菌检室空调系统验证方案.docVIP

方案批准 Protocol approval 签名 Signature 日期Date 起草人 Written by 工程审核 Reviewed by EN QA审核 Reviewed by QA QA经理批准 Approved by QA manager 设备信息 Equipment information 设备名称 Equipment name 空调净化系统HVAC system 型 号Model DLK-0. 3组合式空调机组 出厂编号 ID of manufacture安装地点Location 行政化验楼菌检室 Microbial lab of Administration QC building 供应商 Manufacture 上海德惠空调设备厂 Shanghai Dehui Air conditioner equipment plant 目录 Content TOC \o 1-5 \h \z HYPERLINK \l bookmark01、 目的 Purpose 3 2、 范围 Range 3 3^ 设备描述 Description of System 3 4、 Responsibility 5 5、 参考文件 Reference 5 6、 原理和测试总结 Test principle and test conclusion 6 安装确(IQ) Installation Qualification 6 IQP 的培训及文件资料确认 Qualification of IQP training and documents..…6 HYPERLINK \l bookmark6主要咅IM牛确认 Qualification of main parts 9 设备配套的关键仪表确认 Qualification of assembled key instruments 11 检测用仪表确认 Qualification of instrument for testing 12 公用、安全、环境等支持系统确认 Qualification of support systems 13 风管和空调机组清洁确认 Qualification of pipeline/air conditioner cleaning.. 15 HYPERLINK \l bookmark8高效过［虑醫￡ 检漏 Qualification of HE PA test 16 安装确认(IQ)完成报告 Installation qualification accomplish report 18 运彳亍确认 (OQ) Operation Qualification 19 HYPERLINK \l bookmark12安装确认(IQ)完成情况确认 Check of IQ accomplish status 19 HYPERLINK \l bookmark14文件/培训确认 Check of SOP/training 20 HYPERLINK \l bookmark16空调机组运行?确认 Confirmation of AC operation 22 HYPERLINK \l bookmark18初阻力确认 Confirmation of primary resista nee 23 风速和换气次数确认 25 HYPERLINK \l bookmark20静压差测试 Test of static pressure difference 27 HYPERLINK \l bookmark22光照度测试 Test of light strength 28 HYPERLINK \l bookmark24628. 运行?确认(OQ)完成报告 OQ accomplish report 29 性能确认 (PQ) Performance qualification 29 HYPERLINK \l bookmark26安装/运行确认完成情况确认 Check of IQ/OQ accomplish status 29 HYPERLINK \l bookmark28空调系统自净时间确认 Self clean time confirmation 31 温湿度确认 Confirmation of temperature and humidity 34 HYPERLINK \l bookmark30尘埃粒子确认 Confirmation of dusty particles 35 系统消毒效果确认 Confirmation of disinfection of system 36 HYPERLINK