s o m e p e o p l e w o u l d n ’ t g a m B l e w i t h t h e i r s a m p l e t m

User ManUal

Keofitt Aseptic sAmpling BAg (pAt. pend.) | Item no. 120500, 121000 & 122000

introduction: Manufacturer: KeofittSamplingBagsApS

Industrivænget6-8 5700Svendborg Denmark

type: KeofittAsepticSamplingBag,itemno.120500,121000&122000

year of introduction: 2010 year of revised design: -

ManufacturerretainstherighttochangetechnicalspecificationsandthecontentsofthisUsermanualwithoutpriornotice.TheEnglishversionofthisManualisthegoverningversionanditistheonlyauthorizedversion.Consequently,KEOFITTcannotbeheldliableforotherversionsincludingtranslationsofthisManual.

contentsPresentation ...................................................................................................................................................... 7

AsepticSamplingBagfunction ........................................................................................................................ 8

Sterilization ........................................................................................................................................................ 8

Accessory ........................................................................................................................................................... 9

PartdrawingKeofittAsepticSamplingBag-Item120500,121000,122000 ........................................ 10

HowtoOperate: ............................................................................................................................................... 11

K E O F I T T U S E r M A n U A l P A g E 7

presentAtionTheKeofittAsepticSamplingBagisasingleuseproduct.TheKeofittAsepticSamplingBagisasterile,pre-irradiatedproductsuppliedinasealedPE-bag.Theproductistoberemovedfromitssterilebagimmediatelybeforeuse.Thesterileconditionenablestheusertoextractatrulyrepresentativeasepticsamplefromaliquidprocesslinesamplingpointinaconvenientway.

TheKeofittAsepticSamplingBagistheultimatesamplingbagsolutionbasedonKeofitt’srenownedhighqualityandultrahygienicsamplingvalvedesign.

TheKeofittAsepticSamplingBagprotectsthesampleagainstairbornecontamination,whileextractingthesample,duringtransportationandstorage.

ThestandardoperatingprocedureinvolvessteamingthesamplingvalvewiththeKeofittAsepticSamplingBagconnected,inordertosterilizethesamplingvalveandtheconnectionbetweenthesamplingvalveandtheKeofittAsepticSamplingBag.

The3-wayvalveisdesignedtosealoffsampleandensuresterility–evenaftervalveclosure.Thevalvesealingpartisneverincontactwithnon-sterilearea.

1.Valve is steam sterilized 2. Sample is taken

During sampling the sealing area is never in contact with non-sterile areas

3. The valve is closed and the sample issealed and sterile

UsingstandardadaptorstheKeofittAsepticSamplingBagbecomescompatiblewithallsmallandmediumsizedKeofittsamplingvalves.

TheKeofittAsepticSamplingBagisusedinawiderangeofindustries,suchasbreweries,dairiesandthepharmaceuticalandbiotechnologicalindustries.

warning! � Duringsterilizationwithsteamthesystemwillbecomehotandemitssteam,careshouldbetaken

whenhandlingthesystem.Useprotectiongogglesandgloves.

K E O F I T T U S E r M A n U A l P A g E 8 K E O F I T T U S E r M A n U A l P A g E 9

Aseptic sAmpling BAg functionTheKeofittAsepticSamplingBagisdesignedforextractingonesingleproductsample.ThedesignasasingleuseAsepticSamplingBaggreatlyreducestheriskofsamplecontaminationoccurringduetoinsufficientsterilizationofthesamplecontainer.

TheKeofittAsepticSamplingBagisavailablein3differentsizes–500ml,1000mland2000ml.ItisimportanttochoosetheadequateAsepticSamplingBagsizeinordernottooverfillthebag.

warning! � Anoverfilledorover-pressurizedAsepticSamplingBagmayresultinmaterialburst.Payattention

tosamplingprocessatalltimes.

sterilizAtionSterilizationiscarriedoutbysupplyingsteamthroughthesamplingvalve.Steamflushesthroughthehosepieceandthroughthe3-wayvalve.

TheKeofittAsepticSamplingBagisbasedontheKeofittsteamsterilizablesamplingvalvedesign.AccordingtoatestcarriedoutbyDB-labinDenmarksteamsterilizingtheconnectiontotheAsepticSamplingBagbecomeseffectiveafterjust1minute’ssupplyofsteamatapressureof2bar[a](1bar[g],121˚C).

iMportant! � Sterilizationtakesplacewith3-wayvalveclosed.

