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UltrfitrationFunctionalSpecificationofPCSofBioengineeringParkUnit3100生物工程园3100PCS系统超滤功能说 RevisionHistory修订历版修订内Revised修订日Thefirst目录INTRODUCTION介 Scope范 s关联文 ReferenceGuideline参考指 ListofReferences参考文件.....................................................................................SYSTEMCONTROLFUNCTION系统控制功 CIPROUTECIP路径定 STATUSEDEFINE状态定 CIPstationCOMM CIP站通讯状态定 UFCOMMDEFINE超滤通讯定 Ultrfitration超 EM01: GeneralDescription通用描 P&IDiagram功能 CMTable控制模块 ParametersTable参数 FlowChart流程 EM02: GeneralDescription通用描 P&IDiagram功能 CMTable控制模块 ParametersTable参数 FlowChart流程 EM03:T1007- GeneralDescription通用描 P&IDiagram功能 CMTable控制模块 ParametersTable参数 FlowChart流程 EM04:T1007 GeneralDescription通用描 P&IDiagram功能 CMTable控制模块 ParametersTable参数 FlowChart流程 EM05: GeneralDescription通用描 P&IDiagram功能 CMTable控制模块 ParametersTable参数 FlowChart流程 EM06:UF GeneralDescription通用描 P&IDiagram功能 CMTable控制模块 ParametersTable参数 FlowChart流程 EM07:T1008- GeneralDescription通用描 P&IDiagram功能 CMTable控制模块 ParametersTable参数 FlowChart流程 Reviewand审核与批Draftedby起草部职日Austar-调试工年月Reviewedby审核部职日Austar-验证工年月工程工程部工程年月生产车间生产线年月设备设备自控工程年月QA年月QA验证工程年月Approvedby批准部职日QA质量副总年月INTRODUCTION介Scope范ThisdefinesthecontrolstrategytomeetUltrfitrationcontrolrequirementofPCSofQILUBio-engineeringParkUnit3100.本文件定义的控制策略用于满足齐鲁生物工程园3100单元PCS系统超滤工段控制需求Relateds关联文ReferenceGuidelineThisFunctionalSpecificationhasbeenwrittentomeettheguidanceonFunctionSpecificationofcomputerizedsystemcontainedinGAMPGPGARisk-BasedApproachtoGXPProcessControlGAMP良好实践指南-GxPGMP计ListofReferences参考文Thefollowingsarereferencedinthiss文档编文档名UserRequirementV-PCS-QualityandProjectFunctionalSYSTEMCONTROLFUNCTION系统控制功CIPROUTECIP路径定Accordingtodifferentcleaningtarget,thevalvesofCIPwatersupplyandreturnlooparedefinedas针对不同的目标,将所用到的公共CIP供水及回流管的阀门进行路径定义CIPS6序阀门Route路1234TTF_T-1T2T3T4TCIPS6序阀门Route路5TF_1T2T3T4TSTATUSEDEFINEAccordingtodifferenttarget,statusesaredefinedas序配料罐状数值定储料罐状数值定转料系统状定)1检修、1检修、1完整性测试合12待清2待清2待清23已清3已清3已清34检漏合4检漏合4检漏合45已灭5已灭5已灭56运行6运行6运行6CIPstationCOMM CIP站通讯状态AccordingtoCIPstation,COMMaredefinedasCIPPCS→序名数值类注1请求命令;0无,1请求2启动命令;0无,1开始3暂停命令;0无,1泵和压空停止,计时器停4中断命令;0无,1CIP立即停止5介质输送允许;0无,1泵和压空使能6PCS存在,CIP无响应动作7回流泵允许;0无,1回流泵使能8当前罐液位,管道时此值为9模式;0无每秒加1CIP站检测到此值5秒不变时,认为通讯断5共计80个标记位,每位代表一个点终淋电导测试使能;0不能,1允许CIP站计时使能;0不能1允许CIP→序名数值类注1CIP站是否能够使用(可用状态:无要、处于控制状态、没有运行);0无,1可用;2CIP站运行状态;0待机,1运行3CIP站暂停状态;0无,1暂4CIP站输送状态;0无,1正在输送液压空5CIP站结束状态0无,1结束;(此信仅维持6CIP站状态;0无,1存在需操作检查7CIP站反馈结果;2电导不合格失败电导合格成功8当前动作编号无纯化水预冲洗吹扫纯化水冲吹碱液冲吹酸液冲吹注射水终吹碱液液位调碱液配碱液罐自酸液罐自系统排每秒加1PCS检测到此值5秒不变化时认为通讯断UFCOMMDEFINE超滤通讯定AccordingtoUF,commaredefinedasPCS→序名数值类注1 罐2搅拌频率反3搅拌运行反馈;0停止,14搅拌故障反馈;0无,1故障5供料应答信号;0无,1供料6接料应答信号;0无,1接料7系统管道SIP请求,0无,1请求8系统管道SIP结束,0无,1SIP结束9PCS阀门允许超滤占用,0无,1允许接料管路CIP/SIP请求,0无,1请BUFFPIPE_CIP缓冲液管路CIP请求,0无,1请UF→序名数值类注1底部疏水温2顶部疏水温3搅拌转速设4超滤工作状态(。。。