gdac06四药-认证文件gdac03附件gssf

Doc. IMA File CoreCoatingSystem包衣系FunctionalSpecifications功能性特征说FilmAtomizationand/orSugarDosingCompressedAirAdjustingSystem薄膜雾化压力/糖包衣剂量压缩MED TABLEOFMODIFICATIONS修改章版RequestN.修改申请Modified修改日Descriptionof修改描M.Modified§L.IMAlogo©©IMAReproductionofthisbyanymeans,inwholeorinpart,isprohibitedwithouttheauthorizationofIMAS.p.A.淄博伊马新华制药设备保持如下的权利：淄博伊马新华制药设 以部分或全部该文件。INTRODUCTION说 GLOSSARY术 FUNCTIONALSPECIFICATIONS功能特征说 GeneralFunctionalDescription常规功能描 FUNCTIONS功 ProcessCycle工艺循 CompressedAirPressureAdjustmentSystem压缩空气压力调整系 AtomizationAirPressureControlValve雾化压力控制阀 CompressedAirPressureGauge压缩空气压力测 CompressedAirSystem压缩空气系 CompressedAirSupplyValve压缩空气供给阀 ChecksandAdjustments检查和调 Pre-arrangements预 SoftwareFunctionalSpecifications软件功能说 Data数 Non-functionalfeatures非功能性特 ANNEXES附 NOTES注 Structureof 文件结 REFERENCES参考文 ENTS附 INTRODUCTION说 makesuptheFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystemFunctionalSpecificationsfortheCoreCoatingSysteminthePan.ThescopeofthisistodefinethefeaturesandfunctionsoftheFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystem. wasissuedinconformitywiththefollowingWorkInstructionsofIMA "FunctionalSpecifications(SWQuality "StandardsApplicabletoQualitySystem "ManagementApplicabletoQualitySystem 该文件组成了包衣系统中雾化压力/糖包衣力调整的功能说明该文件的范围是定义雾化压力/糖包衣力的特点和功能 "功能说明(包括质量手册的软件 "质量补充文件的标准应用 "质量补充文件的管理应用GLOSSARY术 IssuanceFormModulo i)文件发布格 NotApplicable不适 Software软FUNCTIONALSPECIFICATIONS功能特征说ThetaskoftheFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystemistosupplyandadjustthecompressairsupplytothesystemsthatdoseandspraythecoatingDependingonthesystem'ssetup[Doc.Ref."FunctionalSpecifications"associatedwiththemachineinquestion§"MachineSetups"],theFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystemsthecompressedairatthepressurerequiredtoactuatethefollowingfunctions:AtomizationoftheproductfortheFilmProductDosingPaticPumpSupplyfortheSugarThecompressedairpressureisadjustedinthesamewayinbothcases.Thedefinitionsofthefunctionsactuatedbythecompressedair,subject-matterofthisspecification,areoutlinedindoc."FunctionalSpecifications"associatedwiththemachineinquestion§"CoreCoating雾化压力/系统设置（文件功能特征与机器中的机器设置有关系），雾化压力/糖包衣压力压缩空气调整系统压缩空气的取决于一下功能：两种情况下压缩空气压力调整是同样的方法。这个功能是靠压缩空气驱动，特征详细"片芯包衣系统"章节。Functions功ProcessCycle工艺循ThefigurebelowshowstheprocesscycleoftheCoreCoatingSystemhighlightingthelocationoftheFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystem.Formoreinformation,refertothesystem'sP&IDP&ID图[2]。SYSTEMATSYSTEMATWASHWASHFLUIDSYSTEMAT

