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多功能车间空调净化系统方案号：版本号：01中美华世通生物医药﹙天门﹚有限公司安装/运行/性能确认Page1of82题目安装/运行/性能确认（IQ/OQ/PQ）方案号版本号01设备名称空调净化系统型号出厂编号资产编号YS-04-1511S安装地点多功能车间供应商吴江市林森空调净化技术有限公司多功能车间空调净化系统方案号：版本号：01中美华世通生物医药﹙天门﹚有限公司安装/运行/性能确认Page2of82方案批准起草人审核人签字日期工程部原料部QCQA批准人签字日期QA经理多功能车间空调净化系统方案号：版本号：01中美华世通生物医药﹙天门﹚有限公司安装/运行/性能确认Page3of82目录1、目的.........................................................................................................................................................52、范围.........................................................................................................................................................53、概述.........................................................................................................................................................53.1系统描述.................................................................................................................................................53.2系统流程图及空调箱结构示意图............................................................................................................73.3系统确认的范围.....................................................................................................................................74、职责.........................................................................................................................................................85、测试部分..................................................................................................................................................86、可接受标准............................................................................................................................................107、要求的测试和原理.................................................................................................................................117.1安装确认（IQ）测试............................................................................................................................11IQ测试1：文件资料及图纸确认........................................................................................................................11IQ测试2：SOP确认与培训确认.........................................................................................................................13IQ测试3：主要部件的安装确认........................................................................................................................15IQ测试4：系统配套的关键仪表确认................................................................................................................30IQ测试5：检测用仪器仪表及其校验确认........................................................................................................33IQ测试6：机组主要部件及辅助设施质量确认................................................................................................357.2安装确认（IQ）完成报告....................................................................................................................397.3运行确认（OQ）测试.........................................................................