寶潔日化培訓課件3-8-010 Piping Do-Don't rv 9-16-2011

Author:DennisMcCulloughCleanDesignPrinciples‘Do/Don’ts’forPipingMicro/CleanDesignDo-Don’tsareprimarilyreferencetrainingmaterials;forP&Gprojectexecution,alwaysrefertotheCleanDesignStandards.Micro/CleanDesignPrinciplesCleanDesignforPipingMOCSlope/DrainabilityPipingDesignRegulatedSystemsNon-RegulatedSystemsPipingReferencesPipeConnections&SystemsSanitaryfittings/Noboltedflanges/NointernalthreadedconnectionsPipetopipeDeadLegsReducersMicro/CleanDesignPrinciplesCleanDesignforPiping(cont.)PipeConnections&SystemsPipetoEquipmentFlexConnections/FlexHoses(duringuseandstorage)DrainConnectionsGaskets/Seals/SightGlassesCIP/SIP/TemperatureMappingVentingInsulation&HeatTracingMINIMALRISK(=standardfornewequipment)MODERATERISKHIGHRISK316LorbetterSSTubingfabricatedinaccordancewithAWSD18.1standard/ASMEBPE(BioProcessEquipmentv.2009)/DIN11866.Linepiping(e.g.,PVDFmaterial)usedonhighlymicrosusceptiblematerialandjoinedhygienically.SS316;3ADairyStandardorDIN11850PipingStandardsLowergradeSSFRPThermoplasticsMinimumRa0.8μm(32μinch)Ra0.8-1.0μm(32-42μinch)MuchhigherRaInternalweldsgroundsmoothandpolishedInternalweldsgroundsmoothInternalweldsnottreatedCheckyourMOCcompatibilitywithyourproduct&sanitizingagentwithCETL!Micro/CleanDesignPrinciplesPipingMaterialsofConstructionMoredetails:SeeP&GCleanDesignStandardsoncGMPsiteMicro/CleanDesignPrinciplesSlope>1%WHY?>1%Aslope<1%willnotallowforgooddrainageofproductandcleaningagentProperpipeslopeandsmoothfinishwillfacilitateproperdrainage,CIP,andSIPDesignandinstallpipingforminimumsloperequirementstopromotedrainability(dependentuponfluidproperties).Preferredminimumslopeis1cmpermeter;2%tofacilitatedrainingwithnodeadlegs.Toachieverequiredpipeslope,90,92,&88degree(nominal1.5Dradiuselbowsfor90s)elbowsisrecommended.Designandconstructoflongpipingruns(e.g.,piperacks,tankfarms,etc.)toachieveproperslopefordrainabilitymaybedifficultduetosignificantelevationdifferencesrequired.Inthesecases,ensuresufficientdrainpointsareinstalledthroughthelengthofthepipingandconsiderahighpointcrowninthemiddleofthepipingrunandslopedtoeachend.Wherepossible,includeelevationchangesatthepointofdirectionchangeofthepipingruntopromotedrainability.“Do”PipingDesignMicro/CleanDesignPrinciples“Do”“Don’t”Example:ProperslopeaidsinmaterialtransferandcleaningeffectivenessPipingDesignNotfullydrainableMicro/CleanDesignPrinciplesP&GWeldingGuidelines:RegulatedProductsSpecificationforSanitaryTubingandPiping(15371,Rev.1)Non-RegulatedProductsSpecificationforSanitaryTubingandPiping(15375,Rev.0)P&GCorporateWeldingSiteReferences(Referencecorporateweldingstandardsandspecificationssite)PipeandTankSpecificationsMicro/CleanDesignPrinciplesPipingDesignReferencesPipingDesignPractice(PDP)Micro/CleanDesignPrinciplesPipingDesignReferencesMicro/CleanDesignPrinciplesCleanDesignforPipingPipeConnections&SystemsSanitaryfittings/Noboltedflanges/NointernalthreadedconnectionsPipetopipeDeadLegsReducersPipetoEquipmentFlexConnections/FlexHoses(duringuseandstorage)DrainConnectionsMicro/CleanDesignPrinciplesFlangedconnectionsarenotacceptableforuseinsanitaryprocesspipingsystemsbecausetheytrapproductandcannotbecleanedviaCIP(cleaninplace)methods.

