Front Cover

Product Guide 2015-2016

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Table of Contents

Guide to VacciXcell

Upstream BioProcessing

Cell Therapy Processing............................................................................................03

Bioreactors and Fermenters.......................................................................................05

Cell Culture Products.................................................................................................09

Formulation

Formulation and Filtration Isolator..........................................................................16

Filling Line

Robotic Filling..........................................................................................................18

Traditional Filling.....................................................................................................19

Sterility Testing

Sterility Testing Isolator............................................................................................21

Isolation and Containment Systems

Airflow Containment Products................................................................................22

Cross Contamination Facility Integrated Barriers....................................................22

Barrier Isolation Systems...........................................................................................22

VacciXcell Guide

3

Upstream BioProcessing - Cell Therapy Processing

Cell Processing Center

Features

• Bio-workstationwithHEPA-filteredairflowandUVsterilization.Aircirculationcanbesinglepassorrecirculating

• EscoOrbicultTMIncubatorShakerBenchtop

• EscoVersatiTMCentrifuge

• Footswitchdesignedtostartandstopcentrifugeandshakingincubatorbyfoot

• Pressuregaugetomonitordifferentialpressureacrossfiltersandalertusertoanyneedforfilterreplacement

Applications

• Stemcellisolation

•Cellhandlingandmanufacturing

• cGMPproductionofautologousandallogeneiccells

Esco’sbio-workstationisdesignedtohelpyouproducecelltherapyproductseasily.Thiseconomicalworkstationisaself-containedsystemthatdeliversanefficientandcosteffectivecGMP-compliantprocessingandmanufacturingsolutionforregenerativeandstemcelltherapy.Thecellprocessingcenterisequippedwithcentrifuge,incubator,shaker,andothernecessaryequipmentforstemcellisolationandcellhandling.

Esco’s C-class (ISO 7) modular room

Multi-functionalBio-work station

A self-contained system

Cell Processing Center

The Concept

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VacciXcell Guide

Features

• ULPAfilterswithatypicalefficiencyof99.999%at0.1to0.3micronsprovide superiorISOClass5aircleanliness.

• SentinelGold™MicroprocessorControlSystemsupervisesallfunctionsand monitorsairflowandpressuresinreal-time.

• Safeglovechangepermitszeroriskofcontaminatingtheworkzone

orenvironment

• RobustconstructionandenhancedsafetyfeaturesqualifytheIsoclean®

PlatformIsolatorforthemostdemandinglaboratoryapplications.The

isolatorisfullyassembledandreadytoinstallandoperatewhenshipped.

• Ergonomicallyangledfrontgloveportsimprovereachandcomfort.

• EscoISOCIDETMantimicrobialcoatingonallpaintedsurfacesminimizes contamination.

• Sharpsdisposalsystemandadjustablehydraulicstandareavailableasoptions.

Applications

• CellProcessing

• ResearchandDevelopment

• AsepticProcessing

• Small-Scalepotentmaterialhandling

• PharmacyCompounding(Chemotherapy/TPN)

Cell Processing Isolator

Containment Barrier Isolator (CBI)

Isoclean® Platform Isolator (HPI-G3)

CellProcessingIsolatorfacilitatestheisolationofaproductofprocesswhileprovidingtherequiredconditionsforasterile/asepticenvironment.Thisequipmentprovidesacomprehensiverangeofpersonnelandproductprotectioninadditiontothesurroundingworkareasandtheenvironment.

General Applications

• CellProcessing

• ResearchandDevelopment

• AsepticProcessing

• Small-Scalepotentmaterialhandling

• PharmacyCompounding(Chemotherapy/TPN)

Features

• Controlsexposure/cross-contaminationrisktohazardous/asepticmaterialsfor

awidevarietyofequipmentandprocesses

• Controlsfalse-positiveriskforsterilitytesting

• ProvidesOperatorExposureLevels(OEL’s)≤1.0μg/m3during controlled operations

• Levelsof≤0.1μg/m3canbeachievedviaclosed-transferprocessesorbased onclientSOPs

• EnhancescGMPpractices

• Quiet,energy-efficientECMfansautoadjusttocompensateforfilterblockage

• Standarddimensionsavailableareeasilycustomizedtosuitprocessrequirements

• Safeglovechangeandlowcontaminationfilterchange

• FDA-approvedstaticseals

• Pressuretestedclass1ISO10648-2standards

• SystemcomeswithaSemi-automatedorAutomatedPressureHoldTesting

• ConfigurableasClassIIICabinetforBiosafetyLevel(BSL)3and4applications

• ULPA

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Upstream BioProcessing – Bioreactors and Fermenters

