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Author:DennisMcCulloughCleanDesignPrinciples‘Do/Don’ts’forValveDesignMicro/CleanDesignDo-Don’tsareprimarilyreferencetrainingmaterials;forP&Gprojectexecution,alwaysrefertotheCleanDesignStandards.CleanDesignforValvesValveDesignRequirementsValveTypesBallValvesActuatorButterflyControlDiverterDoubleBlockandBleedFloatDiaphragmGateGlobeManifoldMicro/CleanDesignPrinciplesMicro/CleanDesignPrinciplesCleanDesignforValves(cont.)ValveDesignRequirementsValveTypesNeedlePinchPlugCheckLiftCheckValveMultiportChangeoverMixproofMultiportSampleValvesPipeConnectionsCIP/SIPMINIMALRISK(=standardfornewequipment)MODERATERISKHIGHRISK316LorbetterSS*SS316Not316SSMinimumRa0.8μm(32μinch)Ra0.8-1.0μm(32-42μinch)MuchhigherRaInternalsurfaceshavenopitting,roughness,orcorrosionInternalsurfaceshaveroughnessbutnopittingorcorrosionInternalsurfaceshavepitting,roughness,andcorrosionCheckyourMOCcompatibilitywithyourproduct&sanitizingagentwithCETL!

*Incaseofnewrawmaterialsorcorrosivematerials,refertoCETLMaterialEngineeringexpertMicro/CleanDesignPrinciplesValvesMaterialsofConstructionMoredetails:SeeP&GCleanDesignStandardsoncGMPsiteCleanDesignSpecsforValvesValvesshould:ProvidecompletedrainabilityCIP/SIPcapableAllpartsofthevalvemustcomeintocontactwithCleaningSolutionPolishedsurfacesZerodeadlegsCompatibility–product,ozone,sanitizersMicro/CleanDesignPrinciplesWithregardtoclean/sanitarydesignrequirementsthereisanorderofpreferencewhenselectingvalvesasindicatedabove.Whenselectingvalvesforspecificapplicatione.g.,control;on/off,stop/backflowprevention;refertotheValverisktableforpreferredvalveselection.“Do”“Don’t”ValveDesign*MayrequireadditionalCIP/SIPstepstoachievefullsanitarycomplianceMicro/CleanDesignPrinciplesSanitaryNon-SanitaryButterflyValvesBallValves(otherthanPBM)DiaphragmValvesGate/Plug/Globe/NeedleValvesPiston/Mixproof/RisingStemValvesPBMBallValves(Self-flushingtype)SanitaryCheckValves*SanitaryControlValves*“Do”“Don’t”Micro/CleanDesignPrinciplesValveDesignExample:BallValve:Notrecommendedforuse.Doesnotmeetmicro-cleandesignrequirements.Requiresfulldisassemblyandcleaning.ThePBMself-flushingvalveistheONLYmicroapprovedforsanitarydesign.Example:PBMValve(Left)andBallValve(Right)AccumulationofmaterialsMicro/CleanDesignPrinciplesExampleshownillustratesleftoverproductcanaccumulatewithinvalveinternalsresultinginMICROriskValveDesign“Don’t”Example:BallValvewithinternalthreaddesignMicro/CleanDesignPrinciplesValveDesignAutomatedactuationvalvesareacceptableassumingweareusingacleandesignvalve.ExamplesincludePBMself-flushingballvalves,butterfly,sanitarycontrolvalves,piston/mixproof/risingstemvalves(Mfgs.:AlfaLaval,Definox,orTuchenhagen)areacceptablecleandesignvalvebodieswhichcanacceptanairactuator.“Don’t”Example:AirActuatedBallValve(NotPBMSelf-flushingtype)Micro/CleanDesignPrinciplesValveDesign*SanitarydesignbutterflyvalvesarerecommendedforPurifiedwatersystems.ButterflyValvesareinherentlydrainable,buthaveasmallcreviceatthelocationofthediscandvalveseat,wherethevalvestempassesthroughtothevalvebody.Thiscrevicecreatesariskforpotentialmicrobiologicalgrowth.Thisvalvemayrequireremovaltoinspectand/orcleanthevalveseat/stemarea.ProperdrainagefromButterflyvalvescanbeachievedbyinstallingthevalveataslightanglesuchthatthevalvestemisnotatthebottomofthepipe.Duetotheinherentdesignofthebutterflyvalvethiswouldbeacriticalpointinacleaningandsanitizationvalidation.Example:ButterflyValve“Do”*ThebodyofthecontrolvalveandassociatedpipingarethecriticalcomponentsindeliveringsanitarydesignMicro/CleanDesignPrinciplesValveDesignExample:ControlValve*Generally,thesetypesofcontrolvalvesdonotmeettherequirementsofcleandesignduetotheirlackofdrainabilityanddisassemblyrequirementstodelivercleaningandsanitization;however,properspecificationandselectionofsanitarycontrolvalvemodelsandattentiontoinstallationandpipingdetailscanalleviatetheseissues.TypicalsanitarycontrolvalvesusedinP&GapplicationsareavailablefromFisher-Baumann;Sampson,andSteriflow“Do”*Typicalcontrolvalvebodytypesinclude:-Globeorslidingstem(mostcommon),-Butterfly,-Vee-ball,etc)Micro/CleanDesignPrinciplesValveDesign“Do”*Example:SanitaryControlValve*Generally,thesetypesofcontrolvalvesdonotmeettherequirementsofcleandesignduetotheirlackofdrainabilityanddisassemblyrequirementstodelivercleaningandsanitization;however,properspecificationandselectionofsanitarycontrolvalvemodelsandattentiontoinstallationandpipingdetailscanalleviatetheseissues.SanitaryControlValvesshown.Micro/CleanDesignPrinciplesValveDesignExample:DiverterValveNotrecommended.Doesnotmeetmicro-cleandesignrequirements.Requiresfulldisassemblyandcleaning.“Don’t”Example:DoubleBlockandBleedValveMicro/CleanDesignPrinciplesValveDesignDoesnotmeetmicro-cleandesignrequirements.Requiresfulldisassemblyandcleaning.Doubleblockandbleedusedinasanitarysystemwithnon-sanitaryvalves.Okforuseinnon-susceptiblesystems.UsecleandesignMixproofValveforsanitaryapplications“Don’t”Note:ReferenceSection19.7OfCleanDesignStandardsforproperuseandapplicationOfblockandbleedvalvesinSanitaryapplicationsMicro/CleanDesignPrinciplesValveDesign“Don’t”Doesnotmeetmicro-cleandesignrequirements.Designconcernforopenatmosphericapplicationsmeetingmicrobial/cleandesign.Example:FloatValveMicro/CleanDesignPrinciplesValveDesignExample:DiaphragmValve“Do”DiaphragmValvesaredrainableandareessentiallyfreeofcrevicestocollectwaterorproduct.Thesevalvesareanexcellentchoiceforsanitarydesign.Preferredsanitaryvalveforfluidscontainingasuspendedsolid.Thediaphragminthevalvemustbeinspectedandreplacedonaregularbasistoensurediaphragmintegrity.DiaphragmValvesareavailablewithsanitaryclamporbutt-weldconnectionstomeetsanitarysystemrequirements.Micro/CleanDesignPrinciplesValveDesignExample:GateValve“Don’t”Notrecommendedforuse.Needle,Gate,andPlugValvesareimpossibletosanitizeproperlyandshouldbeavoided.Likeballvalves,thesevalvescanaccumulatewaterindeadareasthatcanleadtomicroorganismproliferation.Micro/CleanDesignPrinciplesValveDesignExample:GlobeValve“Don’t”Notrecommendedforuse.Doesnotmeetmicro-cleandesignrequirements.Requiresfulldisassemblyandcleaning.Shouldonlybeusedinsteamapplications.Micro/CleanDesignPrinciplesValveDesignExample:NeedleValveusedonManifold“Don’t”Notrecommendedforuse.Needle,Gate,andPlugValvesincludingthoseusedonmanifoldsareimpossibletosanitizeproperlyandshouldbeavoided.Likeballvalves,thesevalvescanaccumulatewaterindeadareasthatcanleadtomicroorganismproliferation.A“better”choicewouldbeadiaphragmorself-flushingPBMballvalve.Micro/CleanDesignPrinciplesValveDesignExample:NeedleValve“Don’t”Notrecommendedforuse.Needle,Gate,andPlugValvesareimpossibletosanitizeproperlyandshouldbeavoided.Likeballvalves,thesevalvescanaccumulatewaterindeadareasthatcanleadtomicroorganismproliferation.Micro/CleanDesignPrinciplesValveDesignExample:PinchValveNotrecommendedforuse.Doesnotmeetmicro-cleandesignrequirementsforliquidapplications.Requiresfulldisassemblyandcleaning.“Don’t”Micro/CleanDesignPrinciplesValveDesignExample:PlugValveNotrecommendedforuse.Needle,Gate,andPlugValvesareimpossibletosanitizeproperlyandshouldbeavoided.Likeballvalves,thesevalvescanaccumulatewaterindeadareasthatcanleadtomicroorganismproliferation.