aseptic sampling system

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

ASEPTIC SAMPLING SYSTEM

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 13th November 2015 Complete revision and new layout.

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

TYPE: ASEPTICSAMPLINGSYSTEM YEAR OF INTRODUCTION: 1998 YEAR OF REVISED DESIGN: 2015 LAST UPDATED: Nov 2015

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

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

1.1Definitionofterms ............................................................................................................................7

2. CLEANING – DISINFECTION – STERILISATION ..........................................................................102.1 Cleaning ......................................................................................................................................... 102.2Disinfection.................................................................................................................................... 102.3Sterilisation ................................................................................................................................... 11

3. DESCRIPTION OF THE ASEPTIC SAMPLING SYSTEM .................................................................12

4. EVERYDAY USE OF THE ASEPTIC SYSTEM .................................................................................144.1Pre-samplingtreatment ................................................................................................................ 144.2 Connections .................................................................................................................................. 144.3Steaming ....................................................................................................................................... 16

5. ASEPTIC SYSTEM OPERATING INSTRUCTIONS ..........................................................................175.1Samplingvalvepreparations ........................................................................................................ 175.2CleaningtheAsepticSystem ........................................................................................................ 175.3ReassemblingandautoclavingtheAsepticSystem ................................................................... 185.4ConnectingtheAsepticSystem ................................................................................................... 185.5Steamsterilisation ........................................................................................................................ 185.6Sampling ........................................................................................................................................ 195.7 Retrieving the sample ................................................................................................................... 20

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

7. MAINTENANCE .............................................................................................................................227.1Sparepartslist ............................................................................................................................... 227.2KeofittSamplingBottleSystems ................................................................................................... 237.3KeofittSamplingBottleSystems-Parts&Accessories ............................................................... 24

8. INSTRUCTIONS ON REPLACING PTFE MEMBRANE ...................................................................25

9. DATA SHEETS ...............................................................................................................................269.1ValveHeadW9TypeQ(PTFE) ....................................................................................................... 269.2PTFEmembrane-art.no.850055 .............................................................................................. 27

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

1. PRESENTATIONTheKeofittAsepticSamplingSystemenablestheusertotakeatrulyrepresentativesterilesample.TheAsepticSystemprotectsthesampleagainstairbornecontamination,whiletakingthesampleandduring transfer to the laboratory.TheKeofittAsepticSamplingSystemisbasedonKeofitt’sguarantiedhighquality,microbiologicallysafevalvedesign.ThecurrentdesignisadoptedfromtheKeofittW9samplingvalve,whichis3-AauthorisedandEHEDGTypeELClassIcertified.TheAmerican3-ASanitaryStandardisnormativeforthecomponent’seaseofcleaningandsterilisationandensuresoptimumconditionsforfoodproducts,whichcomesincontactwiththecomponentinquestion.TheEuropeanEHEDGTypeELcertificateis issued based on the cleanability of the valve and the test method is an indicator of good inherent hygienicequipmentdesign.TheAsepticSystemiscompatiblewithallsmall(M4)andmedium(W9)sizedKeofittsamplingvalves.TheAsepticSystemisusedinawiderangeofindustries,suchasbreweries,dairies,foodandthepharmaceutical and biotechnological industries.

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.Theyaredangerousastheycansurviveinadverseconditionsandre-emergeaslive 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 Validated process used to render an item free of all forms of viable microorganisms.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.

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 CleaningThoroughcleaningoftheAsepticSamplingSystemisaprerequisiteforproperdisinfectionandsterili-sation.Cleaningofthesystemconsistsoftheremovalofanyvisibleresidualproduct,itbeorganicorinorganic. Dependingontheactualprocessmediatheproperdetergentmustbedeterminedincooperationwithyourusualsupplierofdetergents.ThecompanyNovadanApS,Kolding,Denmark,hassuppliedthege-neric table below for your convenience.

