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The lyophilization process generally includes the following steps .

冻干过程包括下列步骤。

Investigators should review the reports and data that support the filed lyophilization cycle .

调查人应回顾报告和数据去支持文件化的大概循环。

Lyophilization ( freeze-drying ) is the most commonly used method for preparing solid protein pharmaceuticals .

冷冻干燥技术是制备固体蛋白质药品的常用方法。

Probably more so than any other product , scale-up of the lyophilization cycle is very difficult .

与其他的产品相比，放大一个冻干循环是十分困难的。

If lyophilization is required , then automated loading and unloading must be provided with freedom from personnel access .

如果冻干机是需要的，那么具备非人工进入的自动装载和卸载装置。