w25™ sampling valve - keofitt uk · 2017. 2. 2. · sip. abbreviation for sterilise-in-place. the...

D O N ’ T G A M B L E W I T H Y O U R S A M P L E ™

W25™ SAMPLING VALVE

User ManUal

DOCUMENT VERSION LOG

The table below lists previous versions of this User Manual and states the major changes between versions.This version list is introduced in October 2015.

Version # Version date Major changes from previous versions1 8th October 2015 Complete revision and new layout.

INTRODUCTION: MANUFACTURER: KeofittA/S Kullinggade 31 5700Svendborg,Denmark

TYPE: W25™SAMPLINGVALVE PATENTS: U.S.PAT.5,246,204•E.P.0468957 YEAR OF INTRODUCTION: 2002 YEAR OF REVISED DESIGN: 2014 LAST UPDATED: Oct 2015

TheEnglishversionofthisManualisthegoverningversionanditistheonlyauthorizedversion.Consequently,KEOFITTcannot be held liable for other versions including translations of this Manual.

CONTENTS1. PRESENTATION .............................................................................................................................7

1.1Definitionofterms ............................................................................................................................71.2Quickstart ........................................................................................................................................9

2. CLEANING – DISINFECTION – STERILISATION ..........................................................................102.1Clean-In-Place(CIP) ....................................................................................................................... 102.2Disinfection.................................................................................................................................... 102.3Sterilisation ................................................................................................................................... 11

3. VALVE FUNCTION ........................................................................................................................12

4. EVERYDAY USE OF THE VALVE ...................................................................................................144.1Pre-productiontreatment ............................................................................................................. 144.2Chemicalcleaning,CIP ................................................................................................................. 144.3ChemicalDisinfection ................................................................................................................... 144.4Steamsterilisation ........................................................................................................................ 14

5. VALVE OPERATIONS ...................................................................................................................155.1ChemicalCIP ................................................................................................................................. 155.2 Chemical disinfection ................................................................................................................... 165.3Steamsterilisation ........................................................................................................................ 185.4Sampling ........................................................................................................................................ 20

6. TECHNICAL DATA .........................................................................................................................216.1Material ........................................................................................................................................... 216.2Certificate ....................................................................................................................................... 216.3Pressure(max.) .............................................................................................................................. 216.4Temperature(max.) ........................................................................................................................ 216.5Surfacetreatment .......................................................................................................................... 21

7. VALVE BODIES .............................................................................................................................22

8. VALVE HEADS ..............................................................................................................................23

9. PARTS & ACCESSORIES ..............................................................................................................24

10.MOUNTING INSTRUCTIONS ........................................................................................................2510.1Location ........................................................................................................................................ 2510.2 Before welding ............................................................................................................................. 25

11. WELDING INSTRUCTIONS..........................................................................................................26

12. BLOCK DIAGRAMS.....................................................................................................................2712.1KeofittvalvetypeT(tank) ............................................................................................................ 27

13. MAINTENANCE ...........................................................................................................................2813.2Disassemblyandassemblyofvalvebodyandhead .................................................................29

14. INSTRUCTIONS ON REPLACING PTFE MEMBRANE .................................................................30

15. MEMBRANES .............................................................................................................................3115.1PTFEmembrane-art.no.870055 ............................................................................................ 31

K E O F I T T U S E R M A N U A L P A G E 7

1. PRESENTATIONTheKeofittW25™samplingvalvecanbereadilycleanedanddisinfected/sterilisedasitmeetsbothhygienicandprocessdesignrequirements.Effectivecleaninganddisinfection/sterilisationofthesampling valve can be carried out between random samples independently of the course of the productionprocesswithoutcompromisingthesame.Thecoaxialdesignandtheelectropolishedvalveinterior ensure absolute cleanability.TheW25™valveis3-AauthorisedandEHEDGTypeELClassIcertified.TheAmerican3-ASanitaryStandardisnormativeforthecomponent’seaseofcleaningandsterilisationandensuresoptimumconditionsforfoodproducts,whichcomesincontactwiththecomponentinquestion.TheEuropeanEHEDGTypeELcertificateisissuedbasedonthecleanabilityofthevalveandthetestmethodisanindicatorofgoodinherenthygienicequipmentdesign.Keofittvalvesareusedinawiderangeofprocessingindustries,suchasbreweries,dairies,juice/softdrinksandthebiotechnologicalandpharmaceuticalindustries.

1.1 Definition of termsInordertoeasethereadingofthismanualandtoavoidanymisunderstanding,pleaserefertothedefinitionoftermsinthetablebelow:

TERM DEFINITION

3-ASanitaryStandard 3-ASSIisanindependent,not-for-profitUScorporationdedicatedtoadvancinghygienicequipmentdesignforthefood,beverageandpharmaceutical industries.

Acids Anacidisachemicalsubstancewhoseaqueoussolutionsarecharacterizedbyasourtasteandtheabilitytoreactwithbasesandcertainmetals(likecalcium)toformsalts.AqueoussolutionsofacidshaveapHoflessthan7.AlowerpHmeansahigheracidity,andthusahigherconcentrationofpositive hydrogen ions in the solution. Removes limestone and most mineral deposits.