“Don’t”Micro/CleanDesignPrinciplesValveDesignExample:LiftType(Flap)CheckValve“Don’t”Lifttypecheckvalvesshouldnotbeusedunlessabsolutenecessary.Theyneedtobespecifiedforsanitarydesign.Thesystemcanbedrainedbyphysicallyremovingthecheckvalveduringsanitizing,orbyinstallingadrainsetupabovethecheckvalveforin-placesanitizing.Ifthisisnotpossible,theymustberemovedandsanitizedonaregularbasis.Note:Onlyusecheckvalveswhereyouhaveto--nevercombinecheckvalvesinlinewithstrainers/filtersthatrequirebackflush.ValveDesignMicro/CleanDesignPrinciples“Do”*Example:CheckValve(Do-All*)Acceptableforuse.Doesmeetmicro-cleandesignrequirements(Moderaterisk)*.CanbedisassembledforcleaningMicro/CleanDesignPrinciplesValveDesignMixproofValve:Recommendforuse.Meetssanitarycleandesignstandards“Do”Example:MixproofValveNote:CanalsobereferredasPiston/Mixproof/RisingStem(Multi-Port)ValvesNote:IfpurchasingtheGEATuchenhagenvalvetheDorBvalveswilldischargeasmallamountoffluideverytimethevalvecyclesandthisdischargeisunavoidable.Ifthisoccurs,theleakagechambermustbepartoftheC&Sprocess.ThereisanothertypeofTuchenhagenMix-proofvalvecalledtheRtype.ThisR-Valveisprovidedspecificallyforthepurposeofpreventingthatdischargeoffluidduringvalvecycling.AlternateselectionistheAlfaLavaldouble-seatdesignMxproofvalve.Micro/CleanDesignPrinciplesChangeoverValve:Recommendforuse.MeetssanitarycleandesignstandardsValveDesignExample:ChangeoverValve“Do”Note:CanalsobereferredasPiston/Mixproof/RisingStem(Multi-Port)ValvesNote:IfpurchasingtheGEATuchenhagenvalvetheDorBvalveswilldischargeasmallamountoffluideverytimethevalvecyclesandthisdischargeisunavoidable.Ifthisoccurs,theleakagechambermustbepartoftheC&Sprocess.ThereisanothertypeofTuchenhagenChangeovervalvecalledtheRtype.ThisR-Valveisprovidedspecificallyforthepurposeofpreventingthatdischargeoffluidduringvalvecycling.AlternateselectionistheAlfaLavaldouble-seatdesignChangeovervalve.Micro/CleanDesignPrinciplesAnyvalvethatrequiresdisassemblyforpropercleaning&sanitizationisnotacceptableandbringsaHIGHMICROrisk.PBMistheonlyvalidated(multi-port)ballvalveallowedperP&Gcleandesignvalvestandards.UseofthePBMballinP&Gsanitaryserviceisrecommendedformicrocleandeignandreliability.Ifautomationrequiredforapplication,reviewuseofcleandesignchangeover/multi-port/piston/risingstemvalve.ValveDesignExample:ManualMulti-PortValve“Don’t”Micro/CleanDesignPrinciplesSampleValve:Example(left)isAlfaLaval.Examplerightisnotsanitarydesign(internalthreads)ValveDesign“Do”“Don’t”Micro/CleanDesignPrinciples“Do”“Don’t”ValveDesignSampleValveApplicationMicro/CleanDesignPrinciples“Do”“Don’t”ValveDesignEnsurevalvematerialselection(316LSS)iscorrecttoavoidproductMicro/QAriskandtomeetcleaningandsanitizingtemperatures(820C(1800F)Micro/CleanDesignPrinciplesValveDesign“Don’t”Avoidboltedflangedand/orinternalthreadedconnectionsMisalignedPipesectionsprovideareasforproductaccumulationProductcanaccumulateinthreadsandatjunctionMicro/CleanDesignPrinciplesValveDesignAvoidboltedflangedand/orinternalthreadedconnections“Do”“Don’t”LowpressuresanitaryclampHighpressuresanitaryclampMicro/CleanDesignPrinciplesValveDesign“Do”“Don’t”SanitaryFlangeconnectiononButterflyValveItisimportanttominimizetheuseofboltedflanges,usedprimarilyatequipmentandinstrumentconnections.Pipemustbeweldedatasmanyjointsaspossible.Byitsverynature,agasketedflangeconnectionisnotasanitarydesign.Theflangesareusuallymachinedorcasttoveryloosetolerances,relativetosanitarydesigntolerances.Thegasketiscutfromalargesheetofmaterial,ofteninthefield.Themate-upofpipesectionsisoftennotstraight,allowingforsmallcrevicesandgasketoverlapthattrapproduct.Goodinteriorcleaning,totheextentrequiredforsanitaryoperation,willusuallyrequiredisassemblyMicro/CleanDesignPrinciplesValveDesignForlargebore

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