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MediaPreparationFunctionalSpecificationofPCSofBioengineeringParkUnit3100 RevisionHistory修訂歷RevisedThefirst Scope范 s關(guān)聯(lián)文 ListofReferences參考文件..................................................................................SYSTEMCONTROLFUNCTION系統(tǒng)控制功 CIPROUTECIP路徑定 STATUSEDEFINE狀態(tài)定 CIPstationCOMM Mediapreparation培養(yǎng)基配制 EM01:MP_.............................................................................................................................GeneralDescription通用描 P&IDiagram功能 CMTable控制模塊 ParametersTable參數(shù) FlowChart流程 EM02: GeneralDescription通用描 P&IDiagram功能 CMTable控制模塊 ParametersTable參數(shù) FlowChart流程 EM03: GeneralDescription通用描 P&IDiagram功能 CMTable控制模塊 ParametersTable參數(shù) FlowChart流程 EM04:MP_FD_TRANS_ONE(one GeneralDescription通用描 P&IDiagram功能 CMTable控制模塊 ParametersTable參數(shù) FlowChart流程 EM05:MP_FD_TRANS_TWO(two GeneralDescription通用描 P&IDiagram功能 CMTable控制模塊 ParametersTable參數(shù) FlowChart流程 EM06: GeneralDescription通用描 P&IDiagram功能 CMTable控制模塊 ParametersTable參數(shù) FlowChart流程 EM08: GeneralDescription通用描 CMTable控制模塊 ParametersTable參數(shù) FlowChart流程 EM09: GeneralDescription通用描 CMTable控制模塊 ParametersTable參數(shù) FlowChart流程 EM10: GeneralDescription通用描 P&IDiagram功能 CMTable控制模塊 ParametersTable參數(shù) FlowChart流程 EM11:MP_T3001_..................................................................................................GeneralDescription通用描 P&IDiagram功能 CMTable控制模塊 ParametersTable參數(shù) FlowChart流程 PublicModuleDescription公共模塊說 KEEP_P_MANAGE保壓控制塊的管 Reviewand起草Draftedby起草部職日Austar-調(diào)試工年月審核Reviewedby審核部職日Austar-驗(yàn)證工年月工程工程部工程年月生產(chǎn)車間生產(chǎn)線年月設(shè)備設(shè)備自控工程年月QA工程年月QA驗(yàn)證工程年月批準(zhǔn)Approvedby批準(zhǔn)部職日QA質(zhì)量副總年月INTRODUCTION介ScopeThisdefinesthecontrolstrategytomeetmediapreparationsectioncontrolrequirementofPCSofQILUBio-engineeringParkUnit3100.Relateds關(guān)聯(lián)文ThisFunctionalSpecificationhasbeenwrittentomeettheguidanceonFunctionSpecificationofcomputerizedsystemcontainedinGAMPGPGARisk-BasedApproachtoGXPProcessControlGAMP良好實(shí)踐指南-GxPGMP計(jì)ListofReferences參考文ThefollowingsarereferencedinthissUserRequirementV-PCS-QualityandProjectFunctionalSYSTEMCONTROLFUNCTION系統(tǒng)控制功CIPROUTECIP路徑定Accordingtodifferentcleaningtarget,thevalvesofCIPwatersupplyandreturnlooparedefinedas針對(duì)不同的目標(biāo),將所用到的公共CIP供水及回流管的閥門進(jìn)行路徑定義 _1Route1234R_R_R_R_1R2R3R4R5R6R7R8R9TTRRRRTT 1Route5678R_T_R1R2R3R4R5R6R7R8R9TTRRRRTT 1Route9R_RR_RR_RR_R1R2R3R4R5R6R7R8R9TTRRRRTT 1RouteRRR7R41R2R3R4R5R6R7R8R9TTRRRRTT 1RouteRRR7R41R2R3R4R5R6R7R8R9TTRRRRTT 1RouteRRR1R1R2R3R4R5R6R7R8R9TTRRRRTT 1RouteRR1R6R51R2R3R4R5R6R7R8R9TTRRRRTT 1RouteR3R21R2R3R4R5R6R7R8R9TTRRRRTTSTATUSEDEFINEAccordingtodifferenttarget,statusesaredefinedas)1檢修、1檢修、1122223333444455556666CIPstationCOMM AccordingtoCIPstation,COMMaredefinedasPCS→123暫停命令;0無,1停4中斷命令;0無,1CIP5介質(zhì)輸送允許;0無,167回流泵允許;0無,18當(dāng)前罐液位,管道時(shí)此值為9模式;01CIP5秒不變化5共計(jì)80個(gè)標(biāo)記位,每位代表一個(gè)點(diǎn)終淋電導(dǎo)測(cè)試使能;01CIP站計(jì)時(shí)使能;01CIP→1CIP站是否能夠使用(可用狀態(tài):無重要、處于控制狀態(tài)、沒有運(yùn)行);0無,1234CIP站輸送狀態(tài);0無,1正在輸送液5CIP0無,1結(jié)束;(6CIP站狀態(tài);0無,1存在需操作7CIP站反饋結(jié)果;1電導(dǎo)不合格失敗,2電導(dǎo)合格成功;8堿液罐自酸液罐自Media MediaSFC11.AddWFI2.AddWFI3.AddWFI4.AddWFI5.6.