PPLF-4205 Integrated Cell Processing Work Station — CPWS My Life. My Work. My Choice. www.sanyobiomedical.com CPWS Features: • Cost effective, space-saving solution for GMP and GTP compliant regenerative medicine and cell therapy. • Minimizes the expense of a cleanroom laboratory
9
Embed
Integrated Cell Station — CPWS · Tissue Engineering Market 2010 & 2015 ... Immunotherapy Dendritic cells; T-cells ... 6 CWPS Integrated Cell Processing Work Station 7 ...
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
2 CWPS Integrated Cell Processing Work Station www.sanyobiomedical.com
3
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.
Making it WorkImprovingefficiencyinhumaninterac-tionisaprimarydesignattributeoftheCPWS.Allworkmustbeperformedwith-outhumanerror,inanasepticenviron-ment,andwithdetaileddocumentationtoassurequalityandcompliance.Gown-uptime,expenseandinconvenienceisminimizedoreliminatedaltogether.Inte-gratedsystemswithintheCPWSpermitcellularextraction,preparation,culturingandadministrationwithasepticassur-anceaswellaseconomicpracticality.
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.
Self-Contained System, Small FootprintTheSANYOconceptofaself-containedworkstationisenabledbythecompany’sdemonstratedproficiencyforinsitudecontaminationrequiredtoseparateprocessesfromonepatienttothenext,oroneprotocoltoanother.ByusingahighlyeffectiveH2O2decontaminationprocess,theCPWScanbecompletelysterilizedwithoutheatandpreparedforthenextprotocolwithintwohoursascomparedtoacleanroomdecontamina-tionfunctioncantakedaysorweeks.
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.
CPWS Work StationTheSANYOCPWSworkstationisacomponent-baseddesignthatper-mitslong-termorquickturnoverself-containedprotocolswithefficiencyandsafetyfortheproductaswellasperson-nel.Asanintegratedsystem,allfunc-tionsassociatedwithgoodlaboratorytechnique,environmentalcontrolandergonomiccomfortareselectedforcom-patibilityandcomplementaryfunctionalperformance.
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)
Ergonomics and SafetyBecausesecondgowningisnotrequired,usercomfortandproductivityissignifi-cantlyimproved.Theworkplaceroutine,includingbathroombreaks,isunencum-beredbytheneedtoleaveandre-enteracleanroom,bleachand/orshower.
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.
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.
Incubator Features and BenefitsTheincubatorisamodificationofSANYO’spopularMCO-5AC.Thecom-pact1.4cu.ft.(49liter)interiorchamberisconstructedofSANYO’sexclusiveinCusaFe™copper-enrichedstainlesssteel,creatinganaturalgermicidalbar-rieragainstairbornecontamination.
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
Modular Incubator Model MCO-5AC(IS) docked to the CPWS
CPWS Centrifuge
11
12 CWPS Integrated Cell Processing Work Station www.sanyobiomedical.com
13
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.
1
23
2 3
Cell Monitoring System (Optional)AnintegratedcellmonitoringsystemreducesadditionalfootprintrequiredinaGMPenvironment.Cellmonitorcompo-nentsarelocatedwithinthebarrierisola-toranddesignedtowithstandrepeatedH2O2decontaminationsequences.
Pre-Delivery and On-Site ServicesPre-deliveryservicesincludefactoryacceptancetesting,calibration,andtemperaturemapping.On-siteservicesincludeinstallationqualification,operationalqualification,performancequalification,calibrationandtemperaturemapping.