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1© 2014 Meissner Filtration Products, Inc. - One-Touch® Single-Use Systems User Guide

One-Touch® User Guide



Table of ContentsDisclaimer 3Trademark Information 3I. Safety 4

A. Intended Use 4B. SafetyAlertDefinitions 4

a. SignalWordsAccordingtoANSIZ535.6-2011 4b. SignalWordsAccordingtoISO3864 4

C. GeneralSafetyMessagesforSingle-UseAssemblies 5D. GeneralDeploymentandOperationalHazards 6

II. Part Number Genealogy 7A. StandardBiocontainerAssemblies 7B. CustomBiocontainerAssemblies 7C. ManifoldAssemblies 8D. BioFlex®FluidPathAssemblies 8

III. Inspection Upon Receipt 9A. GuidelinesforReceivingInspection 9

IV. Unpacking Your Biocontainer Assembly 10A. Pre-UseInspection 10B. GuidelinesforUnpacking 10

V. Deploying Your Biocontainer Assembly 12A. Pre-DeploymentInspection 12B. 2DEnd-PortedBiocontainerDeployment 12

a. HangingYourBiocontainer 12b. DeployingYourBiocontainerinaTrayorOtherSupportDevice 12c. FillingYourBiocontainer 12

C. 2DFace-PortedBiocontainerDeployment 13a. DeployingYourBiocontainer 13b. FillingYourBiocontainer 13

D. FlexFill®BiocontainerDeployment 14E. 3DBiocontainerDeploymentinRigidOuterContainers 16

a. 3DBiocontainerDeploymentinFlexStation®RigidOuterContainers 16b. 3DBiocontainerDeploymentinQuaDrum®RigidOuterContainers 25c. ThirdPartyRigidOuterContainer 26

VI. Operating Your Single-Use Assembly 27A. SupplementaryPackaging 27

a. VinylDustCaps 27b. BubbleWrapPoly-Bags 27c. TamperEvidentPoly-Bags 27

B. GeneralProcessConnections 28a. QuickConnectors 28b. LuerConnectors 29c. SanitaryFlangeFittings 30

C. ControllingFlow 31a. Clamps 31b. Valves 31

D. AsepticProcessConnections 32a. Single-UsetoSingle-UseAsepticConnections 32b. Single-UsetoMultiple-UseAsepticConnections 34

E. AsepticProcessDisconnections 35a. HFC39SeriesConnectors 35b. TubeSealers 35

F. EffectingFluidTransferofLiquids 35G. TakingSamples 36

a. SamplingandInjectionSites 36H. UseofFilters 37

a. OperatingInstructionsforFilters 37b. Pre-useIntegrityTesting 37c. Post-useIntegrityTesting 37

VII. Disposing of Your Biocontainer Assembly 38VIII. References 39IX. Appendices 40

A. SampleCaseandProductLabels 40

GD014-1.0



DisclaimerTheinformationinthisUserGuideisnotintendedtoencompassallfeasibleoperationalscenariosofthesingle-usecomponentsandsystemsdescribedhereingiventhevastarrayofdifferingapplications,usageparadigmsandmethodscontemplatedbypharmaceuticalendusers.

Theparticularapplication,methodsofuseandoperationalconditionsofsingle-usecomponentsandsystemsinyourprocessarebeyondourcontrol.Thus,itisimperativethatyoutestthesingle-usecomponentsandsystemsinyourspecificapplicationtodeterminetheirultimatesuitability.

ThecomponentsandproductslistedinthisUserGuidearedesignedforuseinpharmaceuticalandbiotechnologicalmanufacturingprocessesandarenottobeusedforanyhospitalorpatientcare.

Theinformationinthisdocumentissubjecttochangewithoutnotice.MeissnerFiltrationProducts,Inc.doesnotmakeanywarrantyorrepresentation,expressorimplied,withrespecttotheaccuracy,completenessorutilityoftheinformationcontainedinthisdocument.

TrademarkInformationAdvantaFlex® AregisteredtrademarkofNewAgeIndustriesAdvantaPureAseptiQuik™ AregisteredtrademarkofColderProductsCompanyBioFlex® AregisteredtrademarkofMeissnerFiltrationProducts,Inc.C-Flex® AregisteredtrademarkofSaint-GobainPerformancePlasticsEverLUX® AregisteredtrademarkofMeissnerFiltrationProducts,Inc.FlexCessory™ AtrademarkofMeissnerFiltrationProducts,Inc.FlexFill® AregisteredtrademarkofMeissnerFiltrationProducts,Inc.FlexStation® AregisteredtrademarkofMeissnerFiltrationProducts,Inc.FluoroFlex® AregisteredtrademarkofMeissnerFiltrationProducts,Inc.I/P® AregisteredtrademarkofCole-ParmerL/S® AregisteredtrademarkofCole-ParmerMasterFlex® AregisteredtrademarkofCole-ParmerOne-Touch® AregisteredtrademarkofMeissnerFiltrationProducts,Inc.Pharmed® AregisteredtrademarkofSaint-GobainPerformancePlasticsQuaDrum® AregisteredtrademarkofMeissnerFiltrationProducts,Inc.Steam-Thru® AregisteredtrademarkofColderProductsCompanySteriLUX® AregisteredtrademarkofMeissnerFiltrationProducts,Inc.STyLUX® AregisteredtrademarkofMeissnerFiltrationProducts,Inc.TepoFlex® AregisteredtrademarkofMeissnerFiltrationProducts,Inc.



I. SafetyThankyouforchoosingassembliesfromourOne-Touch®single-usesystemsproductportfolio.

Thischapterprovidesimportantsafetyandcareinformation.Readthisguidebeforeusingthisproduct.Failuretofollowtheinstructionsandsafetyprecautionsinthismanualcouldresultinseriousinjuryordeath.Keepthisuserguideinasafelocationforfuturereference.MeissnerFiltrationProductsprovidesbothcustomerserviceandtechnicalsupport.