Laboratory Scale Tide Motion Bioreactor: CelCradleTM

CelCradle™isadisposablebioreactorcapableofhighdensitycellcultureforproteinexpression,virusandmonoclonalantibodyproduction.Itisdesignedbasedontheconceptofbellow-inducedintermittentflowofmediaandairthroughporousmatrices,wherecellsreside.Thisprovidesalowshear,highaeration,andfoam-freecultureenvironment.Duringoperation,theCelCradle™bottleispartiallyfilledwithmediaandinoculatedwithcells.Themediaisraisedandloweredalternatelytosubmergeandexposethematrices,creatingadynamicinterfacebetweenairandmediaoncellsurfacetomaximizenutrientuptakeandoxygentransfer.CelCradle™isasingle-usepackedbedbioreactorthathaslinearscalabilityfrombench-scaletoproductionscale,withautomatedcellharvesting.

Features

• StainlessSteel304LBACelCradle™

• Pre-sterilized,ready-to-use,disposablebottles

• Lowshearstress,foam-free,noO2limitation

• Largesurfacearea:oneCelCradle™bottlehasaspecificsurfaceareaof15,000cm2,comparableto18-20rollerbottles

• Compactdesign:fitsin6ft3CO2incubator

• Capacitytoproducehundredsofmilligramstoseveralgramsofsecretedproteinsormonoclonalantibodies

• Fewparametersforeasyoptimization

•Choiceofbatch,fed-batchorperfusionculturemodes

• Scale-upbydirectlymultiplyingnumberofbottlesusedorusingTideCell®system

•Compatiblewithmostserum-freemedia

• Speciallytreatedcarriersurfacetogrowmostanchorage-dependentcellsandalloweasyharvestofwholecells,cellularcomponentsor

secretedproteins

Applications

•Mammalianandinsectcellculture

• StemCellCulture

• Proteinandvirusproduction

•Monoclonalantibodyproduction

•GeneandCelltherapy

•Drugdiscovery

• Pharmacokineticsstudy

• Proteomeresearch

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VacciXcell Guide

Upstream BioProcessing – Bioreactors and Fermenters

Laboratory Scale Fermenter: StirCradleTM

TheStirCradle™isabenchtopstirredtankbioreactorsystemthatcandoubleupasbothafermenterandabioreactor,suitableformicrobialfermentationandcellculture.Itisaversatilesystem,capableofsupportingthegrowthofdifferenttypesofbacteria,yeast,plantcells,insectcells,andmammaliancells.Thissystemisavailablein3capacitieswithtotalvolumesof5L,7.5L,and10L.

TheStirCradle™systemisthelightestandcompactofallsimilarbioreactorsavailableinthemarket.Thecontroltowerhas4built-inperistalticpumps,configurableforautomatedfluidaddition.Italsofeaturesapatentedagitationsystemdesignedtoeffectivelyenhanceoxygentransferrate.

TheStirCradle™systemisexpandableandcompatiblewithavarietyofaccessoriessuchasoxygenenrichmentdevices,multiplegasdevice,externalpumps,exhaustgasanalyzer,andothers,inordertosuittheclient’scultureprocessrequirements.

