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in-process materials中文是什么意思

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  • Any substances required for operation , such as lubricants or coolants , shall not come into contact with components , drug product containers , closures , in - process materials , or drug products so as to alter the safety , identity , strength , quality , or purity of the drug product beyond the official or other established requirements
    操作所需的所有物质,例如润滑油、制冷剂,都不能和成分、药物容器、胶塞、中间生成物或者药物接触,以确保不改变药物的安全性、同一性、活性、质量或纯度,使其不满足官方或者其他既定要求。
  • Equipment shall be constructed so that surfaces that contact components , in - process materials , or drug products shall not be reactive , additive , or absorptive so as to alter the safety , identity , strength , quality , or purity of the drug product beyond the official or other established requirements
    接触组分、中间产物或者药品的设备表面必须不和药物反应,没有异物脱落,不吸附药物,以确保不改变药物的安全性、同一性、活性、质量或纯度,使其不满足官方或者其他既定要求。
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