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.

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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.

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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.

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