罐體7.sip8.sip9.Keep1.2.3.Defined31.2.Trans3.Trans4(one1.2.Trans至補(bǔ)料罐管路3.Trans4.Keep5(two1.2.Trans至補(bǔ)料罐管路3.Trans4.Keep61.2.Trans3.Trans4.KeepMediaSFC7FILTER1.2.8FILTER1.2.Integrity3.Integrity9(onlyfor 1.(onlyfor 1.罐體2.sip3.sip4.Keep5.6.7.EM01:EQMEQMClass EQM1.AddWFI2.AddWFI3.AddWFI4.AddWFI5.6.7.sip8.sip9.Keep10.11.12.GeneralDescriptionTheEQMclassisusedtocontrolthemediapreparationP&IDiagramADDWFI CIP(examples:R SIP(examples:R CMTableDEVICEDescriptionRRRCIPCIPWFIWFI--WFIT-T-T-PSR-R-R-罐頂R-R-R-R-R-R-R-R-R-罐頂管路分支R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-罐底管路進(jìn)口R-R-R-R-R-R-罐底管路出口R-R-R-R-R-R-R-R-R-R-R-R-DEVICEDescriptionRRRR-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-設(shè)置------面設(shè)置------面設(shè)置------505050222555555123------塊------------------------------------------DEVICEDescriptionRRRDEVICEDescriptionRR2.1CIPCIPWFIWFI--WFIT-T-PSR-R-罐頂R-R-罐頂管路分支R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-罐底管路進(jìn)口R-R-R-R-罐底管路出口R-R-R-R-R-R-R-R-DEVICEDescriptionRRR-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-設(shè)置----面設(shè)置----面設(shè)置----5050225555位定義45----塊------------------------DEVICEDescriptionRR----ParametersTableAddWFI41CIP間5CIP1012030121.52.2sip80sip/0.8sip/0.61051200.20.055550520030段1--5600--0--0--0--0--0--水控制塊0--0--0FlowChartAddWFImanAddtomanuallysetthenumberofWFIbythroughAtadding,naturalbreathing,firstopenthewatervalve,thewaterbalanceislessthanthepulsatingopenpoint,WFIsupplyvalvebeginsaccordingtothepulsatingopeningtimeandofftimeactionuntiladdenoughwater,closethewatervalve,closetheexhaustvalve;(IntheBATCH,beforestartphaseneedtobeaddedOperationTip:WFIcoolingtemperatureisAddAddWFIDCSTO WFITO valveshavebeenWFIisStep4:A1:disableWFI_DOSE,resetrequireWFI,resetWFI_STA;close(delay5s)A2:closeFCV08,FCV12,FCV15A3:releaseA1:acquireStep3:addA1:sendW_SP_MANtoA2:enableWFI_DOSE,setWFI_STAto1Step2:BreatheandA1:closeFCV05,FCV07,FCV13,FCV14,FCV16, _STAtoA2:openFCV12,FCV15,FCV08;sendWFIrequiretoWFIAddWFIpreAddtoprocessinterfaceplusthepre-setofWFIbythroughAtadding,naturalbreathing,firstopenthewatervalve,thewaterbalanceislessthanthepulsatingopenpoint,WFIsupplyvalvebeginsaccordingtothepulsatingopeningtimeandofftimeactionuntiladdenoughwater,closethewatervalve,closetheexhaustvalve;(IntheBATCH,beforestartphaseneedtobeaddedOperationTip:WFIcoolingtemperatureisAddWFIAddWFI DCSTO WFI