ICS07.080 Q8499 团体标准 T/LTIA10—2020 人脐带间充质干细胞冻干粉 制备规范 RegulationsforPreparationofLyophilizedPowderfromHumanUmbilicalCord MesenchymalStemCell 2020-07-27发布 2020-08-27实施 深圳市生命科技产学研资联盟 全国团体标准信息平台 全国团体标准信息平台 T/LTIA10—2020 I目  录 目  录.................................................................................................................................................................I 前  言...............................................................................................................................................................II 脐带间充质干细胞冻干粉制备技术规范.............................................................................................................1 1范围.....................................................................................................................................................................1 2规范性引用文件.................................................................................................................................................1 3术语、定义和缩略语.........................................................................................................................................1 3.1术语和定义.................................................................................................................................................1 4.缩略语...............................................................................................................................................................2 5.质量要求...........................................................................................................................................................3 5.1脐带来源......................................................................................................................................................3 5.1.1供者筛查.................................................................................................................................................3 5.1.2签署知情同意.........................................................................................................................................3 5.1.3隐私保护措施.........................................................................................................................................4 5.1.4人员资质.................................................................................................................................................4 5.1.5供者样本检测..........................................................................................................................................4 5.2脐带间充质干细胞生产质量控制.............................................................................................................4 5.2.1生产制备中质控点.................................................................................................................................4 5.2.2冻存.........................................................................................................................................................5 5.2.3复苏.........................................................................................................................................................5 5.3脐带间充质干细胞检测指标.....................................................................................................................5 5.4脐带间充质干细胞冻干粉制备.................................................................................................................6 5.4.1原料的准备工作.....................................................................................................................................6 5.4.2胶塞的洗涤灭菌与干燥.........................................................................................................................6 5.4.3西林瓶的清洗和灭菌.............................................................................................................................7 5.4.4铝盖的准备............................................................................................................................................