生产质量管理文件空调净化系统验证方案文件编号：SMP-02YZ002R00修订：年月日审核：年月日颁发部门：年月日使用单位：、批准人：年月日生效日期：年月日目录1.概述：.............................................................31.1．空调净化系统的组成..............................................31.2．注射剂车间洁净级别及面积........................................31.3．空调净化系统的流程..............................................42．验证目的：........................................................43．验证范围：适用于公司注射制剂车间HVAC系统的验证。.................44．验证小组成员职责..................................................55．验证进度安排......................................................56．验证内容..........................................................66.1．验证所需文件及培训..............................................66.2．验证用及空调机设备上仪器仪表的校准情况..........................76.3．设计确认（DQ）..................................................76.4．安装确认（IQ）.................................................146.5．运行确认(PQ)...................................................186.6性能确认（OQ）.................................................266.7．偏差分析.......................................................317．验证结果评价及结论...............................................318．拟定日常监测及再验证周期.........................................319.附件及附表.......................................................32附件1：空调系统流程图...............................................0WJ附表1文件检查培训确认记录.......................................0JZ附表1仪器、仪表校准情况.........................................1DQ附表1设计文件的确认表...........................................2DQ附表2洁净区布局及人流物流的确认表...............................3DQ附表3房间设计参数的确认.........................................0DQ附表4系统负荷和风量的核算.......................................0DQ附表5空调机组性能参数的确认表...................................0DQ附表6系统风管和风口布置图（包括高效过滤器）的确认表.............0DQ附表7仪器仪表配置的确认表.......................................1DQ附表8高效过滤器DOP测试设计的确认表.............................2DQ附表9空调控制系统的确认表.......................................3IQ附表1：空调处理设备安装确认记录...................................4IQ附表2：风管设计要求和安装情况表...................................5IQ附表3：风管及空调设备清洁记录.....................................6IQ附表4：风管漏风（漏光）检查记录...................................7IQ附表5：冷媒安装确认记录...........................................8IQ附表6：初、中效过滤器安装确认记录.................................9IQ附表7：高效过滤器安装确认记录....................................10IQ附表8：高效过滤器检漏记录........................................11IQ附表9：消毒设施安装确认记录......................................12PQ附表1：空调机组运行确认表........................................13PQ附表2：风管运行确认表............................................14PQ附表3：高效过滤器(FFU层流)运行确认表..............................0PQ附表4：洁净室风速、风量及换气次数测试记录.........................0PQ附表5：洁净室温湿度、压差、照度、噪音测试记录.....................0PQ附表6：洁净室自净时间测试记录.....................................0OQ附表1：悬浮粒子...