valveshavebeenWFIisStep4:A1:disableWFI_DOSE,resetrequireWFI,resetWFI_STA;close(delay5s)A2:closeFCV08,FCV12,FCV15A3:releaseStep2:BreatheandA1:closeFCV05,FCV07,FCV13,FCV14,FCV16; _STAtoA2:openFCV12,FCV15,FCV08;sendWFIrequiretoWFIstationA1:acquireStep3:addA1:sendWFI_PREtoWFI_A_VALUE;A2:enableWFI_DOSE,setWFI_STAto1;AddWFInearAddtoprocessinterfaceplusthenear-setofWFIbysprayAtadding,closebreathing,firstopenthewatervalve,thewaterbalanceislessthanthepulsatingopenpoint,WFIsupplyvalvebeginsaccordingtothepulsatingopeningtimeandofftimeactionuntiladdenoughwater,closethewatervalve;(IntheBATCH,beforestartphaseneedtobeaddedOperationTip:Finishedfeeding,feedingportisoff;WFIcoolingtemperatureisconfirmed);(BATCH中,步前需加操作提示:投料完畢,投料口是否已關(guān)閉;WFI溫度是否滿足工藝要AddWFIDCSTO WFITO valveshavebeenWFIisStep4:A1:disableWFI_DOSE,SPRAY_CONTROL;resetrequireWFI,resetcloseFCV01;open(delay5s)A2:closeFCV07,FCV09,FCV10,FCV11A1:closeA2:openFCV07;sendWFIrequiretoWFIStep3:addA1:sendWFI_NEARtoWFI_A_VALUE;enableA2:enableWFI_DOSE,setWFI_STAto1A1:acquireAddWFIendAddtoprocessinterfaceplustheend-setofWFIbysprayAtadding,close breathing,firstopenthewatervalve,thewaterbalanceislessthanthepulsatingopenpoint,WFIsupplyvalvebeginsaccordingtothepulsatingopeningtimeandofftimeactionuntiladdenoughwater,closethewatervalve;(IntheBATCH,beforestartphaseneedtobeaddedOperationTip:Finishedfeeding,feedingportisoff;WFIcoolingtemperatureisconfirmed);(BATCH中,步前需加操作提示:投料完畢,投料口是否已關(guān)閉;WFI溫度是否滿足工藝要AddWFIDCSTO WFITO valveshavebeenWFIisStep4:A1:disableWFI_DOSE,SPRAY_CONTROL;resetrequireWFI,resetcloseFCV01;open(delay5s)A2:closeFCV07,FCV09,FCV10,FCV11A1:closeA2:openFCV07;sendWFIrequiretoWFIStep3:addA1:sendWFI_ENDtoWFI_A_VALUE;enableA2:enableWFI_DOSE,setWFI_STAto1A1:acquireSpraySpraysettime;sprayvalvessequentiallyturnedonaccordingtotheset(IntheBATCH,beforestartphaseneedtobeaddedOperationTip:WFIcoolingtemperatureisDCSTO WFITO valveshavebeenA1:closeA2:openFCV07;sendWFIrequiretoWFIstation;setTIMER_SP3toWFIisTIMER1isStep4:A1:resetTIMER1;disableSPRAY_CONTROL;resetrequireWFI,resetWFI_STA;closeFCV01;openFCV09,FCV10,FCV11;(delay5s)A2:closeFCV07,FCV09,FCV10,FCV11A1:acquireA1:enableA2:openFCV01;startTIMER1;setWFI_STAto1CIP罐體IntheCIPlogic,theCleaningfluidisprovidedbyCIPstation,toppass-throughvalveandsprayvalveaccordingtothesettimetoopeneachpulsation,pulsationcycle.Aftereachstagetoincreaseafterimmersioncleaningspray,CIPstationinteractwiththeneedtore-setimmersioncleaning ,bottomvalveisclosed,stoppedafterthesetweightintotheCIPcleaningsolution,soakthesetmixingtime,tosoakstirringtimeopenbottomvalve,waterrinsestageissetforanimmersioncycles,afterthecycleiscompletestopCIP. foranadvancedsolutionforallopenagainstirred)在運(yùn)行階段,液由CIP站提供。罐頂直通閥門和噴淋閥按設(shè)定脈動(dòng)時(shí)間逐個(gè)打開,進(jìn)行循環(huán)脈動(dòng)。每階段噴淋后增加浸泡、與CIP站交互,需設(shè)定浸泡罐重,關(guān)閉罐底閥后,達(dá)到設(shè)定重量后停止進(jìn)CIP液,設(shè)定浸泡攪拌時(shí)間,達(dá)到浸泡攪拌時(shí)間后開罐底閥,水沖洗階段需設(shè)定浸泡循環(huán)次數(shù),循環(huán)完畢后停止CIP。