Features

• NoneedforPCorlaptopfordatalog

• FreeVNCAppdownloadviawifiorInternetconnectionforinstantremotemonitoring,compatiblewithsmartphones,tablets, laptopsandPC

• TouchScreenHMIwithadjustableangle

• GlassvesselmadeoftemperedglassfromPyrex(US)orSchott(Germany)

• User-friendlyinterface

• Variousimpelleravailablefordifferenttypesofcultureconditions

• Operatingdataissafeandprotected

• Simpleandeasyagitationmotorinstallation

Applications

• Fermentation

• CellCulture

• ResearchandDevelopment

• Biopharmaceuticals

• Proteomics

• Laboratory-scaleproductions

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Upstream BioProcessing – Bioreactors and Fermenters

Pilot and Production Scale Tide Motion Bioreactor: TideCell®

TideCell®High-DensitybioreactorsystemistheextendedlargescalesystemofthelabscaleCelCradleTMbioreactorsystem.Inthissystem,amatrixvesselisfilledwithwithporousBioNOCTMIIcarriersandfunctionsasanartificiallungwithhugecontactsurfacefornutritionandaeration.Culturemediumisperiodicallydrawnfromanexternalmediumbag(mixingbag)intothematrixvesseltosubmergethecarriersandwithdrawnfromthevesseltoexposethecarriers.Asaresult,cellsentrappedinsidethecarriersareabletoreceivesufficientnutrientandoxygen,whilemetabolicwastessuchaslactateandcarbondioxidecanbeefficientlycarriedawayinagentlemanner.TheTideCell®systemcanalsoaccomodateupto5000L.

TideCell®-002

TideCell® -100

TideCell®-010

TideCell®-020

Features•Compactandhighcelldensity(upto6x107cells/ml)• Foamfree,lowshearstress,highoxygentransfer• Single-use,autoclavable,orhybridsystem• Linearscalable•MatricesSamplingforcellmorphologyobservationandcountingwithoutposingrisksofcontamination

•AutomatedCellharvestingisavailable

Applications•Mammalianandadherentinsectcellculture• Proteinandvirusproduction•Monoclonalantibodyproduction•Geneandcelltherapyproductsmanufacturing

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VacciXcell Guide

System Accessories

Features

•Harvestupto1011cellswithin1to3hoursofoperation

•Compatiblewith2Land20Lmatrixvessels

• 6peristalticpumpsforreagentinputandoutput

Applications

•HarvestviablecellsfromlargescaleTideCell®systems

•HarvestseedingcellsfornextscaleofTideCell®culture

TheTideCell®CellHarvestingSystem(TCCHS)isanequipmentforclosedandautomatedharvestingofviablecellsfrom2Land20LTideCell®matrixvessels.TheTCCHSappliestheconventionalcellharvestconceptthroughtheuseofenzymatictreatmentforthedetachmentofcellsfromthematrices.

TheFeedAutoSwitchSystemallowscontinuousnutrientsupplywithoutinterruption.Itcontrolstwofeedingtankssimultaneously;duringfeeding,itswitchesthefeedinglinefromthefirsttanktothesecondoncethefirsttankisempty.Thealarmlightwillswitchonwhenonefeedingtankhasbeendepletedandwillbuzzoncebothfeedingtanksareempty.

TideCell® Cell Harvest System (TCCHS)

Feed Auto Switch System

Upstream BioProcessing – Bioreactors and Fermenters

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System Accessories

Features

• Single-usebioprocessbagsandcontainersfrom0.5Lto2,500L

•MeetsFDAcGMPguideline

• Fulldocumentsupport

Features

• Bearing-lessmagneticpumpthatallowsthepropellertofloatinthemiddleofthepumpheadwithoutanywearingduringpumping

•Quickmediaorliquidheatingandmixing.Heatingof500Lfromroomtemperatureto37°Ctakesonly3to4hours.Mixingin500Ltakesonly2minutestoreachhomogeneity

Features

•Monitorthestatusofoperationofupto16unitssimultaneously,anywhere,anytime

•Canbeusedoff-lineandon-line,andiscompatiblewithportabletabletsystemssuchasiPad

•AlarmnoticewillbesenttousersthroughSkype,e-mail,orotherassignedcommunicationsystems

Applications

•AmodulefortheTideCell®system

•MixingsystemforotherprocessesincGMPoperationenvironment

VacciXcellprovidescustomizedsingle-usebioprocessbagsandcontainerssuitablefortheentirebioprocessstartingfromupstreamtodownstream.

TheTideCell®SCADAsystemsimultaneouslymonitorsmulti-systemsandcollectsdataduringoperation.

