寶潔日化培訓(xùn)課件3-8-017 CIP-SIP Do-Don't rv 9-16-2011

Author:DennisMcCulloughCleanDesignPrinciples‘Do/Don’ts’forCIP/SIPMicro/CleanDesignDo-Don’tsareprimarilyreferencetrainingmaterials;forP&Gprojectexecution,alwaysrefertotheCleanDesignStandards.Micro/CleanDesignPrinciplesCleanDesignSpecsforCIP/SIP*DefinitionsPrinciplesDesign:InertMaterials316LSSRequirementsfortemperatureSurfacefinishRa<0.8microns(32micro-inches)SmoothsurfacesAvoidanceofbio-filmsPreventproduct/materialaccumulationWeldspolishedandgoodqualityAvoidanceofdeadlegsCIP/SIPDesignforCleaningefficiencyProtectedagainstcontaminationfromoutsideenvironment*CIP=Clean-inPlace;SIP=Sanitize-in-PlaceMINIMALRISK(=standardfornewequipment)MODERATERISKHIGHRISKSS316LSS316LowergradeSSFRPThermoplasticsMinimumRa0.8μm(32μinch)Ra0.8-1.0μm(32-42μinch)MuchhigherRaInternalweldsgroundsmoothandpolishedInternalweldsgroundsmoothInternalweldsnottreatedCheckyourMOCcompatibilitywithyourproduct&sanitizingagentwithCETL!Micro/CleanDesignPrinciplesCIP/SIP:MaterialsofConstructionMoredetails:SeeP&GCleanDesignStandardsoncGMPsite.Micro/CleanDesignPrinciplesCIP/SIPDesignCIP/SIPDefinitionsClean(Sanitary)Design–FoundationstartingpointforC&S(Cleaning&Sanitization)Cleaning-theprocessofremovingmaterialtoapre-determinedstandard,freefromdirt,pollution,contamination.(Requiredbeforesanitizationcanoccur)Sanitization–themethodofreducingthenumberofmicroorganismstoa“safelevel”whichwillnotthreatentheintegrityofproductsormaterialsItsoneoftheveryfewpreventativemicrobiologicalcontrolstrategieswecanuse.Micro/CleanDesignPrinciplesCIP/SIPDesignCleanable&Sanitizable:ThepreferredmethodforcleaningisCIP/SIP(cleaninplace,sanitizeinplace).ThepumpmaterialsofconstructionmustbeabletowithstandCIP&SIPcleaningagentsandtemperatures.

Specifythecleaningandsanitizationmethodtotheequipmentsupplier!!Micro/CleanDesignPrinciples*Note:whenusingrinsewateranalysisitisessentialthattheinitialcountoftherinsewaterdoesn’texceed10cfu/ml.CIP/SIPDesignCleaningCriteria:Lessthan1/1000thofthespecifieddoseoftheactivematerialpersquaremeterofsurfaceofthemanufacturingequipment.Lessthan10ppmofresidualproductpersquaremeter.Novisibleresiduesormaterialoverthecompletesurfaceoftheequipment.Micro/CleanDesignPrinciplesCIP/SIPDesignSanitization:Lessthan25colonyformingunits(CFU)per25sqcentimeters(10sqinches)ofsurface.Lessthan10CFUdifferenceintheingoingandoutgoingrinsewatersamples*.Absenceofobjectionableorganisms.Micro-CleanDesignPrinciplesMustcleaneffectivelybeforesanitizationManualorautomaticCleaning/Sanitizationwithminimumdisassemblyorre-assemblyofequipmentMicro/CleanDesignPrinciplesCIP/SIPDesignCIP/SIPPrinciplesDefinedprocess/procedureDefinedfrequencyValidatedaseffectiveMultiplemethods–temperature,hypochlorite,alcohol,ozonePerformancecritical–time,temperature,concentration,contactandexposureMicro/CleanDesignPrinciplesCIP/SIPDesignCIP/SIPPrinciplesTime:AllPipingmustbedesignedtoremainatsanitizationtemperature82C(180F)for30minutesTemperature:Allpipingmustbedesignedtoremainatsanitizationtemperature82C(180F)fornolessthan30minutes.Inthecaseofahotpurifiedwaterdistributionsystem,thesystemmustremainabove82C(180F)(Moistheat)*continuously.Forcoldpurifiedwater,thesystemmustbeprotectedwithaminimumozoneconcentrationof0.25ppmandmaintaincirculationthroughoutthesystem.Equipmentdesignspecificationswillrequiredesignsthatcansupporttheappropriatecleaningandsanitizationprocessasdictatedbyeithertheproductcategoryorthebusinessunit.