5阀门控制信号(0关闭,1打开6阀门控制信号(0关闭,1打开7阀门控制信号(0关闭,1打开8阀门控制信号(0关闭,1打开9阀门控制信号(0关闭,1打开阀门控制信号(0关闭,1打开阀门控制信号(0关闭,1打开阀门控制信号(0关闭,1打开阀门控制信号(0关闭,1打开阀门控制信号(0关闭,1打开阀门控制信号(0关闭,1打开阀门控制信号(0关闭,1打开搅拌控制信号(0关闭,1打开INPUT供料信号(0无,1请求供料OUTPUT收料信号(0无,1请求收料收料管路处理应答信号(0无,1阀门打开BUFFPIPE_CIP注:相关边界阀门7个(KV06,KV08,KV11,KV16,KV17,KV26,KV34),呼吸器所属阀门UFCIPUltrfitration超UltrfitrationSFC11.罐体2.罐体灭3.Keep罐体充4.罐体排5.罐体吹紧急停止状态处暂停状态处暂停恢复处21.停止(中断2.启3.Defined定时运3T1007-1.超滤处2.Trans超滤系统管路3.Trans超滤系统管路灭紧急停止状态处暂停状态处暂停恢复处4T1007-1.Trans2.Trans管路3.Trans紧急停止状态处暂停状态处暂停恢复处51.罐体2.罐体灭3.Keep罐体充4.罐体排5.罐体吹紧急停止状态处暂停状态处暂停恢复处6UF-1.2.Trans管路反向3.Trans紧急停止状态处暂停状态处暂停恢复处7T1008-1.Trans2.Trans管路3.Trans4.滤芯润5.完整性测紧急停止状态处暂停状态处暂停恢复处EM01:EQMEQMClassEQM1.2.3.Keep4.5.GeneralDescriptionTheEQMclassisusedtocontrolthe P&IDiagram功能CMTableDEVICEDescriptionTCIPCIPPST阀TTTTTTTTTT喷淋阀T喷淋阀TTTTTTTTTTT罐底CIPTTTTTTTTTCIPVG的路径值(1CIP_CIP----灭菌时蒸汽控制块--升压结束时计算的参考压力(--稳压结束时计算的参考压力(--(CYCLES=CYCLES---DEVICEDescriptionT--ParametersTable参数CIPCIP1CIP5CIP10sip120sip30sip121.5sip2.2sip限sipsip80sip/Keeppressure0.8sip/Keeppressure0.6sipsipsip长5Keep10Keep5Keep120Keep0.2Keep0.05drain0.05drain5dry5CIP50CIP5CIP浸泡重量上限定200CIP浸泡液重量下10CIP浸泡次数(段1cip20--0--蒸汽阀状态,0为闭,1为打开0--洁净压空状态,0关闭,1为打开0--温度使能,0关闭,1为打开0--动作号(用于0--剩余循环次数(0--0FlowChart流程CIPIntheCIPlogic,theCleaningfluidisprovidedbyCIPstation, toppass-throughvalveandsprayvalveaccordingtothesettimetoopeneachpulsation,pulsationcycle.Aftereachstagetoincreaseafterimmersioncleaningspray,CIPstationinteractwiththeneedtore-setimmersion bottomvalveisclosed,stoppedafterthesetlevelintotheCIPcleaningsolution,soakthesetmixingtime,tosoakstirringtimeopen bottomvalve,waterrinsestageissetforanimmersioncycles,afterthecycleiscompletestopCIP.(Purificationforanadvancedsolutionforallopenagain在运行阶段,液由CIP提供。罐顶直通阀门和喷淋阀按设定脉动时间逐个打开,进行环脉动。每阶段喷淋后增加浸泡、与CIP站交互,需设定浸泡液位,关闭罐底阀后,达设定液位后停止进CIP液,设定浸泡搅拌时间,达到浸泡搅拌时间后开罐底阀,水冲洗阶段CIP。Step17Step17CIPA1MessageSUCCESS,_STAtoA2resetP_REQUEST_ORDER,P_CIP_START_ORDER,PUMP_AIR_SUPPLY-ORDER,_STAStep1A1acquireFCV01~FCV26andCIPVGandCIPStation,VALVES&CIPVG&CIPStation&STIRhavebeenCIP_P_9Step5MEDIUMA1CloseFCV18;resetP_CIP-EN_TIMER;resetP_CIP-RETURNPUMP_ORDER;setACTIONNUMBERTIMER1TIMER1TIMER1Step13A1openFCV18;resetenableCYCLES_CACU;setA2disableCYCLES_CACU;StopSTIR01,resetWCT01<W_L_STIR&CYCLESACTIONNUMBER<>Actualactionnumber&ActualactionnumberNOTStep19A1ReleaseFCV01~FCV26;releaseCIPPVGandCIPstationandStep18CIPA1resetP_REQUEST_ORDER,P_CIP_START_ORDER,PUMP_AIR_SUPPLY-ORDER,P_CIP_EN_Conductivity;A2MessageoperatorFAILStep16CIPA1disable