Step17Step17CIPA1MessageSUCCESS,_STAtoA2resetP_REQUEST_ORDER,P_CIP_START_ORDER,PUMP_AIR_SUPPLY-ORDER,_STAVALVES&CIPVG&CIPStation&STIRhavebeenStep3CIPA1setP_REQUEST_ORDER,P_CIP_START_ORDER,P_CIP-PUMP_AIR_SUPPLY-ORDER,P_CIP-EN_TIMER;resetenable UP_PUSL;StartSTIR01;setCIP_P_9Step5MEDIUMA1CloseFCV16,resetP_CIP-ResetP_CIP-setACTIONNUMBERtoStep11MEDIUMA1CloseFCV16,resetP_CIP_RETURNPUMP_ORDER;setP_CIP_PUMP_AIR_SUPPLY_ORDER;setACTIONNUMBERtoActualactionnumberResetP_CIP_EN_TIMERStep9A1setTIMER_SP13A2openFCV21,FCV24;setDRAIN_CTRL;starTIMER2;setP_CIP_PAUSE_ORDERStep12A1setTIMER_SP11toA2startTIMER1,openFCV12,FCV15;(delay3s)closeTIMER1TIMER1WT01<W_L_STIR&CYCLESACTIONNUMBER<>Actualactionnumber&ActualactionnumberNOTStep19A1ReleaseFCV02~FCV24;releaseCIPPVGandCIPstationandStep18CIPA1resetP_REQUEST_ORDER,P_CIP_START_ORDER,PUMP_AIR_SUPPLY-ORDER,P_CIP_EN_Conductivity;A2MessageoperatorFAILStep16CIPA1disable UP_PUSLA2closeFCV02~FCV24,setCIPVGtocloserouteStep15SYSTEMA1StopSTIR01;resetStep14A1setStep10A1ResetA2closeStep7A1openresetresetsetP_CIP_RETURNPUMP_ORDER;SetP_CIP-EN_TIMER;Step6A1setTIMER_SP11tosetA2startTIMER1,openFCV12,FCV15(delay3s)closeFCV12,FCV15Step8Step13A1openFCV16;resetenableCYCLES_CACU;setA2disableStep4Step2VALVEA1closeFCV02,FCV04,FCV06,FCV12,FCV13,FCV14,FCV15,FCV17,FCV20,FCV21,FCV23,FCV24;A2openFCV03,FCV05,FCV07,FCV08,FCV16,FCV18,FCV19,FCV22;setCIPVGtoCIPVG_ROUTE;setCYCLEStosendCIP_TYPEtoP_CIP_PROG_TYPE,CIPVG_ROUTEtoStep1A1acquireFCV02~FCV24andCIPVGandCIPStation,SIPWHOLE罐體整體滅菌InIntheSIPlogic,theclean injectionintothevesseltoheating.Thevesseltemperature,theventfilterdraintemperature,thevesseldraintemperaturewillbemonitored,whenthesethreetemperatureatthesametimetoreachedsterilizationtemperatureforaperiodtime,thenthesterilizationissuccessful.Ifanytemperatureislowerthesterilizationtemperature,thenthesterilizationtimerisstop,untilthetemperatureisok,thesterilizationtimerisresetandrestart.3個(gè)溫度同時(shí)達(dá)到滅菌溫度且持續(xù)一段時(shí)間后,才認(rèn)為滅菌成功。在滅菌過程中,如果任何一個(gè)溫Firstlyrespiratortopurgethewaterfilm,andthensterilizedbyheating;Sterilizationheatingstage, bottomvalveandexhaustvalveopensuntilitreachesthesettemperature;aftersterilizationtime,pure forthe valveinthe pressureorhigherthanthehighestreferencetemperature(threelowesttemperaturevalue)ishigherthanthetemperatureoffvalvecapclosed,thereferencetemperatureislessthanthelowerlimitofthetemperatureofthevalveopeningopen;Afterthesterilizationprocess,closethetrapdischargerespirator,hydrophobicbottomremainsopen;openthecompressedairvalve,bottomdischargeopeningonly10seconds;whenthebodytemperaturedropsopenjacketcoolanttemperaturepoint,indicatingoperativesjacketcoolingoperation;waitforthetemperaturetocooldownagainwhenthetemperatureoftheendpoint,enablethefunctionofbreathe,closedmouthaftercleaningthe bottomand bottomdrainvalvedischargerefrigerantprompttheoperatortoclosethejacket,end.Referringto pressureandtemperaturetakefullhighlimitalarm;SIPfailureneed10秒;當(dāng)罐體溫度降到開啟夾套冷媒溫度valveshavebeenTIMER1TCT02OrTIMER1isTCT01&TCT02&OrTIMER1isTCT01orTCT02orTIMER2isTIMER1isTCT01&TCT02OrTIMER1isOperatorStep11:CLOSEA1:closeFCV13,FCV19,FCV21,FCV23setPA_STAto0;messageOPERTORclosejack_cool;A2:openFCV12;TCT02A1:messageSIPSUCCESS _STAto5;openFCV12,FCV15A2:resetPA_STA;releaseFCV02~FCV24Step10:JACKA1:messageOPERTORcanopenStep7:DRAINA1:stopTIMER1&TIMER2andresetdisablePS_CONTROL,disableEN_alarm_TA2:closeFCV02,FCV03,FCV14setPS_STAtoA3:openFCV13,FCV24,setPA_STAto1;(delay10s)A4:closeA1:stopTIMER1&TIMER2disablePS_CONTROL,disableEN_alarm_T;A2:closeFCV02,FCV03,FCV14,FCV23,setPS_STAtoA3:messageoperatorSIPStep16:resetTIMER2A1:stopTIMER2andresetTIMER2Step6:SIPA1:startTIMER2,enableA1:closeFCV04,FCV06,FCV17,FCV20,FCV22;setTIMER_SP1toTIMER1;setTIMER_SP2toTIMER2;A2:openA3:setPS_STAto1,enablePS_CONTROL,startStep2:BLOWA1:closeFCV12;setTIMER_SP12toA2:openFCV13,FCV14,FCV15;startStep3:CLOSEA1:closeFCV13;resetA2:openA1:resetTIMER1&TIMER2A1:abortcurrentStep5:CLOSEDRAINandEXHAUSTA1:closeFCV24,FCV12A1:acquireSIPPART罐體滅菌不帶呼吸器InIntheSIPlogic,theclean injectionintothevesseltoheating.Thevesseltemperature,thevesseldraintemperaturewillbemonitored,whenthesetwotemperatureatthesametimetoreachedsterilizationtemperatureforaperiodtime,thenthesterilizationissuccessful.Ifanytemperatureislowerthesterilizationtemperature,thenthesterilizationtimerisstop,untilthetemperatureisok,thesterilizationtimerisresetandrestart.在滅菌運(yùn)行階段,純蒸汽進(jìn)入儲(chǔ)罐,開始升溫,2個(gè)溫度同時(shí)達(dá)到Sterilizationheatingstage,vertical bottomvalveopensuntilitreachesthesettemperature;aftersterilizationtime,pure forthe valveinthe pressureorhigherthanthehighestreferencetemperature(twolowesttemperaturevalue)ishigherthanthetemperatureoffvalvecapclosed,thereferencetemperatureislessthanthelowerlimitofthetemperatureofthevalveopeningopen;Afterthesterilizationprocess,closethetrapdischargerespirator,hydrophobicbottomremainsopen;openthecompressedairvalve,bottomdischargeopeningonly10seconds;whenthebodytemperaturedropsopenjacketcoolanttemperaturepoint,indicatingoperativesjacketcoolingoperation;waitforthetemperaturetocooldownagainwhenthetemperatureoftheendpoint,enablethefunctionofbreathe,closedmouthaftercleaningthe bottomand bottomdrainvalvedischargerefrigerantprompttheoperatortoclosethejacket,end.Referringto pressureandtemperaturetakefullhighlimitalarm;SIPfailureneed10秒;當(dāng)罐體溫度valveshavebeenTCT02OrTIMER1isTCT02&TCT03OrTIMER1isTCT02orTCT03TCT02&OrTIMER1isTIMER2is TIMER1isOperator A1:resetTIMER1TIMER2A2:abortcurrentStep10:REACHA1:closeFCV13,FCV19,FCV21,FCV23setPA_STAto0;messageOPERTORclosejack_cool;A2:openFCV12;TCT02A1:messageSIP _STAtoA2:resetPA_STA;releaseStep9:JACKA1:messageOPERTORcanopenStep5:CLOSEA1:resetTIMER1&TIMER2disablePS_CONTROL,disableEN_alarm_T;A2:closeFCV02,FCV03,setPS_STAto0A3:openFCV13,FCV15,FCV24,setPA_STA1;(delay10s)A4:closeFCV24;Step15:resetTIMER2A1stopTIMER2andresetTIMER2Step4:SIPA1startTIMER2,enableA1closeFCV04,FCV06,FCV12~FCV15,FCV17,FCV20,FCV22;setTIMER_SP1toTIMER1;setTIMER_SP2toTIMER2;A2:openFCV03,FCV05,FCV07,FCV08,FCV09,FCV10,FCV11,FCV16,FCV18,FCV19,FCV21,FCV23,FCV24;A3:setPS_STAto1,enablePS_CONTROL,startStep13:SIPA1:stopTIMER1&TIMER2disablePS_CONTROL,disableEN_alarm_TA2:closeFCV02,FCV03,FCV23,setPS_STAtoA3:messageSIPStep3:CLOSEDRAINandA1:closeA1:acquireKeepPressureOpenthecompressedairvalvetostartuptiming;withinthetimerpressurereachesup_limit,thetimerisreset,closingallvalves,startsteadytiming,timerisover,steady_pressurenormalend;startkeeptiming,timerisover,keep_pressurenormalend;Iftheupstage,thetimerisover,suggestingfailure,directend;Ifthesteadystage,thepressuredowntothelowerlimit,suggestingfailure,directend;Ifthekeepstage,thepressuredowntothelowerlimit,suggestingfailure,directend;Opentheexhaustattheend,relief;KeepvalveshavebeenPCT01TIMER1isPCT01<TIMER2isPCT01<TIMER1isStep7:OKANDA1:resetTIMER1;set _STAto4;A2:messageKEEPpressureresultisOK,Step8:FAILEANDA1:resetA2:messageKEEPpressureresultisStep9:A1:openA2:releaseStep6:FAILEANDA1:resetA2:messageKEEPpressureresultisA1:resetTIMER2;setTIMER_SP10toA2:enableA3:startTIMER1,disableStep4:KEEPA1:closeFCV13,FCV15;resetPA_STAto0;A2:resetTIMER1;messageUPFAILEStep2:PAA1:closeFCV07,FCV08,FCV12,FCV14,FCV16;setTIMER_SP6toA2:openFCV15,FCV13;setPA_STAto1;startA1:closeFCV13,FCV15;resetPA_STAto0;resetTIMER1;setTIMER_SP7toTIMER2;A2:enableBASE_PT1;A3:startTIMER2,disabledrain罐體排空Openthebottomofthe 'sdrain,afterthe weightislessthantheemptyinglimitvalue,delayoffdrain,maintainthenaturalbreathingstate;valveshavebeenStep2:A1:closeFCV13,FCV14,FCV17,FCV20,FCV22,FCV23;set _STAto2;A2:openFCV12,FCV15,FCV16,FCV18,FCV19,FCV21,FCV24WCT01<TIMER1isA1:resetTIMER1;closeA2:releaseStep3:PIPEA1:SetTIMER_SP8toA2:startA1:acquireDRY罐體吹干Afteropeningthe bottomdrainvalve,openthekeeppressuremode,starttimer,timerisover,closethedrainvalves,the naturallybreathe;valveshavebeenTIMER1isStep4:A1:releaseA1:disablePA_KEEP_P;resetPA_STAto0;resetTIMER1A2:closeFCV13,FCV16,FCV18,FCV19,FCV21,FCV24;A3:openA1:closeFCV07,FCV08,FCV14,FCV17,FCV20,FCV22,FCV23;setTIMER_SP9toA2:openFCV15,FCV16,FCV18,FCV19,FCV21,FCV24;enablePA_KEEP_P;setPA_STAto1;startA1:acquirebreathe罐體自然呼吸isthenaturalbreathingstate; A1:acquirevalveshavebeenStep2:Step2:A1:closeFCV13,FCV14;A2:openA3:releaseABORTINGitisdeterminedwhethertheCIPmode,ifso,tostopCIPstation;ifnot,thenJudgmenttemperature,higherthesetvaluestartjacketcoolingtemperature,turnoffthe inletandhydrophobicventvalve,openthebottomofthedrain,afterthepressureislessthantheupperlimitofkeep_pressure,coolinguntilthetemperatureisbelowthesetvaluestartjacketcoolingtemperature;alloftheintermediatestateisinitialized,closeotheroccupiedvalve,retainnaturalbreathing;Iftheoriginalstateisinthe leakdetectionqualified,interruptfunctionwillleadtostatetothehasbeencleaned;Iftheoriginalstateofthe isinoperation,theinterruptfunctionwillcausethe statetorepairandmaintenance;CIPCIP站;如果不是,判斷溫度,溫度高于啟動(dòng)夾套降溫 