三足离心机安装确认方案

设备验证方案EquipmentQualificationProtocol主题：201车间SSL600三足式上卸料离心机IQ验证方案Title:InstallationqualificationofGSHT-300CoatingmachineinPlant206验证编号/ValidationS.N.：日期/Date：设备编号/EquipmentS.N.：页数/totalpages：山东孔府制药股份有限公司SHANDONGPHARMACEUTICALCO.,LTD.11.SSL600三足式上卸料离心机验证方案的审批ReviewandapprovevalidationprotocoloftheGSHT-300coatingmachine职能Function部门Department姓名Name签名Signature日期Date起草/Drafter201车间/Plant201审核/Reviewer201车间/Plant201审核/Reviewer201车间/Plant201审核/ReviewerQA审核/Reviewer机械动力部/MachineandPowerDep.批准/ApprovalQA/qualityassurance批准/Approval机械动力部/MachineandPowerDep.2.SSL600三足式上卸料离心机验证方案的历史修订记录/GSHT-300coatingmachine’svalidationprotocolrevisionhistory版本Version日期Date方案修订者Protocolrevisedbywhom批准人Approval修订说明Revisiondescription2目录Contents1、验证概述Validationoverview···························································32、验证小组成员及职责MembersofValidationteamandtheirconcernedresponsibilities·························································································33、设备概述及工艺流程Equipmentoverviewandprocessflow···········34、设备安装确认（IQ）Equipmentinstallationqualification················44.1安装确认内容Installationqualificationcontent·······························44.2随机文件及附件确认Documentswithshipmentandaccessoriesqualification.····························································································44.3安全/防范safety/precaution·····························································54.4专项安装确认specialinstallationqualification································55、验证用校验仪器及设备测控仪表确认QualifiationofcalibrationinstrumentsandMeasure&controlmetersofequipments·······················105.1验证用校验仪器确认Qualificationofcalibrationinstrumentforvalidationusing······················································································105.2设备所属测控仪表确认Qualificationofmeasure&controlmeters···············································································································1036、结论Conclusion············································································116.1偏差分析Deviationanalysis··························································116.2安装确认结论Installationqualificationconclusion·······················117、人员培训Personneltraining····························································118、附件Appendix·················································································114姓名Name部门Department职务Function职责Responsibility201车间/plant201工程师Engineer起草验证方案、验证报告draftvalidationprotocolandreport201车间/plant201主任Director审核验证方案、验证报告reviewvalidationprotocolandreport计量电气部/MetrologyDep.主管Supervisor负责计量仪器仪表校验审核reviewmeasuringinstrumentcalibrationQA主管Supervisor审核验证方案、验证报告reviewvalidationprotocolandreport机械动力部/Machineand主管Supervisor审核验证方案、验证报告reviewvalidationprotocolandreport1、验证概述validationoverviewSSL600三足式上卸料离心机将用于原料药的生产，为了保证SSL600三足式上卸料离心机的安装符合生产工艺要求，本方案规定了该设备的安装确认内容。确认结果用于鉴定该系统的设备的安装及配套设施的配置能够满足设计标准和GMP要求。ThisGSHT-300coatingmachinewillbeusedforthecoatingofPerrigo(UK)Ibuprofentablets.InordertoensurethattheinstallationoftheGSHT-300coatingmachinecanmeettheproductionprocessrequirements,thisprotocolspecifiedtheinstallationqualificationcontent.TheValidationresultsareusedforverifyingthattheinstallationoftheequipmentandtheconfigurationofauxiliaryfacilitiescanmeetthedesignstandardandtheGMPrequirements.本方案适用于山东孔府制药有限公司201车间2台SSL600三足式上卸料离心机的安装确认。ThisprotocolappliestotheinstallationqualificationoftheGSHT-300coatingmachineinplant206,ShandongXinHuapharmaceuticalCo.,Ltd.2、验证小组成员及职责Membersofvalidationteamandtheirresponsibilities5PowerDep.QA经理助理Assistantmanager批准验证方案、验证报告approvevalidationprotocolandreport机械动力部/MachineandPowerDep.经理Manager批准验证方案、验证报告approvevalidationprotocolandreport3、设备概述及工艺流程Equipmentoverviewandprocessflow201车间共有SSL600三足式上卸料离心机2台（编号分别为C101、C102），由江苏牡丹离心机制造有限公司制造，均安装在山东孔府制药有限公司201车间合成区，用于原料药生产过程中的离心工序。ThisGSHT-300coatingmachineismadebyZIBOIMA-XINHUAPHARMATECHCo.,Ltd.andwillbeequippedinthecoatingroom(roomNo.402)ofPlant206.Thismachinewillbeusedforthecoatingstepduringtheproduction.该设备主要由转鼓部件、橡胶减震器、电动机、变频器、制动单元组成。料液经过离心机达到固液分离的目的。固体形成滤饼存留在离心机转鼓内，滤液通过滤包后通过管道进入滤液储罐。ThisequipmentmainlyconsistsofDosingunit,Horizontalatresypan,Coretemperatureprobe,Ventilationunit,Pistols-supporting-armforsugar-coatingprocess,Controlpanel,Airtreatmentunit,Dustcollector,Pistolsforfilmingprocess,Paddleunit,Outletairsystem.Itcanbeusedforbothfilmingandsugarcoatingprocess.Sprayingsystemforfilmingcoatingismadeupoffilmpump,lowpressurepipeline(withair),andspraygunbattery.Forsugarcoating,therearesugarcoatingpump,highpressurepipeline6(withoutair),spraygunbattery,andsolutionrecylevalve.Coatingsolutionismixedcompletely,andtransferredtospraygunthroughdosingunit.Theairwillbefilteredanddehumidifiedthroughtheairtreatmentsystembeforeenteringintothecoatingpan,andthenheatedtoappropriatetemperature.Inthecoatingpan,adjustpanspeedtomixtabletscompletely,andexhaustsystemdischargestheairoutofpan.Atlasttheairwillbeexhaustedthroughfilter.4.安装验证（IQ）Installationqualification4.1安装确认内容Installationqualificationcontent安装验证主要对设备各组成部分的组装，电气系统及相关配套设施的连接，安装位置等进行确认，并确认每项测