BoltedFlangeConnection“Don’t”PipeConnections&SystemsMicro/CleanDesignPrinciplesValveDesign“Do”“Don’t”SanitaryFlangeconnectiononButterflyValveItisimportanttominimizetheuseofboltedflanges,usedprimarilyatequipmentandinstrumentconnections.Pipemustbeweldedatasmanyjointsaspossible.Byitsverynature,agasketedflangeconnectionisnotasanitarydesign.Theflangesareusuallymachinedorcasttoveryloosetolerances,relativetosanitarydesigntolerances.Thegasketiscutfromalargesheetofmaterial,ofteninthefield.Themate-upofpipesectionsisoftennotstraight,allowingforsmallcrevicesandgasketoverlapthattrapproduct.Goodinteriorcleaning,totheextentrequiredforsanitaryoperation,willusuallyrequiredisassemblyMicro/CleanDesignPrinciplesPipingDesignForlargeborepipingconnectionswheresanitaryconnectionsmaynotbeavailable*,thefollowingmustbeprovided:“Do”Taper-Lock“Zero-GapConnection”Note:TheaboveisanexampleONLYPipeconnectionsmustbealignedwithin<0.50mm(0.020inches)NoprotrusionofthegasketorO-ringsintotheinnerdiameterofthepipeConnectionsmustsealcorrectlywherethereisnoproductleakageorairin.Connectionsshouldrequireminimummaintenanceandarerepeatableiftakenapart.*Mayalsobeapplicablewhereprocessrequirementsprecludeuseofsanitaryclamps(i.e.,highpressureorhazardouschemicals)Micro/CleanDesignPrinciples“Do”“Don’t”Internalthreadedconnectionsarenot

acceptableforuseinsanitaryprocesspipingsystemsbecausetheytrapproductandcannotbecleanedviaCIP(cleaninplace)methods.PipeConnections&SystemsMicro/CleanDesignPrinciples“Do”“Don’t”Internalthreadedconnectionsarenot

acceptableforuseinsanitaryprocesspipingsystemsbecausetheytrapproductandcannotbecleanedviaCIP(cleaninplace)methods.PipeConnections&SystemsSampleValveExampleMicro/CleanDesignPrinciplesWhy?CrevicesinapipingsystemcanharborbacteriaandaredifficulttocleanMinimizeCrevices(productaccumulation)–prefermachineweldconnectionswhenpossible“Do”PipeConnections&SystemsSanitaryTri-ClampSealingRingJointClampSanitaryScrewconnectionExternalThreadpreventsproductaccumulationSealing“O”ringMicro/CleanDesignPrinciplesExample:DeadLegillustrationidentifying“cleaning”effectiveness“Do”“Don’t”Note:RE:Deadlegdesignrequirements:AlwaysaimtominimizedeadleglengthsparticularlyforlargeborepipesinceturbulentflowregimeduringcleaningismoredifficulttoachieveMicro/CleanDesignPrinciples“Do&Don’t”PipeConnections&Systems“Do”“Don’t”“Don’t”Micro/CleanDesignPrinciples“Do”“Don’t”Example:DeadLegillustrationPipeConnections&SystemsMicro/CleanDesignPrinciplesExample:DeadLegillustration“Don’t”PipeConnections&SystemsMicro/CleanDesignPrinciplesPipeConnections&SystemsExample:DeadLegillustration—Canbeadeadlegfromeitherdirection“Don’t”EccentricreducerConcentricreducerMicro/CleanDesignPrinciplesUseeccentricreduceronhorizontalpipe/tubeWhy?Concentricreducersarenotdrainable“Do”“Don’t”PipeConnections&SystemsMicro/CleanDesignPrinciples“Do”“Don’t”Avoidconcentricreducersinahorizontalline—useeccentricreducersConcentricreducerinahorizontallinePipeConnections&SystemsMicro/CleanDesignPrinciples“Do”“Don’t”Avoidconcentricreducersinahorizontalline—useeccentricreducersFluidtrapareaPipeConnections&SystemsNote:DiaphragmValve(“Don’t”)**Forproperdrainage,thevalvemustbemountedeithervertically(inlet/outletintrueverticalline),orifmountedinthehorizontalpositionitmustbecantedatanangle(i.e.,themanufacturerofthevalvewillspecifythecorrectangleposition(normallyonthevalvebodyitself)toensurefulldrainability.Example:Layoutsimplicity:AvoidblockingnormalworkpathflowsMicro/CleanDesignPrinciples“Do”“Don’t”PipetoEquipmentMicro/CleanDesignPrinciples“Do”“Don’t”TanklowpointTankdrainDesignpromotesdrainabilityPipetoEquipmentDesignpipingtopromotedrainabilityforequipmentExistingSystemStorageTanksDayTanksFiller3Storagetanks5daytanks4-5pumps16-20by-passes80+valves