Alkali Alkalisareallbases,whichformhydroxideions(OH-)whendissolvedinwater.Theterms“base”and“alkali”areoftenusedinterchangeably.AlkalishaveapHvalueabove7.Alkalisdissolvesfatandoil,destroysproteinandattackslightmetal.

Asepticsampling Theprocessofwithdrawingasamplefromtheproductionequipmentthroughaclosedcircuit,whichhasbeensterilisedandkeptsterilewithnoexposuretotheambientduringthesamplingprocess.

Bioload SeeMicrobialload.Bioburden SeeMicrobialload.ChemicalSterilant Afewdisinfectantswillkillsporeswithprolongedexposuretimes(3–12

hours);thesearecalledchemicalsterilants.Chlorine ChlorineisachemicalelementwithsymbolClandatomicnumber17.It

belongstothehalogengrouptogetherwithforinstanceiodine.Itisastrongoxidizingagentandreactswithmanysubstances.Thesepropertiesmakechlorinecompoundsefficientdisinfectants.

CIP AbbreviationofClean-In-Place.Theprocessofcleaningaprocesscomponent(likeasamplingvalve)withoutremovingitfromtheproductionline.

Cleaning Removal,usuallywithdetergentandwaterorenzymecleanerandwater,ofadherent visible soil on a surface.


Complexingagent Asubstancecapableofformingacomplexcompoundwithanothermaterialinsolution.Improvesthecleaningpropertiesofadetergent.

Contact time The time span during which the item is in contact with the detergent or the disinfectant.

Enzymes Molecules,whichareaddedtocleaningagentstoeasetheremovalofspecificorganicmaterial.Assuressamecleaningeffectatalowertemperature.

Disinfectant Usually a chemical agent that destroys harmful microorganisms but might notkillbacterialspores.

Disinfection Thermalorchemicaldestructionofmicroorganisms.Disinfectionislesslethalthansterilisation,becauseitdestroysmostrecognisedmicroorganismsbutnotnecessarilyallmicrobialforms(e.g.bacterialspores).

Detergent Acleaningagentthathasnoantimicrobialeffect,butindilutedsolutionsgood cleaning properties.

EHEDG AbbreviationfortheEuropeanHygieneEngineeringandDesignGroup.EHEDGisaconsortiumofequipmentmanufacturers,foodindustries,research institutes as well as public health authorities promoting safe food by improving hygienic engineering and design in all aspects of food manufacture.

Electropolishing Electropolishingisanelectrochemicalprocessbywhichthehighpointswithinthemicroscopicsurfacetextureareremovedandthecornersrounded.ThisresultsinReducedProductAdhesion,EaseofCleaningandImprovedCorrosionResistance.

Exposuretime Periodinasterilisation/disinfectionprocessduringwhichtheitemisexposedtothesterilant/disinfectantatthespecificsterilisation/disinfectionparameters.

Flowpath Thepaththesampleflowsfromthetankorprocessequipmenttothesample recipient.

Germicidal The property of an agent to destroy microorganisms.Microbial load The number and types of viable microorganisms with which an item is

contaminated;alsocalledbioloadorbioburden.Microorganisms Animalsorplantsofmicroscopicsize.Asusedinfoodandpharmaceutical

industries,generallyreferstobacteria,fungi,virusesandbacterialspores.Peraceticacid Acommonlyuseddisinfectant,whichisefficientatlowtemperatureand

short contact time. Relatively harmless as it decomposes into carbon dioxide(CO2)andwater(H2O).

Processmedia Theproductintheprocessequipmentandtheproductfromwhichasampleistaken.

Representative sample Asamplewhichwhenitreachesthelaboratoryisstillidenticaltotheprocessmedia.Asamplewhichisinnowaycontaminatedoralteredduringneither the sampling process nor the transport to the laboratory.

Sanitization The application of a chemical agent that reduces the number of bacterial contaminants to a safe level as judged by the public health authorities. The officialsanitizerprotocolindicatesthat99.999%ofthespecifictestbacteriabekilledin30secondsundertheconditionsofthetest.

SIP AbbreviationforSterilise-In-Place.Theprocessofrenderingaprocesscomponent(likeasamplingvalve)sterilewithoutremovingitfromtheproduction line.


Spores Relativelywater-poorrestingcellssurroundedbyanimperviouscellwall,whichmakesthemrelativelyresistanttodisinfectantsandsterilants.Theyare dangerous as they can survive in adverse conditions and re-emerge as live bacteria at a later stage.

Sporicidal Thepropertyofanagentthatkillsspores.Steaming The process of using saturated steam under pressure as the sterilising

agent.Sterile Stateofbeingfreefromalllivingmicroorganisms.Inpractice,usually

describedasaprobabilityfunction,e.g.,astheprobabilityofanymicroorganism surviving sterilisation being one in one million.

Sterilant Afewdisinfectantswillkillsporeswithprolongedexposuretimes(3–12hours);thesearecalledchemicalsterilants.