Torequestadditionalinformation,pleasecontact:NorthAmericaMeissnerFiltrationProducts,Inc.4181CalleTesoro Camarillo,CA93012USA

Phone:+18053889911Fax:+18053885948

Europe MeissnerFiltrationProductsGmbHAmKuemmerling24-2655294BodenheimGermany

Phone:+49613571695252Fax:+49613571691299

A. Intended UseTepoFlex®andFluoroFlex®biocontainerassemblies,aswellasBioFlex®fluidpathassemblies,fromourOne-Touch® single-usesystemsproductportfolioareintendedtobeusedforliquidmanagementapplicationsinpharmaceuticalandbiotechnologicalresearch,developmentandmanufacturingbyqualifiedpersonnelforinprocessuseonlyandarenottobeusedforanyhospitalorpatientcare.

B.SafetyAlertDefinitionsa. SignalWordsAccordingtoANSIZ535.6-2011

DANGERindicatesahazardoussituationwhich,ifnotavoided,willresultindeathorseriousinjury.

WARNINGindicatesahazardoussituationwhich,ifnotavoided,couldresultindeathorseriousinjury.

CAUTIONindicatesahazardoussituationwhich,ifnotavoided,couldresultinminorormoderateinjury.

NOTICEisusedtoaddresspracticesnotrelatedtophysicalinjury.

Safetyinstructions(orequivalent)signsindicatespecificsafety-relatedinstructionsorprocedures.

b. SignalWordsAccordingtoISO3864DANGER Signalwordusedtoindicateanimminentlyhazardoussituationwhich,ifnot

avoided,willresultindeathorseriousinjury.

WARNING Signalwordusedtoindicateapotentiallyhazardoussituationwhich,ifnotavoided,couldresultindeathorseriousinjury.

CAUTION Signalwordusedtoindicateapotentiallyhazardoussituationwhich,ifnotavoided,couldresultinminorormoderateinjury.

GENERALWARNINGSIGNThegeneralwarningsignisusedtoalerttheusertopotentialhazards.Allsafetymessagesthatfollowthissignshallbeobeyedtoavoidpossibleharm.



C. GeneralSafetyMessagesforSingle-UseAssembliesANSI Z535.6 ISO 3864 Description

WARNINGDonotpressurize.Biocontainerassembliesarenotpressurerated.Biocontainerassembliesthatincludeafilterintheirupstreamfluidpathmustbeoperatedsoasnottopressurizethebiocontainer.

WARNINGDonotexceedmaximumoperatingtemperatureof60°Cor140°F.

WARNING Donotconstrictflowonthedownstreamsideofapumpduringoperation.Peristalticpumpscanintroducepressurecapableofcausingalossoffluidintegritywhenflowisrestricted.

CAUTIONDonotusesingle-useassembliesbelowminimumoperatingtemperatureof0°Cor32°F.Biocontainerassembliesthatarenotdesignedandqualifiedforfreeze/thawapplications,suchasforexamplethoserequiringtheuseofprotectiveouterrigidtraysorcontainers,mayresultinfluidintegrityfailures.Fluidpathassembliesthatarenotdesignedandqualifiedforfreeze/thawapplicationsmayresultinfluidintegrityfailures.

CAUTIONDonotpuncture.Single-useassemblieswhicharenotprotectedfromcontactwithsharpobjectsmayresultinfluidintegrityfailures.

CAUTIONDonotdrawvacuum.Single-useassembliesarenotratedforvacuum.

CAUTIONDonotoverfill.Biocontainersaredesignedwithamaximumoverageof10%oftheirstatednominalvolume when deployed under standard conditions.Exceedingthatlimitmayresultinfluidintegrityfailures.



D.GeneralDeploymentandOperationalHazardsANSI Z535.6 ISO 3864 Description

CAUTIONCuttinghazard.Boxcutterscancausedamagetoyoursingle-useassembly.

CAUTIONBursthazard.Donotexceedtheoperatingparametersforthespecificfilteryouareusing.Iftubingislocatedupstreamofthefilterdonotexceedoperatingparametersofthetubing.

CAUTIONFluidIntegrityhazard.Donotleanonanyrigidoutercontainerasthiscouldcauseawalltocollapseresultingindamagetoabiocontainerandpossibleinjury.Testanyhangingapparatusfirsttoensurethatitcansupporttheweightofafullbiocontainer.



II. PartNumberGenealogyA.StandardBiocontainerAssemblies

B.CustomBiocontainerAssemblies



C.ManifoldAssemblies

D.BioFlex®FluidPathAssemblies



III.InspectionUponReceiptSingle-useassembliesarepackagedintwocardboardboxes,i.e.,oneouterboxandoneormultipleinnerboxesforsecuretransportation.

TheCertificateofQualityisenclosedwithinthepackaging.Thesterilizingdosageinformationisavailableseparatelyfordownloadathttps://extranet.meissner.com/certificates.

A.GuidelinesforReceivingInspectionPlease refer to the following step-by-step guidelines: 1.Verifythatshippingdocumentationisingoodorder. 2.Inspecttheouterboxforpotentialshippingdamageandimmediatelyreportanydamagetothecarrier. 3.Opentheouterboxwithcautionasboxcutterscancausedamagetoyoursingle-useassembly. 4.Inspectinnerboxforpotentialshippingdamage. 5.VerifythattheCertificateofQualityisenclosedandreportanabsencethereofimmediatelytoMeissner. 6.VerifyCertificateofQualitywithCaseLabeloninnerbox.

AnannotatedsampleCaseLabelisfeaturedinAppendixA.TheCaseLabelwillonlyfeaturethecustomerpartnumberandcustomerpurchaseordernumberperspecificcustomerrequest.

7.Opentheinnerboxwithcautionasboxcutterscancausedamagetoyoursingle-useassembly. 8.Inspectsingle-useassembliesforpotentialshippingdamage. 9.VerifyCertificateofQualitywithProductLabel.