UP_PUSLA2closeFCV01~FCV26,setCIPVGtocloserouteStep15SYSTEMA1StopSTIR01;resetStep14A1setresetP_CIP-Step7A1openFCV18;resetTIMER1;StopSTIR01;resetSTIR_STA;resetP_CIP_PAUSE_ORDER;setP_CIP_RETURNPUMP_ORDER;SetP_CIP-EN_TIMER;Step10A1resetresetResetStep6A1setTIMER_SP11tosetP_CIP_PAUSE_ORDER;StartSTIR01;setSTIR_STA;A2startStep12A1setTIMER_SP11toTIMER1;StartSTIR01;setresetP_CIP_PUMP_AIR_SUPPLY_ORDER;A2startTIMER1Step8A1setStep4Step2VALVEA1closeA2openFCV02,FCV04,FCV06,FCV08,FCV11,FCV18,FCV19,FCV22,FCV24;setCYCLESsendCIP_TYPEtoP_CIP_PROG_TYPE,CIPVG_ROUTEtoStep9A1setDRAIN_EN;openFCV23,FCV26setP_CIP_PAUSE_ORDER;SetTIMER_SP20toA2startStep11MEDIUMA1CloseFCV18,resetsetP_CIP_PUMP_AIR_SUPPLY_ORDER;resetP_CIP-setACTIONNUMBERStep3CIPA1setP_REQUEST_ORDER,P_CIP_START_ORDER,P_CIP-PUMP_AIR_SUPPLY-ORDER,P_CIP-resetP_CIP_EN_Conductivity,P_CIP_RETURNPUMP_ORDER;enable UP_PUSLSIPInIntheSIPlogic,theclean injectionintothevesseltoheating.Thevesseltemperature,theventfilterdraintemperature,thevesseldraintemperaturewillbemonitored,whenthesethreetemperatureatthesametimetoreachedsterilizationtemperatureforaperiodtime,thenthesterilizationissuccessful.Ifanytemperatureislowerthesterilizationtemperature,thenthesterilizationtimerisstop,untilthetemperatureisok,thesterilizationtimerisresetandrestart.3个温度同时达到灭菌温度且持续一段时间后,才认为灭菌成功。在灭菌过程中,如果任何一个温Firstlyrespiratortopurgethewaterfilm,andthensterilizedbyheating;Sterilizationheatingstage,verticalbottomvalveandexhaustvalveopensuntilitreachesthesettemperature;aftersterilizationtime,pure forthe valveinthepressurepressureorhigherthanthehighestreferencetemperature(threelowesttemperaturevalue)ishigherthanthetemperatureoffvalvecapclosed,thereferencetemperatureislessthanthelowerlimitofthetemperatureofthevalveopeningopen;Afterthesterilizationprocess,closethetrapdischargerespirator,hydrophobicbottomremainsopen;openthecompressedairvalve,bottomdischargeopeningonly10seconds;whenthebodytemperaturedropsopenjacketcoolanttemperaturepoint,indicatingoperativesjacketcoolingoperation;waitforthetemperaturetocooldownagainwhenthetemperatureoftheendpoint,Buckexhausttodwelllimit,closedmouthaftercleaningthebottomandbottomdrainvalvedischargerefrigerantprompttheoperatortoclosethejacket,end.Referringtothepressureandtemperaturetakefullhighlimitalarm;SIPfailureneed10秒;当罐体温度降到开启夹套冷媒温度罐体压力和参照温度全程采取高限位;SIP失败需要提示valveshavebeenTIMER1TCT02OrTIMER1isTCT01&TCT02&OrTIMER1isTCT01orTCT02orTIMER2isTIMER1isTCT01&TCT02&OrTIMER1isOperatorTCT02A1:closeFCV15,FCV18,FCV19;messageSIP _STAto5;disableEN_alarm_P;A2:resetPA_STA;releaseA1:closeFCV16,FCV22,FCV23,FCV25,;resetA2:openStep7:DRAINA1:stopTIMER1&TIMER2andresetdisablePS_CONTROL,disableEN_alarm_T;A2:closeFCV01,FCV02,FCV04,FCV06,FCV08,FCV17;setPS_STAtoA3:openFCV11P,FCV16,FCV26;setPA_STA(delay10A4:closeFCV26;enableA1:stopTIMER1&TIMER2disablePS_CONTROL,disableEN_alarm_T;A2:closeFCV01,FCV02,,setPS_STAtoA3:messageoperatorSIPA1:resetStep6:SIPA1:startTIMER2,enableA1:closeFCV03,FCV05,FCV07,FCV09,FCV20,FCV21,FCV24;setTIMER_SP1toTIMER1A2:openA3:setPS_STAto1,enablePS_CONTROL,startStep2:BLOWA1:closeFCV15;setTIMER_SP12toA2:openFCV14,FCV16,FCV17;startStep3:CLOSEA1:closeFCV16;resetTIMER1;A2:openFCV15;A1:resetTIMER1&TIMER2A1:abortcurrentStep5:CLOSEDRAINandA1:closeFCV15,FCV26,setTIMER_SP2toA1: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;KeepvalveshavebeenTIMER1isPCT01PCT01<TIMER2isPCT01<TIMER1isStep8:FAILEANDA1:resetA2:messageKEEPpressureresultisStep9:A1:openA2:releaseStep7:OKANDA1:resetTIMER1;set _STAto4;A2:messageKEEPpressureresultisOK,Step6:FAILEANDA1:resetA2:messageKEEPpressureresultisA1:resetTIMER2;setTIMER_SP10toA2:enableA3:startTIMER1,disableStep4:KEEPA1:closeFCV16;resetPA_STAto0A2:resetTIMER1;messageUPFAILEStep2:PAA1closeFCV10~FCV13,FCV15,FCV17,FCV18;setTIMER_SP6toA2openFCV14,FCV16;setPA_STAto1;startA1:acquireA1:closeFCV16;resetPA_STAto0;resetTIMER1;setTIMER_SP7toTIMER2;A2:enableA3:startTIMER2,disabledrainOpenthebottomofthe 'sdrain,afterthe levalislessthantheemptyinglimitvalue,delayoffdrain,maintainthenaturalbreathingstate;valveshavebeen DRAINA1:closeFCV16,FCV17,FCV20,FCV21,FCV24,FCV25; _STAtoA2:openWCT01<TIMER1isA1:resetTIMER1;closeA2:releaseStep3:PIPEA1:SetTIMER_SP8toA2:startA1:acquireDRYAfteropeningthe bottomdrainvalve,openthecompressedairvalve,starttimer,timerisover,closethedrainvalves,the naturallybreathe;打开罐底排放阀,打开压空阀门,计时,时间到后关闭排放,罐体自然呼吸valveshavebeenTIMER1isStep4:A1:releaseA1:resetA2:closeFCV16,FCV18,FCV19,FCV22,FCV23,FCV26A3:openStep2:PAA1:closeFCV10~FCV13,FCV15,FCV20,FCV21,FCV24,FCV25;setTIMER_SP9toA2:openFCV14,FCV16,FCV18,FCV19,FCV22,FCV23,FCV26;startA1:acquireABORTINGitisdeterminedwhethertheCIPmode,ifso,tostopCIPstation;ifnot,thenJudgmenttemperature,higherthesetvaluestartjacketcoolingtemperature,turnoffthe inletandhydrophobicventvalve,openthebottomofthe drain,afterthe pressureislessthantheupperlimitofkeep_pressure,coolinguntilthetemperatureisbelowthesetvaluestartjacketcoolingtemperature;alloftheintermediatestateisinitialized,closeotheroccupiedvalve,retainnaturalbreathing;Iftheoriginalstateisintheleakdetectionqualified,interruptfunctionwillleadtostatetothehasbeencleaned;Iftheoriginalstateoftheisinoperation,theinterruptfunctionwillcausethestatetorepairandmaintenance;CIPCIP站;如果不是,判断温度,温度高于启动夹套降温如果原罐体状态处于运行中,中断功能会导致罐状态转为检修、;CIPstationhavenotbeenCIPstationhaveNOTStep2:RELEASECIPA1:ReleaseCIPstation,resetTCT02<=TCT02>_STA_STA_STA<>4_STA Step10CLOSEA1:resetTIMER1andTIMER2;setPS_STA,PA_STA,DRAIN_ENtodisableEN_alarm_T;disable A2:setCIPVGtocloseroute,closeFCV01~FCV13,FCV6~FCV26;openFCV13,FCV15;stopSTIR01;A3:releaseCIPVG,releaseFCV01~FCV26,STIR01;Step5:PAA1:openFCV14,FCV16,FCV25,closeStep4:DRAINA1:disablePS_CONTROL,EN_alarm_T;resetTIMER1,TIMER2;A2:closeFCV01,FCV02,FCV04,FCV06,FCV08,FCV17,FCV25;setPS_STAto0;A3:openStep3Step1:ABORTCIPA1:setP_CIP_ABORT_ORDER;resetA2:resetP_CIP_REQUEST_ORDERStep7:STATUSEStep8:STATUSEA1:_STAtoA1:_STAtoPAUSINGAccordingtothestateofpause,andclosingthecorrespondingsuspendopenedair,water,inletvalveandCIPstations;inaddition,thesuspendedstateinterlockingwatercontrolblock,cleaningpulsationblock, controlblocktemporarilycontrolvalves,pressurecontrolblockmaintaincontrol.(Inadditiontomanualoperationoutside,cip_p_alarmsignalCIPstationalsoactivatesthepause(除人为操作外,CIP站的cip_p_alarm信号也会激活暂停功能
