Containment Barrier Isolator (CBI)

PLATFORMSPECIALIST.

• PassChambercomesin2sizes:

-Small,non-gloved

-Large,non-gloved/gloved

Applications• PharmacyCompounding(Chemotherapy/TPN)

• AsaClassIIICabinetforBiosafetyLevels(BSL)3and4

• SmallBatchSterilityTesting

• Small-scalePotentMaterialHandling

• CellProcessing

• AsepticProcessing

• ResearchandDevelopment

Key Features• Controlsexposure/cross-contaminationrisktohazardous/aseptic

materialsforawidevarietyofequipmentandprocesses

• Controlsfalse-positiveriskforsterilitytesting

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

controlledoperations

• Levelsof≤0.1μg/m3canbeachievedviaclosed-transferprocesses

orbasedonclientSOPs

• EnhancescGMPpractices

• Quiet,energy-efficientECMfansautoadjusttocompensatefor

filterblockage

• Standarddimensionsavailableareeasilycustomizedtosuitprocess

requirements

• Safeglovechangeandlowcontaminationfilterchange

• FDA-approvedstaticseals

• Pressuretestedclass1ISO10648-2standards

• SystemcomeswithaSemi-automatedorAutomatedPressureHold

Testing

WarrantyOneyearwarranty(excludingconsumables).Consumablesareballast,fluorescent,andfilters.Thewarrantywillcoverallotherpartsincludingtheblower, fan switch, and electricalmain board.During theperiodof warranty, any repair, modification, testing and commissioningperformedbyanyunathorizedpartyotherthanEscoServiceTeamwillvoidthewarrantyoftheunit.

Introduction

Containment BarrierIsolator (CBI)

Filtration PackageProcess Chamber• RoomInletFilter–F6filtration.Panelfilter,glassfibermedia.• Chamber Inlet Filter – SingleU15ULPAfiltration. Panel filter, gel

seal,glassfibermedia.• Chamber Return Filter – Single H14 HEPA filtration. Panel filter,

gasketseal,glassfibermedia.• ChamberOutletFilter–StandardF6filtration,optionalH14HEPA

filtration.Panelfilter,gasketseal,glassfibermedia.

Note: Hydrogen Peroxide Vapor (HPV) will pass through the filters during the HPV cycle to allow decontamination of the filters and air path.

Pass Chamber• RoomInletFilter–G4filtration.Panelfilter,polyestermedia.• ChamberInletFilter–SingleU15ULPAfiltration.Panelfilter,gasketseal,glassfibermedia.• ChamberExhaustFilter–F6filtration.Panelfilter,gelseal,glassfibermedia.

Note: HPV will pass through the HEPA filters during the HPV cycle to allow decontamination of the filters and air path.

Basic Principles

• Equipped with dual SentinelTM Platinum Microprocessor ControlSystem

• StandardControlssuitableforsafeareaapplications• IncludestwoIP66electricalsocketsasstandard

Esco Containment Barrier Isolator (CBI) facilitates the isolation of aproductorprocesswhileprovidingtherequiredconditionsforasterile/asepticenvironment. It isconfiguredtooperateatpositiveornegativepressure.Thisequipmentprovidesacomprehensiverangeofpersonneland product protection in addition to protection for the surroundingworkareasandtheenvironment.

CBI'sdesignhascompletecompliancetoPIC/sandEUcGMPstandardswithits19mmradiuscovedinternalcornersinasinglepiecechamber(noperforationsorgrillesforcontaminantstobetrappedonall4corners).ItsRearReturnFilterensures thatductsarenotcontaminated.Thesystemcomesineitherrecirculatoryorsinglepassairflow.

ENGINEERING DRAWING

770mm(3

0.3"

)

841mm(3

3.1"

)

553mm(21.8")

627mm(24.7")

920mm(36.2")

916

917

918

919

915

914

913

912

615mm(24.2")

660mm(2

6.0"

-M

in)

960mm(3

7.8"

-M

ax)

1200mm(47.2")

1600

mm(6

3.0"

)

1815mm(71.5")

2560

mm(1

00.8"-Max)

2260

mm(8

9.0"

-M

in)

91

92

93

94

97

96

98

99

910

911

95

7. Sliding Tray 8. Main Control Panel 9. Foot Switch10. Leveling Feet11. Caster Wheel12. F6 Pre-filter13. Inlet EC Centrifugal Fan

14. Exhaust EC Centrifugal Fan

15. Gel-Sealed U15 Inlet Filter

16. T5 Fluorescent Lamp

17. Magnetic Interlock

18. Gasket-Sealed H14 Return Filter

19. Hydraulic Adjustable Support Stand (Optional)

1. Dampers

2. Emergency Stop or E-Stop

3. Pressure Injection Buttons

4. SentinelTM Platinum Microprocessor Control System

5. Pass Chambers

6. Process Chamber

CBI-2G CBI-3G CBI-4G

Main Chamber Nominal Size (Width) 1.2m 1.6m 2.0m

Working Chamber Dimensions - Min (L x W x H) 1.2mx0.55mx0.77m 1.6mx0.55mx0.77m 2.0mx0.55mx0.77m

Working Chamber Dimensions - Max (L x W x H) 1.2mx0.63mx0.84m 1.6mx0.63mx0.84m 2.0mx0.63mx0.84m

