PPLF-4205

Integrated Cell Processing Work Station — CPWS

My Life. My Work. My Choice.

www.sanyobiomedical.com

CPWS Features:• Costeffective,space-savingsolutionforGMPandGTPcompliantregenerativemedicineandcelltherapy.

•Minimizestheexpenseofacleanroomlaboratory

2 CWPS Integrated Cell Processing Work Station www.sanyobiomedical.com

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The Essential Work Station for Cell Therapeutics

Continued worldwide development of new methods and processes in cell therapy and regenerative medicine requires renewed emphasis on tools and technologies required to establish and maintain aseptic conditions demanded of the clinical environment. SANYO has met that challenge.

In designing the industry’s first viable alternative to a conventional Class 10,000 cleanroom for both Class 100 air quality and barrier isolation, SANYO has introduced the Cell Processing Work Station (CPWS) to bring the potential of cell therapeutics to more facilities while mitigating acquisition and operation costs and protracted time lines.

regeneration.Immunotherapyapplicationsmayextendtodendriticcells,T-cellsandmore.

Making it WorkImprovingefficiencyinhumaninterac-tionisaprimarydesignattributeoftheCPWS.Allworkmustbeperformedwith-outhumanerror,inanasepticenviron-ment,andwithdetaileddocumentationtoassurequalityandcompliance.Gown-uptime,expenseandinconvenienceisminimizedoreliminatedaltogether.Inte-gratedsystemswithintheCPWSpermitcellularextraction,preparation,culturingandadministrationwithasepticassur-anceaswellaseconomicpracticality.

Becauseconventionalautoclavingisnotpossible,theSANYOH2O2decon-taminationprocessdiminishesbothtimeandlaborassociatedwiththiscriticalstepbetweenpatients,positioningtheCPWSsquarelyintheequationforcost/benefitjustificationassociatedwithinvestmentdecision-making.Allowancesforintegratedcentrifuge,microscopy,dataacquisitionandincubationfunc-tionsareimportantconsiderationsintheCPWSdesign;auniquedockingstationpermitsinterfaceandexchangewithunlimitednumberofcellcultureincuba-torsdedicatedtoindividualpatientsorcelllines.

On the Work SurfaceSincehumansremainthesinglemostcommonsourceofcontamination,theCPWSprovidesbothphysicalandpro-cessbenefitstominimizecontaminationandcross-contaminationintheworkarea.Withinthefour-portgloveboxtheCPWSdeliversmorethanaconventionalClassII,TypeA2biologicalsafetycabinettypicallyinstalledwithinacleanroomtoachievethesameobjective.Here,themanuallyinitiated,automaticallydeployedH2O2decontaminationprocesssupple-mentscontinuousHEPAfiltration.As0.3micronparticlesareremovedfromthefreshairexchange,H2O2decontami-nationneutralizescontaminantsbroughtforthbyinstrumentationorequipment.Anumberofsterilizationsequencesareavailabletoprotecttheasepticenviron-ment.

$25,000

$20,000

$15,000

$10,000

$5,000

$0

Cell/TissueBanking

Cancer

General Surgery,GI, Gyn, Others

Ophthalmalogy

Organ

Dental

Skin

Urology

Ortho

Neuro

Cardio

Mill

ion

s o

f D

olla

rs

2010 2015

Orthopedics/Spine

Cord Blood and Cell BankingCancer

GeneralOphthalmalogy andOrgan Replacement/

Preservation

Dental/Oral

Skin

Urology

Neurology

Cardiology

Global Cell Therapy and Tissue Engineering Market

2010 & 2015

The MarketImmediatebeneficiariesoftheSANYOCPWSincludebothprivateandpublicinstitutionsservingthelifescience,clinical,biotechnologyandpharmaceuticalmarkets.Theseincludemainstreamandscale-uppharmaceuticalcompaniesfocusedondrugandmedicaldevicedevelopmentrelatedtohumancells,medicalresearchersapplyingcellulartherapiesinclinicaltrials,andhospitalsnowdeployingFDAapprovedcellulartherapeuticstotreatabroadrangeofdiseases.

Asthescienceprogressesandresultsarepropagatedthroughoutthemedicalandscientificcommunity,theneedforbench-levelresearchandproductionisexpandingexponentially.Asaresult,theavailabilityoftheSANYOfree-standing,self-containedworkstationapartfromtheconventionallayeredcleanroomapproachtocontainmentandprotection,isbringingthecapabilityforon-sitecellulartherapeuticstomorefacilitiesmorequicklyandatalowercapitalandoperationalcost,allwithintheGMPperformanceenveloperequiredofthecelltechnologyitself.

Self-Contained System, Small FootprintTheSANYOconceptofaself-containedworkstationisenabledbythecompany’sdemonstratedproficiencyforinsitudecontaminationrequiredtoseparateprocessesfromonepatienttothenext,oroneprotocoltoanother.ByusingahighlyeffectiveH2O2decontaminationprocess,theCPWScanbecompletelysterilizedwithoutheatandpreparedforthenextprotocolwithintwohoursascomparedtoacleanroomdecontamina-tionfunctioncantakedaysorweeks.