NOT
CIP_stationStep1:CLOSEA1:disableA2:close
nhasStep5:PAUSStep5:PAUSCIPA1:setA2:messageCIP
notbeen
NOT
NOTNOTStep6:STOPStep6:STOPA1:stopStep3:CLOSEA1:closeRESTOREDependingonthestateofpause,opentheclosedair,water, inletvalveandCIPrecoverystation;inaddition,theremovalofthesuspendedstateinterlockcontrolblockwater,cleaningpulsationblock,vaporcontrolblock.NOTStep1:OPENA1:enableA2:opennhasNOTNOTStep3:OPENA1:openStep6:STARTA1:startStep5:RESTORECIPA1:resetEM02:EQMEQMClassEQM1.2.3.DefinedGeneralDescriptionTheEQMclassisusedtocontroltheSTIR P&IDiagram功能CMTableTTT-T-T-T-T-SU01-T-SU01-ParametersTable参数Start/Dfined10010FlowChart流程Stopaborting)停止(中断Switchingtoautomaticmode,sendingstopsignal;interruptalsoperformsstopoperation;(Exceptstophumanoperator,underthelowerofthe weightwilldirectlyinterlockstop);(除操作工人为停止外,罐重的下下限也会直接联锁搅拌停止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:T1007-EQMEQMClassT1007-EQM1.2.Trans3.TransGeneralDescriptionTheEQMclassisusedtocontrolthetransfunctionbetween andP&IDiagram功能Ultrfitration(转料Ultrfitration(浓缩CMTableDEVICEDescriptionT-PSTT阀TTTTTTTTT喷淋阀T喷淋阀TTTTTTTTTTT罐底CIPTTTTTTTUF底部疏水温 UF顶部疏水温 UF工作状-灭菌时蒸汽控制块--罐当前状态--管路当前状态--ParametersTable参数Trans120Trans30Trans121.5Trans10Trans限Trans--蒸汽阀状态,0为闭,1为打开0--闭,1为打开0--0--0--控制(0不允许,1许0FlowChart流程Ultrfitration超 topacking,thematerialwastransportedtotheproductfromthechromatographyandwaitfortheoperatortoconfirmtheendofthetransfermaterial,closeallvalves;;PCS系统保持关闭,产品罐呼吸器自然呼吸,产品罐搅拌器由超滤系统根据罐重控制; &(PIPES_STA_FB==5orvalveshavebeenOperatorA1:releaseFCV02~FCV22,FCV27,FCV28,A1:resetA1:messageUFRELEASEStep2:PREA1:closeA2:openFCV14,FCV15;setVALVES_EN; 2_STAto6,PIPES_STAtoA1:acquireFCV02~FCV22,FCV27,FCV28,TransCIPCleaningmethodusingthereverse;Intheoperationalphaseofcleaning,thecleaningsolutionisprovidedbyCIPstation.控制由超滤主控,PCSPCS系Transvalveshavebeen OperatorStep5A1:releaseFCV02~FCV11,A1:resetVALVES_EN;setPIPES_STAtoA1:messageUFRELEASEStep2:PREA1:closeFCV03,FCV05,FCV07,FCV22,FCV28;A2:setVALVES_EN;A1:acquireFCV02~FCV11,TransSIPDuringthesterilizationstage,thepure entersthepipelineandbeginstoheatup.Itmonitorsthetemperatureofthedrainlineandthetemperatureoftheultrafiltrationcommunication.Sterilizationsuccess.Inthesterilizationprocess,ifanytemperatureislowerthanthesterilizationtemperature,thesterilizationtimerisstoppeduntilthetemperatureisreachedandthetimerisresetandrestarted.Sterilizationheatingstage,thebottomstraightvalvedelayoff;aftersterilization,closeallReferringtothehightemperaturelimitalarmtakefull;SIPfailurealarm参照温度全程采取高限位;SIP失败需要提示;TransVALVEShavebeenUF_STA==’TIMER2Step3:CLOSEA1:closeA2:resetTIMER2;setTIMER_SP2toOrTIMER1isTCT01orTCT02orA1:resetTIMER2is