What to clean for Generic cleaning agents Comments

Fat AlkaliandTensides Heat will facilitate the cleaning process as 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 DisinfectionAlthoughcleaningremovesallvisibleresiduesoftheprocessmediathesystemsurfaceswillstillbecontaminatedonamicroscopiclevel.Dependingonyouractualprocessmediaitwillbenecessarytocarryoutadisinfectionoperationinordertoa)reducethemicrobialloadtoanacceptablelevel(alsoreferredtoasSanitization)orb)destroycriticalmicroorganisms,butnotnecessarilyallmicrobialforms(e.g.bacterialspores).DisinfectionoftheAsepticSystemissplitinto2operations:

• Initialautoclavingofthesystemcomponents• Steamingoftheflowpathofthesystemtogetherwiththesamplingvalveontheprocess

equipmentjustpriortotakingthesampleUsingaliquidchemicaldisinfectantisgenerallyavalidalternativetosteaminganordinarysamplingvalveonaprocessline.HowevertotakeanasepticsampleusingtheAsepticSampleSystemsteamingisgenerallythepreferredmethod(seeexplanationinchapter2.3Sterilisation).Ifyouweretoconsiderusingaliquidchemicaldisinfectant,itisimportanttochoosetherightone,therightconcentrationandcontacttimeandtherightmethodforyourcurrentapplication.Yourusualsup-plier of chemical disinfectants can support you in choosing the right disinfectant for your process media andthespecificgroupofmicroorganismsyouareaimingat.


ThecompanyNovadanApS,Kolding,Denmarkhassuppliedthetablebelow,asapreliminaryindicationofwhichtypeofdisinfectanttouse:

Disinfectant

Microbes to inactivate

Halogenes(Clorine)

Peroxides(hydrogenperoxid&peraceticacid)

Alcohol(70%)

Gram-negbacteriaSalmonellaCampylobacterE.Coliandothers...

Gram-posbacteriaListeriaBacilluscereusClostridium and others...

BacteriasporesBacilluscereusandothers...

BacteriophageYeastFungiVirus

Legend: Efficient Limitedeffect Little/Noeffect

NOTE!Thefinalchoiceofdetergent,disinfectantandmethodlieswiththeuser,supportedbythesupplieroftheCIPfluidsanddisinfectants,asitisverymuchdependantonindividualconcernsand circumstances.

2.3 SterilisationSterilisationisahigh-leveldisinfectiondesignedtorenderthevalvefreeofallformsofviablemicroorganisms(incl.bacterialspores)toahighlevelofcertainty;theso-calledSterilityAssuranceLevelorSAL.ASALvalueof10-6meansthattheprobability(orrisk)ofasingleviablemicroorganismbeingpresentontheequipmentinteriorafterwardsisonly1in1,000,000whichisagenerallyacceptedlevelforcallinganitemsterile.Althoughtheprobabilitycanbereducedtoaverylownumber,itcanneverbereducedtozero.Sterilitymayinpractiseonlybeobtainedbysteaming.Disinfectantsexistthatinhighconcentrationsandforaprolongedexposuretimewillbeabletoinactivateallformsofmicroorganismsandrendertheequipmentinteriorsterilewithahighprobability;thesedisinfectantsarecalledchemicalsterilants.Thereasonsformakingtheirusageimpracticalarea)arequiredhighconcentration,whichcausesanoperatorhazardandb)theseveralhoursofexposuretime.

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


3. DESCRIPTION OF THE ASEPTIC SAMPLING SYSTEM TheAsepticSamplingSystem(hereaftercalledAsepticSystemorjustSystem)ismeanttoregularlytakesterilerepresentativesamplesfromtheproductionprocessintoaplasticbottle.TheAsepticSystemisthereforedesignedsothateffectivecleaning,sterilisationandsamplingcanbecarriedoutregularlywithout interrupting the production process.

• TheAsepticSystemconsistsof:• Asystembodywithinlet/outletports• Avalveheadwithaleveractuator(typeQwithPTFEmembrane)• Anintegratedscrewcap(disconnectable)• Ahandlewitharubbercover

Air Outlet

Inlet

Steam Outlet

Screw Cap

Handle

Valve head (type Q w/ PTFE membrane)

Availableaccessoriesseechapter7.3.

