隔离系统按相关的要求进行验证，其内部环境的洁净度须符合无菌检查的要求。
The isolation system shall be validated according to the relevant requirements, and the cleanliness of the internal environment shall comply with the requirements of the sterility test.
一般认为要做到无菌，温度起码必须达到121摄氏度。
A temperature of 121C is a regarded as the minimum necessary to achieve sterility.
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