ISO/TS 23565:2021 生物技术 生物处理 治疗用细胞制造用设备系统的一般要求和注意事项

标准编号：ISO/TS 23565:2021

中文名称：生物技术 生物处理 治疗用细胞制造用设备系统的一般要求和注意事项

英文名称：Biotechnology — Bioprocessing — General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use

发布日期：2021-10

标准范围

This document specifies minimum requirements and general considerations for equipment, consisting of hardware, software and consumables, used in the manufacturing of cells for therapeutic use. This includes equipment for processing cells for therapeutic use starting from cell isolation/selection, expansion, washing and volume reduction, from cell finish through to cryopreservation for the storage of cells for therapeutic use.

标准预览图