v-pcsstfsbl00緩沖液存儲(chǔ)生物工程園300單元PCS系統(tǒng)儲(chǔ)存罐區(qū)功能說明

Bufferstorage FunctionalSpecificationofPCSofBioengineeringParkUnit3100生物工程園3100單元PCS系統(tǒng)緩沖液罐區(qū)功能說RevisionHistory修訂歷版修訂內(nèi)Revised修訂日The Scope范 Relateds關(guān)聯(lián)文 ReferenceGuideline參考指 Listof s參考文件.....................................................................................SYSTEMCONTROLFUNCTION系統(tǒng)控制功 CIPROUTECIP路徑定 STATUSEDEFINE狀態(tài)定 CIPstationCOMM CIP站通訊狀態(tài)定 Bufferstorage緩沖液 EM01:BS_...................................................................................................................................GeneralDescription通用描 P&IDiagram功能 CMTable控制模塊 ParametersTable參數(shù) FlowChart流程 EM02:BS_ 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: GeneralDescription通用描 P&IDiagram功能 CMTable控制模塊 ParametersTable參數(shù) FlowChart流程 EM05:BS_TP_TRANS(forT311002012&T311002009 EM06:BS_TP_TRANS(forT311002012&T311002009trans EM07:BS_UYS_TRANS(forT311002012–UYS311001001trans EM08:BS_UF/DF_TRANS(forT311002016&T311002022to EM09: EM10: Reviewand審核與批Draftedby起草部職日Austar-調(diào)試工程年月Reviewedby審核部職日Austar-驗(yàn)證工程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Approvedby批準(zhǔn)部職日QA質(zhì)量副總年月Scope范ThisdefinesthecontrolstrategytomeetbufferstoragecontrolrequirementofPCSofQILUBio-engineeringParkUnit3100.本文件定義的控制策略用于滿足齊魯生物工程園3100單元PCS系統(tǒng)緩沖液罐區(qū)工段控制需Relateds關(guān)聯(lián)文ReferenceGuideline參考指ThisFunctionalSpecificationhasbeenwrittentomeettheguidanceonFunctionSpecificationofcomputerizedsystemcontainedinGAMPGPGARisk-BasedApproachtoGXPProcessControlGAMP良好實(shí)踐指南-GxPGMP計(jì)ListofReferences參考文ThefollowingsarereferencedinthisNo.文s文檔名UserRequirementV-PCS-QualityandProjectFunctionalSYSTEMCONTROLFUNCTION系統(tǒng)控制功CIPROUTECIP路徑定Accordingtodifferentcleaning,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)行路徑定義序閥門Route路_____123456789序閥門Route路_____序閥門Route路_____序閥門Route路_____123456789CIP311001002-序閥門Route路_____CIP311001002-序閥門Route路_____CIPS2序閥門Route路_____123456789CIP311001002-序閥門Route路_____CIPS2序閥門Route路_裝柱123456789CIP311001002-序閥門Route路_裝柱CIP311001002-序閥門Route路_裝柱注釋：每列代表一個(gè)目標(biāo)，綠色標(biāo)識(shí)閥門（最左側(cè)閥門列表）為需打開閥門，無色為需關(guān)閉閥序閥門Route路123456789CIP311001002-序閥門Route路CIP311001002-序閥門Route路序閥門Route路123456789CIP311001002-序閥門Route路CIP311001002-序閥門Route路注釋：每列代表一個(gè)目標(biāo)，綠色標(biāo)識(shí)閥門（最左側(cè)閥門列表）為需打開閥門，無色為需關(guān)閉閥序閥門Route路123456789CIP311001002-序閥門Route路CIP311001002-序閥門Route路注釋：每列代表一個(gè)目標(biāo)，綠色標(biāo)識(shí)閥門（最左側(cè)閥門列表）為需打開閥門，無色為需關(guān)閉閥序閥門Route路123456789CIP311001002-序閥門Route路CIP311001002-序閥門Route路注釋：每列代表一個(gè)目標(biāo)，綠色標(biāo)識(shí)閥門（最左側(cè)閥門列表）為需打開閥門，無色為需關(guān)閉閥STATUSEDEFINE狀態(tài)定Accordingtodifferent,statusesaredefinedas序配料罐狀數(shù)值定儲(chǔ)料罐狀數(shù)值定轉(zhuǎn)料系統(tǒng)狀定）1檢修、1檢修、1完整性測(cè)試合12待清2待清2待清23已清3已清3已清34檢漏合4檢漏合4檢漏合45已滅5已滅5已滅56運(yùn)行6運(yùn)行6運(yùn)行6CIPstationCOMM