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·································································································································31概述·······························································································································32目的·······························································································································33职责·······························································································································34验证内容与记录···········································································································34.1安装确认···············································································································34.2运行确认···············································································································35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24.2.1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，每点测量三次。5验证记录（见附件）表1：安装确认记录项目接受标准检查结果外观不锈钢表面应光滑平整，装