题目:TZB车间HVAC验证方案编号:SMP-VMP-003版本号:00第3页共17页目录Tableofcontents1设备基本情况Overview···········································································41.1概述Description..............................................................................................................41.2设备基本情况Overview..................................................................................................42、验证目的Purpose················································································53、范围Scope·························································································54、职责Responsibilities···········································································54.1验证小组Qualificationteam.........................................................................................54.2设备工程部Equipment&engineeringdepartment...................................................54.3生产车间Productionworkshop....................................................................................64.4质量管理部Qualityunit.................................................................................................65、验证培训Tranining···············································································66.验证内容Qualification···········································································66.1仪器仪表确认Instrumentsconfirm................................................................................66、验证内容Qualification··········································································66.1仪器仪表确认Instrumentsconfirm................................................................................66.2安装确认(IQ)...................................................................................................................66.3运行确认(OQ)..................................................................................................................96.4性能确认(PQ)................................................................................................................147、偏差Deviation···················································································158、验证结果评定与结论Evaluationandconclusion······································159、验证文件记录Qualificationworksheet···················································16题目:TZB车间HVAC验证方案编号:SMP-VMP-003版本号:00第4页共17页1设备基本情况Overview1.1概述Description车间精烘包净化级别为D级,使用ZKW型组合式空调机组进行空气净化。该空气净化系统由南昌医药设计院依据净化行业技术标准及GMP要求设计,由苏州鼎新空调净化设备有限公司负责安装施工。本空调净化系统采用卧式空调箱送回风系统,新风与回风混合经初效过滤器(防止新风经回风直接进入洁净区,新风的电动调节阀、回风电动阀与主风机联动即主风机停,新风阀、回风电动阀自动关闭,另外防止出现差错在新风上安装了初效过滤)、表冷器、风机、加热器、加湿器、中效过滤器、高效过滤器送至洁净区,气流组织顶送侧下回风(结晶按侧送,侧下回风)。