gdac03人福認(rèn)證文件附件gssf12ukch

Doc. IMA File CoreCoatingSystemFunctionalSpecificationsDrilledPanMED TABLEOFMODIFICATIONSRequestN.修改Modifiedby修改DescriptionofModifications修L.IMAlogoP.Modified§(onlyEnglishversion);.1;;Added§.3;?IMAReproductionofthis byanymeans,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)備以部分或全部該文件。. ProcessCycle工藝循 Productcontainmentduringtheprocess工藝過的產(chǎn)品控 Base底 容腔 DrilledCup有孔鍋 DrilledCupMotorDrive有孔鍋電機(jī)驅(qū) DrilledCupSpeedAdjustment有孔鍋速度調(diào) CupRotationCheck鍋體旋轉(zhuǎn)檢 ChecksandAdjustments檢查與調(diào) CoreTemperatureMeasuring片芯溫度測 ChecksandAdjustments檢查與調(diào) SafetiesandProtections安全與保 SafetyGuards安全護(hù) Accessdoors檢修 DoorSafety門的安全裝 DisablingInspectionWindowSafetyDevice關(guān)閉檢修門安 Emergency ChecksandAdjustments檢查與調(diào) aticSealGaskets充氣密封 CompressedAirSystem壓縮空氣系 ChecksandAdjustments檢查與調(diào) ControlPanels控制面 PanControlPanel鍋體控制面 Data數(shù) Structureof 文件結(jié) REFERENCES參 ThismakesuptheDrilledPanFunctionalSpecificationsfortheCoreCoatingSysteminthePan.ThescopeofthisistodefinethefeaturesandfunctionsoftheDrilledThiswasissuedinconformitywiththefollowingWorkInstructionsofIMA "FunctionalSpecifications(SWQuality "StandardsApplicabletoQualitySystem "ManagementApplicabletoQualitySystem IMAS.p.A發(fā)布指令統(tǒng)一用以下的工作指令: "功能介紹(SW質(zhì)量手冊 IssuanceFormModulo NotApplicable Thisistheproducttobecoated.Itmaybeintheformoftablets,pelletsormicrogranules這是用作包衣的產(chǎn)品.它的形狀可以是片劑，小丸或微顆粒TheDrilledPanisthatpartofthesysteminwhichthecoatingprocesstakesceandismadeupofametallicboxthathousesthedevicesthecontaintheproductduringthecoatingThefunctionsoftheDrilledPanareasContainingandmixingtheproductduringtheMeasuringtheproduct'stemperatureduringtheToimplementthefunctions,thePanisfittedwithacontrolpanelviawhichtheoperatorcancheckthemainsystemfunctions.TheDrilledPanisthecentralsectionoftheCoreCoatingSystemthathousesthecorecontainmentandmixingdevices,thecoatingproductsprayingdevicesandthecoredryingdevicesandtowhich,therefore,allthesystem'smaincomponentsareconnected,namely:theAirTreatmentSystematInlet,theAirTreatmentSystematOutletandtheDosingandSprayingSystem.Thefunctionsoftheaforementionedsystemsareoutlinedindetailindoc"FunctionalSpecifications"associatedwiththemachineinquestion.有孔鍋是包衣系統(tǒng)的一部分，整個包衣過程是由一個屬容器的裝置包容著產(chǎn)品完成包衣的，這個裝置就是有孔鍋。有孔鍋的功能介紹如下在生產(chǎn)過容納和混合產(chǎn)在包裝過測量產(chǎn)品的溫為了實(shí)現(xiàn)以上功能,有孔鍋是包衣系統(tǒng)的部分，是容納和混合藥品的裝置,含有包衣產(chǎn)品噴射裝置所有系統(tǒng)主要的部件是相互聯(lián)系著的換句話說進(jìn)氣系統(tǒng)，ProcessCycleThefigurebelowshowstheprocesscycleoftheCoreCoatingSystemandhighlightsthelocationoftheDrilledPan.Formoreinformation,refertothesystem'sP&ID[2].下圖展示的是包衣系統(tǒng)的流程圖和信息P&ID[2]AIR

