标准编号：ISO 20404:2023
中文名称：生物技术 生物处理 含有治疗用细胞的包装设计的一般要求
英文名称：Biotechnology — Bioprocessing — General requirements for the design of packaging to contain cells for therapeutic use
发布日期：2023-04
标准范围
This document specifies general requirements and considerations for the design of packaging used to contain cells for therapeutic use. This document is applicable to packaging intended to contain the final products of cells for therapeutic use, as well as their starting and intermediate materials. This document does not apply to: a) receptacles used for processing cells in manufacturing processes, e.g. cell culture flask or bag; b) shipping containers containing packages for transportation; c) services that utilize packages, e.g. storage services. NOTE 1 Examples of packaging, packages and shipping containers are illustrated in Annex A. NOTE 2 The design of packaging includes processes to ensure that the designed packaging is manufactured to a required specification through trial manufacturing, testing and implementation of quality management. NOTE 3 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
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