Sterilisation Validatedprocessusedtorenderanitemfreeofallformsofviablemicroorganisms.Inasterilisationprocess,thepresenceofmicroorganismsisexpressedintermsofprobability.Althoughthisprobabilitycanbereducedtoaverylownumber,itcanneverbereducedtozero.

SterilityAssuranceLevel

The probability of a viable microorganism being present on an item after sterilisation.Usuallyexpressedas10–n;aSALof10-6means<1/1millionchance that a single viable microorganism is present on a sterilised item.

Tensides Atensideisasurfactantthatreducesthesurfacetensionofwaterandassures a faster and better contact between the detergent and the soil.

1.2 Quick startThe table below gives you an overview of the relevant chapters to read depending on the operations you wanttoperformtoobtaintherequiredhygieniclevel.

Required hygienic level

4.1Pre-

prod

uctio

n tre

atm

ent

4.2Chemical

cleaningCIP

4.3Chemical

disi

nfec

tion

4.4Steam

ing

5.1

Che

mic

al

CIP

5.2

Che

mic

al

disi

nfec

tion

5.3Steam

st

erili

satio

n

5.4Sam

pling

Cleaning

Disinfection

Sterilisation

K E O F I T T U S E R M A N U A L P A G E 1 0

2. CLEANING – DISINFECTION – STERILISATION

2.1 Clean-In-Place (CIP)Thoroughcleaningofthevalveisaprerequisiteforproperdisinfectionorsterilisation.Cleaningofthevalveistheremovalofanyvisibleresidualproduct,itbeorganicorinorganic.Itmaybedoneusingeithersteam(continuoussteamwilleventuallyleadtosterility;SIP=Sterilise-In-Place)orasuitableliquiddetergent.Cleaningistheremovalofadheringsoilfromtheenvironmentandfromtheprevioussample(totheextentithasnotbeenremovedbytherecommendedpost-samplecleaning).Cleaningisusuallyperformedbyflushingwithwaterfollowedbyathoroughwashingwithanappropriatedetergentandfinishedoffwithathoroughrinsingwithwater.Dependingontheactualprocessmediatheproperdetergentmustbedeterminedincooperationwithyourusualsupplierofdetergents.ThecompanyNovadanApS,Kolding,Denmark-www.novadan.dk,has supplied the generic table below for your convenience.

What to clean for Generic cleaning agents Comments

Fat AlkaliandTensides Heatwillfacilitatethecleaningprocessas the fat melts

Protein Alkali,Acids,TensidesandChlorine Coagulationandburningwhenheated,whichmakestheproducthardtoremove.

Sugar,Salt Waterisusuallysufficientastheproduct is water soluble

Sugarcarameliseswhenheated,turningintoahardstickysubstance,whichisdifficulttoremove

Minerals Acids,Complexingagent Often seen as lime scaleBiofilm AlkaliandChlorine,Peraceticacid,

possiblyEnzymesBiofilmisanaccumulatedmassofmicroorganisms that is tightly adhered to a surface and cannot be easily removed.

Starch AlkaliandChlorine

2.2 DisinfectionAlthoughCIPremovesallvisibleresiduesoftheprocessmediathevalvesurfaceswillstillbecontaminatedonamicroscopiclevel.Dependingonyouractualprocessmediaitwillbenecessarytocarryoutadisinfectionoperationinordertoa)reducethemicrobialloadtoanacceptablelevel(alsoreferredtoasSanitization)orb)destroycriticalmicroorganisms,butnotnecessarilyallmicrobialforms(e.g.bacterialspores).The disinfection process may be carried out in one of two ways and to different levels of disinfection dependingona)theinitialmicrobialloaddistribution,b)therequiredhygieniclevelandc)thetype,exposuretimeandconcentrationofthechemicalsused(ifusingachemicaldisinfectant):

• Bysteaming(inacontinuedprocessaftersteamcleaning)• Byapplyingoneormoresuitableliquidchemicaldisinfectants

Thereareanumberofchemicaldisinfectants.Itisimportanttochoosetherightone,therightconcentration and contact time and the right method for your current application. Your usual supplier of chemical disinfectants can support you in choosing the right disinfectant for your process media and thespecificgroupofmicroorganismsyouareaimingat.ThecompanyNovadanApS,Kolding,Denmarkhassuppliedthetablebelow,asapreliminaryindicationofwhichtypeofdisinfectanttouse:


Disinfectant

Microbes to inactivate

Halogenes(Clorine)

Peroxides(hydrogenperoxid&peraceticacid)

Alcohol(70%)

Gram-negbacteriaSalmonellaCampylobacterE.Coliandothers...

Gram-posbacteriaListeriaBacillus cereusClostridium and others...

Bacteria sporesBacillus cereus and others...

BacteriophageYeastFungiVirus

Legend: Efficient Limitedeffect Little/Noeffect

NOTE!Thefinalchoiceofdetergent,disinfectantandmethodlieswiththeuser,supportedbythesupplieroftheCIPfluidsanddisinfectants,asitisverymuchdependantonindividualconcernsand circumstances.