AIRSYSTEMATSYSTEMATSYSTEMATDOSINGANDDOSINGAND

WASHWASH

WASHFLUIDProductcontainmentduringtheprocess工藝過的產(chǎn)品控制(FS-Base容腔DrilledCupBaseThemachine'sstructureismadeupofametalBasethatsupportsandcontainsallthecomponents.TheBasebearsontheflooronfouradjustablefeet.機(jī)器是由金屬底架組成的，4個可調(diào)地腳。TheishousedinsidetheBasethatsupportsitanditstaskistoencloseandsealtheproductionareaandactasmachineexternalstructure.Theproductionareaconsistsofarotarydrilledcontainer(DrilledCup)thatcontainsandmixestheproduct.Assuch,thiscontainstheprocessair,whichduringthedryingprocedurecrossestheproductbypassingthroughtheCup'sholes,separatestheareawheretheprocesstakescefromtheareainwhichthemechanicsarehousedandcollectsthewaterysolutionwithwhichthewashcycleiscarriedout,conveyingitthroughadrain.Thisisaccesedthroughaserisofdoors.密封的容腔在底架里面并靠它支撐著，作為機(jī)器外部構(gòu)造的容腔目的是密閉裝入的產(chǎn)品所在的區(qū)域。產(chǎn)品區(qū)域包括旋轉(zhuǎn)的有孔包衣鍋來容納和攪拌藥品。就其本身而言,這個容腔結(jié)構(gòu)是密封的，容腔包含進(jìn)氣裝置,氣體通過有孔鍋上的小孔，物料來烘干藥品。用循環(huán)系統(tǒng)收集溶液，通過管道。容腔和各密封門連結(jié)。DrilledCupThetaskftheCupistocontainadmixtheprodcttoecoated.Onepartismadeupofacylinricldrilledsheetandtheotheroftwonon-drilledcoicalcups,ofwhichthefrontoneisopentoformthepan'southwhereastherearoehousesahaftfromwhichittakesitsmotion.ThesealbteentherearpartofteCupthatrotatesandte consistsfasalgaske.Thecontinousmiingofthemassofcores,obainedbytherollingfteCup,distributestecoatingsoluionevelyndhelpsinryingit.ThecoatingprodctisdriedylettingtheairflowthroughtheproductmassandtentroughtheCup'sdrilledwall.SomeflapsreresentisidetheCup,whichreweledtothecp'sintrnalurfae,andtheirtaskistoassittemixingofthemassofcores.錐板組成的,前面一個圓錐是開口的，從而形成鍋的開口，而鍋后面通過傳動軸帶動鍋轉(zhuǎn)可以使得包衣液和藥品充分?jǐn)嚢韬瓦B續(xù)混合，還可以用它來干燥。大量氣流穿過大量包衣藥品，然后再穿出有孔包衣鍋，焊接在有孔鍋內(nèi)內(nèi)表面的一些小攪拌槳葉，是為了促進(jìn)藥品的充分混合。DrilledCupMotorDriveTheCupisrotatedbyanelectricmotor(PanMotor)checkedbyaninverterthattransmitsmotionthroughashaftintegralwiththebackpartoftheDrilledCup.Thepanmotorisfittedwithanelectromagneticbrake,managedaccordingtotheCup'sstartorstoppedstatus,andacoolingfan.Thecharacteristicsoftheelectricmotorsaregiveninthesystem'selectricalprojectation[1].鍋旋轉(zhuǎn)。鍋電機(jī)要有電磁剎車和冷卻風(fēng)扇，實(shí)現(xiàn)鍋的開始和停止?fàn)顟B(tài)。電機(jī)的特性在電氣文件材料[1]中提供。DrilledCupSpeedAdjustmentTherotatingspeedoftheCupisregulateddirectlybythePan'smotormanagedbytheControlSystemviaanInverter.變頻器控制系統(tǒng)控制著鍋電機(jī)，而電機(jī)直接控制著有孔鍋的旋轉(zhuǎn)CupRotationCheckThedrivetransmissiontotheDrilledCupisthroughadrivebeltwhich,ifdamaged,mightnotfunction,eitherpartiallyorcompley.ThecheckoftheeffectiveCuprotationisperformedbya“PanRotationCheckSensor”sensor.動力通過皮帶傳送給有孔鍋，如果皮帶損壞，Theprocess'criticalparametersthatdeterminethemainchecksandadjustmentsaredefinedindoc."FunctionalSpecifications"associatedwiththemachineinquestion.TheDrilledPanhasbeenpre-arrangedforrunningthefollowingchecksandPanSpeed