TheAsepticSystem’sinletportisconnectedtotheoutputportoftheproductionlinesamplingvalveusingaPTFEtubingandsupplyingsteamthroughtheconnectedpartscarriesoutsterilisationoftheentireflowpath.WiththeSysteminitsuprightpositionitisautodrainable,suchthataftersteaminganycondensatewillflowoutofthesystembody.TheKeofittAsepticSystemisbasedontheacknowledgedKeofittvalvedesignandaccordingtoanEHEDG-basedtestcarriedoutbytheBiotechnologicalInstituteinDenmark,asamplingvalveissterilisedafterjust1minute’ssupplyofsteamatapressureof1bar(g),121°C.Steamingdoesflushing,cleaning,rinsingandsterilisationinoneoperation.SteamingisthereforeaSIPprocess(Sterilise-In-Place).AftersterilisationandshuttingoffthesteamsupplytheAsepticSystem’svalveisopenedusingtheleverallowingaflowpathintothesamplebottle.Subsequentlyopeningofthesamplingvalvewillcauseproductmediafromtheprocesstoflowintothesamplebottlethroughthesterilisedflowpath.DuringfillingairfromthebottlewillbeexpelledthroughtheAirOutlet.Tomaintainasepticconditionsforthesamplingprocessasterilefilter,aflexibleexpansionbag,anexpansiontankorsolutionmustbe


connectedtotheAirOutletpriortoautoclavingthesystem.Whentherequiredsamplevolumeisobtained,bothvalvesareclosedandsteamcouldbeadministeredtorinsetheflowpath.TheAsepticSystemnowcontainsasterilesampleofthemediaintheproductionline and may be safely carried to the laboratory for analysis.

WARNING• DuringsterilisationwithsteamthesamplingvalveandtheAsepticSystemwillbecomehotand

careshouldthusbetakenwhenoperatingthevalves• Whensteamingalwaysusedrysaturatedsteamwithoutcondensationatmax.1bar(g).• IncaseofobstructionoftheAirOutletpressurewillbuildupinthebottleeventuallycausingit

toburstiffilledwithliquid• Alwaysremembertousesafetygoggleswhensteamingandtakingsamplesandduringall

otheroperationsofthesamplingvalveandtheAsepticSystem


4. EVERYDAY USE OF THE ASEPTIC SYSTEMThischaptergivesanintroductiontothedifferentworkingstepswhenusingtheASEPTICSYSTEM.Forspecificoperatorinstructionspleaserefertothechapter“ASEPTICSYSTEMOPERATINGINSTRUCTIONS”.

NOTE! Forspecificinstructionsonoperatingthesamplingvalveonyourproductionline,pleaseread the corresponding user manual carefully.

4.1 Pre-sampling treatmentTheAsepticSystemisare-usablesystem,whichmustbecleanedandautoclavedpriortoeachuse.Thesamplingvalveontheproductionlinemustbepreparedfortakingsamplesaccordingtotheinstructions in its user manual.

4.2 ConnectionsTheSystem’sdifferentconnectionsareseenontheillustrationbelow.

Air Outlet

Inlet

Steam Outlet

Screw Cap

Handle

Valve head (type Q w/ PTFE membrane)

Thesteaminletofthesamplingvalveisconnectedtoasteamsupplyfeaturingashut-offvalvetocutthe steam supply after sterilisation.TheoutletportofthesamplingvalveisconnectedtotheinletportoftheAsepticSystemviaaPTFEtube(accessory).TheAsepticSystem’sSteamOutletportisconnectedtodrainorsimilartakingcaretoavoidgettinginjuredbythesteamjet.Usingasteamtrapisnotrecommendedhere,asitwillimpedetheflowofsteamandthustheflushingeffect.


TheAsepticSystem’sAirOutletconnectstotheinteriorofthebottleandallowsairtobeexpelledasthesampleliquidfillsthebottle.Thereareanumberofwaystoventtheinitialairvolumeinthebottle,asexplainedinthetablebelow:

Solution Description Comments

1.Sterileventingfilter(replaceable/reusable)

Theyareeithera)astainlesssteelhousingwithreplaceablefilterinsertsorb)sealedplasticfilters,which can be autoclaved many times.