2.3 SterilisationSterilisationisahigh-leveldisinfectiondesignedtorenderthevalvefreeofallformsofviablemicroorganisms(incl.bacterialspores)toahighlevelofcertainty;theso-calledSterilityAssuranceLevelorSAL.ASALvalueof10-6meansthattheprobability(orrisk)ofasingleviablemicroorganismbeingpresentonthevalveinteriorafterwardsisonly1in1,000,000whichisagenerallyacceptedlevelforcallinganitemsterile.Althoughtheprobabilitycanbereducedtoaverylownumber,itcanneverbereducedtozero.Sterilitymayinpractiseonlybeobtainedbysteaming.Disinfectantsexistthatinhighconcentrationsandforaprolongedexposuretimewillbeabletoinactivateallformsofmicroorganismsandrenderthevalveinteriorsterilewithahighprobability;thesedisinfectantsarecalledchemicalsterilants.However,theapplicationofchemicalsterilantsismostoftenproblematicduetoa)arequiredhighconcentration,whichcausesanoperatorhazardandb)theseveralhoursofexposuretime.

NOTE!Furthermore,sterilisationwithachemicalsterilantmaynotconveythesamesterilityas-suranceassterilisationwithsteam,becausethegermicidalandsporicidalkineticsaremuchlessinvestigated and documented for chemical sterilants compared to steam.


3. VALVE FUNCTIONThevalveisdesignedtoregularlytakerepresentativesamplesintheproductionprocess.Thevalveisthereforedesignedsuchthateffectivecleaning,disinfection/sterilisationandsamplingcanbecarriedout regularly without interrupting the production process.

NOTE! The membrane functions as a dynamic seal in the valve seat as well as a hygienic static sealing against the valve head.

Thetablebelowdescribesthetwofundamentallydifferentwaysofpreparingthevalveforsampling,1)Chemicalcleaning/disinfectionand2)Steaming:

Method Description Pros & Cons

Chem

ical

Chemical cleaning

Liquiddetergentsareusedtocleanthevalve.CIP=Clean-In-Place

This process is adopted where steam is not available or where the product cannotwithstandtheexposuretoheat.Involvesseveralstageswithflushing,cleaning and rinsing between batches.

Chemical disinfection

Adisinfectionprocessusinganappropriatechemicalliquiddisinfectantusually follows the cleaning process.Thevalveinterioriswetted,soakedorflushedwithanappropriatedisinfectant.

Itadds2morestagestotheCIP:applicationofdisinfectantandfinalrinse.Involveshandlingofpotentiallyhazardouschemicals.

Ther

mal

Sterilisation Steamissuppliedfor1minutejustbefore and immediately after sampling.

Steamingdoesflushing,cleaning,rinsing and sterilisation in one operation.Steamingisnotsuitablewithheatsensitive products.Steamingentailstheriskofburns.

Flushingwithwaterfollowedbythesupplyofachemicaldetergentthroughtheupperofthevalve’stwo1”Tri-clampconnectionsresultsincleaningthevalve(CIP).Itistheperfect,hygienicdesignandsurfacefinishoftheinnerpartofthevalve,whichenableseasy,efficientandreliablecleaninginaclosed state of the valve. Supplyingsteamthroughtheupperofthevalve’stwo1”Tri-clampconnectionsresultsincleaningandsterilisation.Itistheperfect,hygienicdesignandsurfacefinishoftheinnerpartofthevalve,whichenablessterilisationinaclosedstate.AccordingtoanEHEDGbasedtestconductedbytheBiotechnologicalInstituteinDenmark,thevalveissterileafterjust1minute’ssupplyofsteamatapressureof1bar(g),121ºC.SteamingisthereforeaSIPprocess(Sterilise-In-Place).FollowingCIPorSIP,butpriortosampling,asterileplugofrubberorstainlesssteelisfittedtothetop1” Tri-clamp connection. When the valve is opened the process product will run out of the lower 1” Tri-clamp connection.

WARNING• Duringsterilisationwithsteamthevalvewillbecomehotandcareshouldthusbetakenwhen

operating the valve• Thevalveisdesignedforuseinworkingconditionsofupto6bar(g)pressureandtemperatures

ofupto121C.Itisthereforeimportanttobeawarethattherubberplug(designedformax.3bar(g))orthesteelplug(designedformax.10bar(g))maybeforcedoutathighspeed,ifnot


seated properly• Whensteamingalwaysusedrysaturatedsteamwithoutcondensationatmax.1bar(g).At

higherpressurethemembranemaybedamaged/split• Alwaysremembertousesafetygoggleswhensteaming,CIPping,takingsamplesandallother

operations of the sampling valve

IMPORTANT• Thevalvecannotbeusedforvacuumsincethemembranewillbesuckedhardintotheseat

and the valve will not function properly• ThemembraneisavailableinPTFE• ThePTFEmembraneresistsallCIPfluidsanddisinfectantsexcepthighlyoxidisingacidsinhigh

concentrations


4. EVERYDAY USE OF THE VALVEThischaptergivesanintroductiontohowthesamplingvalveworksindifferentoperatingconditions.Forspecificoperatorinstructionspleaserefertothechapter“VALVEOPERATIONS”.