TheControlSystemdeterminesandrecordstheturningspeedoftheCupthroughthePanMotorspeedadjustmentsignal.MotorOverloadsTheelectricalpowerdevices(MotorsandMotorBrake)canbefittedwithsystemsthatcheckcurrentabsorptiontoavoidForthedefinitionofthedevicesprotectedagainstoverloads,seeelectricalprojectationRef.[1].TheoverloadchecksystemsstopthecheckeddevicesandfeedbackasignalacquiredbytheControlSystem.CupRotation

TheControlsystemcheckstheeffectiverotationoftheDrilledCupthroughthePanRotationCheckSensor.Ifnochangeinthestateoftheacquiredsignalisidentifiedwithinthetimesetinset-up,themachineisstopped.Theoperatoriswarnedbythedisyofanalarmmessage.Referto§3.4SoftwareFunctionalSpecificationsforthecompletedefinitionofthechecks鍋速控制系統(tǒng)決定了鍋的運(yùn)行速度，并通過鍋馬達(dá)速度調(diào)整信電機(jī)超載(電機(jī)和電磁剎車)要與系統(tǒng)匹配，并且仔細(xì)檢查對防止過載的保護(hù)裝置的解釋參考電氣文件[1]信號。檢查鍋的旋轉(zhuǎn)在設(shè)置時間之內(nèi)如果被識別信號的狀態(tài)沒有變化,機(jī)器停參考§3.4CoreTemperatureMeasuring片芯溫度測 ThetaskoftheTemperatureMeasuringistodetectthetemperatureofthemassofcoresinsidetheDrilledCupduringthecoatingprocess.ThesensorislocatedinsidetheanddetectstheairtemperatureafterithascrossedtheMassofCoresandthewalloftheDrilledCup.TheairtemperaturedetectedrightaftertheairhascrossedtheMassofCoresmaybeconsideredthetemperatureofthecores.片芯溫度測量是在包衣過檢查有孔鍋里面物料的溫度。位于排風(fēng)口接近鍋體測的傳感器檢查接近藥品和有孔鍋內(nèi)壁之后的空氣溫度。正確測量空氣溫度的時機(jī)是在空氣穿過大量藥品之后，考慮到藥品的溫度。Theprocess'criticalparametersthatdeterminethemainchecksandadjustmentsaredefinedindoc."FunctionalSpecifications"associatedwiththemachineinquestion.TheDrilledPanhasbeenpre-arrangedforrunningthefollowingchecksandadjustments:程序的關(guān)鍵參數(shù)決定了主要的檢查和調(diào)整，在談及機(jī)器相關(guān)的文檔“功能介紹”中有CoreTemperatureAcquisition片芯溫