Byincreasingthroughputwithintheparam-etersofGMPcomplianceandFDAguide-lines,theCPWSisdeployedforbothresearch,cellularmanipulationandgrowth,cellproductextractionandemergingpro-cessesthatfallwithinsimilarguidelines.

CurrentandfutureapplicationsoftheCPWSincludeorganandtissueregenerationsuchasskin,cartilage,alveolarbone,cornea,cardiacmuscle,nerve,liverandpancreas

Thegloveboxdesignoffersbarrierisola-tionprotectionfortheoperatorandtheworkinside.Usercomfortandergonom-icsareinherenttotheCPWSdesign,includingaslopedfrontforeasieraccessandglarereduction.

What You Don’t NeedTherelativelysmallfootprintpermitsinstallationintoexistingornewClass100,000labspacewithconventionalutilitiesandminimalsitepreparation.Multi-layeredairlocksinmultipletreatedroomsareavoided.Capitalintensiveexpensesareloweredandleadtimesfromdecisiontooperationareshortened.Onceinplace,operationalcostsarehighlycontainedandpredictable,withsterilizationavailablemorefrequentlyandatafractionofconventionalcost.

The SANYO DifferenceSANYOBiomedical,adivisionofSANYONorthAmericanCorporation,ishead-quarteredinsuburbanChicago.Foroverfortyyears,SANYOhasestablishedareputationasapremiermanufacturerofprecisionbiomedicalandlaboratoryequip-ment.Knownthroughouttheworldasaleadingbrandinconsumerelectronicsandappliances,SANYOaddressesglobalneedssuchasenergy,food,housing,healthcareandinformationtechnology.

AsapartoftheSANYOproductlineworldwide,theCellProcessingWorkStationexemplifiesouruniqueVerticalComponentIntegration™approachtoproductdevelopment,combiningideasandinnovationsfromourglobalindustrialandconsumerproductsnetworkintoanintegratedproductfeaturingadvancedtechnology,controls,constructionandperformanceattributes.

TheCPWSandsubcomponentsystemshavebeenextensivelytestedtomeetthetoughestqualitystandardsforperfor-mance,ergonomicsandcostofowner-ship.TheCPWSisdesignedtominimizeitscarbonfootprintthroughenergysav-ingsandenvironmentalstewardship.

SANYO CPWS Integrated Cell Processing Work StationMinimizesCleanroomExpenseSelf-ContainedSpace-SavingQuicktoAcquireandInstallGMPandFDACompliantforAsepticProcessUserFriendlyEnergyEfficient,GreenDesign

PPLF-4205

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SANYO CPWS Series Technical Attributes

TheSANYOCPWSworkstationisdesignedtodeliverefficient,cost-effectiveandGMPcompliantcelltherapyandmanufacturingcapabilitywithouttheexpenseandinconvenienceofaclass10,000cleanroom.TheCPWSofferssignificantadvantagesoverconventionalhardwallcleanroomconstruction.

TheCPWSislessexpensive•thanacleanroom.

Itisquickertoacquireandplace•intooperation.

Thesmallfootprintincreasesoptions•forlocationandorientation.

Theuser-friendlygloveboxdesign•eliminatesgowningandimprovesoperatorcomfortandconvenience.

Operatingcostsarelowerthan•cleanroomcosts

Workiseasilysuspendedand•resumedwithouttheneedtode-gownandre-gown,improvingusercomfort.

Fastdecontaminationandchange-•overimproveproductivity,increasethroughputanddeliverquickerreturnoninvestment.

Recordkeepingandprocess•documentationareeasiertomanage.

ComponentsandoperatingsystemsareconfiguredaroundacentralworkstationwithaHEPAfiltrationandairmanage-mentsystemdesignedtodeliverClass100airtotheworksurfacewithintheglovebox.

Centralbarrierisolator•

Passboxinterchange•

IntegratedH• 2O2decontaminationsystem

Optionalcellobservationsystemwith•microscopeandmonitor

Optionalcentrifugeintegratedinto•theworksurface

OptionalCO• 2incubatorwithdockingcollar

Theoptionalincubatorandoptional•centrifugeoperatewithinaClass100environment.

CPWS Work StationTheSANYOCPWSworkstationisacomponent-baseddesignthatper-mitslong-termorquickturnoverself-containedprotocolswithefficiencyandsafetyfortheproductaswellasperson-nel.Asanintegratedsystem,allfunc-tionsassociatedwithgoodlaboratorytechnique,environmentalcontrolandergonomiccomfortareselectedforcom-patibilityandcomplementaryfunctionalperformance.