CIPstationhavenotbeenCIPstationhaveNOTStep2:RELEASECIPA1:ReleaseCIPstation,resetTCT02<=TCT02>_STA_STA_STA<>4_STA _STAtoA1:Step7STATUSEStep5:PAA1:openFCV13,enableA2:openStep4:DRAINA1:disablePS_CONTROL,EN_alarm_T;resetA2:closeFCV02,FCVV03,FCV14,FCV23,setPS_STAtoA3:openStep1:ABORTCIPA1:setP_CIP_ABORT_ORDER;stopSTIR01;resetA2:resetP_CIP_REQUEST_ORDERP_CIP_EN_ConductivityStep10:CLOSEA1:resetTIMER1andTIMER2;setPS_STA,WFI-STA,PA_STAtodisableEN_alarm_T;disableWFI_DOSE,CIP_ A2:setCIPVGtocloseroute,closeFCV01~FCV11,FCV13,FCV14,FCV16~24;openFCV12,FCV15A3:releaseCIPVG,releaseFCV01~FCV24,resetP_CIP_PAUSE_ORDER&CIP_ Step8:STATUSEA1:_STAtoPAUSINGAccordingtothestateofpause,andclosingthecorrespondingsuspendopenedair,water,inletvalveandCIPstations;inaddition,thesuspendedstateinterlockingwatercontrolblock,cleaningpulsationblock, controlblocktemporarilycontrolvalves,pressurecontrolblockmaintaincontrol.(Inadditiontomanualoperationoutside,cip_p_alarmsignalCIPstationalsoactivatesthepause根據(jù)暫停時(shí)的狀態(tài),關(guān)閉相應(yīng)被打開的空氣、水、蒸汽進(jìn)口閥和CIP站的暫停;另外,暫停狀態(tài)聯(lián)NOTNOTStep1:CLOSEA1:disablePS_CONTROLA2:closeFCV02NOTCIP_stationnotbeennhasbeenStep3:CLOSEA1:closeNOTA1:stopStep7:PAUSCIPA1:setA2:messageCIPStep5:CLOSEA1:disableWFI_DOSEA2:closeFCV01RESTOREDependingonthestateofpause,opentheclosedair,water,inletvalveandCIPrecoverystation;inaddition,theremovalofthesuspendedstateinterlockcontrolblockwater,cleaningpulsationblock,vaporcontrolblock.根據(jù)暫停時(shí)的狀態(tài),打開相應(yīng)被關(guān)閉的空氣、水、蒸汽進(jìn)口閥和CIP站的恢復(fù);另外,去除暫停狀 NOTNOTA2:openFCV02A2:openFCV01NOTnotbeenA1:opennhasbeenNOTA1:startA1:resetEM02:EQMEQMClassEQM1.2.3.DefinedGeneralDescriptionTheEQMclassisusedtocontroltheSTIRofP&IDiagramCMTableRRRRRR05-R04-R03-R02-R01-R05-R04-R03-R02-R01-RRRRRParametersTableStart/Dfined10010FlowChartStopaborting)停止(中斷Switchingtoautomaticmode,sendingstopsignal;interruptalsoperformsstopoperation;(Exceptstophumanoperator,undertheloweroftheweightwilldirectlyinterlockstop);A1:stopA2:setSTIRmodetoStep1:MODEA1:setSTIRmodetoStartChangworkmodeofstirtoautomode,sendoutstartA1:setRPMtoRPM_SPA2:startSTIRStep1:MODEA1:setSTIRmodetoDefinedperiodSwitchingmodetoautomatically,transstartsignal,startthetimer,timerisover,stopstir.whentimerisrunning,stirisinterlockedtostoped,thentheprogramisendbyautomatically;STIRSTIRTIMERisOrNOTStep4:resetTIMERA1:resetTIMERA2:stopSTIRA3:setSTIRmodetoA1:setTIMER1_SPtoA2:startA1:setRPMtoRPM_SPA2:startSTIRStep1:MODEA1:setSTIRmodetoEM03:EQMEQMClassEQM1.2.Trans3.TransGeneralDescriptionTheEQMclassisusedtocontrolthetransfunctionbetweenmedia P&IDiagramTRANS TRANSCIP — TRANSSIP CMTableDEVICEDescription---2.1CIPR-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-------DEVICEDescription---R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-DEVICEDescription---R-R-R-內(nèi)------后------有1有111義------------塊------DEVICEDescription--2.1CIPR-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-DEVICEDescription--R-R-R-R-R-R-R-R-R-R-R-R-----R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-DEVICEDescription--R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-R-內(nèi)----后----有1有00義98--------塊----ParametersTable0.80.7200Trans1Trans120Trans30Trans121.5Trans10Trans10Trans限Trans1--0--0--0--0--0--0--0--0--0--0FlowChartTrans