaging Materials of Eye Drops

目的对滴眼剂包装材料的灭菌方法进行归纳分析,为药品生产企业及监管机构提供参考。方法对环氧乙烷(EO)灭菌、过氧化氢灭菌、臭氧灭菌、辐照灭菌等几种灭菌方法的原理和特点进行比较、归纳。结果药品生产过程执行2010年版《药品生产质量管理规范》(GMP),其生产环境级别的要求高于相同级别药包材生产环境的标准,导致药品与所使用的包装材料洁净度要求不匹配。结论几种灭菌方法各有利弊,须针对所包装的药品品种进行充分研究与验证。滴眼剂生产企业须高度重视滴眼剂瓶的灭菌方式,对滴眼剂瓶生产厂家实行严格的供应商审计,根据材料不同选择有针对性的灭菌方式并建立相应的标准,尽可能采用更符合药品GMP要求的吹灌封技术。包装材料生产企业须提高生产环境级别,与药品的生产环境相匹配;研发灭菌后残留少、风险小、基本对产品质量不产生影响的新型包装材料。监管部门须在关注药品生产的同时,更加关注直接接触药品的包装材料,提高对包装材料的要求。

Objective To summarize and analyze sterilization methods for packaging materials of eye drops and provide a reference for drug manufacturers and regulators.Methods Rationales and characteristics of several different sterilization methods were compared and summarized,such as ethylene oxide sterilization,hydrogen peroxide sterilization,ozone sterilization,and irradiation sterilization.Results The drug production process was performed in accordance with Good Manufacturing Practice（GMP,2010version）in which requirements for production environment were higher than the criteria for drug packaging materials at the same level,thus drugs were not accordant with the requirement of neatness of the applied packaging material.Conclusion As each method has its advantages and disadvantages,a full study and verification of the packaging varieties must be performed.Manufacturers of eye drops should pay high attention to the sterilization method of eye drop bottles and perform strict audit to bottle suppliers.Manufacturers should choose specific sterilization methods according to different materials and establish corresponding standards.They should use blowing-filling-sealing technology in line with the drug GMP requirements as strictly as possible.Manufacturers of packaging materials should improve the production environment level to match with the drug production level,at the same time,develop new packaging materials which have less residuals after sterilization,low risk and almost no influence to the quality of the products.Supervision departments should pay more attention to the drug immediate packaging materials apart from focusing on drug production,and improve requirements for packaging materials.