CIP站通訊狀態(tài)定AccordingtoCIPstation,COMMaredefinedasPCS→序名數(shù)值類注1請(qǐng)求命令；0無，1請(qǐng)求2啟動(dòng)命令；0無，1開始3暫停命令；0無，1泵和壓空停止，計(jì)時(shí)器停4中斷命令；0無，1CIP立即停止5介質(zhì)輸送允許；0無，1泵和壓空使能6PCS存在，CIP無響應(yīng)動(dòng)作7回流泵允許；0無，1回流泵使能8當(dāng)前罐液位，管道時(shí)此值為9模式；0無1234每秒加1CIP站檢測(cè)到此值5秒不變時(shí)，認(rèn)為通訊斷4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；0不能，1允許CIP站計(jì)時(shí)使能；0不能1允許CIP→序名數(shù)值類注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，1可用2CIP站運(yùn)行狀態(tài)；0待機(jī)，1運(yùn)行3CIP站暫停狀態(tài)；0無，1暫4CIP站輸送狀態(tài)；0無，1正在輸送液壓空5CIP站結(jié)束狀態(tài)0無，1結(jié)束；（此信僅維持6CIP站狀態(tài)；0無，1存在需操作檢查7CIP站反饋結(jié)果；1電導(dǎo)不合格失敗電導(dǎo)合格成功8當(dāng)前動(dòng)作無純化水預(yù)沖洗吹掃純化水沖吹堿液沖吹酸液沖吹注射水終吹堿液液位調(diào)堿液配堿液罐自酸液罐自系統(tǒng)排每秒加1PCS檢測(cè)到此值5秒不變化時(shí)認(rèn)為通訊斷Bufferstorage緩沖液Buffer緩沖罐SFC11.罐體2.罐體滅3.Keep罐體充4.罐體排5.罐體吹緊急停止?fàn)顟B(tài)處暫停狀態(tài)處暫?；謴?fù)處21.AddWFI人工定量加注射2AddWFI液位維持加注射3.罐體4.罐體滅5.Keep罐體充6.罐體排7.罐體吹緊急停止?fàn)顟B(tài)處暫停狀態(tài)處暫?；謴?fù)處31.停止(中斷2.啟3.Defined定時(shí)運(yùn)41.至層析轉(zhuǎn)接板轉(zhuǎn)2.Trans至層析轉(zhuǎn)接板管路3.Trans至層析轉(zhuǎn)接板管路滅緊急停止?fàn)顟B(tài)處暫停狀態(tài)處暫?；謴?fù)處5T311002012&T3110020091.至層析轉(zhuǎn)接板和超濾轉(zhuǎn)緊急停止?fàn)顟B(tài)處暫停狀態(tài)處暫停恢復(fù)處6T311002012&T311002009trans1.Trans至層析轉(zhuǎn)接板管路2.Trans至層析轉(zhuǎn)接板管路滅緊急停止?fàn)顟B(tài)處暫停狀態(tài)處暫?；謴?fù)處7trans1.Trans至超濾管路2.Trans至超濾管路滅緊急停止?fàn)顟B(tài)處暫停狀態(tài)處暫停恢復(fù)處8(forT311002016&T311002022to1.至超濾轉(zhuǎn)2.Trans至超濾管路3.Trans至超濾管路滅Buffer緩沖罐SFC緊急停止?fàn)顟B(tài)處暫停狀態(tài)處暫停恢復(fù)處91.至產(chǎn)品儲(chǔ)罐轉(zhuǎn)2.Trans至產(chǎn)品儲(chǔ)罐管路3.Trans至產(chǎn)品儲(chǔ)罐管路滅緊急停止?fàn)顟B(tài)處暫停狀態(tài)處暫停恢復(fù)處1.至裝柱間轉(zhuǎn)2.Trans至裝柱間管路緊急停止?fàn)顟B(tài)處暫停狀態(tài)處暫停恢復(fù)處EM01:EQMEQMClass EQM1.2.3.Keep4.5.GeneralDescription通用描TheEQMclassisusedtocontroltheBuffer 該設(shè)備模塊用于緩沖液罐的控制P&IDiagram功能CIP（examples:T311002020）IPCMTable控制模塊DEVICEDescriptionRef2.1CIPPS罐頂閥前料罐頂罐頂管路分支罐底管路罐底出口前料罐底管路出口罐底出口后料罐底管路出口后罐底管路出口后DEVICEDescription點(diǎn)標(biāo)記位定義塊DEVICEDescriptionRef2.1CIPPS罐頂閥前料罐頂罐頂管路分支罐底管路罐底出口前料罐底管路出口罐底出口后料罐底管路出口后罐底管路出口后DEVICEDescription點(diǎn)標(biāo)記位定義塊DEVICEDescriptionRef2.1CIPPS罐頂閥前料罐頂罐頂管路分支罐底管路罐底出口前料罐底管路出口罐底出口后料罐底管路出口后罐底管路出口后DEVICEDescription點(diǎn)標(biāo)記位定義塊DEVICEDescriptionRef2.1CIPPS罐頂閥前料罐頂罐頂管路分支罐底管路罐底出口前料罐底管路出口罐底出口后料罐底管路出口后罐底管路出口后DEVICEDescription點(diǎn)標(biāo)記位定義塊ParametersTable參數(shù)CIP1CIP5CIP1012030121.52.2800.80.660點(diǎn)間30105300.20.050.0555505CIP浸泡液位上0.2CIP浸泡液位下0.05CIP浸泡次數(shù)（階段156000000動(dòng)作號(hào)（0剩余循環(huán)次數(shù)（于0FlowChart流程CIP罐體IntheCIPlogic,theCleaningfluidisprovidedbyCIPstation, toppass-throughvalveandsprayvalveaccordingtothesetti peneachpulsation,pulsationcycle.Aftereachstagetoincreaseafterimmersioncleaningspray,CIPstationinteractwiththeneedtore-setimmersioncleaning, bottomvalveisclosed,stoppedafterthesetlevelintotheCIPcleaningsolution,soakthesetmixingtime,tosoakstirringtimeopen bottomvalve,waterrinsestageissetforanimmersioncycles,afterthecycleiscompletestopCIP. foranadvancedsolutionforallopenagain在運(yùn)行階段，液由P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)行環(huán)脈動(dòng)。每階段噴后加浸泡與P站，需設(shè)浸泡液，閉罐底后達(dá)到設(shè)定液位后進(jìn)P，設(shè)定泡拌時(shí)間達(dá)浸泡攪時(shí)后開罐閥水沖洗段設(shè)定浸泡P。