1. ModularCO2incubator,shownoncart,dockedtobarrierisolator.

2. Incubatorcartwithlockingcasters;offsetcastersnestwithframeassemblywhendocked.

3. Lidcamlatch

4. Centrifugecontroller

5. Centrifugemoduleaccessiblefortheasepticworkarea.

6. Gloveport

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7. Hingedfrontaccessassembly;frontliftsupwhentotalinterioraccessisrequired.

8. Interchangepassboxwithmanuallyinitiated,automaticsequenceH2O2decontaminationsystem.

9. Systemcontroller

10.H2O2liquidsupplycartridge

11.HEPAsupplyandexhaustfiltrationblowermotorassembly

12.Electricalcompartment

13. Interiorfluorescentlamps

14.Electropolishedinteriorsurfaces

15.Angled6°frontforusercomfort,reducedglare

16.Lockingscrewstosecurehingedfront.

17.Adjustablelevelingfeet

18.OptionalcellmonitorLCD

ApplicationsTheSANYOCPWSenablesabroaderaccesstocelltherapeuticsrelatedtobothminimallymanipulatedandnon-minimallymanipulatedcellproductsbyloweringthecostofentry,extendingtheprocesstothewidestrangeofapplications,andminimizingoperatingexpenseswhencomparedtoaconven-tionalcleanroomenvironment.

Minimallymanipulatedproducts•areassociatedwithcellwashing,enrichment,selection,HSC(PB,BM,CB),cancertherapiesandotherunderGTPrequirements.

Non-minimallymanipulated•productsareassociatedwithexpanded,differentiatedortransformedcells(DC,MSC,ESC,TC)incancercenters,biotechlabs,stemcellinstitutesandcontractmanufacturingfacilitiesoperatingunderGMPrequirements.

GMPs(GoodManufacturing•Practices)aremandatedbytheUnitedStatesFoodandDrugAdministrationtoensurethatdrugdevelopmentandmanufacturingissafe,qualitycontrolledforrepeatabilityandthoroughlydocumented.

GMPstypicallyrequireexpensive•hardwalllaboratoriesandlaboratorysuitesusingbiologicalsafetycabinetsinClass10,000cleanroomssurroundedbyaClass100,000room.

Clinical Applications of Cell Therapies

Disease States Cell Therapies

Cancer

HematopoieticStemCell(HSC)Transplantation

AutologousandallogeneicHSC;ExvivoexpansionofHSC;‘Suicide’T-cells–genetransfer;Stemcelltransplantation

Immunotherapy Dendriticcells;NK/Tcells;Macrophage-activatedkillercells;T-cellexpansion;NKcells;Co-stimulatorymolecules(genetransfer)

Orthopedic

Expandedchondrocytes;Mesenchymalstemcells

Neurodegenerative Disorders/Trauma

Adultstemcell-derivedcells;Embryonicstemcell-derivedneuralcells

Cardiovascular Disease

Infusionofmarrow/blood-derivedangioblasts;CD34stemcells;cardiaccells

Organ Replacement

Pancreas(diabetes) Pancreaticisletcells;Embryonicstemcell-derivedisletcells;Adultstemcell-derivedisletcells

Liver(failure,metabolicdisorders) Bioartificialliver;Isolatedhepatocytes;Hepatocytestemcells

Kidney(failure) Bioartificialkidney

Wound Healing

Keratinocytes;Skinstemcells

Infectious Diseases

Antigen-loadeddendriticcells;Lymphocyteexpansion;Macrophages

Genetic Deficiencies

Hemophilia GeneTherapy

SCID GeneTherapy

CysticFibrosis GeneTherapy

Autoimmune Diseases

Immunotherapy Dendriticcells;T-cells,Mesenchymalstemcells;Lymphocyteexpansion;NaturalKillercells

HSC, hematopoietic stem cells; NK, Natural Killer; SCID, severe combined immunodeficiency Currently in clinical studies.

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SANYO CPWS Series Applications

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Comparative Operating Costs1 (Nominal), SANYO CPWS vs. Conventional Cleanroom, Annual

SANYO Cell Processing Work Station (CPWS) Conventional GMP Cleanroom

Function Annual Budget (nominal)

Function Annual Budget (nominal)