Bioprocess Container

TideCell® Mixing System

TideCell® SCADA system

Upstream BioProcessing – Bioreactors and Fermenters

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VacciXcell Guide

Upstream BioProcessing – Cell Culture Products

BioNOC™ II Carriers

Analytical Tools and Reagents

BioNocTMIIcellculturematrixarecarriersforthegrowthofanchorage-dependentanimal,mammalian,andinsectcells.BioNOCTMIIsupportsgrowthofmanycelllines,includingCHO,CHO-K1,rCHO-hIgG,rC-127-TPA,HEK293,Hybridoma,Vero,Sf-9,Hi-5,BHK-21,rBHK-FactorVIII,HepG2,Hela,Huh7,RK-13,humanforeskinfibroblasts,humanmuscleskeletoncells,humanmesenchymalcells,andhumanembryonicstemcells.

GlucCell®glucosemonitoringsystemsimplifiesandacceleratesglucosemeasurementduringcellculture.Thedisposableglucoseteststripsenablethemeasurementofglucoseconcentrationduringmammaliancellandinsectcellcultureinafewseconds.Justinsertthestrip,addthesample,andreadtheresult.

CrystalVioletDyeNucleiCountcontainscrystalvioletdye,citricacidanddetergenttodisruptcellsandreleasecellnucleiforcellcount.Thisprovidesanefficientreagentforcellcountinporousmatrix.

Features

• 100%purePETmaterial

• Animalcomponent-free

• Lowlint

• Lightweight:1gramofcarriersoccupy15mlofspace

•Highsurfacetovolumeratio(S/V≈150cm-1)

• Highcapacity:1gramcarriersprovidespaceforupto1x109cellstopropagate

• Specialsurfacetreatmenttoenhancebiocompatibility

• Hydrophilicitystableforfouryears

• Specialgeometricdesigntoenhancemixingandsupport load-bearingcapacityinpacked-bed

•Compressibleforhighercelldensity

• Non-pyrogenic,non-cytotoxic

•ManufacturedincGMP-compliantfactory

• Sterilizablebyautoclave,gamma-irradiation,andEOsterilization

Features

•Calibration-free

• Ready-to-use

• Plug&Playsystem

•Disposableteststrips

• Accuracyindependentofculturemediumingredientsandserum-relatedcomponents

• 99.5%correlationwithYSIbiochemicalanalyser

ApplicationsGrowthofanchorage-dependentanimal,mammalian,andinsectcellsinfixedbedcellculturesystems:CelCradleTMculturedevice,TideCell®culturedevice,andanycommercialpackedbedculturedevice

GlucCell® Glucose Meter

Crystal Violet Dye (CVD) nucleus count kit

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Upstream BioProcessing – Cell Culture Products

Cell Culture Media and Supplement

Plus™MDCKisananimalcomponent-freeculturemediumdevelopedspecificallyforMDCKcellculture.

Plus™ MDCK

Features

•Animalcomponent-freeculturemedium

• Enablesserum-freeculturewithcomparablecellgrowthratetocellculturewithserum

•Upto10-foldhigherviraltitrecomparedtocultureusingcommercialmedium

•Availableinpowderorliquidform

Plus™VEROisananimalcomponent-freeculturemediumdevelopedspecificallyforVEROcellculture.

Plus™ VERO

Features

•Noanimalnorhumanorigincomponents

• Completelydefinedwithlowproteincontent(≤5μg/ml)

• Enablesserum-freeculture

• Nohydrolysates,yeastextract,peptone,and/orothercomplexcomponents

• Allowscellstoadherewithin5minandsuitableforagitatingculturesystem

• Superiorvirusoutputyieldoverothercommercially-availablemedia

• Availableinpowderedorliquidform

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VacciXcell Guide

Cell Culture Media and Supplement

Upstream BioProcessing – Cell Culture Products

VacciXcellprovidesmediumformulamodificationandoptimizationspecificallyforyourcellcultureneeds.