TheSensorthatMeasurestheAirTemperatureatOutletsasignalaccordingtothedetectedtemperature.TheControlSystemacquiresthesignalandrecordsthetemperaturevalue.測量空氣溫度的傳感器根據(jù)檢測到的溫度向外輸出Referto§3.4SoftwareFunctionalSpecificationsforthecompletedefinitionofthechecksandadjustments.§3.4軟件功能說明有關(guān)于檢查和調(diào)整的詳細(xì)說明。SafetiesandProtections安全與保 Inordertoguaranteetheoperator's alsafetyandthemachine'sfunctionalsafetyduringalltheoperatingandmaintenancephases,themachinehasbeenequippedwithaccidentpreventionsystems.為了保證在操作和過操作者的安全和機(jī)器功能的安全，機(jī)SafetyGuardsThemacie'sprodctiveareaandtheelectrcalandmechanicalpwerdevicesareprotetedbyappropriteguardsthetaskofwhichistoprevntanycontactwiththeperator.機(jī)器的生產(chǎn)區(qū)域和電力與機(jī)械動力裝置都被護(hù)罩很好得保護(hù)起來，它們阻擋著操作者與機(jī)器內(nèi)部的接觸。AccessdoorsThePan'sCupisfittedwithafrontdoorwhereasthehastwosidedoorsandonefrontAdoorfittedwithaninspectionwindowshutsthefrontaccesstothePanCup.Thepaticsealgasketsarelocatedbothonthedoorandinthewindow.Thefrontaccessdoorisusedforvisualinspections(throughthewindow),forsamplingtheproductandforalltheoperationsthatentailcleaningandadjustingthecomponentspresentinsidetheCup.Moreover,saiddoorisintegralwiththeSprayGunsSupportArm.Theaccessdoorstothecontainerareusedforinspectingandcleaningthecomponentsthatareinsidetheandarefittedwithpaticsealgaskets.鍋配有前門，容腔有兩個側(cè)，前門配有檢查窗口擋住了鍋的前面杯狀部分。門和窗戶上配有密封墊圈。用前面的檢修門（通過窗戶）可直觀得檢查產(chǎn)品的取樣和鍋內(nèi)正在組件的所有操作。此外,前門帶有完整的噴撐臂。容腔的檢修門被用來檢查和容腔里面的各組件和密封圈DoorSafetyTheinspectionwindowischeckedviaapositionswitchwhereasthePanCup'saccessdoor,whichisintegralwiththeGunsSupportArm,ischeckedbyasensorthatchecksforthepositionofthearmitself.Theinspectionwindowandtheaccessdoorcanonlybeopenedaftertherelativepaticsealgasketshavebeendeflated.Ifthedoorisopenedduringtheproductioncycle,themachinemightstopimmediayregardlessofitscurrentoperatingstage,theairflowthatcrossestheRotaryCupmightkeepblowing,"zing"atthevaluesthatexistedbeforethedoorwasopened,toguaranteeitremainsdepressurizedandpreventsairfromleakingfromthedoor.Themachine'sControlSystemdisysanalarmmessageontheUserInterfacescreen.Positionswitchescheckthe'ssidedoorsandthefrontAlldoorsandotheraccessesareopenedmanually.檢查窗口通過位置開關(guān)檢查，該傳感器與噴撐臂集成，用于檢查噴撐臂自身的位置。打開,機(jī)器可能立即停機(jī)而不按照原來的步驟,氣流可能會穿過旋轉(zhuǎn)容腔保持吹氣,在打開門之前閥中的參數(shù)被凍結(jié),來防止空氣從門。機(jī)器的控制系統(tǒng)會在顯示屏上DisablingInspectionWindowSafetyDeviceThedeflationofthepandoorandinspectionwindowgasketsisnormallypreventedbyinterlocksontherespectiveactuations.Toallowproductsamplingduringtheprocessthereisatwo-positionkey-selector(SafetyDeviceDisablingSelector)throughwhichthegasketdeflationcanbeenabledwiththeconsequentopeningofthewindowwithoutinterruptingtheproduction.Theoperatoriswarnedwithwarninglightsand/oracousticsignalsduringtheenablingofthisfunction.泄氣的鍋門和可視窗口的密封圈通常由各動器上的互鎖裝置保護(hù)。在生產(chǎn)過允許產(chǎn)品取樣，由一個兩位選擇開關(guān)(安全裝置失效選擇器)通過密封圈泄氣可以打開門而不會中斷EmergencyOneormoremushroom-shapedbuttons(withmechanicallocking)areinstalledonthePanfortheemergencystopsandarelocatedintheoperatingareasthattheoperatormayaccessIndicationsregardingwheretheemergencybuttonsareinstalledareoutlinedinthesystem'selectricdesignation[1].Forthedefinitionoftheemergencystopfunctions,seedoc."FunctionalSpecifications"associatedwiththemachineinquestion§"SafetiesandProtections".一個或的蘑菇型按關(guān)于急停開關(guān)安裝位置的顯示在系統(tǒng)的電氣文件[1]中有所概述。關(guān)于急停功能的介紹，Theprocess'criticalparametersthatdeterminethemainchecksandadjustmentsaredefinedindoc."FunctionalSpecifications"associatedwiththemachineinquestion.TheDrilledPanhasbeenpre-arrangedforrunningthefollowingchecksandadjustments:工藝的關(guān)鍵參數(shù)決定了主要的檢查和調(diào)整，在談及機(jī)器相關(guān)的文檔“功能介紹”中有CheckforPanWindowClosingSafetyDevice檢查

Theclosedwindow[Ref.§.1]isarequredconditionforrunningtheworkcycle.Thego-aheadsignalforstartingthecycleisissuedbyapositionenorthatindicateswhentewindowisclosedinactalfact.[§.1]是機(jī)器旋轉(zhuǎn)前一個必需的條件，一個位置傳感器指示當(dāng)窗戶目前確實(shí)關(guān)閉時，會發(fā)出一個確認(rèn)信號來啟動機(jī)器旋轉(zhuǎn)。SafetyDeviceDisablingkey

