业内对于无菌药品生产的要求日趋严格。针对欧盟、世界卫生组织、国际药品检查合作计划组织、国家药品监督管理局有关法规变化点，以非最终灭菌产品用西林瓶洗烘灌联动线为切入点，从监管角度系统剖析洗瓶机、隧道烘箱、灌装机、联动线计算机化系统的检查要点，为国内无菌药品生产企业、药品检查员响应法规要求提供了方法指导和技术参考。

The industry's requirements for sterile drug production are becoming increasingly strict. This article takes the penicillin bottle washing, drying, and filling linkage line for non-final sterilized products as the starting point to systematically analyze the inspection items of bottle washing machines, tunnel ovens, filling machines, and computerized systems of linkage lines from a regulatory perspective, in response to regulatory changes in relevant regulations of the European Union, World Health Organization, the International Drug Inspection Cooperation Program, and the National Medical Products Administration. It provides method guidance and technical reference for sterile drug manufacturers and drug inspectors to respond to regulatory requirements.

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