_STAStep17CIPStep17CIPA1MessageSUCCESS,_STAtoA2resetP_REQUEST_ORDER,P_CIP_START_ORDER,PUMP_AIR_SUPPLY-ORDER,VALVES&CIPVG&CIPStation&STIRhavebeenCIP_P_9Step8TIMER1TIMER1TIMER2LCT01<L_L_STIR&CYCLESACTIONNUMBER<>Actualactionnumber&ActualactionnumberNOTStep19A1ReleaseFCV01~FCV21;releaseCIPPVGandCIPstationandStep18CIPA1resetP_REQUEST_ORDER,P_CIP_START_ORDER,PUMP_AIR_SUPPLY-ORDER,A2MessageoperatorA2closeFCV01~FCV21,setCIPVGtocloserouteUP_PUSLStep16CIPA1disableStep14A1setStep7A1openFCV11;resetTIMER1;StopSTIR01;resetSTIR_STA;resetP_CIP_PAUSE_ORDER;setP_CIP_RETURNPUMP_ORDER;SetP_CIP-EN_TIMER;CloseStep10A1resetA2resetStep6A1setTIMER_SP11tosetP_CIP_PAUSE_ORDER;StartSTIR01;setSTIR_STA;A2startStep9A1setSP16toTIMER2,openFCV18,FCV21;setDRAIN_CTRL;A2Step5MEDIUMA1CloseFCV11,resetP_CIP-setACTIONNUMBERtoResetStep13A1openFCV11;resetTIMER1;StopSTIR01;resetSTIR_STA;enableCYCLES_CACU;setP_CIP_RETURNPUMP_ORDER;A2disableStep12A1setTIMER_SP11toTIMER1;StartSTIR01;setresetP_CIP_PUMP_AIR_SUPPLY_ORDER;A2startTIMER1Step11MEDIUMA1CloseFCV11,resetsetP_CIP_PUMP_AIR_SUPPLY_ORDER;resetP_CIP_EN_TIMERsetACTIONNUMBERtoActualactionnumberStep4Step3CIPA1setP_REQUEST_ORDER,P_CIP_START_ORDER,P_CIP-PUMP_AIR_SUPPLY-ORDER,P_CIP-resetP_CIP_EN_Conductivity;enable UP_PUSLStep2VALVEA1closeFCV01,FCV02,FCV05,FCV07~FCV10,FCV12,FCV15,FCV17,FCV18,FCV20,FCV21;A2openFCV03,FCV04,FCV11,FCV13,FCV14,FCV16,FCV19;setCYCLEStoNUMBER_SP;sendCIP_TYPEtoP_CIP_PROG_TYPE,CIPVG_ROUTEtoP_CIP_SELECTED_ORDER_UNITStep1A1acquireandCIPVGandCIPStep15SYSTEMIPInIntheSIPlogic,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lyrespiratortopurgethewaterfilm,andthensterilizedbyheating;Sterilizationheatingstage, bottomvalveandexhaustvalveopensuntilitreachesthesettemperature;aftersterilizationtime,pure forthe valveinthe pressureorhigherthanthehighestreferencetemperature(threelowesttemperaturevalue)ishigherthanthetemperatureoffvalvecapclosed,thereferencetemperatureislessthanthelowerlimitofthetemperatureofthevalveopeningopen;Afterthesterilizationprocess,closethetrapdischargerespirator, bottomremainsopen;openthecompressedairvalve, bottomdischargeopeningonly10seconds;whenthebodytemperaturedropsopenjacketcoolanttemperaturepoint,indicatingoperativesjacketcoolingoperation;waitforthetemperaturetocooldownagainwhenthetemperatureof point,Buckexhausttodwelllimit,closedmouthaftercleaning bottomand bottomdrainvalvedischargerefrigerantprompttheoperatortoclosethejacket,end.Referringto pressureandtemperaturetakefullhighlimitalarm;SIPfailureneed10秒；當(dāng)罐體溫度降到開啟夾套冷媒溫度罐體壓力和參照溫度全程采取高限位；SIP失敗需要提示Step7:DRAINA1:stopTIMER1&TIMER2andresetdisablePS_CONTROL,disableEN_alarm_T;A2:closeFCV01,setPS_STAtoA3:openFCV08,FCV21,setPA_STA1;(delay10A4:closeFCV21;enableTCT02valveshavebeenvalveshavebeenTIMER1TCT02OrTIMER1isTCT01&TCT02&OrTIMER1isTCT01orTCT02orTIMER2isTIMER1isTCT01&TCT02OrTIMER1isOperatorOperatorA1:closeFCV07;messageSIPSUCCESS; _STAto5;disableEN_alarm_P;A2:resetPA_STA;releaseStep11:CLOSEA1:closeFCV08,FCV14,FCV16,FCV18,FCV20setPA_STAto0;A2:openStep18:JACKA1:messageOPERTORcancloseA1:stopTIMER1&TIMER2disablePS_CONTROL,disableEN_alarm_T;A2:closeFCV01,setPS_STAtoA3:messageoperatorSIPStep16:resetTIMER2A1:stopTIMER2andresetTIMER2Step6:SIPA1:startTIMER2,enableA1:closeFCV01,FCV02,FCV05,FCV12,FCV15,FCV17,FCV19;setTIMER_SP1toTIMER1;setTIMER_SP2toA2:openA3:openFCV01(FCV01baseonA3:setPS_STAto1,enablePS_CONTROL,startStep2:BLOWA1:closeFCV07;setTIMER_SP15toA2:openFCV08,FCV09,FCV10;startStep3:CLOSEA1:closeFCV08;resetA2:openA1:resetTIMER1&TIMER2A1:abortcurrentStep5:CLOSEDRAINandEXHAUSTA1:closeFCV21,FCV07A1:acquireStep10:JACKA1:messageOPERTORcanopenOpenthecompressedairvalvetostartuptiming;withinthetimerpressurereachesup_limit,thetimerisreset,closingallvalves,startsteadytiming,timerisover,steady_pressurenormalend;startkeeptiming,timerisover,keep_pressurenormalend;Iftheupstage,thetimerisover,suggestingfailure,directend;Ifthesteadystage,thepressuredowntothelowerlimit,suggestingfailure,directend;Ifthekeepstage,thepressuredowntothelowerlimit,suggestingfailure,directend;Opentheexhaustat,relief;Step2:PAStep2:PAA1closeFCV01~FCV07,FCV10,FCV12,FCV14~FCV21;setTIMER_SP6toA2openFCV08,FCV09,FCV11,FCV13,;setPA_STAto1;startA1:acquireFCV01~FCV21Keep TIMER1is PCT01< TIMER2isPCT01<TIMER1isStep8:FAILEANDA1:resetStep7:OKANDA1:resetTIMER1;A2:message_STAtoA2:messageKEEPpressureresultisStep11:A1:openFCV07;closeA2:releaseStep6:FAILEANDA1:resetA2:messageKEEPpressureStep4:KEEPA1:closeFCV08,FCV09,FCV11,FCV13resetPA_STAto0A2:resetTIMER1;messageUPFAILEA1:resetTIMER2;setTIMER_SP14toA2:enableA3:startTIMER1,disablevalvesvalveshavebeenPCT01PCT01A1:closeFCV08;resetPA_STAto0;TIMER1;setTIMER_SP12toA2:enableBASE_PT1;set_STAtoA3:startTIMER2,disabledrain罐體排空Openthebottomofthedrain,afterthe levelislessthantheemptyinglimitvalue,delayoffdrain,maintainthenaturalbreathingstate;LCT01<TIMER1isA1:resetTIMER1;closeA2:releaseStep3:PIPEA1:SetTIMER_SP8toA2:startA1:closeFCV08,FCV10,FCV12,FCV15,FCV17,FCV19,FCV20; _STAtoA2:openStep2:A1:acquireDRY罐體吹干Afteropeningthe bottomdrainvalve,openthekeeppressuremode,starttimer,timerisover,closethedrainvalves,the naturallybreathe;打開罐底排放閥，打開保壓模式，計(jì)時(shí)，時(shí)間到后關(guān)閉排放，罐體自然呼吸valveshavebeenTIMER1isStep4:A1:releaseA1:disablePA_KEEP_P;resetPA_STAto0;resetTIMER1A2:closeFCV08,FCV11,FCV13,FCV14,FCV16,FCV18,FCV21;A3:openStep2:PAA1:closeFCV01~FCV06,FCV10,FCV12,FCV15,FCV17,FCV19,FCV20;setTIMER_SP9toA2:openFCV09,FCV11,FCV13,FCV14,FCV16,FCV18,FCV21;enablePA_KEEP_P;setPA_STAto1;startA1:acquireABORTINGitisdeterminedwhethertheCIPmode,ifso,tostopCIPstation;ifnot,thenJudgmenttemperature,higherthesetvaluestartjacketcoolingtemperature,turnoffthe inletandhydrophobicventvalve,openthebottomofthedrain,afterthepressureislessthantheupperlimitofkeep_pressure,coolinguntilthetemperatureisbelowthesetvaluestartjacketcoolingtemperature;alloftheintermediatestateisinitialized,closeotheroccupiedvalve,retainnaturalbreathing;Iftheoriginalstateisinthe leakdetectionqualified,interruptfunctionwillleadtostatetothehasbeencleaned;Iftheoriginalstateofthe isinoperation,theinterruptfunctionwillcausethe