Selectorinposition選擇Selector

Thedeflationoftheinspectionwindowgasketisallowed.TheopeningofthepanwindowdoesNOTcausetheterminationoftheprocessinginprogress.當(dāng)允許檢查窗口密封圈泄氣ThedeflationoftheinspectionwindowgasketisNOTallowedthusthewindowcannotbeopened.不允許密封圈泄氣，打CheckforDoorsClosingSafetyDevice檢查容腔側(cè)CheckforEmergencybuttons

Positionswitchescheckthe'sdoors.TheControlSystemchecksthestatusofthedoorsanddoesnotallowthesystemtorunifanydoorisnotclosedproperly.位置開關(guān)檢查容器的門?？刂葡到y(tǒng)檢查門的狀態(tài)，如果任意一個門沒有關(guān)ThemachinestopsinsafetyconditionswhenanyEmergencybuttonispressed(electricandpaticsupplyarecutoff).InthiscasetheControlSystemdisysanalarmmessage.當(dāng)按路同時關(guān)閉)，以防控制系統(tǒng)。Referto§3.4SoftwareFunctionalSpecificationsforthecompletedefinitionofthechecksandadjustments.參考§3.4軟件功能說明書有關(guān)于檢查和調(diào)節(jié)的詳細(xì)說明。 aticSealGaskets充氣密封 Theaccessestothe andPanCup[ref.§]areprotectedbydoorsthetightnessofwhichisensuredbyp aticgaskets.Eachp aticgasketisdbycompressedairfromastandalonefeedline.Thefollowingcomponentsareinstalledoneachcompressedairfeedline:門上的充氣密封圈緊緊地保護(hù)著容腔和有孔鍋[§]On/offvalve開/關(guān)閥 istomanagetheinflatinganddeflatingofthePressurereducer減壓 Devicethatmanuallyadjuststhegasket'spressure.Safetyvalve安全 SafetyvalvethetaskofwhichistobleedtheairCheckpressureswitch壓力檢測Pressuresensorthatcheckscompressedairpressureenough.TheoperatordeflatesthePanwindowgasketbypressingabuttononthePan'sControlPanelwhereasthegasketisinflatedautomaticallyonclosingthewindow.Theinflation/deflationofthepaticgasketsonthesideaccessdoorsisactuatedmanuallybytheoperatorwiththeopeningdevice.Duringproductionitisnotpossibletodeflatethedoorgaskets,onlythedeflationoftheinspectionwindowgasketisallowedafterthe“InspectionWindowSafetydeviceDisabling”functionhasbeenactivated[ref§.2].Thedeflationofthewindowgasketcausestheinterruptionofthesprayduringproductionandthestopofwaterinflowduringwashing.當(dāng)操作者通過控制面板上的按鈕對鍋門密封圈減壓時，然而密封圈會在關(guān)門時自動增壓。操作者用打開裝置手動對側(cè)門的氣動密封圈，手動進(jìn)行增壓或泄壓。在生產(chǎn)過不可能對密封圈減壓,在“檢查窗口安全裝置失效”功能起作用之后[參考§在生產(chǎn)過窗口密封圈減壓會引起噴霧的中斷，在過窗口密封圈減壓會引CompressedAirSystemTheairforinflatingthesealgasketsisdbythesystem'scompressedairsystem§"RequiredUtilities"doc."FunctionalSpecifications"associatedwiththemachineinquestion].Thecompressedair'sspecsareoutlinedintheTechnicalLayoutoftheCoreCoatingSystem,ref.[3].壓縮空氣系統(tǒng)提供給密封圈充氣來實(shí)現(xiàn)增壓。[§"必選裝置"在機(jī)器涉及的[3]Theprocess'criticalparametersthatdeterminethemainchecksandadjustmentsaredefinedindoc."FunctionalSpecifications"associatedwiththemachineinquestion.The aticSealGasketsSystemisprearrangedforthefollowingchecksand工藝的關(guān)鍵參數(shù)決定了主要的檢查和調(diào)整，在談及機(jī)器相關(guān)的文檔“功能介紹”中有PresenceofAirPressureatthePaticGaskets充CheckforCompressedAirPresenceatthePaticSe