H2O2Cartridge,25g,TotalSystemDecontamination $9,000 Disinfection,Cleaning $9,000

H2O2Cartridge,5g,PassBoxOnlyDecontamination $13,320 RoutineSanitation $12,000

ResidualH2O2Detector $2,664 ParticleSensors $3,000

Gloves,3gloves,2× $1,140 Sterilized,Non-SheddingGowns $18,000

Sleeves,3gloves,1× $3,640

HEPAFilters HEPAFilters

WorkStation $907 BiosafetyCabinet,SupplyFilter $343

InterchangePassBox $294 BiosafetyCabinet,ExhaustFilter $190

Room $833 CertifierLabor,BSCFormalinDecontamination $956

Labor $1,330 CleanroomAirSupply $2,916

CleanroomAirExhaust $1,516

CertifierLabor,CRFormalinDecontamination $1,500

ValidationExpenses ValidationExpenses

CleanlinessandAirVolumeReport $1,440 BiosafetyCabinetandReport $1,050

DecontaminationPerformanceBIInspection $3,230 CleanroomandReport $10,000

H2O2MistUniformityInspection $720 CentrifugeandReport $1,350

CentrifugeModuleandReport $1,350 CO2IncubatorModuleandReport $850

CO2IncubatorModuleandReport $1,250

PowerConsumption $18,057 PowerConsumption $28,972

NominalAnnualBudget $60,100 NominalAnnualBudget $91,600

1 Comparative operating costs listed herein are nominal and based on actual installations in Japan. Total cost of ownership and operation will vary according to type of installation, method of use, geographic location and other factors. SANYO offers consultative assistance in developing a cost/benefit analysis specific to your facility and protocol. Contact SANYO to arrange a report unique to your prospective application

Approximately 35% Less Expensive to Operate

The SANYO CPWS offers significantly lower operating costs when compared to a conventional cleanroom (open system). Comparison methodology and assumptions are available from SANYO. Soft-cost benefits related to user convenience and comfort, flexibility, throughput and other demonstrated advantages of the CPWS can be established through consultative review. Contact SANYO for details.

SANYO CPWS Benefit vs. Conventional Cleanroom (Closed System vs. Open System)

ComparisonSANYO CPWS BarrierIsolator

Cleanroom withBiologicalSafetyCabinets

General Closedsystem,requiresonlyClass100,000air

Opensystem,requiressignificantinvestmentandmaintenanceofbackgroundenvironment,

Class10,000air

LeadTimeandCost Minimal;CostofClass100,000roomplusCPWS High;CostofClass10,000cleanroomplusClass100oneormoreClass100biologicalsafetycabinets

Space/FootprintAllowance Minimalfootprintinexistingspace Dedicatednew/retrofitfacilitywithsignificantrequirementforHVAC,filtration,airshowers

ValidationCosts Minimal;RequiresClass100,000only. High;RequiresbothClass100andClass100,000.

OperationCost Low High;Repeateddecontaminationandmaintenancecosts.Higherconsumablescost

Implementation Weeks MonthsorYears

ErgonomicsandUserComfortNosecondgowningrequired.Centralbarrierisolator

withergonomicallyangledfrontpermitseasyaccessthroughgloveports.Reducesstressonworkforce.

Conventionalfirstandsecondgowning,externalairsupply,interlockdoors/airshowers

Flexibility

Eliminationofhazardousfumesfordecontaminationpermitsdiverseapplications.Eliminationofdepolymerizingformaldehyde,formalinandothertoxicchemicalspermits

transitionbetweenapplicationsseamlessly.

Inflexible

ThroughputExpanded.Quickchangeoverextendsuse,

optimizesreturnoninvestment.Componentintegrationstreamlinesworkflowwhileenhancingasepticprocessing.

Limitedduetoproductchangeovercriteria

Security

DecontaminationandSterilization TwoHours UptoTwoWeeks

EquipmentandInstrumentation Microscopesandotherinstrumentationcanbededicatedtotheworkstation.

Sharedinstrumentationinanopensystemexposesprocessestocrosscontamination.

Barrier IsolatorThebarrierisolatorformsthecentralcomponenttotheworkstationandcontainstheprimaryoperatingsystemsrequiredtoestablishandmaintainasep-ticconditionstomeetGMPcriteria.

Thebarriercompletelyisolatestheinte-•riorworkproductfromtheoperator.

Thebarrierisolatorcreatesaclosed•Class100environment,eliminatingtheneedforbiologicalsafetycabinetsinacleanroom.

Isolatorinteriorairis100%Class•100totalcirculation;norecirculatedairisused.

Thepolishedstainlesssteelglove•boxinteriorisdesignedformaximumexposureofallinteriorsurfacessub-jecttoH2O2decontamination.

Beforecommissioningandinitialuse,•theisolatorfrontcanbeopenedon

ahingedframeforinstallationofinstru-mentationorotherdeviceslargerthantheinterchangepassboxopening.

TheHEPAfilterandairflowsystemis•mountedontopoftheisolator.

Theinternalairflowsystemisdesigned•tocreateapositivepressuretomitigatethepossibilityofinflowcontamination.

Viabilityofthecontainmentarea•isnotdelegatedtothird-partyclean-roomcontractorswhoarehiredtodecontaminate.

Ergonomics and SafetyBecausesecondgowningisnotrequired,usercomfortandproductivityissignifi-cantlyimproved.Theworkplaceroutine,includingbathroombreaks,isunencum-beredbytheneedtoleaveandre-enteracleanroom,bleachand/orshower.

Theinconvenienceandexpenseof•cumbersomecontainmentssuitswithairandvacuumhosesiseliminated.IfworkingwithBL3agents,thebuddysystemisnotrequired.

Thebarriereliminatesthepotential•forroomcontaminationfrombloodorotheraerosols.Workflowisnotimpactedbyroutinecolds.