4.1 Pre-production treatmentBeforeeverynewproductionbatchthesamplingvalveiscleanedanddisinfected/sterilisedtogetherwiththetankorvesselortheentireproductionline.MakesurethevalveisinitsopenpositionduringtheinitiallineCIPtoallowcleaningofthevalveseatand the membrane contact surface.AlsoallowCIPfluid,disinfectantorsteamtoflowthroughtheinletandoutlet1”Tri-clampconnections.Remembertoclosethevalveafterthefinalrinseandpriortostartingupthenextproductionbatch.

4.2 Chemical cleaning, CIPDuringproductionandpriortosampling,cleaningtakesplacewiththevalveclosedandinvolvesthefollowingstages:

1. Pre-rinse Flushingwithwatertomechanicallyremoveproductresidues

2. Clean Applyingadetergenttoremoveremainingvisibleproductresidues

3. Final rinse Rinse with clean water to remove all traces of detergents

Usuallythisprocedureisfollowedbydisinfection(seebelow),butforsomeapplicationCIPmightbesufficient.Itdependsonyour(microbiological)requirements,thedetergentsappliedandtheprocessmediatocleanfor.ConsultyoursupplierofCIPfluids.Insomecaseswheretheprocessmediaisforinstancewater,CIPmightnotevenbenecessaryandyoumay go directly to disinfection.

4.3 Chemical DisinfectionDisinfectiontakesplacewiththevalveclosedandinvolvesthefollowingstagesofwhichthefirst3areidenticaltoCIP:

1. Pre-rinse Flushingwithwatertomechanicallyremoveproductresidues

2. Clean Applyingadetergenttoremoveremainingvisibleproductresidues

3. Intermediate rinse Rinse with clean water to remove all traces of detergents

4. Disinfection Applyanappropriatedisinfectanttargetingoneormoreorallmicroorganisms

5. Final rinse Rinse with cleaned water to remove all traces of the disinfectant

4.4 Steam sterilisationSteaminghastheadvantagethatitdoesflushing,cleaningandsterilisationinoneoperation.Howeverthe heat from the steam will cause sugary substances to caramelise and substances containing protein tocoagulateandburn;seechapter2.1.Inthiscaseflushingwithanappropriatefluidmustprecedepost-sampling steaming. Ifsteamingisthepreferredprocedure,butnosteamisinstallednearthesamplingpoint,anoptionistouseaportablesteamgenerator.KeofittsuppliesfittingsforaKärchersteamgenerator.ThesteamingprocesswithaKeofittsamplingvalvehasbeenvalidatedtoobtainsterilityafter1minuteofsteamingat121°C(1bar(g)).DocumentationisavailableattheKeofittOnlineServiceCenteronwww.keofitt.dk.


5. VALVE OPERATIONSThis chapter provides clear instructions on how to operate the sampling valve in different situations.Beforesamplingthevalvemustbecleanedfollowedbydisinfectionorsterilisation,dependingonyourrequirements.

5.1 Chemical CIPTheCIPtakesplacewiththevalveremaininginitsclosedposition.Performthefollowingsteps:

1. Remove any plugs or blinds that might cover the mini clamp ports

2. Connect a water hose to the upper 1” Tri-clamp connection

3. Connect a hose to the lower 1” Tri-clamp connection and let the hose go to a drain

4. Flushwithcleanwater

5. RemovethewaterhoseandlettheCIPliquidflowthroughtheupper1”Tri-clampconnection.IftheCIPliquidmustnotgotodrain,circulate it or collect it in a suitable container and dispose of correctly

6. Reconnect the water hose to the upper 1” Tri-clamp connection and rinse with clean water

Ifdisinfectionisnotneededthevalveisnowreadyfortakingasample.Ifdisinfectionisrequiredproceed with the steps mentioned in the section “Chemical disinfection” below.Flushwithcleanwateraftersampling.Iftheprocessmediaissticky,viscousoraggressiveorforanyotherappropriatereason,dorepeatthefullCIPcycleaftersampling.


WARNING• Carefully follow the guidelines given for the chemicals involved • Alwaysremembertousesafetygoggleswhensteaming,CIPping,takingsamplesandallother


5.2 Chemical disinfectionImmediatelyfollowingtheCIP,performthedisinfection,ifrequired.Thedisinfectiontakesplacewiththevalve remaining in its closed position.Thereare2recommendedwaystocarryoutthedisinfection: A)bylettingthedisinfectantflowthroughthevalvechamber B)byfillingthevalvechamberwiththedisinfectant(advantage:smallervolumeofdisinfectant

neededandquickerandmorereliabledisinfection)

Stepstoperform,whenadoptingA:

1. Connect a hose with an empty bottle to the lower 1” Tri-clamp connection. This bottle or similar recipient is to collect the disinfectant(step3)andtherinsingwater(step6)

2. Fillaflexiblebottlewiththedefinedamountofdisinfectant

3. Connecttheflexiblebottleviaahosetotheupper1”Tri-clampconnection and press the disinfectant slowly through the valve to wet the interior of the valve.