Forbothtypesitiscriticaltodiscardthefiltersregularlytoavoidusingablockedfilter,whichmayleadtoseriouspressurebuild-upinthesamplebottlecausing it to blast.

2.Sterileventingfilter(single-use)

Smalldiscshapedplasticfilterswithhosebarb,luerlockorsimilarconnections.

Acostefficientsingle-usesolution,which may be autoclaved together with theAsepticSystem.

3.Flexibleexpansionbag

Aflatlaidplasticbagwillblowupto balance the air displacement whenfillingthebottle.

AnappropriatebagcanbeusedseveraltimesandautoclavedwiththeAsepticSystem

4.Expansiontank Anexpansiontankthesizeofthebottle will reduce the pressure buildupto2bar(a)from1bar(a).Alargertankwillreducethepressurebuild-upfurther.

Asomewhatmorebulkysolution.

5.Plug(blindcap) Ifthebottleisonlypartlyfilledandsomepressurebuild-upisacceptable plugging the outlet is an option.

Makesurethepressurestaysbelowthemax.pressurespecifiedforthebottle.The pressure build up is limited to the actualpressureinthetankortubing.


4.3 SteamingOncetheAsepticSystemisconnectedtothesamplingvalvesteamingcantakeplace.

Steaminghastheadvantagethatitdoesflushing,cleaningandsterilisationinoneoperation.Howeverifsteamingisalsocarriedoutaftersampling,pleasenotethatheatfromthesteamwillcausesugarysubstancestocarameliseandsubstancescontainingproteintocoagulateandburn;seechapter2.1.Inthiscaserinsingwithanappropriatefluidmustprecedepost-samplingsteaming.Ifnosteamisinstallednearthesamplingpoint,anoptionistouseaportablesteamgenerator.KeofittsuppliesfittingsforaKärchersteamgenerator.ThesteamingprocesswithaKeofittsamplingvalvehasbeenvalidatedtoobtainsterilityafter1minuteofsteamingat121°C(1bar(g)).DocumentationisavailableattheKeofittOnlineServiceCenteronwww.keofitt.dk.


5. ASEPTIC SYSTEM OPERATING INSTRUCTIONSThischapterprovidesclearinstructionsonhowtooperatetheAsepticSystem.BeforesamplingthesamplingvalveandtheAsepticSystemmustbepreparedforthesamplingprocess.

5.1 Sampling valve preparationsIfthesamplingvalvehasbeencleanedproperlyafterthelastsampling,theremightbenoneedforanyaction before steaming.Otherwisethesamplingvalveshouldbecleaned/disinfected/steamedaccordingtotheinstructionsinthe sampling valve user manual.FinalsterilisationisdonewhentheAsepticSystemisconnected(seechapter5.4).

WARNING• Carefully follow the guidelines given for any chemicals involved in the cleaning process• Alwaysremembertousesafetygoggleswhensteaming,CIPping,takingsamplesandallother

operations of the sampling valve

5.2 Cleaning the Aseptic SystemCleaningtheAsepticSystemandpreparingitforthenextsamplingismostefficientlydoneimmediatelyafter the previous sample has been emptied out of the bottle.TocleantheAsepticSystemproperlyitmustbedisassembled.

NOTE! ThescrewcapmayalsobedisconnectedfromtheAsepticSystembodyforpropercleaningof the screw cap interior and the internal retention nut