Staffconfidenceintotalcontainment•improvesmorale.

Gloveportspermiteasierhandlingof•redbagmaterialswhenrequired.

A6ºangledfrontincludesthreeglove•portstopermitaccesstoallinteriorsurfaces.

Theinteriorcabinetincludesinde-•pendentinteriorfluorescentlampstosupplementambientlight.

SANYO CPWS Series Benefits

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H2O2 Decontamination SystemThemanuallyinitiated,automatically•sequencedH2O2decontaminationsystemoffersafast,safeandprovensterilizationprocesstoenhancetheperformanceoftheCPWSbyallowingmorefrequentturnoverofsegregatedcelllines.

ThevalidatedH• 2O2systemgeneratesanH2O2vaporthatpermeatesallexposedsurfacesfromthecentralinterchangepassboxnebulizercontainingareplaceablebottleofenrichedhydrogenperoxide.

Whendeployed,theH• 2O2vaporizationsequencedecontaminatesthepassbox,workstationinterior,centrifugeandCO2incubatorexterioranddockinggaskets.

Oncethevaporizationiscomplete,•theH2O2programimplementsadwellperiodtoensurethatproperexposuretimesaremaintainedfor

awiderangeofpathogens(contactSANYOforindependenttestresults).

Attheendofthepre-programmed•dwellperiodaresolutionprocesseliminatesfumesandtoxicresiduals.

Isolator InterchangeTheinterchangepassboxallowssafe•accesstotheworkareaforsupplies,instruments,devices,sterilemediaandlabware.

Whenmaterialsarebroughtintothe•workstationtheyarefirstpositionedinsidetheinterchangeforH2O2decontamination.

Decontaminationismanuallyinitiated•andautomaticallysequencedoncestarted.

WhentheH• 2O2vaporizationprocessiscomplete,theinnerdoorisopenedandthetransferiscompleted.

Doorinterlockspermitsimultaneous•openingtoprotectthebarrierisolator.

Aseptic Environment Required for Cell Preparation

Usually, human derived cells must be guaranteed that they are prepared and cultured in an aseptic environment because they cannot be treated by heat or pressure.

4 m2

18 m2

18 m2

6 m2

16 m2

3 m2

10 m2

16 m27 m2

10 m211 m211 m2

PS

PS

PSPSPS

PS

Class B(10,000)

Class CIO(100,000)

Class DAR(100,000)

Class A(100)

PSPS

PS PS PS

-152ºC

-32ºCCleanroom: The biological safety cabinets within the cleanroom are open systems which require a stricter background environment. Access in and out of the cleanroom must comply with gown-up protocols consistent with GMP facilities. Class 100 air is ultimately delivered to the work product in one or more biological safety cabinet(s) operating independent of the cleanroom. Decontamination is costly and time-consuming; changeover from one protocol to another is difficult and expensive.

Conventional GMP Cleanroom Facility (Open System) with Biological Safety Cabinets

4 m2

18 m2

18 m2

6 m2

16 m2

3 m2

10 m2

16 m27 m2

10 m211 m211 m2

PS

PS

PSPSPS

PS

Class B(10,000)

Class CIO(100,000)

Class DAR(100,000)

Class A(100)

PSPS

PS PS PS

-152ºC

-32ºC

SANYO CPWS, Barrier Isolator with Integrated SystemsTheSANYOCPWSofferssignificantthroughputpotentialinacomparativelysmallfootprint.

TheCPWScanbeinstalledinman-•ageableGradeD(Class100,000)environment,providingbiologicalandphysicalprotectionbetweentheworkandtheuser.

Standard of Particle Control

ISO14644-1 FDA EU-GMP Annex 1 JP WHO-GMP TRS902 Annex 6

Class5 Class100InOperation3,520

GradeAInOperation3,500

GradeAInOperation3,520

GradeAInOperation3,500

Class7 Class10,000InOperation35,200

GradeBInOperation350,000

Atrest3,500

GradeBInOperation352,000

Atrest3,520

GradeBInOperation350,000

Atrest3,500

Class8 Class100,000InOperation3,520,000

GradeCInOperation3,500,000

Atrest350,000

GradeCInOperation3,520,000

Atrest352,000

GradeCInOperation3,500,000

Atrest350,000

Class9 — GradeDAtrest3,500,000

GradeDAtrest3,520,000

GradeDAtrest3,500,000

Extraction Preparation Culture Administration

PreparedCells

OriginalCells

Aseptic levellow (D)

Aseptic levelmid (C)

Aseptic levelhigh (B)

(A)Aseptic level raised gradually

Highest aspect level = Aseptic(safety cabinets, etc)

Air lock

General environment (not clean)

SANYO CPWS Series Features SANYO CPWS Series Aseptic Environment

PPLF-4205

Accessthroughthegloveports•improvesusercomfort.

TheintegralH• 2O2decontaminationsystemiscompletedinlessthantwohours,permittingfrequentchangeoverandassuringseparationintegrityfromonecellprocesstothenext.