HiSMOP™ Culture Medium Formulation Platform

Features

• cGMPmanufactureofcustom,high-qualityculturemedium

•Optiontopurchasemediumformulaorendmediumproducts

•Morethan16yearsofexperienceinmediumformulation

HiSMOPTM Culture Medium Formulation PlatformFormulation

DesignCustomer

Formula Modification

Result feedback

Customer Test

Discussion

Contract Manufacture or purchase the formula

Confirm Formula

Scale upManufacture under cGMP

CESCO modifies and optimizes medium formula for users. CESCO has accumulated over 16-year experience in medium formulation and has established sound database for reference. CESCO, as a contract manufacture source, users can either purchase formula or order medium products directly . CESCO follows strictly cGMP guideline to manufacture high-quality culture medium.

Bioprocess Softw

areConsum

ablesD

isposable Bioreactor

Cell Culture M

ediumBioprocess System

Platform

Service

SuperPlus™isacellculturesupplementdesignedtoreduceoreliminatetherequirementforseruminthebasalmediumofcellculture.SuperPlus™alsominimizesculturevarianceduetoinconsistentqualitybetweenserumbatches.SuperPlus™-addedmediumsupportsgrowthofmanycelllines,includingMDCK,VERO,BHK,ST,PK-15,HEK-293,andCHO

Super Plus™

Features

•Compatiblewithcommercialbasalmedium

• Saveupto90%serumorcultureserum-free

•Completelydefinedwithlowproteincontent

• Nohydrolysates,yeastextract,peptone,and/orothercomplexcomponents

• Powderform

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Upstream BioProcessing – Cell Culture Products

Cell Culture Equipment

BSCs(BiologicalSafetyCabinets)provideISOClass3workzoneforcelltherapyresearchanddevelopmentprocedures,includingcelllineestablishment,cellpassaging,celltransductionandmore.

Features

• EnergysavingDCECMblowerformostmodels

• ISOCIDEantimicrobialpowdercoating

•ULPAfilterwith>99.999%efficiencyat0.1-0.3μm

• Largeperformanceenvelope

Features

• Preciseparametercontrol

• FastCO2,temperatureandhumidityrecoverywithoutovershoot

• Robustcontaminationcontrolforoptimumprotection:SteriSafeULPAFiltrationSystem,validatedSwiftCon90°CMoistHeatDecontaminationCycle,200°CHighHeatSterilizationCycle,filteredgasinjectionlines,andISOCIDETMantimicrobialcoating

•MonitoringandcontrolsystemforsafeguardingofcellculturesavailableviaVoyagersoftwaresystem

•User-friendlycontrollersoftwareinterfacewithuser-configurablealarms,partsreplacementreminderalarmsystem(CelAlert),andintelligentdataandeventloggerwithbuilt-in16MBflashmemory

• HPA(moistheatdecontamination),ULlisted,andMEA(MouseEmbryoAssay)certifications

Biological Safety Cabinets

CO2 and CO2/O2 Incubators

Biological Safety Cabinets

Class II Type B2NSF Certified

Class II EN Certified

Class III EN Certified

Class II Type A2NSF Certified

Custom Biological Safety Cabinets

Food SafetyCabinets

Stainless Steel Exterior Copper Interior CelSafe®CelCulture®Direct Heat Air-Jacketed,

Water Jacketed and With Cooling System

CelMate®

CO2 and CO2/O2 Incubators

• Ergonomicdesign

• Lownoise

• Easytoclean

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VacciXcell Guide

TheVersatiTMcentrifugesareequippedwithmaintenance-freemotors,robustmechanismandintelligentEcourageTMmicroprocessorcontrolsystem,thatoffersextremereliabilityandsafety.Coveringmicrocentrifugeandlow-to-highspeedgeneral-purposecentrifuge,withvarietyofrotors,adaptersandaccessories,theVersatiTMhasastrongversatilitytofitallyourapplicationneedsandsuitavarietyofconsumabletubes,stripsandplates.

Upstream BioProcessing – Cell Culture Products

Cell Culture equipmentVersatiTM Centrifuge

Features

• Maintenance-free,brushlessmotor

• Diversechoiceofrotors

• Incaseofpowerfailureormalfunction,thelidofthecentrifugecanbeopenedmanuallyviatheemergency

• DistinctcontrolpanelandintelligentEcourage™microprocessorcontrolsystem

• Motor-drivenlidlockensuressafetyandreliability

• Powerfulcombinationofmotorsandrotors

EscoVersatiTMT1000&T1000RCentrifuges

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Upstream BioProcessing – Cell Culture Products

Cell Culture EquipmentLaboratory Shaker

Features

• TriDrive™:Esco’suniquetriple-eccentriccounterbalanceddrivesupportsheavydutyandhighspeedapplications.