TodismantletheAsepticSystem(includingthescrewcap)performthefollowingoperations:1. Disconnectalltubingandhoses2. Fastenthebottletightontothescrewcap3. Holdingthesystembythehousingandbythescrewcaprespectively,nowunscrewthecap,

therebyunscrewingthesteelcapflange,thescrewcapandthebottleasoneassembly4. Dismantlethisassemblytakingcarenottolosetheo-ringandthegasket5. Open the valve using the lever6. Unscrew the valve head and remove it from the system body7. Washthevalvehead,systembody,bottle,hosesandallotherpartshavingbeenusedfor

sampling8. Rinse and dry all parts

TodismantletheAsepticSystemleavingthescrewcapinplaceperformthefollowingoperations:1. Disconnectalltubingandhoses2. Holdingthesystemhousingandthescrewcaptogether,nowunscrewthebottle,making

surethebottleflangeisnotloosened3. Removethecleargasket4. Open the valve using the lever5. Unscrew the valve head and remove it from the system body6. Washthevalvehead,systembody,bottle,hosesandallotherpartshavingbeenusedfor

sampling7. Rinse and dry all parts


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

operations of the sampling valve

5.3 Reassembling and autoclaving the Aseptic SystemAfterpropercleaningtheSystemmustbereassembledandautoclaved,followingthesesteps:

1. Screwthevalveheadonthesystembodymakingsurethevalveheadisinitsopenposition(toavoiddamagingthemembrane)

2. Leavethevalveinitsopenposition3. Addafewdropsofcleanwatertothebottle4. Screwthebottleontothecap5. Loosenthebottlehalfaturntoallowheattoaccesstheinteriorofthebottle6. FitthechosenventingcomponenttotheAirOutlet(seeexamplesinchapter4.2)7. Addanytubing,hosesandotheritemsthatmustbeautoclaved(theseitemsmaybeplaced

inTyveksterilisablebagsforfurtherprotectionuntiluse)8. Autoclavetheassembly

Afterautoclavingperformthefollowingsteps:1. Immediatelyafteropeningtheautoclavescrewthebottlefirmlyontothecap2. Immediatelythereafterclosethevalve3. Immediatelythereafterfitanyhoses4. Takeouttheassemblyandotherpartsfromtheautoclave

Havingdone1and2younowhaveasealedbottleunit,whichissterileontheinside.

5.4 Connecting the Aseptic SystemAfterhavingautoclavedtheAsepticSystemtakeitanditsaccessoriestothesamplingpointintheproduction.Havingpreparedthesamplingvalveaccordingtochapter5.1performthefollowingsteps:

1. UsingaPTFEhoseconnectthesamplingvalve’sloweroutletporttotheinletportoftheAsepticSystem

2. ConnectahosetotheAsepticSystem’sSteamOutletandletitgotodrainorsomeappropriatecollectorofsteam(don’tuseasteamtrapwhichwilllimittheflowofsteamandgreatlyreducetheflushingeffectofthesteamjet)

5.5 Steam sterilisationSteamsterilisationoftheflowpathtakesplacewithboththesamplingvalveandthesystemvalveremainingintheirclosedpositions.Performthefollowingsteps:

1. Makesurethesteamsupplyisconnectedtothesamplingvalve’supperinletport2. OpenthesteamsupplyandletitflowthroughthesamplingvalveandtheAsepticSystemfor

sterilisation.Allowminimum2-3minutesat121C(1bar(g))3. Closethesteamsupply,butleavethehoseinplacetopreventcontaminationfromthe

ambientduringsampling.Ifremovalofthesteamhoseisrequired,immediatelyfitasterilerubberorstainlesssteelplugontothesamplingvalve’supperconnector

Thevalveisnowreadytotakeasample.Thesamplingmustbeperformedimmediatelyaftersteamingtoavoidanycontaminationoftheflowpath,thebottleandhencethesample.Iftheprocessmediaisheatsensitive,itmaybenecessarytowaitforthevalvestocooloff.


WARNING• DuringsterilisationwithsteamtheSystemvalvewillbecomehotandcareshouldthusbetaken

when operating the valve• DonotopentheSystemvalvewhilesterilisingwithsteam,asitwouldleadsteamintothe

bottle. • ForaSystemallowedunderATEXforGroupIIGD,Category2(zone1)boththehandleandthe

topofvalvehead(typeQ)mustbecleanedbeforeuse• Alwaysremembertowearsafetygoggleswhensteaming,CIPping,takingsamplesoranyother

operationsofthesamplingvalveortheSystemvalve

IMPORTANT• Don’tattachasteamtraptothehosefromtheSteamOutletasitwillimpedetheflowofsteam

andhencetheflushingeffect,andmakethesterilisationdependantontemperatureonly,demanding a much longer sterilisation time

• Ifthesteamcapacityislowand/ortheoutlethosefromthevalveislongand/orwithalargediameter,thetemperaturewilldropandcondensationmayoccurinthevalvechamber.Inthiscase a counter pressure must be established using a pressure relief valve or a needle valve at theSystem’sSteamOutlet

• Leavethesteamhoseinplaceonthesamplingvalvetomaintaintheasepticconditionandprevent contamination from the ambient during sampling.