AnannotatedsampleProductLabelisfeaturedinAppendixA.TheProductLabelwillonlyfeaturethecustomerpartnumberandcustomerpurchaseordernumberperspecificcustomerrequest.Iftheproducthasbeenrequestedasnon-sterile,itwillbenotedassuchinlieuoftheirradiationdot.

10.Verifythequantityofsingle-useassembliesreceivedandimmediatelyreportanyshortfalltoMeissner.



IV.UnpackingYourBiocontainerAssemblySingle-useassembliesaremanufacturedinanISOclass7cleanroomandvaccuumpackagedintwopolyethylenebags.Thesingle-useassemblyissealeddirectlyinsidetheinnerpoly-bag,whichissealedinsidetheouterpoly-bag.Certainitemsmayincludeadditionalpackagingtoprovideprotectionduringshipment.FormoreinformationinthisregardseechapterVI.

Oncepackaged,single-useassembliesaregammairradiatedbeforebeingshippedunlessotherwiserequested.

Iftheproducthasbeenrequestednon-sterile,itwillbenotedassuchontheProductLabel.SeeAppendixAforreference.

A.Pre-UseInspectionPlease refer to the following step-by-step guidelines: 1.Removedesiredquantityofsingle-useassembliesfrominnerbox. 2.Verifythatthepackagingisingoodorder. 3.Recycleordiscardpackagingaccordingtolocalregulationsasappropriate. 4.VerifythattheexpirationdateontheProductLabelforeachsingle-useassemblyhasnotpassed. SeeAppendixAforreference.5.Recordthelotand/orserialnumberalongwithanyotherinformationthatyouneedforyourbatchrecordas

appropriate.Meissner’speelandsticklabel(whichislocatedontheoutsideoftheinnerbag)willsavetimeandhelptoeliminatehumanerrorintransferringdatatodocumentation.

B.GuidelinesforUnpackingPlease refer to the following step-by-step guidelines (continued on the next page):

Oftenafterremovingtheouterpoly-bagthesinglebaggedproductwillbetransferredtoacontroledspace,e.g.acleanroom,forsubsequenthandling.

Positionasafetycutterorothercuttingdevicesothatyouwillonlyopentheouterpoly-bag;carefullycutopentheouterpoly-bag.

Carefullyremovetheinnerpoly-bagfromtheouterpoly-bagandretainpeelandsticklabelforyourrecordsshouldyouchoosetodoso.



Positionasafetycutterorothercuttingdevicesothatyouwillonlyopentheinnerpoly-bag.Carefullycutopentheinnerpoly-bag,ensuringthatyoudonotdamageyoursingle-useassembly.

Younowhaveaccesstoyoursingle-useassembly.

Carefullyremoveyoursingle-useassemblyfromtheinnerpoly-bag.



V. DeployingYourBiocontainerAssemblyA.Pre-DeploymentInspection

1.Verifyclamppositionsandleavethemopenorclosethem,dependingonyourapplication.

Single-useassembliesarrivewithclampsopentopreventcompressionsetontubingthatmayhinderfunctionaldeploymentand/oroperation.

2.Verifythatalltubingendtreatmentsaresecuredasrequiredforyourapplication.

B.2DEnd-PortedBiocontainerDeployment2Dend-portedbiocontainersaredesignedtobeoperatedinahangingorpillowposition(eitherlayitflatoratthedesiredangle).Seefiguresbelowforexamples.

2Dend-portedbiocontainer 2Dend-portedbiocontainerinhangingpositionutilizingFlexCessory™cart&hanger

2Dend-portedbiocontainerinaflatpillowposition

2Dend-portedbiocontainerinangledpillowposition

a. HangingYourBiocontainerMeissner’sFlexCessory™dualend-portedbiocontainercartprovidessecuritywhendeployingend-portedbiocontainerassemblies.Thestandcansupportuptotwo20Lend-portedbiocontainersandisadjustable,viaacenterpostclamp,toaheightof72inches.BiocontainerassembliescanbedirectlysupportedonthenotchedheadofthecartorhungfromtheergonomicallydesignedstainlesssteelFlexCessory™hanger.

b. DeployingYourBiocontainerinaTrayorOtherSupportDeviceCarefullypositionbiocontainerinoronsupportdeviceandensurethattheportsonthecontainerareinthecorrectpositionforyourspecificapplication.

c. FillingYourBiocontainerOnceyourbiocontainerispositionedandsupported,decidewhichclampsshouldremainopenandwhichshouldbeclosed,andsubsequentlywhichprocessconnectionsneedtobeengagedbasedontheintendedapplication.SeeChapterVIformoreinformationregardingprocessconnections.

Fluidpathsshouldbepositionedtoenableunrestrictedtransferoffluidandshouldnotbeobstructedbythebiocontainer.



C.2DFace-PortedBiocontainerDeployment2Dface-portedbiocontainersaredesignedtobedeployedandoperatedinapillowposition(eitherlayitflatoratthedesiredangle).Supportdevicesincludethefollowingbutarenotlimitedto:labtables,shelves,trays,othersmooth,flatorslightlyangledsurfaces.Seethefiguresbelowforexampleswith2Dface-portedbiocontainers.

Forlarger2-Dface-portedbiocontainers(i.e.50-200L),cylindricaldrumscanoftenbeusedassupportdevices.ContactMeissnerifyouhavespecificquestionsinthisregard.

2-Dface-portedbiocontainer 2-Dface-portedbiocontainerinaflatpillowposition

2-Dface-portedbiocontainerinangledpillowposition

2-Dface-portedbiocontainersupportedbycylindricaldrums

a. DeployingYourBiocontainerEnsurethattheportsonthecontainerareinthecorrectpositionforyourspecificapplication.

b. FillingYourBiocontainerOnceyourbiocontainerispositionedandproperlysupported,decidewhichclampsshouldremainopenandwhichshouldbeclosed,andsubsequentlywhichprocessconnectionsneedtobeengagedbasedontheintendedprocessapplication.SeeChapterVIformoreinformationregardingprocessconnections.