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10 CWPS Integrated Cell Processing Work Station

Decontaminated Contaminated Possible cell-derivedcontaminated

Pass Box Only

Instruments or materials introduced into the glove box are decontaminated by a pass box cycle only, avoiding the need to decontaminate the entire glove box work area. Work can continue in the glove box while the cycle is in process.

Cell Culture Incubator

Incubator and Work Area. After aseptic protocols are completed, cultures are transferred to the (optional) CO2 incubator where growth can continue under aseptic condi-tions after the incubator is detached. Unwanted materials are removed through the pass box interchange.

Changeover

When handling different cells from the previous protocol, the next (optional) cell culture incubator is docked to the work station glove box. The work station, interchange pass box (optional) centrifuge and incubator door are decontaminated prior to opening. The changeover process is completed in less than two hours.

Total Decontamination

A total H2O2 vapor decontamination creates aseptic conditions in the interchange pass box, the glove box and (optional) centrifuge module.

Decontamination SequenceCO2 IncubatorThemodularCO2incubatorisanadapta-tionofthefull-performanceSANYOMCO-5AC(IS).ThisincubatorisdesignedforprecisetemperatureandCO2controlwithelevatedrelativehumiditytomini-mizecelldesiccation.

Byusingmultiple,detachableCO• 2incubators,theCPWScanmanagemultiplepatientprotocolsthroughcompleteproductsegregation,therebyassuringasepticconditionsandeliminatinganypossibilityofcross-contaminationormishandlingofpatient-specificcells.

Segregationpermitscompliance•withpublishedFDAcriteriaassociatedwithregenerativemedicineandinvivocelltherapies.

Theincubatorattachestoadocking•collaradjacenttothebarrierisolator.

Onceattached,thebarrierisolator•undergoesa2-hourH2O2decontaminationprocessbeforetheincubatordoorisopened.Thisprocesssterilizestheworkarea,incubatorface,centrifugeandpass-thruinterchange.

TheH• 2O2effectivelydecontaminatestheCO2connection.

Whenworkiscomplete,the•incubatorissealed,detachedandmovedtoauser-definedstaginglocationonawheeledcart.

Thenextincubatorcanbemovedinto•positiontorepeattheprocessforanotherpatient.

Thereisnolimittothenumberof•SANYOMCO-5AC(IS)incubatorsthatcanbeusedwiththeworkstation.

Incubator Features and BenefitsTheincubatorisamodificationofSANYO’spopularMCO-5AC.Thecom-pact1.4cu.ft.(49liter)interiorchamberisconstructedofSANYO’sexclusiveinCusaFe™copper-enrichedstainlesssteel,creatinganaturalgermicidalbar-rieragainstairbornecontamination.

Anintegratedmicroprocessorcontrol-•lersupervisesallfunctionsinclud-ingtemperatureandCO2setpoints,control,alarmandmonitoring.

ThepatentedDirectHeatand•AirJacket™controlsystemassurestemperatureuniformityandstabilityessentialtothemostsensitivecelllines.

Therounded-corner,electropolished•interiorisconfiguredforusewithavarietyofstandardcellculturevessels.

Allinteriorcomponentsaredesigned•towithstandrepeatedH2O2decon-taminationcyclesexpectedinhighturnoverenvironments.Componentsareremovablewithouttools.

One CPWS work station can service multiple CO2 incubators to permit easier cell segregation. One incubator is attached to the work station at the docking collar and subjected to a quick, safe H2O2 decontamination process. When work is completed, the incubator is sealed and returned to the staging area and another incubator is attached and the process is repeated.

SANYO CPWS Series Features SANYO CPWS Series Features

CentrifugeThecentrifugeisinstalledbeneaththeinteriorworksurfaceandaccessibleunderasepticconditionswithoutremovingcellsfromtheprotectedenvironment.

Thepositionandorientationof•thecentrifugeassuresthoroughdecontaminationduringtheH2O2vaporizationcycle.

Theintegrateddesigneliminates•therequirementforadditionalfloorspaceinaGMPenvironment.

Avarietyoffixedandswinging•rotorsisavailable.

Centrifugecontrolsarelocated•externaltotheworkareaatthefrontofthecentrifugemodule.

Modular Incubator Model MCO-5AC(IS) docked to the CPWS

CPWS Centrifuge

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Decontamination SystemThe CPWS includes an H2O2 decontamination system that generates H2O2 vapor to produce validated results. This system covers the pass box interchange, glove box work area, optional centrifuge and optional CO2

incubator. The enriched H2O2 solution is contained in a replaceable bottle and inserted as a cartridge inside the decontamination module.

Pass Box DecontaminationMaterials are brought into the work chamber from the outside through the pass box interchange. The H2O2 decontamination is manually initiated and automatically sequenced, thoroughly sterilizing the pass thru material and protecting the integrity of the work surface. The interchange contamination process can function alone, independent of the glove box.