tatetorepairandmaintenance;CIPCIP站；如果不是，判斷溫度，溫度高于啟動(dòng)夾套降溫如果原罐體狀態(tài)處于運(yùn)行斷功能會(huì)導(dǎo)致罐狀態(tài)轉(zhuǎn)為檢修、；CIPstationhaveCIPstationhavenotbeenNOTStep2:RELEASECIPA1:ReleaseCIPstation,resetTCT02<= TCT02>_STA_STA_STA<>4_STA Step10:CLOSEA1:resetTIMER1andTIMER2;setPS_STA,PA_STAtodisableEN_alarm_T;disable A2:setCIPVPtocloseroute,closeFCV01~FCV06,FCV08,FCV10~21;openFCV07,FCV09,A3:releaseCIPVP,releaseFCV01~FCV21;Step5:PAA1:openFCV09,enablePA_KEEP_PStep4:DRAINA1:disablePS_CONTROL,EN_alarm_T;resetTIMER1,TIMER2;A3:closeFCV01,FCV03,FCV10,FCV20,setPS_STAto0;A4:openFCV11,Step1:ABORTCIPA1:setP_CIP_ABORT_ORDER;stopSTIR01;resetA2:resetP_CIP_REQUEST_ORDERP_CIP_EN_ConductivityStep7:STATUSEStep8:STATUSEA1:_STAtoA1:_STAtoPAUSINGAccordingtothestateofpause,andclosingthecorrespondingsuspendopenedair,water,inletvalveandCIPstations;inaddition,thesuspendedstateinterlockingwatercontrolblock,cleaningpulsationblock, controlblocktemporarilycontrolvalves,pressurecontrolblockmaintaincontrol.(Inadditiontomanualoperationoutside,cip_p_alarmsignalCIPstationalsoactivatesthepauseNOTCIP_stationnotbeennhasbeenStep7:PAUSCIPA1:setA2:messageCIPNOTNOTStep3:CLOSEA1:closeStep8:STOPA1:stopStep1:CLOSEA1:disablePS_CONTROL;A2:closeFCV01NOTNOTCIP_stationnotbeennhasbeenNOTNOTStep3:OPENA1:openStep8:STARTA1:startStep7:RESTORECIPA1:resetStep1:OPENA1:openDependingonthestateofpause,opentheclosedair,water, inletvalveandCIPrecoverystation;inaddition,theremovalofthesuspendedstateinterlockcontrolblockwater,cleaningpulsationblock,vaporcontrolblock.EM02:BS_EQMEQMClass EQM1.AddWFI2AddWFI3.4.5.Keep6.7.GeneralDescription通用描TheEQMclassisusedtocontroltheBuffer 該設(shè)備模塊用于緩沖液罐T311002009控制P&IDiagram功能CMTable控制模塊DEVICEDescriptionRef2.1CIPWFIWFIWFIPS罐頂罐頂管路分支罐底管路罐底出口前料罐底管路出口罐底出口后料加水脈動(dòng)啟始點(diǎn)（50DEVICEDescription值加水脈動(dòng)開時(shí)間（界面設(shè)置2加水脈動(dòng)關(guān)時(shí)間（界面設(shè)置5點(diǎn)標(biāo)記位定義----塊ParametersTable參數(shù)AddWFI0AddWFI限1.5AddWFI限1.2CIP1CIP5CIP1012030121.52.2800.80.6105長(zhǎng)300.20.05限0.05555AddWFIAddWFI0AddWFI5AddWFI10600態(tài)0為關(guān)閉，100溫度下限0FlowChart流程AddWFImanAddtomanuallysetthenumberofWFIbythroughWhenaddingwater,openwatervalve,toaddwatermarginissmallerthanthepulseopenpoints,injectionwatersupplyvalvestostartactionaccordingtothepulseofftimeandpulseontime,toaddenoughwater,shutoffthevalveandrespiratortomaintaintheoriginalstate;;通過直通加水添加至人工設(shè)定數(shù)量的注射水（BATCH中，步前需加操作提示：WFI溫度是否滿足工藝要求AddWFIDCSTO WFITO valveshavebeenWFIisWFI_DOSEisStep4:A1:disableWFI_DOSE,resetrequireWFI,resetWFI_STA;FCV03,FCV07,FCV08,FCV12,FCV15A2:releaseA1:acquireStep3:addA1:sendW_SP_MANtoA2:enableWFI_DOSE,setWFI_STAto1Step2:BreatheandA1:closeFCV04~FCV06; _STAtoA2:openFCV07;sendWFIrequiretoWFIAddWFILEVELBystraightwateraddtomanuallysettheliquidleveloftheinjectedwater,andtomaintaintheliquidlevel;通過直通加水添加至人工設(shè)定液位的注射水，并保持該液位（BATCH中，步前需加操作提示：WFI溫度是否滿足工藝要求AddWFIDCSTO WFITO valveshavebeenWFIisOpertorStep4:A1:disableWFI_LEVEL,resetrequireWFI,reset(delay5s)A2:closeFCV03,FCV07A3:releaseA1:acquireStep3:addA1:enableWFI_LEVEL,setWFI_STAto1;messageFEEDINGENDSetWFIrequireto0;sendW_SP_MANtoStep2:BreatheandA1:closeFCV04~FCV06; _STAtoA2:openFCV07;sendWFIrequiretoWFICIP罐體IntheCIPlogic,theCleaningfluidisprovidedbyCIPstation,toppass-throughvalveandsprayvalveaccordingtothesettipeneachpulsation,pulsationcycle.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

