葡萄糖注射液灭菌工艺验证性方案设计

Program Design for Glucose Injection Liquid Sterilization Process Validation

目的验证葡萄糖注射液的灭菌工艺。方法通过对灭菌柜空载热分布实验、满载热分布实验和生物指示剂试验进行验证同时考察产品无菌状态以及主成分的变化。结果灭菌柜能够提供预定的灭菌条件,葡萄糖注射液经过灭菌操作后无菌检查合格,且其主成分改变很少。结论葡萄糖注射液通过灭菌验证。

Objective To verify a good sterilization process for glucose injection liquid. Methods Through the sterilizer is empty, full of heat distribution and heat distribution experiment of biological indicator test for validation and investigation of product sterility and changes of main components. Results Sterilization container to be able to provide pre-sterilized conditions, glucose injection liquid after sterilization operation, sterile check qualified and its main ingredients change very little. Conclusion Glucose injection liquid through sterilization validation.