Upload
vukhanh
View
214
Download
0
Embed Size (px)
Citation preview
2
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
4
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
5
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
6
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
7
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
8
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
9
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
10
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
11
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
12
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
13
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
14
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
15
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
16
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
17
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..
18
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.
19
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
20
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
21
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.
22
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
23
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•[email protected]
www.vaccixcell.com
9010
289_
Vacc
ixce
ll_Pr
oduc
t Gui
de_A
4_Br
ochu
re_J
an20
16Esco
can
accep
tno
respo
nsibilityforpossibleerrorsin
catalog
ues,broch
uresand
otherprin
tedmaterials.E
scoreserves
therig
httoalteritsprodu
ctsan
dspecificatio
nsw
ithou
tno
tice.Alltrad
emarksand
logo
type
sinthismaterialarethe
prope
rty
ofEscoan
dtherespectivecompa
nies.