冻干产品无菌工艺模拟试验方案改进及实施研究

Study on Improvement and Implementation of Aseptic Process Simulation Test Scheme for Freeze-Dried Products

采用培养基代替药品进行无菌工艺模拟试验,是无菌生产工艺的一种必要方式。为了确保无菌产品的无菌性,文章对冻干产品无菌工艺模拟试验方案的实施进行阐述,介绍了该方案的准备条件,灌装、冻干和轧盖过程,过程取样以及环境监控等,对方案进行部分改进,优化了方案内容,并对无菌工艺模拟试验的结果进行分析,结合实例探讨了西林瓶生产线冻干产品培养基试验的策略,以提高非最终灭菌产品的无菌保障水平。

The use of culture media instead of drugs for sterile process simulation testing is a necessary way for sterile production processes.In order to ensure the sterility of sterile products,the article elaborates on the implementation of the aseptic process simulation test plan for freeze-dried products,introduces the preparation conditions,flling,freeze-drying,and capping processes,process sampling,and environmental monitoring of the plan,and makes some improvements to the plan.The content of the plan is optimized,and the results of the aseptic process simulation test are analyzed.The strategy of freeze-dried product culture medium testing in the penicillin bottle production line was explored with examples to improve the sterility assurance level of non final sterilized products.