stpyz12400jcc5d型洁净采样车验证方案.docVIP

JCC-5D型洁净采样车验证方案 起 草 人： 审 核 人： 批 准 人： 起草部门： 起草日期： 审核日期： 批准日期： 执行日期： 验证小组会签 部门 岗位 签名 签名日期 颁发部门： [质量部] Copy №： [ ] 行政部[ ] 物供部[ ] 质量部QA[ ] 质量部QC[ ] 研发部[ ] 生技部[ ] 疫苗车间[ ] 分包装车间[ ] 工程部[ ] 保安部[ ] 营销部[ ] 财务部[ ] 变更记载： 修订号 批准日期 执行日期 00 变更原因及目的： 建立验证文件，并通过验证证明所验证对象有效、稳定、可靠。 目 录 验证方案·································································································································3 1 概述·······························································································································3 2 目的·······························································································································3 3 职责·······························································································································3 4 验证内容与记录···········································································································3 4.1 安装确认···············································································································3 4.2 运行确认···············································································································3 5验证记录·························································································································4 验证方案 1 概述 JCC-5D型洁净采样车用于在库房对原辅内包装材料的取样、车间收料。因此必须对洁净采样车进行验证，以确保洁净采样车能达到万级洁净度要求。验证依据JCC-5D型洁净移动取样室使用说明书、GMP对万级洁净区的要求。 2 目的 对该设备进行验证，以确保该设备能达到万级洁净区要求 3 职责 疫苗车间：负责设备验证方案的实施。 生技部：负责设备验证方案的起草。 质量部QA：协助验证方案的组织实施。负责验证工作的管理，协助设备验证方案的起草，组织协调验证工作，并总结验证结果，起草验证报告。 质量部QC：负责按计划完成设备验证方案中相关检验任务，确保检验结论正确可靠。 质量部部长：负责设备验证方案及报告的审核。 验证领导小组组长：负责设备验证方案及报告的批准。 4 验证内容与记录 4.1 安装确认：记录见表（一） 4.1.1 外观：不锈钢表面应光滑平整，装饰帘子应光滑、垂直、无损伤现象。检验方法：目测。 4.1.2 检查开箱验收是否符合要求，并应建立完整的设备档案。 4.1.3 检查是否已起草该设备使用标准操作规程，并对使用人员进行了相应的培训。 4.2 运行确认：记录见表2 4.2.1 脚轮：灵活可靠。检验方法：目测，同时用手试转。 4.2.2 净化效率 4.2.2.1 尘埃粒子数 大于5.0μm的粒子数小于2000个/m3，大于0.5μm的粒子数小于350000个/m3。 检验方法：调节风速至低、中、高档，分别用尘埃粒子计数器测试，离地面80cm-100cm处测定，每档测三点，每点测量三次。 4.2.2.2 沉降菌：沉降菌≤3个，共测三点，每点测量