External Dimension(with one Pass Chamber) (L x W x H)

WithAdjustableBaseStand(Min) 1.82mx0.92mx2.26m 2.22mx0.92mx2.26m 2.62mx0.92mx2.26m

WithAdjustableBaseStand(Max) 1.82mx0.92mx2.56m 2.22mx0.92mx2.56m 2.62mx0.92mx2.56m

Glove Port Height (Min) 1000mm 1000mm 1000mm

Glove Port Height (Max) 1300mm 1300mm 1300mm

Chamber Environment ISOClass5allChambers(GradeA)

Filter Type - Chamber Inlet ULPAU15withIntegralMeshGuardandKnifeEdgeGelSeal

Filter Efficiency - Chamber Inlet 99.9998%

Filter Type - Chamber Exhaust HEPAH14withIntegralMeshGuardandGasketSeal

Filter Efficiency - Chamber Exhaust 99.995%

Lighting Level ≥700Lux

Sound Level <63dBA TBA TBA

Isolator Construction

Chamber SS316L

ServiceHousing SS304L

SupportFrame SS304L

Isolator Finish

ChamberInternal ≤0.4Ra

ChamberExternal ≤0.6Ra

ServiceHousingExternal ≤0.6Ra

SupportFrame ≤1.0Ra

Electrical Requirements (by Client)

220-240VAC,50/60Hz,1Ø

110-120VAC,50/60Hz,1Ø

Compressed Air Requirement (by Client)if no on-boardcompressor

2Bar-gPressureat5L/sec

Exhaust Duct Requirements (by Client)unless Integral Catalytic Convertor is Included

10"DuctfromIsolatortoOutside

Options

PassChamber(Small,nonglovedorLarge,nongloved/gloved)

Bio-DecontaminationBIOVAP

Non-ViableAirSampler

ViableAirSampler

SterilityTestPump

GloveTester

WasteBagGrommet

SterileContinuousLiner

BagWelderwithTable

RTPØ105,190,270,350,460-Alpha

RTPØ105,190,270,350,460-BetaCanister

RTPØ105,190,270,350,460-BetaLiner

AnalyticalBalance

SprayGun

TemperatureandHumidityMonitor

H2O2Monitoring

ProductWasteEntry/ExitPorts

LiquidWasteEntry/ExitPorts

4"ButterflyValve

Drain

LinerSystem

On-boardAirCompressor

UVLamp

CarbonFilter

AdjustableHydraulicStand

CCTVCamera

TVMonitor

GENERAL SPECIFICATIONSCONTAINMENTBARRIERISOLATOR(CBI)

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LIVE SUPPORTescoglobal.com

PT Esco Bintan IndonesiaCert. No: 651333/E

Esco Micro Pte Ltd Cert. No: 651076

PT Esco Bintan IndonesiaCert. No: Q2N130383797001

Esco Pharma dedicated R&D engineers have a combined 30 years of experience in systems design of a variety of containment and aseptic process equipment. Compared to industry averages, Esco invests a significant percentage of annual revenues in research and development. As a result of our investment, and with continuous feedback and idea evaluation among our research, global sales, marketing, purchasing and manufacturing teams, Esco products reflect the best contemporary designs in performance, ergonomics and customer satisfaction. www.escopharma.com

Sales/Service Subsidiary CompaniesFactory

PLATFORMSPECIALIST.

Esco Pharma Pte Ltd21 Changi South Street 1 Singapore 486777 • Tel: +65 65420833Fax: +65 65426920 • Email: csis.pharma@escoglobal.com

Esco Technologies, Inc.1661 Loretta Ave., Feasterville, PA 19053Tel: 215 322 2155 • Email: eti.pharma@escoglobal.com

Esco Gb LtdUnit 9, Century Park Networkcentre, Dearne Lane,Manvers, Rotherham, South Yorkshire, S63 5DE.Tel: +44 (0) 1709 761 669 • Email: egb.info@escoglobal.com

Esco Global Offices: Sydney, Australia | Manama, Bahrain | Beijing, China | Chengdu, China | Guangzhou, China | Shanghai, China

Kowloon, Hong Kong | Bangalore, India | Delhi, India | Mumbai, India | Jakarta, Indonesia | Rome, Italy | Osaka, Japan

Kuala Lumpur, Malaysia | Melaka, Malaysia | Manila, Philippines | Moscow, Russia | Singapore | Midrand, South Africa

Seoul, South Korea | Bangkok, Thailand | Barnsley, United Kingdom | South Yorkshire, United Kingdom | Philadelphia, PA, USA | Hanoi, Vietnam

Pharma Equipment Product Range

Air ShowerAseptic Containment Isolator (ACTI)Ceiling Laminar Airflow UnitsContainment Barrier Isolator (CBI)Dynamic Pass BoxEsco Straddle Unit SingleEvidence Drying CabinetGarment Storage CabinetGeneral Processing Platform Isolator (GPPI)Hard CapsuleLaminar Flow Horizontal TrolleyLaminar Flow Straddle UnitsLaminar Flow Vertical TrolleyPass BoxSoft CapsuleSputum BoothWeighing and Dispensing Containment Isolator (WDCI)

ESCO GlObal NEtwOrk