*Typicalmoistheatishotwaterorsteam(2bar)maximumMicro/CleanDesignPrinciplesCIP/SIPDesignCIP/SIPPrinciples(cont.)Wherehotwaterandsteamcannotbeutilizedduetoexistingsystemconfiguration,orformulationconsiderations,chemicalsanitizationagentscanbevalidatedaseffective.Ifchemicalsanitizersaretobeusedthesystemandproductmustbeshowntobefullycompatiblewiththesanitizer.Note:UseofanyotherchemicalsanitizerrequiresagreementfromtheRegionalMicrobiologistandapprovalbythesite’schangereviewboard,priortopurchase.Personalprotectiveequipmentrequirementsmustbeidentified,priortostartofcleaningorsanitizingwithchemicals.Twocommonlyusedalternativestoheataredetailedbelowwithstandardchemicalconcentrationsandexposuretimes.Hypochloritesolution-minimumhypochloriteconcentrationof250ppmonspentfluidandnomorethana25ppmdropfromtheconcentrationintroducedintothesystem.Allequipmentbeingsanitizedmustbeexposedforminimum30minutes.Ethanol/IPA-minimum70%Ethanol/IPA/IPAconcentrationwith30minuteexposuretime.Micro/CleanDesignPrinciplesCIP/SIPDesignCIP/SIPPrinciples(cont.)Poorcleaning&sanitizationisamajorcontaminationriskThemostcommonrootcausesforcleaning/sanitizationfailuresareLackofsanitarydesignindevelopment/process/storage/packingequipment.InadequatecompletionoftheprocedurePoorchangecontrol–newproducts/repairsLackofawareness&understandingReblendandeffluentdisposalsystems

DiluteproductallowsbacterialadaptationMicro/CleanDesignPrinciplesCIP/SIPDesignInertMaterialsInerttoproduct,processconditionscleaning/sanitizingagentsNonreactive,additiveorabsorptiveStructuralconsiderationsProductdeterminesmaterialofchoiceStainlesssteel–316LSinglepolymerplastic-PE,PP,PTFESeals&gaskets-EPDM,PTFE,Viton,SiliconeAggressiveproducts/materials-TitaniumCostaconsiderationbutnottheconsiderationPseudomonas

sp.AccumulationonStainlessSteelMicro/CleanDesignPrinciplesCIP/SIPDesign“Don’t”Micro/CleanDesignPrinciples“Do”“Don’t”316L;SurfacefinishRa<0.8microns(32micro-inches)Poorsurfacefinishquality;leadstowatercollectionafterCIP/SIPGoodsurfacefinishquality<0.8microns;leadstohigherqualityCIP/SIPCIP/SIPDesignMicro/CleanDesignPrinciplesCIP/SIPDesignCleaningsystemadequatelydesigned:CleaningagenteffectiveforproductremovalSufficientpressure/flowDesign-locationofsprayballsSystemdesignedtoallowaccesstoallcontactparts:Noproductaccumulation(connections!)Simplifieddesign(maintainingCD*standards)Pipingslope/equipmentdrainabilityNothingoverheadproductzonesNodeadlegs*CleanDesignStandardsShadowAreaMicro/CleanDesignPrinciplesCIP/SIPDesignCIP/SIPDesign:Sprayballcleaningefficiency“Don’t”Micro/CleanDesignPrinciples“Don’t”TankDesign:Jet-ball-Cleaningefficiencyisbetter*

