传递窗验证方案

传递窗验证方案Validation protocol of the delivery windows 编号 Code： 版本 Version： 编写 Prepared by:日期 Date:审 核 人 日 期 Reviewed by Data批准 Approved by:日期 Date:变更记录 Change Log版本号Version变更描叙Description变更细节Section changed批准日期Release Date目 录Contents1简介................................................................................................................42实施计划........................................................................................................43验证小组成员................................................................................................44仪器及用具....................................................................................................45菌株和培育基................................................................................................56安装确认........................................................................................................57运行确认........................................................................................................58性能确认........................................................................................................69再验证............................................................................................................810 修改事项........................................................................................................811 相关 SOP........................................................................................................812 附件................................................................................................................81 简介传递窗是一种干净室的辅助设备，主要用于干净区与干净区之间，干净区与非干净区之间小件物品的传递，以减少干净室的开门次数，使干净室的污染降低到最低程度。传递窗内安装有紫外灯，物品经紫外线照射消毒后进入干净区。紫外线是一种电磁辐射，波长 190～350nm，其中以 253.7nm 的杀菌力最强，可使 DNA 链上相邻嘧啶碱基之间...