Work station Glove BoxThe work station creates Grade A Class 100 air quality within the glove box, and permits installation within a Grade D Class 100,000 room, eliminating the need for a typical cleanroom. The self-contained, closed system protects both the user and the work product without the need for a second gowning. An ergonomically shaped front access is angled 6° for user comfort, glare reduction and reach throughout the work surface.

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Cell Monitoring System (Optional)AnintegratedcellmonitoringsystemreducesadditionalfootprintrequiredinaGMPenvironment.Cellmonitorcompo-nentsarelocatedwithinthebarrierisola-toranddesignedtowithstandrepeatedH2O2decontaminationsequences.

Theinteriorcomponentsinclude•alarge,19"LCDmonitor,andaseparatecollectionmodule.

Thecollectionmoduleincludes•ahigh-performanceCCDcamera(chargecoupleddevice)withobjectivelensandphasedifferencefilter.

Themonitordisplaysrealtimeimages•withtotalmagnificationof110×.

Imagescanbecapturedviaanon-•contactphotosensor,2.4×1.8mmformonitordisplayanddigitalrecording.

Astandardpersonalcomputer•externaltotheasepticisolatorworkareaisusedfordataacquisitionandimagemanagement.

PC for CapturingControl/Relay

Box

Lighting VCC, GNDLight Dimming Signal

Cameral IF (power, image signals)

Power SW SignalCapture SW Signal

Images from PC

Camera IF

AC Power

Various Signals IF

Operator’s Monitor

ObservationModule

System Summary Specifications

Component Order Number

BaseWorkStation,BarrierIsolator

PPLF-4025

Interchange Included

HEPAFiltrationSystem Included

Centrifuge Optional

CellObservationModule Optional

CO2Incubator MCO-5AC(IS)

Component Specifications

Component Description

BarrierIsolator BaseUnit

InterchangePassBox Included

AirflowandHEPAFiltrationSystem Included

H2O2System Included

Centrifuge Optional

CO2Incubator Optional

CellObservationSystem Optional

SANYO CPWS Series Features SANYO CPWS Model PPLF-4025 Specifications

Centrifuge and Module

Feature Specification

ExteriorDimensions(wxf-bxh) 21.25"×22.9"×30.3"(540x582x771mm)

MaximumSpeed 2100RPM

MaximumCentrifugalAcceleration 10to970Gcentrifugalaccelerationsettablerange

Controls,Alarms Externallymounted,front,withfootswitchforcut-off.Doorlockstatusdisplayed.

Pre-Sets Upto4patternsinmemory

TimeSettableRange 10to50seconds(10secondincrements);1to99minutes(1minuteincrements);andinfinite

Acceleration/DecelerationSettings 3stage

MotorShaft Stainlesssteel

Capacity 1000ml(50mltubes,×20)

1

14 CWPS Integrated Cell Processing Work Station www.sanyobiomedical.com

15

Barrier Isolator

Dimensions

OverallExteriorDimensions(wxf-bxh) 115"×41"×87.8"(2920×1045×2230mm)netofattachedoptionalincubator

InteriorDimensions(wxf-bxh) 70.7"×28.5"×34"(1796×726×864mm)

InteriorWorkSurfaceElevation 31.5"abovefloor(800mm)

GloveElevation 41.3"abovefloor(1050mm

PassBoxInterchange(wxf-bxh) 19.6"×16.7"×15.8"(500×425×400mm)

NetWeight 2207lbs/1000kg,nominal

Controls, Alarms

PressureMonitor RedLCDandaudiblealarmifpressurefallsbelowalarmsetpoint.

FanMotor Audiblealarmduringmotorshutdown

Construction

ExteriorFinish Paintedsteel

InteriorFinish Polishedstainlesssteel

FrontGlovePortPanel,Angle6° Polycarbonatewithpaintedsteelframe.Hingedforopeningtoloadequipment.

Air System

AirQuality GradeAClass100overworksurface;installationinaGradeD,Class100,000ambientroom

AirflowSystemandVelocity Verticaldownflowoverworksurface,0.2~0.3m/s±20%@6"belowsupplyfilterscreen(150mm)

FiltrationSystem IndependentHEPAsupplyandexhaustfilters,efficiency99.99%(0.3µmPAO),scantestedandpassed

FiltrationSystem,PassBox IndependentHEPAsupplyandexhaustfilters,efficiency99.99%(0.3µmPAO),scantestedandpassed

IntakeandExhaust Electricallyswitchedsystem.RoomairintakethruHEPAsupplyfilter;returnexhausttoroomthruHEPAexhaustfilter

Relative Air Pressure

Workstation Positivepressureafterdecontaminationofworkstationandpassbox;audiblenotificationwhenready,60Pa

PassBoxInterchange Positivepressureafterdecontaminationofpassboxonly;audiblenotificationwhenready,220Pa