*Note:Considerationneedstobegiventosprayballdesignandselectionforapplicationsinvolvingcorrosivematerialsduetopotentialissueswithcrevicecorrosionwhichcouldcauserotatingsprayballstobecomeinoperable.Therefore,specialdesignsofstationarysprayballsmayberequiredtoavoidthisproblemandtostillensurefullcleaningofthetank.“Do”CIP/SIPDesign“Do”Micro/CleanDesignPrinciplesCIP/SIPDesign:UtilizeVendormodelingcapabilitiesforpropersprayballselectionandpositionCIP/SIPDesignExistingSystemStorageTanksDayTanksFiller3Storagetanks5daytanks4-5pumps16-20by-passes80+valves3Mainpipelines-approx60meterslengthOver50othersectionofpipe-jointed1.5mofpipe-6valves&4strainers6weekstoclean&sanitizeMicro/CleanDesignPrinciplesCIP/SIPDesign“Don’t”StorageTanksFillerManifold3x60mlengthofpipeContinuouslyweldedThreepump20valvesIncreasedflexibilityReducedchangeovertime5minutesClean/sanitize=1hour(Systemscanbecleanedandsanitisedseparately)Micro/CleanDesignPrinciplesDesignpipingtoequipmentforsimplicity—Note:ManualmanifoldscanpresentcleandesignrisksCIP/SIPDesignManifoldExecutions:-CleanDesign-PresentQARisk-Requirepre-approvalfromMicrobiology-”Better”systemisAuto-Manifold“Do”Provideequipmentsimplicity“Don’t”CreateQA/Microrisks—cleandesignappliedtomanifolddesign“Do&Don’t”Micro/CleanDesignPrinciplesManifoldExample:Internalmanifoldsmustbedesignedwithinternalslopetopromotedrainability&designedfor“pokeyoke”—toensurepipefittingsonlymatchtoonesystemtoavoidQArisk“Don’t”CIP/SIPDesignMicro/CleanDesignPrinciplesDesignpipingtopromotedrainabilityforequipment“Do”CIP/SIPDesignPumpMMTankBottomMillNewSimplifiedDesignToHXMicro/CleanDesignPrinciplesPumpMMTankBottomMillToHXCIP/SIPDesign“Do”“Don’t”O(jiān)riginalDesignDesignpipingtopromotedrainabilityforequipmentPumpFMTankBottomMicro/CleanDesignPrinciplesPumpFMTankBottom“Do”“Don’t”DesignpipingtopromotedrainabilityforequipmentNewSimplifiedDesignOriginalDesignCIP/SIPDesignCIP/SIPDesignMicro/CleanDesignPrinciplesAvoidpipingdirectoverproductzones“Don’t”DeadLegdesignprinciplesMicro/CleanDesignPrinciplesCIP/SIPDesign“Do”DeadLeg1DeadLeg2Micro/CleanDesignPrinciplesCIP/SIPDesignAvoid“DeadLegs”inpipingdesign“Don’t”CriticalFactors–newfindingsWashoutWaterVelocityPipediameterPresenceofdeadlegsLocationofdeadlegsrelativetoanelbowPositionofdeadlegsrelativetowaterflowMicro/CleanDesignPrinciplesCIP/SIPDesignTerminologyx=deadlegpositionDirectionofwaterflowInSideOutSide(ISOS)(hardtoclean)InSideOutBase(ISOB)(easytoclean)InBaseOutSide(IBOS)(moderate)Deadlegrotationrelativetohorizondidnotappeartoaffectwashoutdurations.Micro/CleanDesignPrinciplesCIP/SIPDesignPoorwash-outpipingdesign1"drainToProcess1tontankPITTITToProcess3"1"RO/DIWaterinjection3"PipingSprayballWaterSupply1"drain1"drain213HypotheticalPoorWashoutSequenceStepDescriptionDuration(s)1Sprayballemptytank,pumpouttodrain602CyclePSVtocleanPSVseat,cleanpumpusingwaterinjectionandrunningpumpathighoutput1803OpenPSVandtocleandownstreampiping.Cyclethroughdrains,thenopenalldrains.2404Drainentiresystem30Totalwashouttime8:30Waterpumpedfromtanktowashoutdownstreampipingwouldresultinineffectivecleaningofpiping.Long,multipledeadlegsinISOSpositionNumerous1”drainpointsdonotallowconsistentwash-watervelocity.Waterflowisrestrictedthrough1”waterinjectionanddrains.Usingprocesspumptodrivewatermaylimitwatervelocity.xMicro/CleanDesignPrinciples“Don’t”Betterwash-outpipingdesign2"RO/DIWaterinjection1tontankPITTIT2"drain3"PipingProcessProcess3"2"drainSprayballWaterSupply1a21b31cMicro/CleanDesignPrinciplesAlldeadlegsareinISOBposition,includinginstrumenttees.Lowflowthroughtanksprayballshasminimalimpactonwaterinjectiontopiping.Redundantdrainvalvesremovedfromsystem.Deadlegdistancesareshortenedasmuchaspossible.Upsizedwaterinjectionsanddrainallowadequatewatervelocitythrough3”pipe.HypotheticalBetterWashoutSequenceStepDescriptionDuration(s)1aSprayballemptytank451bCyclePSVtocleanPSVseat151cAfterPSViscleaned,cleanpumpusingwaterinjectionandrunningpumpathighoutput302OpenPSVtocleandownstreampipingusingwaterpressure303ClosePSVandcleanthroughtankblockvalve154Drainentiresystem30Totalwashouttime2:45“Do”Micro/CleanDesignPrinciplesCIP/SIPDesignPrinciplesforeffectivewash:CleaningWaterFlowrate:ForallbusinesscategoriesandproductstheflowratemustbeturbulentatReynoldsnumber>3000(typically;1-1.5m/sec(3-5ft/sec))relativetothesurfacetobecleanedfortheCIPproceduretobeeffective.Higherflowratesimpartingmoreenergy/turbulenceand/orelevatedwatertemperaturemayberequiredforsomeproductcategoriesforexampleviscousmaterialsneedatleast2.5-3meterspersecond(8-10ft/sec)foreffectivewashout.TherequiredflowratemustbedeterminedexperimentallyorviamodelingandfinallyvalidatedaspartoftheCleaning&Sanitizationvalidation.Whateverflowrateusedmustbesufficienttoremoveallproductresiduesthatmayinhibiteffectivesanitization.Ineffectivecleaningwillalsoincreasetheriskofcorrosionduringsanitizationduetotheelevatedtemperaturesandproductresidues.“Do”Micro/CleanDesignPrinciplesCIP/SIPDesignCleanDesignSpecsforCIP/SIPDesign:PrinciplesforeffectivewashMaximizingwashwatervelocityisthemostsignificantfactorforeffectivewashouts–especiallyincaseswheredeadlegsexist.Eliminatedeadlegswherepossible;otherwisekeepdeadlegstominimumL/DratioorpositiondeadlegsinISOBposition.Increasingwash-watervelocityresultsindecreaseinwaterconsumption.PDpumpsshouldrunnearfulloutputduringcleaningtominimizetimetocleanpumpinternals“Do”MaximizingvelocityMicro/CleanDesignPrinciplesHighervelocity=reductionofwaterusagePipesizeVelocitym/sflowrate(gpm)duration(sec)waterusage(gal)Waterreduction3",nodeadlegs21454110070%3",nodeadlegs3.5253730Micro/CleanDesignPrinciplesEquipmentfindingsStaticSprayballDesignMechanicalSprayballDesignSavingsSprayballtypeDuration(min)Waterusage(tons)Duration(min)Waterusage(tons)Time(min)Waterusage(tons)Washout201.58.712.8Sanitizations303.6301.102.5Micro/CleanDesignPrinciplesCIP/SIPDesignPDpumps:PDpumpsshouldrunnearfulloutputduringcleaningtominimizetimetocleanpumpinternals.TankCleaningLeveragevendormodelingtohelpdeterminebestsprayballdesignandoperatingsequencetocleantanks.Partiallyfillw/agitatorrunning,drainfirst(sprayballineffectivebelowwaterline),don’tcleaninlet&tankatthesametime“Do”TipsforwashoutsequenceMicro/CleanDesignPrinciplesCIP/SIPDesignForwashoutsequences,breakupsystemsintocircuitstomaximizeavailablewashwatercapacity.SeparateentiresystemsintocircuitsandevaluatewaterflowsandvelocitiestoensurethattargetvelocitiescanbeachievedthrougheachcircuitGenerally,cleancircuitsclosesttothewatersourcefirst.Thenmovetonextcircuitfartheraway.Noparallelflowpathshouldbeusedinacircuitunlesssufficientwatervelocityisassuredinallpaths.Avoidcontaminatingcleancircuitsbyensuringthatcircuitsthatarebeingcleaneddonotdrainthroughcircuitsthathavealreadybeencleaned.“Do”PipingdesignforwashoutMicro/CleanDesignPrinciplesCIP/SIPDesignConsiderwashoutwhenP&IDsaredevelopedandwhencompletingpipingdetaildesign.UseshortTeesvs.standardlengthTees.Be