xx年度123HVAC再验证方案.doc

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1、xx年度123HVAC再验证方案　　123#洁净区HVAC系统再验证方案方案编号BVP-US-xx***验证方案批准部门姓名签名日期方案执行日期年月日签名起草人一车间生产部审核人计量室QCxx年度123HVAC再验证方案　　123#洁净区HVAC系统再验证方案方案编号BVP-US-xx***验证方案批准部门姓名签名日期方案执行日期年月日签名起草人一车间生产部审核人计量室QCQA批准人QA1/13目录1.概述·····································································

2、····················································32.目的·························································································································33.验证小组成员及职责····················································································

3、···········34.验证进度·················································································································45.验证步骤·················································································································56.偏差及变更控制·············

4、··························································································77.验证结论·················································································································78．附录···························································

5、·····························································92/131.概述1.1.本公司123#的HVAC系统都由ZKJ-35组合式空调机组及其净化系统组成。　　空气处理单元AHU主要包含初效过滤、中效过滤、表冷器、加湿器、臭氧发生器等部件，新风由AHU处理后，经过高效过滤器输送到各洁净区房间内，房间内旧的空气从回风口或排风系统排出，新旧空气不断置换，完成房间内环境的净化。　　当需要消毒时，启动臭氧发生器进行消毒，消毒结束后，通过空气循环将残留的臭氧排出洁净区。　　（HVAC系

6、统工作流程示意图）新风初效过滤器表冷器风机加热器高效过滤器送风口室内循环加湿器中效过滤器(臭氧发生器)回风口回风排风口1.2.空调净化机组的关键部件及参数列表所在工段部件名称保温层箱体面板内板内底板初效过滤段表冷段风机段加热段加湿段中效过滤段臭氧消毒段袋式过滤器表冷器风机加热器蒸汽加湿器袋式过滤器臭氧消毒器型号/规格/参数/材质聚氨酯高压发泡宝钢0.6彩钢板宝钢0.5彩钢板SUS　　304、0.5不锈钢合成纤维SD1026/计重效率81%TL2100*912*8R,DN80KDF70；35000m3/1500rpmGL2000*760*2R,

7、DN50ZSW-SΦ16L合成纤维SD1011A/计重效率95%SCF-NZ10016只2台1台2台1台16只2台1套数量/大小1.3.洁净区环境控制标准1.3.1.温度控制18~26℃；相对湿度控制45%~65%；1.3.2.压差控制各房间压差应符合洁净区压差要求；1.3.3.换气次数洁净区房间应≥15次/h；1.3.4.悬浮粒子和沉降菌符合十万级洁净区要求。　　2.目的2.1.本次验证主要是针对123#洁净区环境控制的HVAC系统工作性能及洁净区环境进行检测，通过一系列环境监测的项目检查和监测，评估123#洁净区的环境是否符合使用需求。　

8、　3.验证小组成员及职责3/133.1.验证小组组织结构及其人员分工姓名部门组内职务需完成工作QA组长批准验证方案及报告；与各部门协调验证工作的安排。　　QC组员审