3Mainpipelines-approx60metersOver50othersectionofpipe-jointed1.5mofpipe-6valves&4strainers6weekstoclean&sanitizeMicro/CleanDesignPrinciplesPipetoEquipmentDesignpipingtoequipmentforsimplicityStorageTanksFillerManifold3x60mlengthofpipeContinuouslyweldedThreepump20valvesIncreasedflexibilityReducedchangeovertime5minutesClean/sanitize=1hour(Systemscanbecleanedandsanitisedseparately)Micro/CleanDesignPrinciplesDesignpipingtoequipmentforsimplicity—Note:ManualmanifoldscanpresentcleandesignrisksPipetoEquipmentManifoldExecutions:-CleanDesign-PresentQARisk-Requirepre-approvalfromMicrobiology-”Better”systemisAuto-ManifoldMicro/CleanDesignPrinciplesPipetoEquipmentManifoldExample:Internalmanifoldsmustbedesignedwithinternalslopetopromotedrainability&designedfor“pokeyoke”—toensurepipefittingsonlymatchtoonesystemtoavoidQArisk“Don’t”Micro/CleanDesignPrinciplesPipetoEquipmentManifoldExample—Usesanitarypipeconnections;ensurecoversinplacewhennotinuseEnsurepipinghasproperslopetopromoteflowanddrainability—Nohosesforpermanentinstallations!!“Do”and“Don’t”Flexiblepipingcomponentsanduseofhosesmustbeeliminatedorminimizedwherepossible.Useofflexiblehose/pipingisonlyintendedfortemporaryuseorapplicationsthatrequireequipmentisolation(e.g.,loadcellsonatank,fillers,vibrationisolation).Micro/CleanDesignPrinciplesPipetoEquipment“Don’t”DesignpipingtomaximizeequipmentcleaningefficiencyHypotheticalPoorWashoutSequenceStepDescriptionDuration(s)1Sprayballemptytank,pumpouttodrain602CyclePSVtocleanPSVseat,cleanpumpusingwaterinjectionandrunningpumpathighoutput1803OpenPSVandtocleandownstreampiping.Cyclethroughdrains,thenopenalldrains.2404Drainentiresystem30Totalwashouttime8:301"drainToProcess1tontankPITTITToProcess3"1"RO/DIWaterinjection3"PipingSprayballWaterSupply1"drain1"drain213POORWASHOUTPIPINGDESIGNMicro/CleanDesignPrinciplesDesignpipingtomaximizeequipmentcleaningefficiencyPipetoEquipment“Do”HypotheticalBetterWashoutSequenceStepDescriptionDuration(s)1aSprayballemptytank451bCyclePSVtocleanPSVseat151cAfterPSViscleaned,cleanpumpusingwaterinjectionandrunningpumpathighoutput302OpenPSVtocleandownstreampipingusingwaterpressure303ClosePSVandcleanthroughtankblockvalve154Drainentiresystem30Totalwashouttime2:45BETTERWASHOUTPIPINGDESIGN2"RO/DIWaterinjection1tontankPITTIT2"drain3"PipingProcessProcess3"2"drainSprayballWaterSupply1a21b31cMicro/CleanDesignPrinciplesPipetoEquipmentDesignpipingtopromotedrainabilityforequipment“Do”SingleentrypointMicro/CleanDesignPrinciples“Do”“Don’t”MinimizeentrypointsfortanksPipingDesignMicro/CleanDesignPrinciplesMinimizeentrypointsfortanks

Tankinletmanifold–Singleentrypoints Tankinletmanifold–Multipleentrypoints“Do”“Don’t”PipingDesignMicro/CleanDesignPrinciplesDesignpipingtopromotecleanabilityforequipmentEuperlan:0.17%Dosing:6.5–20.5kg/h(LLPD3)Viscosity@serviceT(20degC):K=12000cps/n=0.5Consumption:~15T/yearMaxpeak:600kg/dayLTStoragetank(10T):Temperaturecontrol:10-35degCLLPD3(5.5to12T/h)CubiPIFMPDpumpPressurizedcanister8L2barspressureSeepexdosingpumpPackingfloorSpilltray316L“Don’t”PipetoEquipmentMicro/CleanDesignPrinciplesPipetoEquipment“Do”Spilltray316LMaximumweldedPiping,Sloped~40mFilter