1. Openthesteamsupply121°C(1bar[g]).

2. letthesteamflowthroughthe3-wayvalveforsterilizationfor1minute.

3. Closethesteamsupply.

warning! � TheKeofitt3-wayvalveandsiliconehosearedesignedtowithstandsystempressureof1bar[g]

at121°Cfor1minute.

do not at any tiMe appLy systeM pressure aBove 1.5 Bar[g]!

warning! � Duringsteamsterilizationthesystembecomeshotandemitssteam.Careshouldbetakenwhen

handlingthesystem.Useprotectiongogglesandgloves.

AccessoryOptional:Itispossibletoapplyaheatindicatorontothe3-wayvalve.Theheatindicatorwillchangecolourasafunctiontoheatvs.time.Whentheseconddotontheheatindicatorchangestoblacktheindicatormeasuresapprox.77°Candthecorrespondingsteamtemperatureinsidehasbeenapprox.121°Cforapprox.1minute.Thedifferenceintimeandtemperatureisduetoslowheattransferintheplasticvalvematerial.

TheheatindicatorcanbepurchasedseparatelyatKeofittA/S;Itemnr.120055

Itisveryimportanttoplacetheheatindicatorcorrectly–seeillustration.

71 77 82 88

RS

warning! � Theheatindicatorwillindicateasignificantlowertemperatureontheoutsideofthevalvethan

theactualtemperatureinsidethevalve.Bewareofhotsurface.Useprotectiongloves.

iMportant! � Usingaheatindicatorisconvenientwhenassessingsteamtemperature,butshouldbeused

basedontestandexperienceonly!

K E O F I T T U S E r M A n U A l P A g E 1 0 K E O F I T T U S E r M A n U A l P A g E 1 1

pArt drAwing Keofitt Aseptic sAmpling BAg - item 120500, 121000, 122000

Pos. Partname Material Pos. Partname Material

1 Tubefitting PC 6 PinchClamp PP

2 Quickcouplingring PP 7 Tube Silicone

3 3-wayvalvehouse PC 8 luerlock ABS/TPE

4 Tube Silicone 9 SamplingBag PE/PA

5 3-wayvalvepiston PP/TPE

How to operAte: removetheKeofittAsepticSamplingBagfromthesealedpouch.Optional:Placeheatindicatoron

3-wayvalve.

ATTACH TO VALVE OUTLET

AttachtheKeofittSterileSamplingBagtubefittingtothesamplingvalveoutletslidingthebluequickcouplingringtowardsthevalvetolock.The3-wayvalvesteamoutletisdesignedwithastandardKeofittW9connectorallowingtheconnectionoftubing,pressurereliefvalve,steamtrapetc.

STEAM OR FLUSH STERILISATION(WARNING HOT)

Steamsupplyisconnectedtotheupperconnectionofthesamplingvalveandtheassemblyissterilisedfor1minute–1bar[g](121°C).

warning! � Hot.Weargogglesandgloves.

REMOVE SEAL

Aftersterilization:Breakandremovetheprotectiveplasticsealpreventingthevalvepistonfrombeingactivatedunintentionally.

PUSH PISTON TO OPEN VALVE

Pressdownthepistontoopenthe3-wayvalve.

5 OPEN SAMPLE VALVE

Toextractthesample,thesamplingvalveisopenedslowly.

K E O F I T T U S E r M A n U A l P A g E 1 2 K E O F I T T U S E r M A n U A l P A g E 1 3

6 TAKE SAMPLE

Takesample

iMportant! � Donotremovesteamconnectionfromsamplingvalveuntilaftersamplehasbeenextracted.

7 CLOSE SAMPLE VALVE

Closethesamplingvalve

8 PULL PISTON TO CLOSE VALVE

Pullthevalvepistonbackuptoclosethe3-wayvalve.

9 PUSH PINCH CLAMP TO SEAL BAG

PushdownthepinchclamptomaketheKeofittAsepticSamplingBagairtight.

10 PULL QUICK COUPLING TO RELEASE

PullbackquickcouplingringandremovetheKeofittAsepticSamplingBag.

ToextracttestsamplesfromtheKeofittAsepticSamplingBag,eitherpenetratetheluerlockSeptumbyaneedle,connectasyringetothemaleorfemaleadaptor,orsimplydismounttheluerlocktopour.

ForcompletesetofupdateddatasheetsandmanualsforKeofittproductspleaserefertoourwebpagewww.keofitt.dk