Interior Work Area

Lighting Fluorescentlamps(3),30weach,topofpanel,topofright,left

ElectricalOutlet Duplex,drip-proofreceptacle

Pass Box Interchange

Door Frontopeningtooutside;leftsideopeningtointeriorworkarea

Material Polishedstainlesssteel

Decontamination System

Function H2O2vaporization;simultaneousdecontaminationofinteriorbarrierisolatorworkstation,passboxinterchange,optionalcentrifugeandoptionalCO2incubator

H2O2ResolutionandAerationCatalytic,externaltotheworkarea.ResidualH2O2densityatcatalyticoutletisatorbelow1ppm

(byTLV-TWA).Fresh,HEPAfilteredairfollowsresolution

DecontaminationCycleTime Loaddependent;typicalcycletimesrangefrom1.0to2.0hoursfrommanualinitiationofautomaticsequence.

Utilities

Electrical Mainsystem,4500w,220V,AC,60Hz.Electricaloutlet120V,AC,60Hz.

SANYO CPWS Model PPLF-4025 Specifications SANYO CPWS Model PPLF-4025 Specifications

CO2 Incubator (Modular), SANYO MCO-5AC(IS)

Dimensions

ExteriorDimensionsWithoutStand(wxf-bxh) 23.5"W×22.1"×24.7"(597×561×626mm)

InteriorDimensions(wxf-bxh) 13.8"×14.9"×14.8"(350×378×375mm)

NetWeight,Nominal 110lbs/50kg

Volume 1.7cu.ft./49litersnominal

Operating System

CO2Sensor Thermal

InCuSaFe™CopperEnrichedStainlessSteelInterior Standard

MicroprocessorController/Display,DoorMounted Standard

DirectHeat,Air™(DHA)AirJacket Standard

Sterilization and Decontamination

H2O2Decontamination Whendockedtoworkstation

Standard,CopperEnrichedStainlessSteelInterior Germicidalprotection

Environmental Performance

TemperatureControlRange +7.0°Caboveambientto50°Cina5°Cto35°Cambient

TemperatureControlUniformityandDeviation ±0.25°Cin25°Cambient,setting37°C,5%CO2,noload

CO2ControlRangeandDeviation 0%to20%,±0.15%in25°Cambient,setting37°C,5%CO2,noload

Airflow Continuouswithinnerdoorclosed

InteriorHumidity 95%RH@37°CthroughevaporationviaDHA™heatingsystem;optionalreflective/deflectiveopticallowwatersensor

Control, Monitoring, Alarm

TemperatureandCO2Control Setpointresolution0.1°,0.1%

Display LED,resolution0.1°,0.1%

Communications Optional4-20mAconnection;OptionalPCinterfaceMTR-480

Cabinet Design and Construction

Superstructure,ExteriorCabinetandDoor Galvanizedsteelexterior,baked-onenamelfinish

InteriorandShelves Copper-enrichedstainlesssteel

InnerDoor Temperedglass

Insulation Rigidfoampolyurethane

OuterDoor Sideorientedfordockingwithworkstation

AccessPort Single,1.18"/30mmwithsiliconestopper

LevelingFeet Adjustable

Energy, Electrical, Utilities

MaximumPowerConsumption 205W

MaximumHeatDischarge 740kJ/h

Electrical 115V,60Hz

CO2GasConnection 4to6mmbarbedfitting

CO2GasInputPressure Nominal0.03MPaG/0.3kg/cm2/5.0lbs/sq.in;fromtwo-stageCO2regulator

Unique SANYO ServicesOn-siteconsultation•

Specializeddocumentationforeach•individualunit

Customizedtestingprocedures•basedonpersonalizedcustomerrequirements

Pre-Delivery and On-Site ServicesPre-deliveryservicesincludefactoryacceptancetesting,calibration,andtemperaturemapping.On-siteservicesincludeinstallationqualification,operationalqualification,performancequalification,calibrationandtemperaturemapping.

SANYO ConnectSANYO’scustomer-drivenbiomedi-calserviceprogramguaranteeslocalattentionfromqualifiedSANYOservicerepresentatives,wheneverandwher-everyouneedit.

NewUnitInstallationandTraining•

PreventativeMaintenance•

WarrantyandNon-WarrantyRepairs•

Calibration/ValidationServices•

RefurbishmentandReconditioning•

CustomizedServiceandWarranty•Programs

In-StockPartsforImmediateDelivery•

SANYO Service and Support

SANYONorthAmericaCorporationBiomedicalSolutionsDivision

1300MichaelDrive,SuiteA,WoodDale,IL60191USAToll-Free800-858-8442Fax630-238-0074

www.sanyobiomedical.com© 2010 Specifications subject to change without notice.

SafeCell™UVU.S.Patent6255103;DirectHeatandAirJacket™U.S.Patent5519188;SafeCell™UV,inCusaFe™,DirectHeatandAirJacket™,P.I.D./R™andActiveBackgroundContaminationControl™,aretrademarksofSANYOElectricBiomedicalCo.,Ltd.

Model PPLF-4205