4. Allowthedisinfectanttoactfortheprescribedtime

5. Disconnectthehosefromtheupper1”Tri-clampconnectionandconnectaflexiblebottlewithcleanedwatertotheupper1”Tri-clampconnection

6. Rinsethroughtheupper1”Tri-clampconnectionbysqueezingthebottle,thuspressingthewaterthroughthevalvechamber

7. Leavethesqueezedbottleconnectedtothe1”Tri-clampconnectionandclampthehosetoavoidcontaminationfromairbeingsuckedinthrough the valve


Stepstoperform,whenadoptingB:

1. Shutoffthelower1”Tri-clampconnectionbybymeansofacombination of a 1” to mini Tri-clamp connector and a mini Tri-Clamp tohosepiececonnectorfittedwitharubberplug(orsteelplug)orbymeansofpinchinganattachedpieceofflexibletubing

2. Fillthevalvechamberwiththedisinfectantthroughtheupper1”Tri-clamp connection

3. Leavetoactfortheprescribedtime

4. Emptythevalvechamberthroughthelower1”Tri-clampconnectionwhile holding a recipient under the valve allowing the disinfectant to flowout

5. Connectaflexiblebottlewithcleanedwatertotheupperminiconnection and rinse through the upper mini connection

6. Leavethesqueezedbottleconnectedtotheupperminiconnectionand if possible pinch the tube to avoid contamination from air being suckedinthroughthevalve

Thevalveisnowreadytotakeasample.Thesamplingmustbeperformedimmediatelyafterdisinfection to avoid any contamination of the sample.Flushwithwateraftersampling.Iftheprocessmediaissticky,viscousoraggressiveorforanyotherappropriatereason,dorepeatthefullCIPcycleaftersampling.

WARNING• Carefully follow the guidelines given for the chemicals involved • Alwaysremembertousesafetygoggleswhensteaming,CIPping,takingsamplesandallother



5.3 Steam sterilisationChemicalCIPandchemicaldisinfectionarenotneededwhenusingsteam,assteamdoesitall.Anexceptionfromthisiswithsugarysubstances,whichcarameliseandwithsubstancescontainingprotein,whichcoagulateandburn;seechapter2.1.Inthiscaseflushingwithanappropriatefluidmustprecede post-sampling steaming.Steamsterilisationtakesplacewiththevalveremaininginitsclosedposition.Performthefollowingsteps:

1. Remove any plugs or blinds from the 1” Tri-clamp connections

2. Connectthesteamhosetothevalve’supper1”Tri-clampconnection

3. Connect a hose to the lower 1” Tri-clamp connection and let it go to drain

4. Openthesteamsupplyandletitflowthroughthevalveforsterilisation.Allow1minuteat121C(1bar(g))

5. Closethesteamsupply,butleavethehoseinplacetopreventcontaminationfromtheambientduringsampling.Ifremovalofsteamhoseisrequired,fitasterilerubberorstainlesssteelplugontotheupper 1” Tri-clamp connection

Thevalveisnowreadytotakeasample.Thesamplingmustbeperformedimmediatelyaftersteamingto avoid any contamination of the sample.

WARNING• Duringsterilisationwithsteamthevalvewillbecomehotandcareshouldthusbetakenwhen

operating the valve• Thevalveisdesignedforuseinworkingconditionsofupto6bar(g)pressureandtemperatures

ofupto121C.Itisthereforeimportanttobeawarethattherubberplug(designedformax.3bar(g))orthesteelplug(designedfor10bar(g))maybeforcedoutathighspeed,ifnotseatedproperly

• ForvalveheadsallowedunderATEXforGroupIIGD,Category2(zone1)bothhandleandtopofvalveheadsNmustbecleanedbeforeuse

• Alwaysremembertowearsafetygoggleswhensteaming,CIPping,takingsamplesoranyotheroperations of the sampling valve


IMPORTANT• Don’tattachasteamtraptothehosefromthevalvesteamoutlet(lower1”Tri-clamp

connection)asitwillimpedetheflowofsteamandhencetheflushingeffect,andmakethesterilisationdependantontemperatureonly,demandingamuchlongersterilisationtime

• Ifthesteamcapacityislowand/ortheoutlethosefromthevalveisshortand/orwithalargediameter,thetemperaturewilldropandcondensationmayoccurinthevalvechamber.Inthiscase a counter pressure must be established using a pressure relief valve or a needle valve at the outlet

• Leavethesteamhoseinplacetopreventcontaminationfromtheambientduringsampling.Ifremovalofsteamhoseisrequired,closethe1”Tri-clampportbymeansofaplugorblindor

anyotherappropriateclosureinconnectionwithrelevantconnectors/adaptors


5.4 SamplingPreparearecipientforyoursample.For aseptic samplingusesteamandaKeofittAsepticSamplingBag(availableindifferentsizes;pleaseseedatasheetonwww.keofitt.dk).Leavethesteamhoseinplacetopreventcontaminationfromthe ambient during sampling.For all other samplinguseaKeofittSterileSamplingBagoraSpikeBag,whichprovidesaclosedflowpathforyoursampleprotectedagainsttheambient.Alternativesarebottleswithascrewcap,jarsoranyotheravailablecontainer.Ifremovalofsteam/CIPhoseisrequired,closethe1”Tri-clampportbymeansofaplugorblindoranyotherappropriateclosureinconnectionwithrelevantconnectors/adaptors.Takethesampleimmediatelyaftercleaning/disinfection/sterilisationperformingthefollowingsteps:

1. Openthevalveslowlyandtakethesample

2. Closethevalveafterthesamplehasbeentaken

3. Cleanthevalvebyflushingwithsteam,waterorhotwater

Iftheprocessmediaissticky,viscousoraggressiveorforanyotherappropriatereason,dorepeatafullCIPcycleaftersamplingincasesteamisnotavailableandflushingwithwaterproveinsufficient.