D.FlexFill®BiocontainerDeploymentFlexFill®biocontainerassembliesaredesignedforapplicationsrequiringfastanddependableaseptictransferofliquidvolumeslessthanorequalto5L.Itslargescrew-capportallowsforrapidandconvenientfillinginanasepticenvironment(e.g.inalaminarflowhood)usingtheportablestainlesssteelFlexCessory™stand.

FlexFill®biocontainer FlexFill®biocontainersupportedonFlexCessory™stand

FlexFill®Mixingsystemshavebeenoptimizedforsmallvolumepowder-liquidandliquid-liquidmixingapplications.ThedistinctiveblendedshapeoftheFlexFill®biocontainerinconjunctionwiththeuniqueportinglocationsfeaturedonthemixingassembliesproviderobustmixingactionwhenusedwithasuitableperistalicpump.FlexFill®mixingassembliessupportasepticprocessingwhendeployedusingtheportablestainlesssteelFlexCessory™standinalaminarflowhoodorwhenspecifiedwithsterileand/orasepticfluidpathconnectionoptions.

Please refer to the following step-by-step guidelines (continued on the next page):

Decidewhichclampsshouldremainopenandwhichshouldbeclosed,andsubsequentlywhichprocessconnectionsneedtobeengagedbasedontheintendedprocessapplication.SeeChapterVIformoreinformationregardingprocessconnections.

PlaceFlexFill®biocontaineronthestandandadjusttoaccommodatescrewcapremovalandfilling.AdjustsupportpinsonstandsothatslackonthetopoftheFlexFill®isminimizedwithoutstretchingthefilm.

Thescrewcapishandtightenedtomaintainasepticconditionsandmayrequiremoderateforcetoremove.GraspacorneroftheFlexFill® biocontaineratthecrossseamwithonehandwhileturningthescrewcapcounter-clockwisewithyourotherhand.

Thefollowingshouldbecompletedunderalaminarflowhoodtomaintainasepticprocessconditions



FillyourFlexFill®biocontainerinaccordancewithyourinternalproceduresorpracticesregardingaseptichandling.

Ifthethreadsorsealingsurfaceoftheportbecomecontaminatedduringthefillingoperation,cleantheareawithanappropriateantimicrobialdisinfectantaccordingtoyourinternalproceduresorpractices.

Manuallyloosenthescrewcapbyturningitcounterclockwiseuntilitjustbreaksfreefromitsfrictionpoint.

Thissecondtighteningactioncompressesthescrewcaplinercreatingasealwhichis5to7timesstrongerthanasingletighteningalonewhileeliminatingtheneedforslipagentsorotherplasticadditives.

Manuallyinstallthescrewcapbyturningclockwiseuntilitseatsusingmoderateforce.

Immediately,andinthesamemotion,manuallyretightenthescrewcapusingmoderateforce.



IfusingaFlexFill®mixingassembly,deployrecirculationloopinaccordancewithyourinternalproceduresandpracticeswhileadheringtotheperistalticpumpmanufacturer’sinstructions.

Theuseoftubinginaperistalticpumpwhichiseitherincorrectlysizedand/ormanufacturedfrominappropriatematerial,canleadtoprematuretubingfailure.

E.3DBiocontainerDeploymentinRigidOuterContainersRigidOuterContainers(ROCs)offersupportfor3Dbiocontainersandlarger2Dface-portedbiocontainers.Seethefiguresbelowforexamplesof3DbiocontainerssupportedbyROCs.

3Dtopandbottomportedbiocontainer

3DbiocontainersupportedbyaFlexStation® ROC

3Dtop-portedbiocontainerdesignedfor

drumdeployment

3DbiocontainersupportedbyQuaDrum® on dolly

a. 3DBiocontainerDeploymentinFlexStation®RigidOuterContainers3Dbiocontainerscanbesuppliedwithtopand/orbottomports.Arigidoutercontainer(ROC)withbottomportingallowsforeasyproductdrainutilizinggravity,whereastopportedbiocontainerstypicallyrequireaperistalticpumptoevacuate.

100-500LFlexStation®ROC’shaveeitherafalsebottomorafalsewallforaccesstobottomportingandassociatedfluidpathstorage.



i.FlexStation®100and200

FlexStation® 100 and 200 Orientation for Biocontainer DeploymentITEM

1234567

DESCRIPTIONFrontWall-FrontoftheFlexStation®ROCBackWall-BackoftheFlexStation®ROCLeftSideWall-Theleft-handsideoftheFlexStation®ROCRightSideWall-TheRight-handsideoftheFlexStation®ROCFalseBottom-TheinnerbiocontainersupporttrayoftheFlexStation®ROC(notpictured)CollapsibleSupportFrame(notpictured)BottomDrainAccessDoor

Verify that your biocontainer and FlexStation® are compatible:1. 200LbiocontainerassembliesdesignedfortheFlexStation® are used only

withFlexStation®200units.2. 100LbiocontainerassembliesdesignedfortheFlexStation®100canbe

usedwitheithertheFlexStation®100or200.



3. TheFlexStation®canbeeasilyidentifiedbyitsnameplatebutcanalsobeverifiedbythedistancethatthefalsebottomislocatedfromtheflooroftheROC:

a. AFlexStation®200willhaveafalsebottomthatisapproximately4inchesfromthebottomoftheROCwhenerected.

b. AFlexStation®100willhaveafalsebottomthatisapproximately10inchesfromthebottomoftheROCwhenerected.

Prepare the FlexStation® to receive a biocontainer assembly: 1. RemovethelidfromtheROCanderectthewalls.2. Removetheplasticfalsebottom.3. Erectthefalsebottomrack.

a. LifttherackabovetheROCfloor.

b. RotatethelegsoutwardsothatthefeetcontactboththesideandtheflooroftheROC.

