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Biotechnology — General requirements for transportation of cells for therapeutic use 生物技术.治疗用细胞运输的一般要求
发布日期: 2020-06-29
该文件规定了一般要求,并回顾了用于运输的细胞,包括运输过程中储存的考虑事项。 运输从发送方将包装好的单元转移到运输服务提供商开始,到包裹在目的地交付给接收方时结束。 本文件不适用于同一设施内的电池运输。 本文件包括运输计划的制定,包括验证和确认、客户和运输服务提供商之间的沟通以及相关文件。 本文件未规定运输的特殊条件,如运输集装箱规范、环境温度控制等。
This document specifies general requirements and reviews the points to consider for the transportation of cells for therapeutic use, including storage during transportation. Transportation starts from the transfer of the packaged cells by the sender to the transportation service provider and ends when the package is delivered to the receiver at its destination. This document does not apply to transportation of cells within one facility. This document includes the development of a transportation plan including verification and validation, communication between the client and the transportation service provider, and associated documentation. This document does not specify particular conditions for transportation such as specification for shipping container, ambient temperature control, etc.
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归口单位: ISO/TC 276
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