TIMER1isOrTIMER1isOperator A1:resetTIMER1&TIMER2;A2:abortcurrentStep5:CLOSEA1:resetTIMER1&TIMER2;disablePS_CONTROL,disableEN_alarm_T;A2:closesetPS_STAto0Step4:SIPA1:startTIMER2,enableA1:messageSIPSUCCESS;set,PIPES_STAto5;A2:releaseFCV01~FCV09,FCV19~28,A1:stopTIMER1&TIMER2;disablePS_CONTROL,disableEN_alarm_T;A2:close;setPS_STAto0A3:messageoperatorSIPA1:closeA2:openA3:enablePS_CONTROL,setTIMER_SP1toTIMER1;setTIMER_SP4toTIMER2;A4:setPS_STAto1,,startTIMER1,startTIMER2A1:acquireABORTINGWhenStrategyisaborted,closeallvalvesofaccquired;allintermediatestatesareinitialized;Iftheinterruptstatuslineisinoperation,interruptoperationwillresultinturnfeedlinestatetobePIPES_STAPIPES_STAStep3:STATUSEA1:setPIPES_STAtoStep4:CLOSEA1:resetTIMER1,TIMER2;resetPS_STA,disableEN_alarm_T,PS_CONTROL;A2:closeFCV01~FCV28;stopSTIR01;A3:releaseFCV01~FCV28,STIR01;PAUSINGDependingonthestateofpause,closethecorrespondingopenedair, inletvalve,pipelinevalveandsuspendCIPstation;(Inadditiontooperatingoutsidethehumanoperator,cip_p_alarmsignalofCIPstationandmassbalancealarmsignalalsoactivatesthepausefunction);CIP(除操作工人为操作外,CIP站的cip_p_alarm信号、物料平衡信号也会激活暂停功能NOTStep1:CLOSEA1:closeRESTOREDependingonthestateofpause,opentheopenedair, inletvalve,pipelinevalveandCIPrecoverystation;CIPNOTStep1:OPENA1:openEM04:T1007EQMEQMClassT1007-EQM1.Trans2.Trans3.TransGeneralDescriptionTheEQMclassisusedtocontroltheroutebetween and该设备模块用于 和最终灌装的管路控制P&IDiagram功能TRANSTRANSCMTableDEVICEDescriptionTCIPCIPPSTT阀TTTTTTTTT喷淋阀T喷淋阀TTTTTTTTTTT罐底CIPTTTTT从产品罐08来料T从产品罐07来料TFFFFFFTFTFFTCIPVG的路径值(2--DEVICEDescriptionT----ParametersTable参数0.20.1101020TransCIP处理类型(11Trans5Trans10Trans20Trans120Trans30Trans121.5Trans100Trans间10Trans10Trans45--0--0--0--洁净压空状态,0关闭,1为打开0--纯蒸汽状态,0为闭,1为打开0--CIP0为关闭,1为打开0FlowChart流程Trans waspacking,opentheproduct tofillmaterialpassagevalve,whereinthe bottomvalve,valveclosedafterafilter;adjusting pressureisgreaterthanthepressurelimitofinsurance,opencansbottomvalve,openthedrainvalveatthetopofafilter,theexhauststartatimer;timetoset,closethedrainvalveatthetopofafilter,thefiltermaterialafteropeningavalve;waitfortheproducttoemptyliquidfeed transferwhenthebitisset,thematerialbegantoturntheairtrafficcontrol;tosetthetime,thevalvescloseallmaterials,productnaturalbreathing,turntheendofthematerial; 1_STA==5 &(PIPES_STA==5orvalveshavebeenPCT01>WCT01<TIMER2isA1:resetTIMER2;disable 1;resetTRANS_STAA2:closeFCV18,FCV19,FCV21,FCV28,FCV30;setPAV01tomanA3:openFCV15;set 1_STAto2,PIPES_STAto2;A4:releaseFCV10~FCV22,FCV27~FCV32,PAV01;Step4:EMPTYA1::setTIMER_SP6toTIMER2;startA1:setTRANS_STA;openStep2:PREA1:closeA2:openFCV14,FCV19,FCV21,FCV28,FCV30;enable 1;PAV01isMAN100% 1_STAto6,PIPES_STAtoA1:acquireFCV10~FCV22,FCV27~FCV32,TransCIPIntheoperationalphaseofcleaning,thecleaningsolutionisprovidedbyCIPstation.thetopofthefilterdrainvalveopenpulsationsinthecleaningprocess;dischargeoperationwhenthesystembeforeopeningjarsbottom在运行阶段,液由CIP站提供。