5.6 SamplingTheAsepticSystemisnowreadytotakeasterilesampleinanasepticenvironment.Takethesampleimmediatelyaftersterilisation(andcoolingoff,ifrequired)performingthefollowingsteps:

1. OpentheAsepticSystem’svalvefullyandleaveitopen2. Openthesamplingvalveslowlyuntilansuitableflowisobtained3. Fillthebottlewiththerequiredvolumeofsample4. Shutthesamplingvalveafterthesamplehasbeentaken5. ShuttheAsepticSystem’svalve6. DisconnectthehosefromtheAsepticSystem’sInletport7. DisconnectthehosefromtheAsepticSystem’sSteamOutletport8. Clean the sampling valve as appropriate following the instructions from its User Manual

Younowhaveasterilesampleinthebottletotaketothelaboratory.

WARNING• Whensamplingatahighpressureand/orwithalowviscosityprocessmediaitmayflowrapidly

intothesamplerecipient.Thereforeopenthesamplingvalveslowly.Specialcaremustbetakenwithpneumaticallyoperatedsamplingvalves,astheyopenabruptly

• Alwaysremembertowearsafetygoggleswhensteaming,CIPping,takingsamplesoranyotheroperations of the sampling valve


5.7 Retrieving the sampleAftersamplingtaketheAsepticSystemtothelaboratory.InaLAFbenchunscrewthebottlefromtheSystembyholdingontothescrewcap.Thesampleisnowreadytobefilledintoanothercontainerorwhateverelsemightbeneededfortheanalysis.AftertheAsepticSystemhasbeenemptieditmustmadereadyforthenextsamplebyperformingthecleaningprocess(chapter5.2)andtheautoclaving(chapter5.3).


6. TECHNICAL DATA

6.1 MaterialSteelparts: AISI316L(1.4404),AISI304(1.4301),AISI303L(1.4305)Membrane: PTFE(white)O-ring: EPDM(FDA,EU1935/2004)Sealingring: Thermoplasticelastomer(TPE)Screwcap: Polypropylen(PP)

6.2 CertificateAsepticsystem: 3.1*,RaCert.incl.measurements***Membrane: PTFE acc.toFDA&BGA *A6-digitcodeismarkedonthevalvebody.Thiscodereferstoa3.1

certificatewhichaccompanieseveryconsignmentofvalvebodies.The3.1certificateisavailableatwww.keofitt.dk

6.3 Pressure (max.)Inlet: 6bar/87psi Normaloperationispressureless,aspressuredropisacrossthesampling

valveandthesampleflowspredominantlybygravity.

6.4 Temperature (max.)Process: -20°C-+120°C/-4°F-+248°F** **Itisimportantthatthesteamissaturated,butdry,ascondensationcan

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

6.5 Surface treatmentInnersurface: ElectropolishedRa<=0.8µm/32µinchOutersurface: ElectropolishedRa<=1.2µm/47µinch

***Thesurfaceroughnessismeasuredforeachasepticsystemat3criticalplaces.

Aserialnumberidentifieseachasepticsystem.Aspecificsurfaceroughnesscertificateforeachvalvebodyisavailableonwww.keofitt.dk


7. MAINTENANCEKeofittrecommendstochangethePTFEmembraneonceayearorearlierasneeded.Therecommendationisbasedon1-5samplesaday.Intheeventofintensivesterilisationandcleaningitmaybenecessarytoreplaceitmorefrequently.