• RobustDrive™:ThismechanismeliminatestheneedforlubricationastheBrushlessDCMotorreducesmaintenance.

• SmartRun™:Excellentout-of-balancesensorandproprietyimbalancecompensationalgorithmadjusttheoptimumrevolutionsperminute(rpm)toensuresmoothoperationwithoutanyvibration.

• Dataaresavedevenafterpowerfailure.

• Apttofitanyapplicationrequiredforyouroperation.

•Offersmultiplechoiceofaccessorieswhichallowtocustomizeandmeettheappropriateapplication.

• Twotypesoforbit(19mmand25mm)thatmeetsdifferentapplication.

• ExternalsurfacesarepowdercoatedwithEscoISOCIDE™toeliminate99.9%ofsurfacebacteriawithin24hoursexposure.

• Audibleandvisiblealarmeveryendrun.

• Easy-to-usedesignenablestosetparameterprecisely.

• Historicalsettingscaneasilytrackandreviewfromthetouchscreen.

• Audibleandvisiblealarmsalertanyspeedandtemperaturedeviations.

• Shakerautomaticallyrestartsafterpowerinterruptionforthenon-volatileprogramsavedinthememory.

• Eachshakerisindividuallyfactorytestedforperformanceassuranceinaccordancewithinternationalstandards.

OrbiCult™BenchtopIncubatorShaker

OrbiCult™BenchtopAmbientShaker

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VacciXcell Guide

VacciXcellofferslaboratoryfreezersandrefrigeratorsthatprovidesuperiorproductandsampleproduction,longreliabilityandexceptionalquality.VacciXcellFreezershavetemperaturerangesfrom–10°Cto–40°Candcapacitiesof128L,347L,620Land1355L,whileVacciXcellrefrigeratorshavetemperaturerangesof+2°Cto+15°Candcapacitiesof128L,347L,620Land1355L.

Upstream BioProcessing – Cell Culture Products

Cell Culture EquipmentLaboratory Freezers and Refrigerators

Features

•DoorLock

• ExternalsurfacecoatedwithESCOISOCIDETM,whicheliminates99.9%ofsurfacebacteriawithin24hoursofexposure.

• Highqualitystainlesssteelinteriorforsampleprotection.

• InternalLEDlightingsavesupto70%powerwithlessheatexposurecomparedtofluorescentorincandescentlighting

• Standardwheel/castersaswell,foreasylocationormovement

Forced air design

• Superiorforcedairdesigninsteadofregularcoldwall,forbothrefrigeratorandfreezer.

• Rapidcool-downandveryfastrecoveryduetofanassistant.

• Fasttemperatureequilibration;superiorsampleprotection!

Intelligent Automatic defrost for additional sample protection

•Highperformanceunitusesintelligentdefrosttomaximizesampleprotection;

• Computerhasthermocoupleontheevaporator

• Detectsiceformation;

• Defrostsonlywhenneededtokeepunitsatoptimumperformance

• Keepschambertemperaturewithinsafelimits;

• Nosampleriskwhencoldwallfreezermustbedefrosted

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Formulation – Formulation and Filtration Isolator

Aseptic Containment Isolator (ACTI)

Features

• FullyweldedsinglepieceSS316Linternalchamberswithroundedcovedcorners

• PressuretestedtoISO14644-7

• InflatableAnti-bacterial,USPClassVIcompliantandFoodgradeFDAapprovedgasketsforproactiveandreactiveasepticsealingmethod

• Safeglovechangesystem

Typical Applications

•Handlingofbiopharmaceuticalgermseedcellsandasepticcellprocessing

• FormulationofcytotoxicAPI

AsepticContainmentIsolator(ACTI)isanadvancedasepticbarrierprovidingcontrolledenvironmentstominimizefalsepositivesduringsterilitytestingorhandlingofcytotoxicdrugs.