滤芯顶部排放阀在流程中脉动开启;TransOrvalvesandCIPVGandstationhavebeenCIP_P_ActualactionnumberActualactionnumberTIMER1isOPERATORA1:releaseandCIPVGandCIPStep8:CIPA1:resetP_REQUEST_ORDER,P_CIP_START_ORDERP_CIP-PUMP_AIR_SUPPLY-ORDERP_CIP_EN_Conductivity;A2:MessageOperatorFAILStep7:CIPA1:MessageSUCCESS;setPIPES_STAtoA2:resetP_REQUEST_ORDER,P_CIP_START_ORDERP_CIP-PUMP_AIR_SUPPLY-ORDERP_CIP_EN_ConductivityStep12:JUMPA1:resetTIMER1;closeresetA2:resetStep6:CIPA1:setCIPVGtocloseroute;resetDRAIN_EN;disableFILTER_CONTROL;A2:closesetPAV01tomanA1:setP_CIP_PAUSE_ORDER;setTIMER1_SPtoTIMER_SP20;A2:openFCV22,FCV23,FCV26;setDRAIN_EN;startStep5A1:openStep3:CIPA1:setP_REQUEST_ORDER,P_CIP_START_ORDER,P_CIP-PUMP_AIR_SUPPLY-ORDER,P_CIP_EN_ConductivityP_CIP_RETURNPUMP_ORDER;enableFILTER_CONTROL;A1:acquireandCIPVGandCIPStep2:PREA1:closeA2:openFCV03,FCV04,FCV06,FCV09,FCV20,FCV21,FCV28,FCV30,FCV33,FCV35;setPAV01toman100%;A3:sendCIP_TYPEtoP_CIP_PROG_TYPE,CIPVG_ROUTEtoP_CIP_SELECTED_ORDER_UNIT;TransSIPIntheoperationalphasesterilization,pure intothepipeline,begantoheatup,monitoringthefilterhydrophobictemperature,onlywhenthistemperaturewhileachievingthesterilizingtemperatureanddurationaftersometime,thatthesterilizationwassuccessful.Inthesterilizationprocess,iftemperaturebelowthesterilizationtemperature,sterilizationtimerisstoppeduntilthetemperatureafterpassingthetimerisresetandstartthetimer.在灭菌运行阶段,纯蒸汽进入管路,开始升温,且持续一段时间后,才认为灭菌成功。在灭菌过程中,如果温度低于灭菌温度,则灭菌计时器停止,直到温度合格后计时器复位并重新开始计时。Thefirststagefilterforpenetrationandthetopdischargedelaybasedonthefilterwhenthehydrophobictemperaturereachesthesettemperaturewhentheclosed;afilterbeforethecontrolvalvefirstdifferentialpressureAdjustment,inthefilterthroughthecompletionofthe regulatingvalveandthenadjustthepressure(behindthepressurepoint);Aftersterilization,closethevalve,closeallFilterpressureandreferencetemperaturetotakefullhighlimitalarm;SIPfailurerequires灭菌升温阶段,产品罐罐底直排阀门延时关闭;一级滤芯进行蒸汽和顶部排放延时基于滤器的疏水温度达到设定温度时关闭;一级滤器前调节阀首先按压差调节,在滤器蒸汽完成,调节阀滤器压力和参照温度全程采取高限位;SIP失败需要提示TransvalveshavebeenTIMER3isTCT02OrTIMER1isTCT02OrTIMER1isTCT02TCT02OrTIMER1isisisOperatorStep13:CLOSEA1:stopTIMER1&TIMER2;disableEN_alarm_T;A2:closeFCV01,FCV03,FCV25,FCV31,FCV34;setPS_STAtoA3:messageoperatorSIPStep6:SIPA1:startTIMER2,enableA1:releaseFCV01~FCV09,Step5:PREA1:closeFCV32,FCV35A2:enablePS_FV(basepressure);setTIMER_SP2toTIMER2;A1:resetTIMER1&TIMER2;disablePS_FV;disableEN_alarm_T;messageSIPSUCCESS;A2:closeFCV01~FCV09,FCV19~FCV35;setPAV01toMAN0%;setPIPES_STAtoStep15resetA1:resetStep3:CLOSEA1:closeFCV26;resetTIMER3A2:enablePS_FV(basedifferentialStep2A1:closeFCV02,FCV05,FCV07,FCV08,FCV19,FCV24,FCV27,FCV29;settoMANA2:openA3:opensetTIMER_SP1toTIMER1;setTIMER_SP11toA4:setPS_STAto1;startTIMER1;startA1:resetTIMER1&TIMER2A2:abortcurrentA1:acquireFCV01~FCV09,FCV19~FCV35,ABORTINGitisdeterminedwhethertheCIPmode,ifso,tostopCIPstation;ifnot,alloftheintermediatestateisinitialized,closeotheroccupiedvalve,retainnaturalbreathing;Iftheoriginalstateisintheleakdetectionqualified,interruptfunctionwillleadtostatetothehasbeencleaned;Iftheoriginalstateofthe