Step3ismosteasilyaccomplishedbyfirstrotatingthebacklegsoutwardsimultaneouslyandthen,whilerestingtherackonthebacklegs,rotatingthefrontlegsoutwardsimultaneously.

Falsebottomrackinplace Falsebottomtrayinplace

4. Reinsertthefalsebottomtray.

a. OrientthetraywiththesidespointedupandtheholeclosesttothefrontoftheROC(nearestthefalsebottomdoor).

b. Pressdownonthecornersofthefalsebottomtraytomakesurethetrayisseatedflatagainstthefalsebottomrack.

Orient and install biocontainer assembly:1. FlexStation®compatiblebiocontainerassembliesarepackagedina

rectangularformat.Whenopenedandlaidflat,theyformanoctagon.Thisoctagonhastwolongsideedgesthatarefourfilmlayersthick(identifiedasLeftandRightinbiocontaineroctagonfigure)andafrontandbackedgethataretwofilmlayersthickwithdiagonalcornersinbetween.



a. Theshortsidesofthebiocontainer(twolayersthick)willfoldupagainstthefrontandbackwallsoftheROC.

b. Thelongsidesofthebiocontainer(fourlayersthick)willmeettheleftandrightsidesoftheROCwhenlaidflatagainstthefalsebottom.

c. Oftheeightcornersoftheoctagon,thefourcornersthatarefourfilmlayersthickshouldmeeteachcorneroftheROCatthefalsebottom.

d. Notethesectionofthebiocontainer(layingflatintheFlexStation®

ROC)thatisonlytwofilmlayersthick.ThiswillappearasastripofmoretransparentmaterialrunningfromfronttobackoftheROC.Thebiocontainerportswillbecenteredfromlefttorightinthisstrip.

100Lor200LBiocontainerOctagon 100Lor200LBiocontainerinFlexStation®ROC

2. Ifatop-portedbiocontainerassemblyisbeinginstalled:

a. Installtheassemblypertheoctagonorientationmakingsurethatallportingisfacingup.

b. Verifythatnotubingistrappedbythebiocontainer.NotubingshouldberunningbetweentheROCwallsandthebiocontainer.

3. Ifatopandbottom-portedbiocontainerassemblyisbeinginstalled:

a. Locatethebottomport,whichisoffsettomeettheholeinthefalsebottomtray.

b. Routeallbottomtubing/fittingsthroughtheholeinthefalsebottomtrayandoutthefalsebottomdoor,takingcarenottostressthebiocontainerduringinstallation.



Tubingroutedthroughholeinfalsebottomtray

c. Completeinstallationofthebiocontainerassemblypertheoctagonorientationpreviouslydescribed.

d. Verifythatnotubingistrappedbythebiocontainer.NotubingshouldberunningbetweentheROCwallsandthebiocontainer.

Fill the biocontainer assembly:1. Forportingconnectionsonthetopofthebiocontainer,carefullyreachover

thefrontoftheROCforaccess.2. Thebiocontainermaybefilledfromeithertoporbottomports.

a. Thebiocontainerwillself-deployasitisfilled.




ii.FlexStation®500

FlexStation® 500 Orientation for Biocontainer DeploymentITEM

1234567

DESCRIPTIONFrontWall-FrontoftheFlexStation®500ROCBackWall-BackoftheFlexStation®500ROCLeftSideWall-Theleft-handsideoftheFlexStation®500ROCRightSideWall-TheRight-handsideoftheFlexStation®500ROCFalseBottom-TheinnerbiocontainersupporttrayoftheFlexStation®500ROCWallReleaseLatchesBottomDrainAccessDoor

Verify that your biocontainer and FlexStation® are compatible:1. Only500LbiocontainerassembliesareusedwithFlexStation®500units.2. TheFlexStation®canbeeasilyidentifiedbyitsnameplatebutcanalsobe

verifiedbytheinterior“footprint”or“base”dimensionsoftheROC:a. AFlexStation®500willbe102cmx72cm(40"x28").

3. Thebiocontainerassemblycanbeidentifiedbyitslabel.

Prepare the FlexStation® to receive a biocontainer assembly:

1. RemovethelidfromtheROCanderectthewalls.

a. Openthefrontwalllast,makingsuretheredlatchesaresecure.



2. Erectandlatchthefalsewall.

a. Thefalsewallwillbeleaningawayfromthefrontwall.

b. Movethetopofthefalsewalltowardthefrontuntilthewallclearsthestopblocksattheverybottomofthebin.

Erectingthefalsewall

c. Movethetopofthefalsewallbackawayfromthefrontuntilthereisenoughroomfortheupperlinkstorotateout.

d. Insertthelinksintotheirrectangularreceivers(boththeleftandrightlinksshouldbeinsertedsimultaneously).

e. Insertthedraw-latchpinsintotheirslotsandlatchlatches

Latchingthefalsewall

Thelatchesshouldsnapclosedwithonlylightpressure.Ifthelatcheswillnotclose,ordonotstayclosed,thedraw-latchpinsmayrequireadjustment.



Orient and install biocontainer assembly:

1. FlexStation®compatiblebiocontainerassembliesarepackagedinarectangularformat.Whenopenedandlaidflattheyformanoctagon.Thisoctagonhastwolongsideedgesthatarefourfilmlayersthickandaleftandrightedgethataretwofilmlayersthickwithdiagonalcornersinbetween.

a. Theshortsides(leftandright)ofthebiocontainer(twolayersthick)willfoldupagainsttheleftandrightwallsoftheROC.

b. Thelongsidesofthebiocontainer(fourlayersthick)willmeetthefrontandbacksidesoftheROCwhenlaidflatagainstbottom.

c. ThebackcornersofthebiocontainershouldbelocatedatthebottombackcornersoftheROC.

d. ThebiocontainerportswillbecenteredatthefrontoftheROCandwillmeetwiththebottomdrainreliefintheflooroftheROC.