setpacking,usetheinnertubepressuredifferencebetweenthetwowillbetransportedfromthefeedliquidtransfer tothereceiving ,thenormaltransfermaterialfor1minutetoenablemassbalancemonitoring;waitsturnfedtothetransferwhentheemptyweightoftheset,toeliminatemassbalancemonitoring,begantoturnfeedATC;tosetthetime,closeallvalves,theendofthetransfermaterial; 1_STA==5 & 2_STA==5 &(PIPES_STA==5orvalveshavebeenWCT01<TIMER1isA3:openFCV08,FCV11 1_STAto2,PIPES_STAA4:release1,1;resetA1:resetTIMER1;disablePA_KEEP_A2:closeStep4:EMPTYA1:startTIMER1;disableStep2:PREA1:closeA2:openA3:enable 1;set 1 1_STAto 2_STAto6,PIPES_STAtoStep3:TRANSA1:openFCV12,setTRANS_STAto1;(delay1M)A2:enableEN_ADD_WCT04,A3:disableEN_ADD_WCT04;enableA1:acquireA2:setTIMER_SP3toTransCIPIntheoperationalphaseofcleaning,thecleaningsolutionisprovidedbyCIPWhenpurgingaction,pulsatingopenjarsbeforetheendofthedischarge;dischargeoperationwhenthesystembeforeopeningjarsbottomdischarge;Afteradjustingtopvalvepurgevalve,duetowaterinjectionandpipelineoperationswillbeaddedatthesametime,theuseofpre-startfunctionpipelineoperationtoclosethevalve,thenreleasethecontrol,duetotheinjectionofwatertoaddfunctionality;在運(yùn)行階段,液由CIP站提供TransvalvesandCIPVGandstationhavebeenCIP_P_ActualactionnumberActualactionnumberActualactionnumberNOTOPERATORA4:releaseFCV36~FCV42,andCIPVGandCIPStep11:CIPA1:resetP_REQUEST_ORDER,P_CIP_START_ORDERP_CIP-PUMP_AIR_SUPPLY-P_CIP_EN_Conductivity;A2:MessageOperatorFAIL;Step10:CIPA1:MessageSUCCESS;setPIPES_STAtoA2:resetP_REQUEST_ORDER,P_CIP_START_ORDER,P_CIP_EN_ConductivityStep9:CIPA1:setCIPVGtocloseroute;resetA2:closeStep7:JUMPA1:closeA2:resetTIMER2,resetStep6A1:openFCV16,FCV18,FCV21,enableDRAIN_CONTROLA2:setSP6toTIMER2,setP_CIP_PAUSE_ORDER;A1:openFCV16,FCV18,FCV21A2:setDRAIN_CTRLStep3:CIPA1:setP_REQUEST_ORDER,P_CIP_START_ORDER,P_CIP-PUMP_AIR_SUPPLY-ORDER,P_CIP_RETURNPUMP_ORDER,P_CIP-EN_TIMERStep2PREA1:closeFCV01,FCV03,FCV04,FCV13,FCV15,FCV16,FCV24,FCV25,FCV27,FCV36,FCV38,FCV40,FCV18~FCV21;A2:releaseFCV04;openFCV02,FCV05,FCV14,FCV17,FCV22,FCV23,FCV26,FCV28,FCV37,FCV39,FCV42A3:sendCIP_TYPEtoP_CIP_PROG_TYPE,CIPVG_ROUTEtoA1:acquireFCV01~FCV05,FCV13~FCV28,FCV36~FCV42,CIPVGandCIPTransSIPIntheoperationalphasesterilization,pure intothepipeline,begantoheatup,monitoringthetoplineofhydrophobicmaterialtemperature,onlywhenthetemperaturewhileachievingthesterilizingtemperatureandforaperiodoftime,sterilizationwasconsideredasuccess.Inthesterilizationprocess,iftemperaturebelowthesterilizationtemperature,sterilizationtimerisstoppeduntilthetemperatureafterpassingtimerreset
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