WARNING• Whensamplingatahighpressureand/orwithalowviscosityprocessmediaitmayflowrapidly

intothesamplerecipient.Thereforeopenthevalveslowly.Specialcaremustbetakenwithpneumaticallyoperatedvalves,astheyopenabruptly

• Alwaysremembertowearsafetygoggleswhensteaming,CIPping,takingsamplesoranyotheroperations of the sampling valve


6. TECHNICAL DATA

6.1 MaterialValvebody: AISI316L(1.4404)Valvehead: AISI316L(1.4404)Membrane: PTFE(white)

6.2 CertificateValvebody: 3.1*Membrane: PTFE acc.toFDA&BGA *A6-digitcodeismarkedonthevalvebody.Thiscodereferstoa3.1

certificatewhichaccompanieseveryconsignmentofvalvebodies.The3.1certificateisavailableattheKeofittOnlineServiceCenteronwww.keofitt.dk.ClickCertificatesandthen3.1.

6.3 Pressure (max.)Rubberplug: 3bar(g)/44psi(g)**Steelplug: 15bar(g)/218psi(g)** **Ifusedwithclamp-to-hosepiececonverters

6.4 Temperature (max.)Sterilisationtemp.:121°C/250°F*** ***Itisimportantthatthesteamissaturated,butdry,ascondensationcan

damagethemembrane.(Drysteamatmax.1bar(g)).

6.5 Surface treatmentInside: ElectropolishedRa<=0.8µm/32µinchOutside: ElectropolishedRa<=1.2µmProcessconnection ElectropolishedRa<=0.8µm/32µinch

ValveswithinternalelectropolishingareidentifiedbyanEprecedingtheserialnumbere.g.E12345678

Thesurfaceroughnessismeasuredforeachvalveat4criticalplaces.Aserialnumberidentifieseachvalvebody.Aspecificsurfaceroughnesscertificateforeachvalvebodyisavailableonwww.keofitt.dk

IfsurfaceroughnesslowerthanRa=0.8µmisrequiredpleasecontactyourKEOFITTdealer

6.6 Viscosity:Viscosityrange: 0-250.000cP,withparticlesupto17mmindiameter.


7. VALVE BODIES

Forfurtherproductinformation-material,dimensionsetc.-pleaserefertothespecificdatasheetatwww.keofitt.dk


8. VALVE HEADS



9. PARTS & ACCESSORIES



10.MOUNTING INSTRUCTIONS

10.1 LocationThevalveshouldalwaysbelocatedwithitscentrelineinahorizontalpositionandwiththetwo1”Tri-clampconnectionsinaverticalpositionwiththearrowpointingupwardsasshownonthefigure.Onlywith this orientation the valve will be self draining.

10.2 Before weldingRemember to disassemble the valve body and head. The valve body and head must be separated duringwelding.Themembranemustberemovedfromthevalvebody,asotherwiseheatfromthewelding process will damage them.


11. WELDING INSTRUCTIONS

FortypeT(tank)itisnecessarytodrillaholeø100mmintothetankwall,andthenfitthevalveintothisholeflushwiththeinsideofthetank.Weldingshouldbecarriedoutasapenetrationwelding. Materialthicknesslessthan4mm:Weldfrominside.Materialthicknessgreaterthan4mm:Weldfromboth outside and inside. SincetypeThasasolidendpiece,thevalvewillnotbedamagedbypenetrationwelding.However,theuseofpurgegasintheformofeitherArgonorFormiergasisrecommendedinordertogivethebestresult.

IMPORTANT!• Whengrinding/polishingtheinternalweld,thevalveseatmustnotbetouched.


12. BLOCK DIAGRAMS

12.1 Keofitt valve type T (tank)


13. MAINTENANCEThePTFEmembranesshouldbereplacedevery12months.Intheeventofintensivesterilisationandcleaningitmaybenecessarytoreplaceitmorefrequently.Theappropriatereplacementfrequencyshouldbedeterminedbytheuserbystartingwithshortintervalsandcontinuouslyextendthetimeinuseintilonereachesthelimitofthemembrane’sdurability.Basedonthedesiredsafetymargintheuser then decides on the replacement interval to adapt.Ineachindividualcaseastandardoperatingprocedureincludingmaintanceintervalsshouldbeendorsedbasedonexperience.Fordisassemblyofvalvebodyandvalvehead,seeinstructions.