A1:acquireFCV01~FCV20andCIPVGandStep2:VALVEA1:closeFCV01~FCV03,FCV06,FCV08~FCV11,FCV13,FCV16,FCV17,FCV19,FCV20;A2:openFCV04,FCV05,FCV07,FCV12,FCV14,FCV15,FCV18;sendCIP_TYPEtoStep2:VALVEA1:closeFCV01~FCV03,FCV06,FCV08~FCV11,FCV13,FCV16,FCV17,FCV19,FCV20;A2:openFCV04,FCV05,FCV07,FCV12,FCV14,FCV15,FCV18;sendCIP_TYPEtoP_CIP_PROG_TYPE,CIPVG_ROUTEtohavebeenStep3:CIPStep3:CIPA1:setP_REQUEST_ORDER,P_CIP_START_ORDER,P_CIP-PUMP_AIR_SUPPLY-ORDERP_CIP_EN_ConductivityP_CIP_RETURNPUMP_ORDER,P_CIP-EN_TIMER;enable UP_PUSLCIP_P_

A1:setA1:set

A1:setDRAIN_CTRL,sendSP13toTIMER2A2:setP_CIP_PAUSE_ORDER,startTIMER2Step6:CIPA1:disableStep6:CIPA1:disable UP_PUSLA2:closeFCV01~FCV20,setCIPVGtocloserouteA1:resetA2:reset

NOTStep7:CIPStep7:CIPA1:MessageSUCCESS, 1_STAtoA2:resetP_REQUEST_ORDER,P_CIP_START_ORDER,PUMP_AIR_SUPPLY-ORDER,P_CIP_EN_ConductivityStep8:CIPA1:resetP_REQUEST_ORDER,P_CIP_START_ORDER,PUMP_AIR_SUPPLY-ORDER,P_CIP_EN_ConductivityA2:MessageFAIL

A1:A1:ReleaseFCV01~FCV20;releaseCIPPVGandCIP

IPInIntheSIPlogic,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lyrespiratortopurgethewaterfilm,andthensterilizedbyheating;Sterilizationheatingstage, bottomvalveandexhaustvalveopensuntilitreachesthesettemperature;aftersterilizationtime,pure forthe valveinthe pressureorhigherthanthehighestreferencetemperature(threelowesttemperaturevalue)ishigherthanthetemperatureoffvalvecapclosed,thereferencetemperatureislessthanthelowerlimitofthetemperatureofthevalveopeningopen;Afterthesterilizationprocess,closethetrapdischargerespirator, bottomremainsopen;openthecompressedairvalve, bottomdischargeopeningonly10seconds;whenthebodytemperaturedropsopenjacketcoolanttemperaturepoint,indicatingoperativesjacketcoolingoperation;waitforthetemperaturetocooldownagainwhenthetemperatureof point,Buckexhausttodwelllimit,closedmouthaftercleaning bottomand bottomdrainvalvedischargerefrigerantprompttheoperatortoclosethejacket,end.Referringto pressureandtemperaturetakefullhighlimitalarm;SIPfailureneed10秒；當(dāng)罐體溫度降到開啟夾套冷媒溫度罐體壓力和參照溫度全程采取高限位；SIP失敗需要提示valveshavebeenTIMER1TCT02OrTIMER1isTCT01&TCT02&OrTIMER1isTCT01orTCT02orTIMER2isTIMER1isTCT01&TCT02OrTIMER1isOperatorA1:closeFCV09,FCV15,FCV17,FCV19setPA_STAto0messageOPERTORcloseA2:openFCVO8 TCT02A1:closemessageSIP _STAto5;disableEN_alarm_P;A2:resetPA_STA;releaseFCV01~FCV20Step10:JACKA1:messageOPERTORcanA1:stopTIMER1&TIMER2disablePS_CONTROL,disableEN_alarm_T;A2:closeFCV01,setPS_STAtoA3:messageoperatorSIPStep7:DRAINA2:stopTIMER1&TIMER2andresetdisablePS_CONTROL,disableEN_alarm_T;A3:closeFCV01,setPS_STAtoA4:openFCV09,FCV20,setPA_STAto1;(delay10s)A5:closeFCV20;enableStep16:resetTIMER2A1:stopTIMER2andresetTIMER2Step6:SIPA1:startTIMER2,enableA1:closeFCV01,FCV02,FCV03,FCV06,FCV13,FCV16,FCV18A2:openA