AIRCompressedAirPressureAdjustmentSystem压缩空气压力调整系统(FS-Thesystem'smaincomponentsareindicatedbelow.AtomizationAirPressureControlValve雾化压力控制阀Apressure-regulatingvalve(TPC)managedbytheControlSystemislocatedonthecircuitthatscompressedairtothecoatingproduct'sdosingandsprayingsystems.Thelocationofthevalveisindicatedinthe"layout"oftheCoreCoatingSystemref.[3].给产品糖包衣和喷射系统供给压缩空气的管安装了一个由控制系统控制的一个压力调CompressedAirPressureGauge压缩空气压力测TheairpressuregaugeislocatedontheairductdownstreamoftheAtomizationAirPressureControlValveanditstaskistodetectthepressureoftheairthatfeedsthecoatingproduct'sdosingandsprayingsystems.空气压力表安装在雾化压力控制阀的下游，他的任务是检测CompressedAirSystem压缩空气系Theairforthecoatingproduct'sdosingandsprayingsystemsisdbythesystem'scompressedairsystem[ref.§"RequiredServices"doc."FunctionalSpecifications"associatedwiththemachineinquestion].ThespecificationsofthecompressedairareoutlinedintheTechnicalLayoutoftheCoreCoatingSystem,ref.[3].TheCompressedAirSystemnotonlysairtothecoatingproduct'sdosingandsprayingsystemsbutalsosairtoallthesystem'sserviceunits.ThedefinitionoftheserviceunitsdbytheCompressedAirSystemisoutlinedinthe"P&ID"oftheCoreCoatingSystem,ref.[2].Beforeitisused,theCompressedAirisfilteredthroughaseriesoffiltersthatretaintheimpurities.Thetypeoffiltersinstalledisindicatedinthe"P&ID"relatingtotheCoreCoatingSystemref.[2].产品包衣剂量和喷射系统的压缩空气是由设备的压缩空气系统供给（请参考机器“功能说明”中“需求服务”）压缩空气说明概述请参考技术文件片芯包衣系统[3]压缩空气系统不仅是为产品包衣剂量和喷射系统供给压缩空气同样也为整个系统单元供给压缩空气。压缩空气系统单元的详细描述请参考片芯包衣系统"P&ID"图纸。压缩空气在被使用之前会被一个过滤器过滤出杂质。这个过滤器会在片芯包衣系统"P&ID"图中标出CompressedAirSupplyValve压缩空气供给阀AvalvecheckedbytheControlSystemisinstalledontheCompressedAirsupplycircuitanditstaskistomanagethecompressedair'ssupplytothesystem.压缩空气供给管安装有一个由控制系统检测的阀门，它的任务是控制系统压缩空Theprocess'criticalparametersthatdeterminethemainchecksandadjustmentsaredefinedindoc."FunctionalSpecifications"associatedwiththemachineinquestion.TheFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystemhasbeenpre-arrangedforrunningthefollowingchecks:雾化压力/CompressedairpressureCompressedairpressureacquisitionandcheck压缩空气Checkforcompressedairpresence检查压缩

TheControlSystemregulatesthepressureofthecompressedair.Theoperatorsetsthereferencevalue,theadjustmentiscarriedoutbymeasuringthepressurewithagauginginstrumentandthentheopeningoftheAirPressureControlValve(TPC)isadjustedaccordingly.Thecompressedairpressuregauge[ref.§3.2.2.2]sasignalaccordingtothecircuit'sinternalpressure.TheControlSystemacquiresthesignal,recordsthepressurevalueandchecksthatthepressuredoesnotdropbelowtheminimumlevel.压缩空气压力表[参考。§3.2.2.2]提供一个信号到电子压力ApressureswitchisinstalledontheCompressedAirsupplysystemthatfeedsbackasignalwhenpressureisnotenough.Referto§3.4SoftwareFunctionalSpecificationsforthecompletedefinitionofthechecksandadjustments.参考§3.4SoftwareFunctionalSpecificationsPre-arrangements预Theforegoingunitispre-arrangedfortheutilizationofapiston-fittedvolumetricpumpinlieuoftheperistalticoneinstalledforhigh-viscositycoatingsolutions.上文提到的单元是在高粘SoftwareFunctionalSpecifications软件功能