isinoperation,theinterruptfunctionwillcausethe statetorepairandmaintenance;CIPCIP站;如果不是,对所有的中间状态进行初始化,关如果原罐体状态处于运行中,中断功能会导致罐状态转为检修、CIPstationhavenotCIPstationhaveNOTStep2:RELEASECIPA2:ReleaseCIPstation,resetPIPES_STAPIPES_STAPIPES_STA &PIPES_STA Step6:CLOSEA1:resetTIMER1andTIMER2;resetPS_STA,PA_STA,TRANS_STA,DRAIN_ENdisable 1,FILTER_CONTROL,A2:setCIPVGtocloseroute,closeFCV01~FCV35;PAV01issettoMANA3:releaseCIPVG,releaseFCV01~FCV35,PAV01Step5:Step4:STATUSEA1:PIPES_STAtoStep3:STATUSEA1: 1_STAto1,PIPES_STAtoStep1:ABORTCIPA1:setP_CIP_ABORT_ORDER;A2:resetP_CIP_REQUEST_ORDERPAUSINGAccordingtothestateofpause,andclosingthecorrespondingsuspendopenedair,water,inletvalveandCIPstations;inaddition,thesuspendedstateinterlockingwatercontrolblock,cleaningpulsationblock, controlblocktemporarilycontrolvalves,pressurecontrolblockmaintaincontrol.(Inadditiontomanualoperationoutside,cip_p_alarmsignalCIPstationalsoactivatesthepause(除人为操作外,CIP站的cip_p_alarm信号也会激活暂停功能CIP_stationnotbeenNOTnhasbeenStep1:CLOSEA1:closeNOTStep5:PAUSStep3:PAUSCIPA1:setA2:messageCIPRESTOREDependingonthestateofpause,opentheclosedair,water, inletvalveandCIPrecoverystation;inaddition,theremovalofthesuspendedstateinterlockcontrolblockwater,cleaningpulsationblock,vaporcontrolblock.CIP_stationnotbeenNOTnhasStep1:OPENA1:openNOTStep5:OPENStep3:RESTORECIPA1:resetEM05:EQMEQMClassEQM1.2.3.Keep4.5.GeneralDescriptionTheEQMclassisusedtocontrolthe P&IDiagram功能CMTableDEVICEDescriptionTCIPCIPPST罐顶管路TTTT罐顶管路分支TTTTTTT罐底口前料T罐底管路进口T罐底管路口后料T罐底管路出口TT罐底CIPTTT从产品罐08来料T从产品罐07来料TFFFFFFTTTTFTFFTCIPVG的路径值(3CIP_CIP----灭菌时蒸汽控制块--DEVICEDescriptionT--------(CYCLES=CYCLES-----ParametersTable参数CIPCIP1CIP5CIP10sip120sip30sip121.5sip限2.2sip限sipsip80sip/Keeppressure0.8sip/Keeppressure0.6sipsipsip长5Keep10Keep5Keep120Keep0.2Keep0.05drain0.05drain5dry5CIP50CIP5CIP浸泡重量上限定200CIP浸泡重量下限定20CIP浸泡次数(段1cip20--0--0--蒸汽阀状态,0为闭,1为打开0--洁净压空状态,0关闭,1为打开0--温度使能,0关闭,1为打开0--动作号(用于0--剩余循环次数(0--0FlowChart流程CIPIntheCIPlogic,theCleaningfluidisprovidedbyCIPstation, toppass-throughvalveandsprayvalveaccordingtothesettimetoopeneachpulsation,pulsationcycle.Aftereachstagetoincreaseafterimmersioncleaningspray,CIPstationinteractwiththeneedtore-setimmersion bottomvalveisclosed,stoppedafterthesetlevelintotheCIPcleaningsolution,soakthesetmixingtime,tosoakstirringtimeopen bottomvalve,waterrinsestageissetforanimmersioncycles,afterthecycleiscompletestopCIP.(Purificationforanadvancedso
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