3:enablePS_CONTROL,setTIMER_SP1toTIMER1A4:setPS_STAto1,startStep2:BLOWA1:closeFCV08;setTIMER_SP15toTIMER1A2:openFCV09,FCV10,FCV11;startTIMER1;Step3:CLOSEA1:closeFCV09;resetA2:openA1:resetTIMER1&TIMER2A1:abortcurrentStep5:CLOSEDRAINandA1:closeFCV20,FCV08,setTIMER_SP2toA1:acquireKeepPressureOpenthecompressedairvalvetostartuptiming;withinthetimerpressurereachesup_limit,thetimerisreset,closingallvalves,startsteadytiming,timerisover,steady_pressurenormalend;startkeeptiming,timerisover,keep_pressurenormalIftheupstage,thetimerisover,suggestingfailure,directend;Ifthesteadystage,thepressuredowntothelowerlimit,suggestingfailure,directend;Ifthekeepstage,thepressuredowntothelowerlimit,suggestingfailure,directend;Opentheexhaustat,relief;Step2:PAStep2:PAA1closeFCV01~FCV08,FCV11,FCV13,FCV15~FCV20;setTIMER_SP6toA2openFCV09,FCV10,FCV12,FCV14,;setPA_STAto1;startA1:acquireFCV01~FCV20Keep TIMER1is PCT01< TIMER2isPCT01<TIMER1isStep8:FAILEANDA1:resetStep7:OKANDA1:resetTIMER1;A2:message_STAtoA2:messageKEEPpressureresultisStep11:A1:openFCV08;,FCV10,FCV12,FCV14;closeA2:releaseStep6:FAILEANDA1:resetA2:messageKEEPpressureStep4:KEEPA1:closeFCV09,FCV10,FCV12,FCV14resetPA_STAto0A2:resetTIMER1;messageUPFAILEA1:resetTIMER2;setTIMER_SP14toA2:enableA3:startTIMER1,disablevalvesvalveshavebeenPCT01PCT01A1:closeFCV09;resetPA_STAto0;TIMER1;setTIMER_SP12toA2:enableBASE_PT1;set_STAtoA3:startTIMER2,disabledrain罐體排空Openthebottomofthedrain,aftertheliquidlevelislessthantheemptyinglimitvalue,delayoffdrain,maintainthenaturalbreathingstate;valveshavebeen DRAINA1:closeFCV01~FCV07,FCV09,FCV11,FCV13,FCV16,FCV18,FCV19;A2:open_STAtoLCT01<TIMER1isA1:resetTIMER1;closeA2:releaseStep3:PIPEA1:SetTIMER_SP8toA2:startA1:acquireDRY罐體吹干Afteropeningthe bottomdrainvalve,openthekeeppressuremode,starttimer,timerisover,closethedrainvalves,the naturallybreathe;打開罐底排放閥，打開保壓模式，計(jì)時(shí)，時(shí)間到后關(guān)閉排放，罐體自然呼吸valveshavebeenTIMER1isStep4:A1:releaseA1:disablePA_KEEP_P;resetPA_STAto0;resetTIMER1A2:closeFCV13,FCV14,FCV15,FCV17,FCV20,FCV09;A3:openStep2:PAA1:closeFCV01~FCV07,FCV11,FCV13,FCV16,FCV18,FCV19;setTIMER_SP9toA2:openFCV10,FCV12,FCV14,FCV15,FCV17,FCV20;enablePA_KEEP_P;setPA_STAto1;startA1:acquireABORTINGitisdeterminedwhethertheCIPmode,ifso,tostopCIPstation;ifnot,thenJudgmenttemperature,higherthesetvaluestartjacketcoolingtemperature,turnoffthe inletandhydrophobicventvalve,openthebottomofthedrain,afterthepressureislessthantheupperlimitofkeep_pressure,coolinguntilthetemperatureisbelowthesetvaluestartjacketcoolingtemperature;alloftheintermediatestateisinitialized,closeotheroccupiedvalve,retainnaturalbreathing;Iftheoriginalstateisinthe leakdetectionqualified,interruptfunctionwillleadtostatetothehasbeencleaned;Iftheoriginalstateofthe isinoperation,theinterruptfunctionwillcausethe tatetorepairandmaintenance;CIPCIP站；如果不是，判斷溫度，溫度高于啟動(dòng)夾套降溫如果原罐體狀態(tài)處于運(yùn)行斷功能會(huì)導(dǎo)致罐狀態(tài)轉(zhuǎn)為檢修、；CIPstationhaveCIPstationhavenotbeenNOTStep2:RELEASECIPA1:ReleaseCIPTCT02<= TCT02>_STA_STA_STA<>4_STA