VLP-016-00 CT-C热风循环洁具烘箱验证方案要点.doc

热风循环洁具烘箱验证方案 文件编号：VLP-016-00 设备名称：CT-C热风循环洁具烘箱 设备编号： SB-02-020  验证标准文件审批页 起草人 部门 职务 签名 日期 年 月 日 审核人 部门 职务 签名 日期 年 月 日 年 月 日 年 月 日 年 月 日 年 月 日 年 月 日 批准人 部门 职务 签名 日期 年 月 日 CT-C热风循环洁具烘箱 设计/安装/运行确认1 概述··································································································2 目的···········································································································验证范围··························································································· 4 人员职责··························································································4 5 验证起止时间···················································································5 6 验证实施依据·····························································································5 7设计确认·····························································································5 8 安装确认························································································5 9 运行确认·······························································································7 10偏差及异常情况··················································································8 11 验证结果评价与建议··········································································8 12 再验证周期····················································································9 CT-C热风循环洁具烘箱 设计/安装/运行确认1 、概述 CT-C热风循环洁具烘箱是干燥工程有限公司生产的，CT-C热风循环洁具烘箱主要由箱体、加热系统、排风系统、推车、烘盘、控制系统等组成，用于物料的干燥。其原理是利用蒸汽作为热源，利用风机进行对流换热，对物料进行热传递，并不断补充空气和排除湿空气，大部分热风在箱内循环，从而使物料干燥。 2、 目的 2.0 检查并确认热风循环干燥箱安装及运行的正确性，符合GMP规定, 以及其对工艺的适应性。证实该设备能达到设计要求及规定的技术指标。 2.1 确认CT-C热风循环洁具烘箱设计符合药品生产和GMP要求。 2.2 确认CT-C热风循环洁具烘箱安装符合设计要求，文件、资料符合GMP的管理要求。 2.3 确认 CT-C热风循环洁具烘箱运行性能指标符合设备设定要求，并能满足生产工艺要求。 2.4 确认部分与 CT-C热风循环洁具烘箱有关的管理文件职责 按照GMP的要求，成立验证小组验证小组 验证所需文件SMP-08-013-00 3 《热风循环烘箱标准操作规程》 SOP-08-035-00 4 《热风循环烘箱维修保养规程》 SOP-08-125-00 5 《热风循环烘箱标准清洁规程》 SOP-