500LBiocontainerOctagon 500LBiocontainerinFlexStation®ROC

2. Ifatop-portedbiocontainerassemblyisbeinginstalled:

a. Installtheassemblypertheoctagonorientationdescribedpreviouslymakingsurethatallportingisfacingup.




3. Ifatopandbottom-portedbiocontainerassemblyisbeinginstalled:

a. Locatewhichportyourorganizationhasdesignatedasthebottomportandverifythatthisportisfacingdown.


i. Ifastandardbiocontainerassemblyisused,thebottomportwillbeasinglelargerport.

i. Takecarenottostressthebiocontainerduringinstallation.

Tubingroutedthroughreliefinbottomoffalsewalland outtheaccessdoor

c. Completeinstallationofthebiocontainerassemblyperthepreviouslydecribedoctagonorientation.

Fill the biocontainer assembly:

1. Forportingconnectionsonthetopofthebiocontainer,carefullyreachoverthefrontoftheROCforaccess.

2. Thebiocontainermaybefilledfromeithertoporbottomports.

a. Thebiocontainerwillself-deployasitisfilled.

iii.AdditionalFlexStation®InformationFlexStation®1000ROC’sareavailableforbiocontainerassemblieswithvolumeslargerthan500L.PleasecontactMeissnerfordetailedproductinformation.

SupportandtransferofFlexStation®ROC’scanbeaccomplishedwithMeissnerFlexStation®specificmobilecartsorhandpallettruck.PleasecontactMeissnerfordetailedsupportproductinformation.




b. 3DBiocontainerDeploymentinQuaDrum®RigidOuterContainersPlease follow the step-by-step instructions:

Holdthebiocontaineratthetopandunfolditasshown.

Placethebiocontainer,topportsup,inthedrumwithtubingontheoutside.

Ifusingadolly,placethedrumondollybeforebiocontainerdeployment.

Positionthebiocontainersothatthefourgussetedcornersofthebiocontainerfitintothecornersofthedrum.

Whilefillingthebiocontainer,ensurethatplacementofthegussetedcornersissecureforapproximatelythefirstfiveliters.

Thebiocontainerisdesignedtoself-deployhoweverduetothehighaspectratiooftheQuaDrum®itisrecommendedtomonitorthefillingprocessandadjustthebiocontainerwhennecessary.

Decidewhichclampsshouldremainopenandwhichshouldbeclosed,andsubsequentlywhichprocessconnectionsneedtobeengagedbasedontheintendedapplication.



c. ThirdPartyRigidOuterContainersMeissnerFiltrationProductsdesignscustombiocontainersthatfitinthirdpartyrigidoutercontainerssuchasindustrystandardcylindricaldrums;however,itisultimatelythecustomer’sresponsibilitytocorrectlydeployourbiocontainersinthirdpartyoutercontainers.It’simperativethatcustombiocontainersaretestedfortheirspecificdeploymentanduse.

PleaseconsultMeissnerifyouhavefurtherquestionsregardingtheuseofthirdpartyROC’s.



VI.OperatingYourSingle-UseAssemblyA.SupplementaryPackaging

a. VinylDustCapsSomeendfittingsaresuppliedwithvinyldustcapsasaprecaution.Forexample,manysimpleLuerend-fittingsandsomeTCconnectionsutilizethese.Simplyremovethedustcapwhenaccesstoagivenconnectionisrequired.

Single-useassembliesmayincludesupplementarypackagingitemstoprovidetamperevidenceand/oradditionalprotectionduringshipment.Thethreemostcommontypesofsupplementarypackagingareidentifiedbelowhoweverthisisnotanexhaustivelist.PleaseconsultMeissnerifyouhaveanyquestionspertainingtosupplementarypackagingnotcoveredhere.

b. BubbleWrapPoly-BagsFiltersandlongerfluidpathswithbulkycomponentryareoftenplacedinsealedbubblewrappoly-bagstoprovideadditionalprotection.Thesecaneasilyberemovedduringdeploymentoftheassociatedsingle-useassembly.

c. TamperEvidentPoly-BagsQuickconnectors,asepticconnectorsandsomeothertubingend-treatmentsmayincludetamperevidentre-closablepoly-bagssecuredwithacabletie.Togainaccesstotheprocessconnectionsimplyremovetheperforatedtamperevidentplasticstripandopenthepoly-bagviathere-closableseal.Thepoly-bagcanbepushedbackawayfromthefluidpathandtheconnectionthenmade.



B.GeneralProcessConnectionsa. QuickConnectors

Quickdisconnectcouplings(QDC’s)arecommonlyusedtoaccomplish1/4"–1/2"innerdiametertubingconnections.Thesearenotconsideredasepticconnectors,howevertheycanbeoperatedasepticallygiventheproperenvironmentandtechnique.TherearetwogeneraltypesofQDC’s;MPCfittingsaccommodateflowpathsbetween1/8"and3/8"innerdiameterwhileMPXfittingscanbeusedwith3/8"and1/2"innerdiameterflowpaths.

Tomakeaconnection,simplypushthecouplinginsertintothecouplingbodyuntilyouhearanaudible“click”.

QDC’saredeliveredwithcapsorplugstocloseoff thefluidpath.

Whenreadytomakeaconnection,ensurethatfluidflowisrestrictedaccordinglyandremovecapandplugaccording

toyourinternalproceduresandpractices.

Todisconnect,ensurethatfluidflowisrestrictedaccordinglyanddepresswhitelatchoncouplingbodyto

pullcouplinginsertout.



b. LuerConnectorsLuerconnectorsaretypicallyusedforsamplingoperationsandsmallvolumefluidtransferapplications.

Luerconnectorsaredeliveredwithcapsorplugstocloseoffthefluidpath.