Step10:CLOSEA1:resetTIMER1andTIMER2;setPS_STA,PA_STAtodisableEN_alarm_T;disable A2:setCIPVPtocloseroute,closeFCV01~FCV07,FCV09,FCV11~20;openA3:releaseCIPVP,releaseFCV01~FCV20_STAtoA1:Step7:STATUSEStep5:PAA1:openFCV09,enablePA_KEEP_PA2:setPA_STAto1Step4:EXHAUSTA1:disablePS_CONTROL,EN_alarm_T;resetTIMER1,TIMER2;A3:closeFCV01,FCV04,FCV11,FCV19,setPS_STAto0;A4:openFCV12,Step1:ABORTCIPA1:setA2:resetP_CIP_REQUEST_ORDERP_CIP_EN_Conductivity;Step8:STATUSEA1:_STAtoPAUSINGAccordingtothestateofpause,andclosingthecorrespondingsuspendopenedair,water,inletvalveandCIPstations;inaddition,thesuspendedstateinterlockingwatercontrolblock,cleaningpulsationblock, controlblocktemporarilycontrolvalves,pressurecontrolblockmaintaincontrol.(Inadditiontomanualoperationoutside,cip_p_alarmsignalCIPstationalsoactivatesthepauseStep1:CLOSEA1:disableA2:Step1:CLOSEA1:disableA2:closeFCV01NOTStep3:CLOSEA1:closeNOTNOTStep7:PAUSCIPA1:setA2:messageCIPStep5:CLOSEA1:disableNOTCIP_stationnotbeennhasRESTOREDependingonthestateofpause,opentheclosedair,water, inletvalveandCIPrecoverystation;inaddition,theremovalofthesuspendedstateinterlockcontrolblockwater,cleaningpulsationblock,vaporcontrolblock.Step1:OPENA1:openNOTStep3:OPENStep1:OPENA1:openNOTStep3:OPENA1:openNOTNOTStep7:RESTORECIPA1:resetStep5:OPENA1:enableNOTCIP_stationnotbeennhasEM03:EQMEQMClassEQM1.2.3.DefinedGeneralDescription通用描TheEQMclassisusedtocontroltheSTIRof該設(shè)備模塊用于罐的攪拌控制P&IDiagram功能CMTable控制模塊ParametersTable參數(shù)Start/Dfined10010FlowChart流程Stopaborting)停止(中斷Switchingtoautomaticmode,sendingstopsignal;interruptalsoperformsstopoperation;(Exceptstophumanoperator,underthelowerofthe liquidlevelwilldirectlyinterlockstop);（除操作工人為停止外，液位的下下限也會(huì)直接聯(lián)鎖攪拌停止A1:stopA2:setSTIRmodetoStep1:MODE*1)A1:setSTIRmodeto*1)Ax:x=1,2,3…thenumberrepresenttheaction’sexecutesequence,whieansthenextactiondosenotbeexecutedbeforethepreviousactioncompleydone.StartChangworkmodeofstirtoautomode,sendoutstartA1:setRPMtoRPM_SPA2:startSTIRStep1:MODEA1:setSTIRmodetoDfinedSwitchingmodetoautomatically,transstartsignal,startthetimer,timerisover,stopstir.whentimerisrunning,stirisinterlockedtostoped,thentheprogramisendbyautomatically;STIRSTIRTIMERisOrNOTA1:setTIMER1_SPtoA2:startA1:setRPMtoRPM_SPA2:startSTIRStep1:MODEA1:setSTIRmodetoStep4:resetTIMERA1:resetTIMERA2:stopSTIRA3:setSTIRmodetoEM04:EQMEQMClassEQM1.2.Trans3.TransGeneralDescription通用描TheEQMclassisusedtocontrolroutebetweenbuffer andtransfer該設(shè)備模塊用于緩沖液罐和轉(zhuǎn)接板之間的路徑控制P&IDiagram功能TRANS（examples:T311002021—TRANSCIP（examples:T311002021—TRANSSIP（examples:T311002021—CMTable控制模塊DEVICEDescriptionRef2.1CIPPS罐頂閥前料罐頂罐頂管路分支罐底管路分支閥罐底管路分支閥罐底管路罐底出口前料罐底管路出口罐底出口后料轉(zhuǎn)料路徑開閥轉(zhuǎn)料路徑開閥轉(zhuǎn)料路徑開閥轉(zhuǎn)料路徑開閥轉(zhuǎn)料路徑開閥轉(zhuǎn)料路徑關(guān)閥TPTPDEVICEDescriptionTPTP同時(shí)用作CIP站的點(diǎn)滅菌時(shí)蒸汽控制塊DEVICEDescriptionRef2.1CIPPS罐頂閥前料罐頂罐頂管路分支罐底管路分支閥罐底管路分支閥罐底管路罐底出口前料罐底管路出口罐底出口后料轉(zhuǎn)料路徑開閥轉(zhuǎn)料路徑開閥轉(zhuǎn)料路徑開閥轉(zhuǎn)料路徑開閥轉(zhuǎn)料路徑開閥轉(zhuǎn)料路徑關(guān)閥TPTPDEVICEDescriptionTPTP同時(shí)用作CIP站的點(diǎn)滅菌時(shí)蒸汽控制塊DEVICEDescriptionRef2.1CIPPS罐頂