gdac06四藥-認(rèn)證文件gdac03附件gssf

Doc. IMA File CoreCoatingSystem包衣系FunctionalSpecifications功能性特征說(shuō)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(qǐng)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(shè)備保持如下的權(quán)利：淄博伊馬新華制藥設(shè) 以部分或全部該文件。INTRODUCTION說(shuō) GLOSSARY術(shù) FUNCTIONALSPECIFICATIONS功能特征說(shuō) GeneralFunctionalDescription常規(guī)功能描 FUNCTIONS功 ProcessCycle工藝循 CompressedAirPressureAdjustmentSystem壓縮空氣壓力調(diào)整系 AtomizationAirPressureControlValve霧化壓力控制閥 CompressedAirPressureGauge壓縮空氣壓力測(cè) CompressedAirSystem壓縮空氣系 CompressedAirSupplyValve壓縮空氣供給閥 ChecksandAdjustments檢查和調(diào) Pre-arrangements預(yù) SoftwareFunctionalSpecifications軟件功能說(shuō) Data數(shù) Non-functionalfeatures非功能性特 ANNEXES附 NOTES注 Structureof 文件結(jié) REFERENCES參考文 ENTS附 INTRODUCTION說(shuō) makesuptheFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystemFunctionalSpecificationsfortheCoreCoatingSysteminthePan.ThescopeofthisistodefinethefeaturesandfunctionsoftheFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystem. wasissuedinconformitywiththefollowingWorkInstructionsofIMA "FunctionalSpecifications(SWQuality "StandardsApplicabletoQualitySystem "ManagementApplicabletoQualitySystem 該文件組成了包衣系統(tǒng)中霧化壓力/糖包衣力調(diào)整的功能說(shuō)明該文件的范圍是定義霧化壓力/糖包衣力的特點(diǎn)和功能 "功能說(shuō)明(包括質(zhì)量手冊(cè)的軟件 "質(zhì)量補(bǔ)充文件的標(biāo)準(zhǔn)應(yīng)用 "質(zhì)量補(bǔ)充文件的管理應(yīng)用GLOSSARY術(shù) IssuanceFormModulo i)文件發(fā)布格 NotApplicable不適 Software軟FUNCTIONALSPECIFICATIONS功能特征說(shuō)ThetaskoftheFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystemistosupplyandadjustthecompressairsupplytothesystemsthatdoseandspraythecoatingDependingonthesystem'ssetup[Doc.Ref."FunctionalSpecifications"associatedwiththemachineinquestion§"MachineSetups"],theFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystemsthecompressedairatthepressurerequiredtoactuatethefollowingfunctions:AtomizationoftheproductfortheFilmProductDosingPaticPumpSupplyfortheSugarThecompressedairpressureisadjustedinthesamewayinbothcases.Thedefinitionsofthefunctionsactuatedbythecompressedair,subject-matterofthisspecification,areoutlinedindoc."FunctionalSpecifications"associatedwiththemachineinquestion§"CoreCoating霧化壓力/系統(tǒng)設(shè)置（文件功能特征與機(jī)器中的機(jī)器設(shè)置有關(guān)系），霧化壓力/糖包衣壓力壓縮空氣調(diào)整系統(tǒng)壓縮空氣的取決于一下功能：兩種情況下壓縮空氣壓力調(diào)整是同樣的方法。這個(gè)功能是靠壓縮空氣驅(qū)動(dòng)，特征詳細(xì)"片芯包衣系統(tǒng)"章節(jié)。Functions功ProcessCycle工藝循ThefigurebelowshowstheprocesscycleoftheCoreCoatingSystemhighlightingthelocationoftheFilmAtomizationand/orSugarDosingCompressedAirAdjustingSystem.Formoreinformation,refertothesystem'sP&IDP&ID圖[2]。SYSTEMATSYSTEMATWASHWASHFLUIDSYSTEMAT

AIRCompressedAirPressureAdjustmentSystem壓縮空氣壓力調(diào)整系統(tǒng)(FS-Thesystem'smaincomponentsareindicatedbelow.AtomizationAirPressureControlValve霧化壓力控制閥Apressure-regulatingvalve(TPC)managedbytheControlSystemislocatedonthecircuitthatscompressedairtothecoatingproduct'sdosingandsprayingsystems.Thelocationofthevalveisindicatedinthe"layout"oftheCoreCoatingSystemref.[3].給產(chǎn)品糖包衣和噴射系統(tǒng)供給壓縮空氣的管安裝了一個(gè)由控制系統(tǒng)控制的一個(gè)壓力調(diào)CompressedAirPressureGauge壓縮空氣壓力測(cè)TheairpressuregaugeislocatedontheairductdownstreamoftheAtomizationAirPressureControlValveanditstaskistodetectthepressureoftheairthatfeedsthecoatingproduct'sdosingandsprayingsystems.空氣壓力表安裝在霧化壓力控制閥的下游，他的任務(wù)是檢測(cè)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(chǎn)品包衣劑量和噴射系統(tǒng)的壓縮空氣是由設(shè)備的壓縮空氣系統(tǒng)供給（請(qǐng)參考機(jī)器“功能說(shuō)明”中“需求服務(wù)”）壓縮空氣說(shuō)明概述請(qǐng)參考技術(shù)文件片芯包衣系統(tǒng)[3]壓縮空氣系統(tǒng)不僅是為產(chǎn)品包衣劑量和噴射系統(tǒng)供給壓縮空氣同樣也為整個(gè)系統(tǒng)單元供給壓縮空氣。壓縮空氣系統(tǒng)單元的詳細(xì)描述請(qǐng)參考片芯包衣系統(tǒng)"P&ID"圖紙。壓縮空氣在被使用之前會(huì)被一個(gè)過(guò)濾器過(guò)濾出雜質(zhì)。這個(gè)過(guò)濾器會(huì)在片芯包衣系統(tǒng)"P&ID"圖中標(biāo)出CompressedAirSupplyValve壓縮空氣供給閥AvalvecheckedbytheControlSystemisinstalledontheCompressedAirsupplycircuitanditstaskistomanagethecompressedair'ssupplytothesystem.壓縮空氣供給管安裝有一個(gè)由控制系統(tǒng)檢測(cè)的閥門，它的任務(wù)是控制系統(tǒng)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?！?.2.2.2]提供一個(gè)信號(hào)到電子壓力ApressureswitchisinstalledontheCompressedAirsupplysystemthatfeedsbackasignalwhenpressureisnotenough.Referto§3.4SoftwareFunctionalSpecificationsforthecompletedefinitionofthechecksandadjustments.參考§3.4SoftwareFunctionalSpecificationsPre-arrangements預(yù)Theforegoingunitispre-arrangedfortheutilizationofapiston-fittedvolumetricpumpinlieuoftheperistalticoneinstalledforhigh-viscositycoatingsolutions.上文提到的單元是在高粘SoftwareFunctionalSpecifications軟件功能