Thehoseneedstobefoodgrade,tohavecleandesignconnectionsandtobesanitizedbeforeuseAmicrobiofilterneedstobefittedbeforeunloadingLTLSHHEvent+microbiofilter(0.2microns)+PVVV(!Size&settings)Storage(10T):Temperaturecontrol:10-35degCFLLPD3(5.5to12T/h)CubiPIFMPDpump(cleandesign)+CleandesignpressurereliefPressurizedcanister8L2barspressureDryfilteredair(<0.01micron)SeepexdosingpumpDNxPackingfloorSprayballwithSteam/WaterhoseconnectionEuperlan:0.17%Dosing:6.5–20.5kg/h(LLPD3)Viscosity@serviceT(20degC):K=12000cps/n=0.5Consumption:~15T/yearMaxpeak:600kg/dayMOC:316LSSwithHasteloyfittings.Passivated,Ra<0.8microns,VitonSeals/GasketsDesignpipingtopromotecleanabilityforequipmentMicro/CleanDesignPrinciples“Do”“Don’t”Example:QA&MicroRiskFlexConnections/FlexHoses(duringuseandstorage)Flexiblepipingcomponentsanduseofhosesmustbeeliminatedorminimizedwherepossible.Useofflexiblehose/pipingisonlyintendedfortemporaryuseorapplicationsthatrequireequipmentisolation(e.g.,loadcellsonatank,fillers,vibrationisolation).Installpermanentpipeandcomponentsintendedforuseoverextendedperiodsverticallyorwithsufficientandconstantslope(dependentuponthematerial’sviscosity)toallowforproperdrainingMicro/CleanDesignPrinciples“Do”“Don’t”Example:DonotusehoseclampconnectionsFlexConnections/FlexHoses(duringuseandstorage)Micro/CleanDesignPrinciples“Do”“Don’t”Example:DonotusehoseclampconnectionsMaterialselectionpoordesignchoice—notfullydrainable;cleanableFlexConnections/FlexHoses(duringuseandstorage)Micro/CleanDesignPrinciples“Do”“Don’t”UsesanitaryflexhoseconnectionsFlexConnections/FlexHoses(duringuseandstorage)FlexConnections/FlexHoses(duringuseandstorage)“Do”“Don’t”Example:EnablehosestorageconditionsthatallowcompletedrainabilityMicro/CleanDesignPrinciplesNote:Watch-outforlongerhoseswhenstoredhosecurvaturedoesnotimpededrainabilityMicro/CleanDesignPrinciplesTruck/RailCarUnloading:Ensureunloadinghosesaresanitary.Unloadhosescannotbeplacedongroundorstoredincorrectly

“Don’t”FlexConnections/FlexHoses(duringuseandstorage)Micro/CleanDesignPrinciplesFlexConnections/FlexHoses(duringuseandstorage)Truck/RailCarUnloading:EnsureunloadinghosesaresanitaryUnloadhosescannotbeplacedongroundorstoredincorrectlyNote:Watch-outforlongerhoseswhenstoredhosecurvaturedoesnotimpededrainability“Don’t”Micro/CleanDesignPrinciplesDrainConnectionsExample:Providesanitarydrainconnections“Don’t”Micro/CleanDesignPrinciplesDrainConnectionsExample:Providesanitarydrainconnections“Don’t”Micro/CleanDesignPrinciplesDrainConnectionsTrenchdrainsarenotsanitarydesign!!Openchannelsortrenchdrainsmustbeavoidedwhenpossibleastheyaredifficulttoclean,pronetooverflowingandposeamajorcontaminationriskduetotheirlargeexposedsurfacearea.Iftheyareabsolutelynecessary,theymustbeshallowandhaveacurvedprofiletofacilitatecleaninganddisinfecting,andthesitemustdevelop,documentandvalidatearegular,robustcleaningprogram(MDM).Routinecleaningandflushingwithasanitizationagentarerecommendedaspartofhousekeepingorpreventivemaintenanceprocedureswhenwashwaterorsanitizationwaterisnotflushedthroughthetrench.“Don’t”“Do”“Don’t”Micro/CleanDesignPrinciplesExample:Providesanitarydrainconnectionsproperlyventedper901.2.1oftheInternationalPlumbingCodeDrainstothefloormusthaveanatmosphericbreakofatleast25mm(1”),50mm(2”)orgreaterideally.Capsmustbeprovidedtosealdrainhubswhentheyarenotinuse.DrainsmustbelocatedatthelowestpointofanareawithsufficientfloorslopingforproperdrainageThelocationandseparationoftheinlettothedrainmustalsopreventsplashingofthewaterbackuptotheoutletandsurroundingareas.Ensurewateraccumulatingindikedareasdoesnotcompromisetherequiredairgapforthedrains.DrainConnectionsMicro/CleanDesignPrinciplesGaskets/Seals/SightGlassesExternallymountedlevel/sightglasses,particularlyiftheyareopenatthetop,areimpossibletocleanproperlyandprovidearapidandeasymeansofentryforbacteria.Theymustbeeliminated.Whereeliminationisnotpossible,documentedandvalidatedperiodiccleaningandsanitizationproceduresmustbeexecuted—Note:Onlyuseforcommissioningactivities.Avoidsightglasses—theyarenotsanitarydesign!!“Don’t”Micro/CleanDesignPrinciplesEnsuregasketsMOCcorrect(compatiblewithproduct)“Do”“Don’t”Pipinggasket(Viton)issueofPMCX-ray3forConcertoLPDSpec’dat900C(194F)orgreaterGaskets/Seals/SightGlassesCIP/SIP/TemperatureMappingcanbeusedtoevaluatetheeffectivenessoftheCIP/SIPprocessinthemostdifficulttoreachareasbutmustneverbethesolemeasureofsuccess.Micro/CleanDesignPrinciplesCIP/SIP/TemperatureMapping“Do”Temperaturemappingisconductedwheresteamorhotwatersanitizationsarebeingusedtosanitizeequipment.Theprocedureisintendedtoidentify“coldspots”inthesystemthataredifficulttoheatortakeanextendedperiodoftimetoreacheffectivesanitizationtemperatures.Thecoldspotsarethenroutinelyusedtomonitorthesanitizationproceduretoensureefficacy.“Coldspots”areidentifiedbystrategicallyplacingtemperaturemonitoringdevices/indicatorsaroundthesurfaceoftheequipmentand/orthroughouttheprocessandthenexecutingtheproposedsanitizationprocedure.Thesitethattakesthelongestperiodoftimetoreachtheminimumdesiredtemperatureisthe“coldspot”.

