This is accomplished primarily by validation of the sterilization process or of the aseptic processing procedures.
这主要是通过灭菌工艺或者无菌操作程序的验证来完成。
The company shall establish documented procedure for the validation of sterilization process, which shall be earlier than the initial use.
公司对灭菌过程的确认建立文件化程序，灭菌过程确认应在最初使用前进行。
The company shall establish documented procedure for the validation of sterilization process, which shall be earlier than the initial use.
公司对灭菌过程的确认建立文件化程序，灭菌过程确认应在最初使用前进行。
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