Whenreadytomakeaconnection,ensurethatfluidflowisrestrictedaccordinglyandremovecapandplugaccording

toyourinternalproceduresandpractices.

Tomakeaconnection,holdoneconnectorwithyourlefthandandturnoppositeconnectorclockwisewithyourright

hand.

Todisconnect,ensurethatfluidflowisrestrictedaccordinglyandholdoneconnectorwithyourlefthandandturnoppositeconnectorcounter-clockwisewithyourright

hand.



c. SanitaryFlangeFittingsSanitaryflangefittingsareoftenusedasaconnectionbetweensingle-usesystemsandtraditionalprocessingequipment.Theyaresuitableforhighpressureapplicationswhenusedinconjunctionwithhighpressuretubingandhighpressurehosebarbconnectivity.

Sanitaryflangefittingscanbedeliveredwitheitheravinyldustcaporsecuredwithablindcap,gasketandclamp.Toconnecttwosanitaryflangefittingsyou’llneedonegasket

andoneclamp.

Whenreadytomakeaconnection,ensurethatfluidflowisrestrictedaccordingly,removeanyprotectivecoveringandplacesiliconegasketintoridgeononesanitaryflange.

Connecttheflangestogetherwiththegasketbetweenthem.

Applyclamparoundtheoutsideoftheflangesandtightenthebutterflyscrewbyturningitclockwise.Toremove

clamp,turnbutterflyscrewcounter-clockwise.



C.ControllingFlowa. Clamps

Ratchetingpinchclampsarecommonlyusedforcontrollingfluidflowandarecompatiblewithmoststandardtubing.

Torestrictorstopfluidflow,pinchclamptogether.

Toallowfluidflow,openclampbypullingbottomofclampsothatratchetisreleasedandpullboth

endsasshown.

b. ValvesSingleusevalvescanbeusedasclampstoshutofffluidfloworasvalvestocontrolflowrates.ForhighpressureapplicationsMeissnerrecommendstheuseofheavydutyvalvesliketheoneinthefiguresbelowinconjunctionwithbraidreinforcedsiliconetubing.

Torestrictorstopfluidflow,tightenbutterflyscrewbyturningclockwise.

Toallowfluidflow,loosenbutterflyscrewbyturningcounter-clockwise.



D.AsepticProcessConnectionsa. Single-UsetoSingle-UseAsepticConnections

i.AsepticConnectors

AseptiQuik™connectorsaredeliveredwithprotectivecaps.Removethesecapswhenreadytomakeanaseptic

connection.

Ensurethatfluidflowisrestrictedaccordingly.Lineupbluetabsandclickthecouplinginsertintothecouplingbody.

Pullbluemembranetabsouttogether. Holdcouplingbody(whiteconnection)inplaceandtwistcouplinginsertbluecollarclockwiseuntilyouhearaclick.

TherearetwogeneraltypesofasepticconnectorsthatMeissnerrecommends;AseptiQuik™connectors,whichutilizeacouplinginsertandacouplingbody,andAseptiQuik™Gconnectors,whicharegenderless.Alternatively,tubewelderscanbeusedtomakeasepticprocessconnections.

FormoreinformationabouttheAseptiQuik™refertotheColderProductsCompany®websiteat www.colder.com.



FormoreinformationabouttheAseptiQuik™GrefertotheColderProductsCompany®websiteat www.colder.com.

iii.TubeWeldersTubeweldersareusedtoasepticallyconnectthermoplasticelastomer(TPE)orPVCtubingmaterials.Tubingthatisspecifiedtobeweldedwilltypicallyterminatewithahosebarbplugorasealedend.Refertoyourtubeweldermanufacturerforsafetyinformationanduserinstructions.

ii.GenderlessAsepticConnectors

AseptiQuik™Gconnectorsaredeliveredwiththeirbluemembranepulltabscoveringtheconnections.

Whenreadytomakeanasepticconnection,ensurethatfluidflowisrestrictedaccordinglyandopentabssothat

theylineup.

Clicktheconnectionstogether. Pullbluemembranetabsouttogether.



ProcessFlowDiagramforSteam-Thru®

b. Single-UsetoMultiple-UseAsepticConnectionsi.Steam-Thru®Connectors(STC’s)

1. Tosterilizetheconnection,allowsteamtoflowfromtheprocessequipmentthroughtheSTCintoasteamtrap.

2. Removeprotectivesleevewhenreadytodisconnectfromthesteamtrapandpushtogethertoactuate.

ProcessFlowDiagramforSteam-Thru® II

1. Tosterilizetheconnection,allowsteamtoflowfromtheprocessequipmentthroughtheSTCIIintoasteamtrap.

2. Removeprotectivesleevewhenreadytodisconnectfromthesteamtrap.Depresslatchandpushtogethertoactuate.TheSTCIIisnowinthe“flowposition.”

4. Toreturnto“sterilizationposition”,depresslatchandmovevalvebackuptooriginallocation.

Establishflowbetweenprocessequipmentandsingleusesystem.3.

Establishflowbetweenprocessequipmentandsingleusesystem.3.

FormoreinformationaboutSteam-Thru®andSteam-Thru®IIconnectorsrefertotheColderProductsCompany®websiteatwww.colder.com.

ii.Steam-Thru®IIConnectors(STCII’s)



E.AsepticProcessDisconnectionsa. HFC39SeriesConnectors

TheHFC39seriesconnectorsaredesignedtoshutofftheflowpathwhendisconnected,providingsingle-useasepticdisconnectfunctionality.Theseconnectorsaredesignedforsingleactuation;i.e.donotreconnectthem.

HFC39seriesconnectorsaredeliveredconnected,ensuringsterility.

Whenreadytomakeanasepticdisconnection,depressthumblatchandpullconnectorsapart.

DonotreconnectonceHFC39connectorshavebeendisconnected.

b. Tube SealersTubesealersareusedtoasepticallydisconnecttubing.TPEtubingcanbesealedwiththermalequipment.PVCandEVAtubingcanbethermallysealedorRFwelded.Refertoyourtubesealermanufacturerforsafetyinformationanduserinstructions.