7.1 Spare parts list1. Valve body2. Sealingring3. Screwcap4. Spring5. Steelbushing6. Lowerstem7. MembranePTFE(White)


7.2 Keofitt Sampling Bottle Systems

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


7.3 Keofitt Sampling Bottle Systems - Parts & Accessories

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


8. INSTRUCTIONS ON REPLACING PTFE MEMBRANE Toremoveanoldmembranefromthevalvehead:

1. OPENthevalve(leverpositionasinillustrationA).2. Unscrew the valve head from the valve body. 3. CLOSEvalvehead(illustrationA).4. Pushthemembraneandbushingapart(illustrationB)untilthetoolformembranefitsunder

it. 5. Inserttoolformembrane,betweenthemembraneandthebushing(illustrationB).6. OPENvalvehead(illustrationC).7. Now the membrane is loosened from the valve head and can be replaced.

Toattachanewmembranetothevalvehead:8. SetthevalveheadtoCLOSEDposition(leverpositionasinillustrationB).9. Placethenewmembraneonvalvehead.10. MountthemembranebushingwiththenewTeflonmembranebypressingthemembrane

withyourhanduntilitclicks.11. SetthevalveheadinOPENposition.12. Insertthevalveheadintothevalvebody.13. 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.

A. B. C.


9. DATA SHEETS

9.1 Valve Head W9 Type Q (PTFE)

Last updated 04-11-2015*For further information please visit keofitt.dk

VALVE HEAD W9 TYPE Q PTFE ART. NO. 855543

GENERALThe KEOFITT CLASSIC W9 Sampling Valve is the original and leading sterilizable sampling valve in the world. Used in all industries for decades. + 320 standard valve configurations. Unique serial no. for each valve ("E" = internal electro polish).

The sampling valve can be used for any process sampling for microbiological, chemical and/or physical analysis.

The valve can be sterilized by means of SIP (EHEDG test) and cleaned by means of CIP (EHEDG certified). Suited for autoclave.

Designed for sampling of liquids with a viscosity of up to approx. 1.000 cP containing no particles larger than Ø3 mm. Sampling of more viscous liquids is possible, only will it take longer (depending on process pressure).

FEATURESInstallation: Threaded connection Operation: Lever handle

Depending on choice of valve body Membrane: PTFE (TFM 1600 - white)

CERTIFICATION* · Conforms to 3-A · EHEDG CIP · EU 1935/2004

TECHNICAL DATAMaterial (product contact)

· Membrane

PTFE (TFM 1600 - white)

Material (without product contact)· Steel parts· Steel parts

AISI 303L (1.4305)AISI 316L (1.4404)

Membrane· Article· Certification*

PTFE, WHITE (# 850055)FDA · USP · EU 1935/2004

Pressure & Temperature· Pressure· Temperature· Air supply

0 - 6 bar (g) / 0 - 87 psi (g)1 - 150°C / 34 - 302° F-

Net Weight· Kg/lbs 0,311 kg /0,68 lbs

Spareparts778541 PARTS FOR W9 HEAD 855541/42/43/47 104,2 mm

88,7

mm

M22x1.5


9.2 PTFE membrane - art. no. 850055

Last updated 19-12-2014*For further information please visit keofitt.dk

MEMBRANE W9/SIMPLEX PTFE ART. NO. 850055

GENERAL

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

Compatible with all KEOFITT W9 & Simplex valve heads for PTFE membrane

Compatible with all KEOFITT W9 & Simplex valve heads for PTFE membrane

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 0,004 kg /0,01 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

SERVICE LIFEAverage service life of a PTFE membrane is 12 months - actual life expectancy must be experimentally determined by the 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 or similar

32,0 mm

11,5I. D.

mm17,9

O. D. mm

KEOFITTA/SKullinggade 31DK-5700SvendborgDenmark

Phone+4563167080Fax+4563167081

[email protected]

Keofittreservestherighttochangetechnicaldatawithoutnotice!ForcompletesetofupdateddatasheetsandmanualsforKeofittproductspleaserefertoourwebpagewww.keofitt.dk

aseptic sampling system

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