Somekeyareastomonitorwhentemperaturemappinginclude:lowturbulentareasareaswithpoorheatpenetrationduetodesignareaswheremanualinterventionisrequiredforpropercleaningequipmentconfigurationandheatsourceinletconfigurationventsanddustcollectionsystemsHeatExchangerExamplePipingExample:HighPointVentsMicro/CleanDesignPrinciplesPipeVenting(HighPointVents)Providinghighpointventsonpipingtoremovetrappedairisgooddesignpracticebutneedstotakeintoaccountmicrocleandesignrequirements.Inparticular,ifa“u”-bendisinstalledonthedischargesideofthehighpointventvalve,ensureitcanberemovedforcleaningorCIP.Alsoensurethehighpointvent,valve,anddischarge‘U’-bendarecleanedandsanitizedduringnormalC&SofthepipingsystemaspertheMDMProgram.Inaddition,ensureinstallationofthehighpointventdoesnotcreateadeadleg(less<3pipediametersoftheactualventpipediameter).Forexample,thedesignofthepump(andorientation)mustallowforwaterandproducttobedrainedfromthepumphousingleavingaslittlewaterbehindaspossible.Thiswouldalsoapplytotheinletandoutletpipingofthepump.Forpumpsthataredesignedorinstalledinsuchawaythatstandingwaterwouldremaininthepumphousingafterdraining,proceduresmustbeinplacetoeliminatethestandingwaterwithinthetimelimitsdefinedintheclean/sanitizationprocedure.“Do”“Do”PipingExample:HighPointVents—notcleandesignforCIP/SIPMicro/CleanDesignPrinciplesPipeVenting(HighPointVents)Providinghighpointventsonpipingtoremovetrappedairisgooddesignpracticebutneedstotakeintoaccountmicrocleandesignrequirements.Inparticular,ifa“u”-bendisinstalledonthedischargesideofthehighpointventvalve,ensureitcanberemovedforcleaningorCIP.Alsoensurethehighpointvent,valve,anddischarge‘U’-bendarecleanedandsanitizedduringnormalC&SofthepipingsystemaspertheMDMProgram.Inaddition,ensureinstallationofthehighpointventdoesnotcreateadeadleg(less<3pipediametersoftheactualventpipediameter).“Don’t”Micro/CleanDesignPrinciplesInsulation&HeatTracing“Do”“Don’t”Example:EnsureshoesareusedwhensupportingheattracedpipingMicro/CleanDesignPrinciples“Do”Insulation&HeatTracingMicro/CleanDesignPrinciples“Don’t”Example:Ensureheattracingrequirementsfittheprocess/product/siteenvironmentInsulation&Heat