Doc. IMA File CoreCoatingSystem包衣系FunctionalSpecifications功能性特征說FilmAtomizationand/orSugarDosingCompressedAirAdjustingSystem薄膜霧化壓力/糖包衣劑量壓縮MED TABLEOFMODIFICATIONS修改章版RequestN.修改申請Modified修改日Descriptionof修改描M.Modified§L.IMAlogo??IMAReproductionofthisbyanymeans,inwholeorinpart,isprohibitedwithouttheauthorizationofIMAS.p.A.淄博伊馬新華制藥設備保持如下的權利：淄博伊馬新華制藥設 以部分或全部該文件。INTRODUCTION說 GLOSSARY術 FUNCTIONALSPECIFICATIONS功能特征說 GeneralFunctionalDescription常規功能描 FUNCTIONS功 ProcessCycle工藝循 CompressedAirPressureAdjustmentSystem壓縮空氣壓力調整系 AtomizationAirPressureControlValve霧化壓力控制閥 CompressedAirPressureGauge壓縮空氣壓力測 CompressedAirSystem壓縮空氣系 CompressedAirSupplyValve壓縮空氣供給閥 ChecksandAdjustments檢查和調 Pre-arrangements預 SoftwareFunctionalSpecifications軟件功能說 Data數 Non-functionalfeatures非功能性特 ANNEXES附 NOTES注 Structureof 文件結 REFERENCES參考文 ENTS附 INTRODUCTION說 makesuptheFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystemFunctionalSpecificationsfortheCoreCoatingSysteminthePan.ThescopeofthisistodefinethefeaturesandfunctionsoftheFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystem. wasissuedinconformitywiththefollowingWorkInstructionsofIMA "FunctionalSpecifications(SWQuality "StandardsApplicabletoQualitySystem "ManagementApplicabletoQualitySystem 該文件組成了包衣系統中霧化壓力/糖包衣力調整的功能說明該文件的范圍是定義霧化壓力/糖包衣力的特點和功能 "功能說明(包括質量手冊的軟件 "質量補充文件的標準應用 "質量補充文件的管理應用GLOSSARY術 IssuanceFormModulo i)文件發布格 NotApplicable不適 Software軟FUNCTIONALSPECIFICATIONS功能特征說ThetaskoftheFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystemistosupplyandadjustthecompressairsupplytothesystemsthatdoseandspraythecoatingDependingonthesystem'ssetup[Doc.Ref."FunctionalSpecifications"associatedwiththemachineinquestion§"MachineSetups"],theFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystemsthecompressedairatthepressurerequiredtoactuatethefollowingfunctions:AtomizationoftheproductfortheFilmProductDosingPaticPumpSupplyfortheSugarThecompressedairpressureisadjustedinthesamewayinbothcases.Thedefinitionsofthefunctionsactuatedbythecompressedair,subject-matterofthisspecification,areoutlinedindoc."FunctionalSpecifications"associatedwiththemachineinquestion§"CoreCoating霧化壓力/系統設置（文件功能特征與機器中的機器設置有關系），霧化壓力/糖包衣壓力壓縮空氣調整系統壓縮空氣的取決于一下功能：兩種情況下壓縮空氣壓力調整是同樣的方法。這個功能是靠壓縮空氣驅動，特征詳細"片芯包衣系統"章節。Functions功ProcessCycle工藝循ThefigurebelowshowstheprocesscycleoftheCoreCoatingSystemhighlightingthelocationoftheFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystem.Formoreinformation,refertothesystem'sP&IDP&ID圖[2]。SYSTEMATSYSTEMATWASHWASHFLUIDSYSTEMAT

AIRCompressedAirPressureAdjustmentSystem壓縮空氣壓力調整系統(FS-Thesystem'smaincomponentsareindicatedbelow.AtomizationAirPressureControlValve霧化壓力控制閥Apressure-regulatingvalve(TPC)managedbytheControlSystemislocatedonthecircuitthatscompressedairtothecoatingproduct'sdosingandsprayingsystems.Thelocationofthevalveisindicatedinthe"layout"oftheCoreCoatingSystemref.[3].給產品糖包衣和噴射系統供給壓縮空氣的管安裝了一個由控制系統控制的一個壓力調CompressedAirPressureGauge壓縮空氣壓力測TheairpressuregaugeislocatedontheairductdownstreamoftheAtomizationAirPressureControlValveanditstaskistodetectthepressureoftheairthatfeedsthecoatingproduct'sdosingandsprayingsystems.空氣壓力表安裝在霧化壓力控制閥的下游，他的任務是檢測CompressedAirSystem壓縮空氣系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].產品包衣劑量和噴射系統的壓縮空氣是由設備的壓縮空氣系統供給（請參考機器“功能說明”中“需求服務”）壓縮空氣說明概述請參考技術文件片芯包衣系統[3]壓縮空氣系統不僅是為產品包衣劑量和噴射系統供給壓縮空氣同樣也為整個系統單元供給壓縮空氣。壓縮空氣系統單元的詳細描述請參考片芯包衣系統"P&ID"圖紙。壓縮空氣在被使用之前會被一個過濾器過濾出雜質。這個過濾器會在片芯包衣系統"P&ID"圖中標出CompressedAirSupplyValve壓縮空氣供給閥AvalvecheckedbytheControlSystemisinstalledontheCompressedAirsupplycircuitanditstaskistomanagethecompressedair'ssupplytothesystem.壓縮空氣供給管安裝有一個由控制系統檢測的閥門，它的任務是控制系統壓縮空Theprocess'criticalparametersthatdeterminethemainchecksandadjustmentsaredefinedindoc."FunctionalSpecifications"associatedwiththemachineinquestion.TheFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystemhasbeenpre-arrangedforrunningthefollowingchecks:霧化壓力/CompressedairpressureCompressedairpressureacquisitionandcheck壓縮空氣Checkforcompressedairpresence檢查壓縮

TheControlSystemregulatesthepressureofthecompressedair.Theoperatorsetsthereferencevalue,theadjustmentiscarriedoutbymeasuringthepressurewithagauginginstrumentandthentheopeningoftheAirPressureControlValve(TPC)isadjustedaccordingly.Thecompressedairpressuregauge[ref.§3.2.2.2]sasignalaccordingtothecircuit'sinternalpressure.TheControlSystemacquiresthesignal,recordsthepressurevalueandchecksthatthepressuredoesnotdropbelowtheminimumlevel.壓縮空氣壓力表[參考。§3.2.2.2]提供一個信號到電子壓力ApressureswitchisinstalledontheCompressedAirsupplysystemthatfeedsbackasignalwhenpressureisnotenough.Referto§3.4SoftwareFunctionalSpecificationsforthecompletedefinitionofthechecksandadjustments.參考§3.4SoftwareFunctionalSpecificationsPre-arrangements預Theforegoingunitispre-arrangedfortheutilizationofapiston-fittedvolumetricpumpinlieuoftheperistalticoneinstalledforhigh-viscositycoatingsolutions.上文提到的單元是在高粘SoftwareFunctionalSpecifications軟件功能