Weighing and Dispensing Containment Isolator (WDCI)

Features

• Standardconfigurabledesignsabletoadapttovariousweighinganddispensingquantitiesandaccuracies

• FullyweldedsinglepieceSS316Linternalchamberswithroundedcovedcorners

• PressuretestedtoISO14644-7

• InflatableAnti-bacterial,USPClassVIcompliantandFoodgradeFDAapprovedgasketsforproactiveandreactiveasepticsealingmethod

• Safechangeglovesystem

• Integratedanti-vibrationgraniteplatformforweighscaleplacement

• Safe change filters to allow in-process fi lterreplacement

• Integratedautomatedheightadjustmentproviding280mmofmotionforergonomiccomfort

Typical Applications

• FormulationofcytotoxicAPI

WeighingandDispensingContainmentIsolator(WDCI)isanadvancedcontainmentsystem,providingcontrollednegativepressuretoenvironmentstomaximizepersonnelprotectionduringweighinganddispensingofpotentcompounds..

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VacciXcell Guide

Formulation – Formulation and Filtration Isolator

General Processing Platform Isolator (GPPI)

Features

• FullyweldedSS316Linternalchamberswithrounded

covedcorners

• Userselectablepositiveornegativechamberpressures

andsinglepassorrecirculatingairflowregimes

• Automatedpressureholdtest

• Self-containeddesignofcontrolsystemandelectrics

allowforsimple,plug-ininstallation

• Safeglovechangesystem

TheEscoGeneralProcessingPlatformIsolator(GPPI)isahighlyadaptable,unidirectionallaminarairflowisolatorthatcanbeusedforanyprocessthatrequireanISOClass5(GradeA)asepticenvironment.

Filling Line - Traditional Filling

ASEPTiCell™

Features• Integrated -RTU(Ready-To-Use) -Singleuse -Isolator-barrier -Robotics

• Capacity -Vials:2–30ml -Syringes:0.5–20ml -Cartridges:3ml,5ml

•Options:semi-automated/mobile-transfer

•Option:tubExteriorBio-decontamination

ASEPTiCell™isafullyintegrated,highlyflexiblemanufacturingsystemdesignedtoasepticallyfill-finishsterileinjectable.ASEPTiCell™advancedautomatedfeaturesthatsimplifythefill-finishprocess,provideflexibilityandenhancesterilityassurance.

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Filling Line - Conventional Filling

Automatic TrayloadersFeatures

•Abletoloadanexactnumberofvials

• Availablesingle/dualtray

• Tool-Free,QuickChangeover

• Smallfootprint

• Simplechangeover

• Costeffective

Depyrogenation Tunnel

Features

• cGMP-compliantdesignandconstruction

•Widerangeoftunnelstochoosefrom,dependingonrequirements

• Detecttheairspeedandkeepitconstantwithaprecisionof0.01m/s

• HEPAfilteredairsupplyacrosstunnelchambers

• Capableofupto6-logbacterialendotoxinlevelreduction

• RecycledairintheCoolingChamber

• Have“NightMode”tosaveenergywhileavoidingcontamination

Vial WashingFeatures

• Semi/Fullyautomated

• Twomovingpartsinsidethewashchamber

• Centralcolumn&Outfeedmechanism

• Individuallyprogrammableintermittentsprayvalves

• Recirdulationpackages

• Non-penetratingSprayNozzles

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VacciXcell Guide

Automatic Loading / Unloading EquipmentFeatures

• Semi/fullyautomaticloadingsystem

• LaserGuidedLoadingandUnloadingSystems

• Self-poweredviabattery:Noneedforthex-rail

• Unitturnsaboutitself:Noneedforarotatingturret

Capping MachinesFeatures

• Stand-alonecappingmachine

• Spinningvials

• Upto200vials/min

• 2–100mlvials

• Centerstationarydisk

•Maintenance-freedesign

• Integratedfilling/stoppering/cappingmonoblockisavailable

External Vial WasherFeatures

•Hangingvialsforcompleteundersideexposureforcleaninganddrying

• Servomotormainandheightadjustmentdrives

• Universalchangepart(belts):13mmcaps/20mmcaps

•Quicktool-freechangeover

• Builtinlowpressure,highvolumecentrifugalblowerfordrying

• Lowernoisevolume

• Simpletovalidate

• CRAB/Isolatorenclosureready

Filling/Stopper Inserting MachinesFeatures

• In-lineorstand-alone

• Fillingstationwithoptionalpre/postnitrogenflush

•Dualstopperinsertingstation

• Vialrange:2-100ml

•Output:upto100vials/min

• Pump:PeristalticPump/RotaryPistonPump

•Option:statisticalcheckweighing/RejectStation

•QuickChangeover

• Isolator/RABS(RandomAccessBarrierSystem)Ready

-EasilyintegratedwithIsolatororRABS

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Supplementary Equipment

Sanitary rotary table Raised-bed sanitary and non-sanitary conveyrs

Loading and unloading tables

Cleanroom pass-through Downed vial reject systems

Sterility Testing

Sterility Testing Isolator

Features

• PositiveornegativepressureoperationavailableforbothsterilitytestingandQCtestingapplications

• Availableinvariousconfigurations:2-,3-,or4-glovedmainchamberandwithorwithoutatransferchamber

• Transferchamberwithindependentoperationandbiodecontamination

• Full316Lstainlesssteelconstructionwithcriticalchamberthicknessof4mmandtechnicalhousingthicknessof1.5mm

• Frontvisortomainchambersandtransferchambermanufacturedfrom10mmthicktoughenedsafetyglass.Themainchambervisorbeinginclinedforergonomiccomfort

• FDA-approvedinflatableseals

• BiologicalClassIIImodeavailablemeetingBSEN14629:2000standards

• Leaktightnessmeetingthatoftype1isolatorinISO14644-7

Thesterilitytestingisolatorprovidesacost-effectivepharmaceutical-gradeisolatorforsterilitytestingandotherQCtestingapplications.

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VacciXcell Guide

Cross Contamination Facility Integrated Barrier

Infinity® Pass Boxes, Infinity® Shower Pass Boxes,Infinity® Cleanroom Transfer Hatches

Cleanroom Air Showers

Soft Capsule® Soft Wall Cleanrooms

Dynamic Passboxes andDynamic Floor Label Hatches

Pharmaceutical Equipment

Airflow Containment Products

Barrier Isolation Systems

PharmaconTM Downflow Booths Ceiling Laminar Airflow Units Laminar Flow Horizontal TrolleysLaminar Flow Vertical Trolleys

Isoclean® Pharmacy Compounding Aseptic Containment Isolators (Recirculating)

Isoclean® Pharmacy Compounding Aseptic Isolators

Cytotoxic Safety Cabinets

Isolation and Containment Systems

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Since 1978, Esco has emerged as a leader in the development of controlled environment, laboratory and pharmaceutical equipment solutions. Products sold in more than 100 countries include biological safety cabinets, fume hoods, ductless fume hoods, laminar flow clean benches, animal containment workstations, cytotoxic cabinets, hospital pharmacy isolators, and PCR cabinets and instrumentation. With the most extensive product line in the industry, Esco has passed more tests, in more languages, for more certifications, throughout more countries than any biosafety cabinet manufacturer in the world. Esco remains dedicated to delivering innovative solutions for the clinical, life science, research and industrial laboratory community. www.escoglobal.com.

Air ShowerAseptic Containment Isolator (ACTI)Ceiling Laminar Airflow UnitsCleanroom Transfer HatchContainment Barrier Isolator (CBI)Downflow Booth (DFB)Dynamic Floor Label HatchDynamic Pass BoxEvidence Drying CabinetGarment Storage CabinetGeneral Processing Platform Isolator (GPPI)Laminar Flow Horizontal TrolleyLaminar Flow Straddle Units, Single and Double Laminar Flow Vertical TrolleyPass BoxSoft Wall CleanroomSputum BoothVentilated Balance Enclosure (VBE)Weighing and Dispensing Containment Isolator (WDCI)

Global Offices

Distributors

Factories

R&D Centers

Regional Distribution Centers

ESCO GLOBAL NETWORK

21ChangiSouthStreet1•Singapore486777

Tel+6565420833•Fax+6565426920•mail@vaccixcell.com

www.vaccixcell.com

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