(附件1.车间HVAC流程示意简图)1.2设备基本情况Overview1.2.1主要设备基本情况设备名称组合式空调机组臭氧产量35g/h规格型号ZKW-13生产厂家苏州鼎新空调净化设备有限公司额定风量13000m3/h全压力1138~1953Pa电机功率11KW制冷量240kw加热量105kw加湿量80kg/h出厂编号NO.16出厂日期2008年6月1.2.2过滤器情况概述过滤器名称材质安装位置备注初效过滤器无纺布材质安装在新风混合段后中效过滤器无纺布材质安装在送风段高效过滤器超细玻璃纤维滤纸安装在房间送风口处回风过滤器铝合金百叶加滤袋过滤或尼龙过滤网安装在洁净区回风口粉尘房间滤袋过滤其他房间阻尼过滤直排过滤器中效过滤器(超细玻璃纤维滤纸)安装在中效排风箱内风机、中效、止回阀、百叶1.2.3净化装修情况:各面材质备注顶\前\后\左\右面彩钢板彩钢板的侧边用槽型铝合金封固题目:TZB车间HVAC验证方案编号:SMP-VMP-003版本号:00第5页共17页地面环氧树脂自流平面与面的联接弧型材和R型材圆弧联接管线、灯具、高效风口与彩钢板间密封专用环型不锈钢密封圈、玻璃密封胶管线在夹层;灯具与玻镁彩钢板吸顶布置,HEPA在夹层安装1.3安装及维修服务情况Installationandmaintenanceservice安装及维修服务单位地址苏州鼎新空调净化设备有限公司江苏省吴江市金家坝金鑫东路19号电话传真邮编0512-632028950512-632089882152152、验证目的Purpose检查并确认空调净化系统经安装调试后是否符合设计要求,是否满足生产工艺及GMP要求,试验并确认空调净化系统运行参数,监测空调净化系统洁净区的性能参数。3、范围Scope本验证方案适用于SBA车间空调净化系统。4、职责Responsibilities4.1验证小组Qualificationteam4.1.1负责验证方案的审核。4.1.2负责验证的协调工作,以保证本再验证方案规定项目的顺利实施。4.1.3负责验证数据及结果的审核。4.1.4负责验证报告的审核。4.1.5负责发放验证证书。4.1.6负责空调净化系统日常监测项目及验证周期的确认。4.2设备工程部Equipment&engineeringdepartment4.2.1负责设备的验证前维护,并做好相应的记录。4.2.2负责建立设备档案。4.2.3负责仪器、仪表的校正。4.2.4负责拟订空调净化系统日常监测项目及验证周期。4.2.5负责收集各项验证、试验记录,报验证小组。4.2.6负责起草空调净化系统操作、清洗、维护保养的标准操作程序。4.2.7负责空调净化系统的操作、清洗和维护保养。题目:TZB车间HVAC验证方案编号:SMP-VMP-003版本号:00第6页共17页4.3生产车间Productionworkshop4.3.1配合设备工程部门完成确认,检查验证项目是否完成;4.3.2核对报告所需的内容是否完成可上报批准;4.3.3审核验证方案和最后报告;4.4质量管理部Qualityunit4.4.1负责洁净监控的质量标准、检验规程及取样程序。4.4.2负责洁净区监控的检验、并根据检验结果出具检验报告单5、验证培训Training在本方案执行之前,必须对涉及的人员进行相应的培训,且经确认合格之后,方可进行下一步确认。方法:根据本验证文件培训要求,执行本方案培训;合格标准:相关人员均已接受培训,且都通过考核,能够执行本设备验证。记录:培训确认记录(附件1)6.验证内容Qualification6.1仪器仪表确认Instrumentsconfirm目的:确保验证中所用到的仪器仪表是经校验合格的且在有效期内。序号计量器具名称规格/型号制造厂家01数字风速仪QDF-6北京市远大仪器仪表开发部02激光尘埃粒子仪BCJ-1江苏华达仪器设备有限公司03温、湿度表-20~40℃、0~100%R.H天津吉星04压差计A2-060PaSAILSORS6、验证内容Qualification6.1仪器仪表确认Instrumentsconfirm目的:确保验证中所用到的仪器仪表是经校验合格的且在有效期内。序号计量器具名称规格/型号制造厂家01数字风速仪QDF-6北京市远大仪器仪表开发部02激光尘埃粒子仪BCJ-1江苏华达仪器设备有限公司03温、湿度表-20~40℃、0~100%R.H天津吉星04压差计A2-060PaSAILSORS6.2安装确认(IQ)题目:TZB车间HVAC验证方案编号:SMP-VMP-003版本号:00第7页共17页6.2.1安装确认所需文件资料设备工程部在设备开箱验收后建立设备档案,整理安装、使用说明和设计图纸等技术资料,归档保存。安装确认所需资料及存放处6.2.2关键性仪表及消耗性备品列出关键性仪表及消耗性备品的目录,汇总统计,作为空调净化系统的关键资料,用来与仪器以后的变动比较。6.2.3机组的安装确认:安装确认主要是指机组设备、风管等安装后,对照设计图纸及供应商提供的技术资料,检查安装是否符合设计及安装规范。检查项目主要有电气、管路连接、自控部分、风机安装、加热器、表冷器安装、加湿器安装、效过滤器安装等并记录安装检查结果6.2.4风管制作及安装确认:.风管制作及安装确认主要对照设计图纸检查风管材料,保温材料,安装紧密度,管道走向及风管检漏。风管检漏方法:对一定长度的风管,在周围漆黑环境下,用一个电压在36V以内、功率100W以上带保护罩的灯泡,在风管内由一端缓缓移向另一段,若在风管外能够观察到有光线射出,说明有严重的漏风现象。6.2.5空调净化系统通风管道必须进行清洁在风管吊装前先用洁净的擦布蘸饮用水将风管擦拭干净,再用75%乙醇擦拭后,同时在风管两端用无纺布封好后吊装。空调器拼装完毕,内部用洁净湿擦布擦拭风机隔