前验证完成后,建立变更控制系统,以确保灭菌器保持在受控状态。
After the prospective validation has been completed, change control systems are established to ensure that sterilizers are maintained in a state of control.
各种包装材料适用于灭菌过程的规定,内包装密封性良好,能保证在产品有效期内内装物保持无菌。
All the package materials shall be suitable for sterilization process. The inner package shall have excellent air-tightness and ensure the product free of Bacterium within its shelf life.
结论:本方法既可使盐酸普鲁卡因含量保持在标示量的95% - 105%范围,又达到了灭菌要求。
Conclusion: This method can not only keep between 95% and 105% of the mark amount in the content of procaine hydrochloride, but also reach the criteria of sterilization.
经过伽马辐射灭菌之后,这种材料依然能够保持颜色稳定性和机械性能,能实现大批量灭菌。
After undergoing gamma ray radiation sterilization, it is still able to maintain color stability and mechanical properties. Large scale sterilization also becomes possible.
经过伽马辐射灭菌之后,这种材料依然能够保持颜色稳定性和机械性能,能实现大批量灭菌。
After undergoing gamma ray radiation sterilization, it is still able to maintain color stability and mechanical properties. Large scale sterilization also becomes possible.
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