F. EffectingFluidTransferofLiquidsThetwomostcommonmethodsofaffectingafluidtransferto,from,orthroughasingle-usesystemareviagravityandviatheuseofaperistalticpump.Typicallyperistalticpumpsrequirespecificsizetubinginordertofunction.Anabbreviatedtableisprovidedbelow.However,pleaseconsultyourpumpmanufacturer’soperatingmanualforspecifictubingsizeandmaterialrecommendations.

Theuseoftubinginaperistalticpumpwhichiseitherincorrectlysizedand/ormanufacturedfrominappropriatematerial,canleadtoprematuretubingfailure.

Peristaltic Pump Tubing Sizing ChartTubing Size Masterflex® Watson Marlow

ID x OD Number L/S® High Performance I/P® Precision 520R 520R2 620R1/8"x1/4" 16 x3/16"x5/16" 25 x3/16"x3/8" 15 x x1/4"x3/8" 17 x1/4"x7/16" 24 x x1/4"x1/2" 26 x x3/8"x9/16" 36 x3/8"x5/8" 73 x x1/2"x3/4" 82 x x

FormoreinformationaboutHFC39seriesconnectorsrefertotheColderProductsCompany®websiteatwww.colder.com.



G.TakingSamplesa. SamplingandInjectionSites

Therearemultiplesamplingandinjectionoptionsavailable.Meissnertypicallyrecommendsswabablevalvesorneedlefreeconnectors,whicharedesignedassamplesitesthatcanbeutilizedwithoutaneedle.Firstswabthesiliconesealthenconnectamaleluersyringetotakeasampleaccordingtoyourinternalproceduresorpractices.

i.SwabableValve/NeedlelessInjectionSite

ii.NeedleFreeConnector

Swabablevalvesaredeliveredwithaprotectivecap.Whenreadytomakeaconnection,removecap.

Connectmaleluersyringetovalve. Takesampleoraddtosingle-usesystemaccordingtoyourinternalproceduresorpractices.

NeedleFreeconnectorsaredeliveredwithaprotectivecap.Whenreadytomakeaconnection,

removecap.

Connectmaleluersyringetovalve. Takesampleoraddtosingle-usesystemaccordingtoyourinternalproceduresorpractices.

FormoreinformationabouttheClave®NeedleFreeConnector,refertotheICUMedicalwebsiteatwww.icumed.com.

FormoreinformationabouttheswabablevalverefertotheHalkey-RobertsCorporationwebsiteat www.halkeyroberts.com.



1. Securetheinletandoutletofthefilterasrequiredbythesingle-useassemblydesignanditsusage.

2. Slowlyinitiateflowthroughthefilter.

Filterwithhosebarbsoninletandoutlet Filterwithsanitaryfittingsoninlet and outlet

3. Ifventingisnecessary,positionthefiltersotheventopeningpointsupwardandslowlyopenthevent.Continuetoventuntilliquidexitstheventorallairisexpelled.

4. Graduallyincreasethepressureorflowratetothevaluequalifiedbyyourinternalprocedures.

5. Monitorthefilterduringtheprocessforpressurebuildupandventasnecessary.

6. Whenfiltrationiscompletestopflowtofilter.

7. Inthecaseofafluidfiltrationprocessstep,filter(s)willgenerallyneedtobeasepticallydisconnectedfromthedownstreamprocesswithin8hoursoffiltration.

Refertofiltermanufacturer’stechnicaldatasheetsforfilterspecificinformation.MeissnerFiltrationProductsprovidesfilterdatasheetscalled,“GreenDocs”atwww.meissner.com.

b. Pre-useIntegrityTestingCertainsingle-usesystemscanbedesignedtoaccommodatepre-useintegritytestingfunctionality.Thespecificationsforpre-useintegritytestsvarydependingontheassemblyandtypeoffilter.PleasecontactMeissnerTechnicalServicesformoreinformation.

c. Post-useIntegrityTestingDisconnectfiltersfromthesingle-useassemblyandpost-useintegritytestaccordingtoyourinternalproceduresandpracticesandthefilterspecifications.PleasecontactMeissnerTechnicalServicesformoreinformation.

H.UseofFiltersa. OperatingInstructionsforFilters

Thefollowinginstructionsarefairlybroadastherearemanydifferenttypesandconfigurationsoffilters.MorespecificusageinstructionsforMeissnerfilterscanbedownloadedbyselectingthecorrespondingfilterGreenDocatwww.meissner.com/greendocs.YoucanalsocontactMeissnerTechnicalServicesformoreinformationandassistance.



VII.DisposingofYourBiocontainerAssemblyTherearevariousdisposaloptionsforbiocontainerassemblies.Basedonyourinstitution’sproceduresandpracticesandcompliancewithlocalregulations,theappropriatemethodofdisposalshouldbedetermined.



VIII.References1. MeissnerFiltrationProducts,Inc.(2009)“One-Touch®BiocontainerDeployment

forFlexStation®100-200ROCs”,TechnicalBulletin(TBOT06),November2009.

2. MeissnerFiltrationProducts,Inc.(2010)“One-Touch®BiocontainerDeployment–FS0500”,TechnicalBulletin(TBOT07),October2010.

3. MeissnerFiltrationProducts,Inc.(2011)“One-Touch®FlexFill®DeploymentandCapInstallation”,TechnicalBulletin(TBOT09),August2011.

4. MeissnerFiltrationProducts,Inc.(2012)“One-Touch®DualBiocontainerStand&Accessories”,TechnicalBulletin(TBOT10),March2012.

5. MeissnerFiltrationProducts,Inc.(2012)“One-Touch®QuaDrum®”,TechnicalBulletin(TBOT12),March2012.



A.SampleCaseandProductLabels

Case Label

ProductLabel

IX.Appendices

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