13.1 Spare parts list1. Valvebody2. MembranePTFE(White)3. Lowerstem4. Spring(excepttypeB)5. Steelbushing


13.2 Disassembly and assembly of valve body and head

Inordertodissassembleandassemblethevalvebodyandvalveheadpleaseperformthefollowingoperations:

1. SetthevalveheadattheOPENposition.2. Release and remove the clamp ring.3. Pulloutthevalveheadfromthevalvebody.4. Performwhateverisrequired.5. Refitthevalvehead(intheOPENposition).6. Attachandcloseclampring.7. Close the valve head.

WARNING!• DuringdisassemblyandreassemblyofthevalveunitsetthevalveheadintheOPENposition

before it is pushed in or pulled out of the valve body. Omitting to do so may result in damaging themembraneanditwillcomplicatethemountingoftheclampasyouwillworkagainstthespring force.

• Don’tcleanthevalveheadinanultrasonicbathorbydippingitintoadegreasingliquid,asitwillimpeadeproperfunctioningofthescrewaction.Whenindoubt,contactyourlocalKEOFITTdealer.


14. INSTRUCTIONS ON REPLACING PTFE MEMBRANE Toremoveoldmembranefromvalvehead:1. OPENvalve.2. Release and remove the clamp ring.3. Remove the valve head from the valve body.4. Makesurevalveisfullyopened(membranefullycompressed)-seeillustrationAbelow.5. CLOSEvalveheadbywhichagapwillappearbetweenthecompressedmembraneandthe

bushing(seeillustrationBbelow).6. Ifneededpushthemembraneupwardsuntilthetoolformembranefitsinthegap(see

illustrationCbelow).7. Inserttoolformembrane,betweenthemembraneandthebushing(seeillustrationC

below).8. OPENvalvehead.9. Nowthemembraneisloosenedfromthevalveheadandcanbereplaced.

To attach new membrane to valve head.10. Setthevalveheadtoclosedposition.11. Placethenewmembraneonvalvehead.12. MountthemembranebushingwiththenewTeflonmembranebypressingthemembrane

withyourhanduntilitclicks.13. Setthevalveheadinopenposition.14. Insertthevalveheadintothevalvebody.15. Attachandcloseclampring.16. Closevalvehead.

IMPORTANT

• Oncethemembranehasbeenremovedfromthevalveheadtheclicksysteminthemembranemight be damaged. Therefore the membrane might be unsafe for further use and it is recommended not to use the membrane again.

• Donotusehammerorothertoolthatmightscratchthesurfaceofthemembrane.

WARNING!• DuringdisassemblyandreassemblyofthevalveunitsetthevalveheadintheOPENposition

before it is pushed in or pulled out of the valve body. Omitting to do so may result in damaging themembraneanditwillcomplicatethemountingoftheclampasyouwillworkagainstthespring force.

A. B. C.


15. MEMBRANES

15.1 PTFE membrane - art. no. 870055

Last updated 08-10-2015*For further information please visit keofitt.dk

MEMBRANE W25 PTFE ART. NO. 870055

GENERAL

KEOFITT has the widest selection of spare parts and accessories to complete your sampling system

Compatible with KEOFITT W25 valve head

Compatible with KEOFITT W25 valve head

CERTIFICATION*FDA · USP · EU 1935/2004

TECHNICAL DATAMaterial:Range of temperature in dry atmospheric air:Ball hardness (N/mm2):Tensile strength (DIN53455 - N/mm2):Elongation at break (DIN53455 - %): Density (DIN 53479 - g/cm3):Shore D (DIN 53505): Thermal conductivity (W/m.k DIN 52612):Expansion coefficient (DIN 53752 [K^-1]):Flammability:Chemical resistance:

PTFE (TFM 1600 - white)-200° - +200°C / -328° - +392°2935350 2,1757 0,2212-17x10^-5Inflammable UL 94Is not attacked by common chemicals with the exception of strongly oxidising acids

Net Weight· Kg/lbs 0,083 kg /0,18 lbs

The patented membrane design is an essential part of the hygienic design of the KEOFITT sampling valves

It allows for optimal exposure to CIP and SIP media while also integrating the capacity to remove the membrane from the valve body without the use of tools

FEATURES

LIFE TIMEAverage life time of a PTFE membrane is 12 months - to be determinated by user.Temp. max.:Steam pressure:Process pressure:CIP:

1 - 150°C / 34 - 302° F0 - 2 bar (g) / 0 - 29 psi (g)0 - 6 bar (g) / 0 - 87 psi (g)NaOH <3% or similar

84,5 mm

34,0I. D.

mm55,0

O. D. mm

KEOFITTA/SKullinggade 31DK-5700SvendborgDenmark

Phone+4563167080Fax+4563167081

[email protected]

Keofittreservestherighttochangetechnicaldatawithoutnotice!ForcompletesetofupdateddatasheetsandmanualsforKeofittproductspleaserefertoourwebpagewww.keofitt.dk

w25™ sampling valve - keofitt uk · 2017. 2. 2. · sip. abbreviation for sterilise-in-place. the...

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