Containment Barrier Isolator - III (CBI-III)

Your Practical Solution to cGMP Compliance

Containment Barrier Isolator - Class III Biosafety Cabinet (CBI-III) offers the highest level of operator, product, and environmental protection from infectious/biohazardous aerosols and is suitable for microbiological work with agents assigned to biosafety levels 1,2,3, or 4. It is designed for an absolute level of containment, it is frequently used for work involving the deadliest biohazards, bacteria, viruses, and microorganisms.

CBI-III is configured to operate at a minimum of -125 Pa to provide adequate containment for handling highly pathogenic and lethal biological agents.

Applications:

Laboratory containment for handling biological agents of up to level 4
Virus and vaccine production
Cell Processing
Research and development

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Features

Fully welded stainless steel 316L internal chambers with stainless steel 304 external housingg
Exhaust air is double-filtered through high-quality ULPA filters (per IEST-RP-CC-001.3) with typical efficiency of >99.999% for 0.1 to 0.3 micron particles, better than HEPA filters.
An integrated pass-through with interlocking doors permits materials transfer without risk of contamination
Single-piece, leak-tested glove assemblies which guarantee maximum protection.

Principle

containment barrier isolator III (cbi-III) airflow scheme

Ambient air is pulled through the inlet prefilter located on top of the isolator. Air from the top inlet and from work zone is pulled by the fan which creates a positive pressure on the plenum that creates downflow. The HEPA (H14) downflow filter creates a laminar and particle-free ISO Class 5 air cleanliness as per ISO 14644-1 (equivalent to Class 1 as per US Fed Std 209E) inside the isolator to protect the work material inside the main chamber and pass-thru. Air from the work zone and pass-thru is quickly purged out by the fan to keep the area clean. The fan pulls approximately 90% of the purged air back to the plenum and after passing through the HEPA (H14) downflow filter.
The high rate of airflow recirculation helps to prolong filter life and reduces the chances of ambient contaminants entering the work zone. For a recirculating model, approximately 10% of the purged air is exhausted through an HEPA-filter to prevent heat build-up inside the isolator that can be detrimental to drug compounding. This exhausted air is replenished by ambient air coming from the top inlet prefilter and a filter with 80% efficiency for positive pressure model. For a Total Exhaust/Single-Pass Model, 100% of the air is exhausted out of the isolator.

Models

GENERAL SPECIFICATIONS Containment Barrier Isolator - Class III Biosafety Cabinet		CBI-III-2G	CBI-III-3G	CBI-III-4G
Main Chamber Nominal Size (Width)		1.2 meter (4’)	1.6 meter (5.2’)	2.0 m (6.6’)
Working Chamber Dimensions - Min (W x D x H)		1.2 m x 0.55 m x 0.77 m (4’ x 1.8’ x 2.6’ )	1.6 m x 0.55 m x 0.77 m (5.2’ x 1.8’ x 2.6’ )	2.0 m x 0.55 m x 0.77 (6.6’ x 1.8’ x 2.6’ )
Working Chamber Dimensions - Max (W x D x H)		1.2 m x 0.63 m x 0.84 m (4’ x 2.1’ x 2.9’ )	1.6 m x 0.63 m x 0.84 m (5.2’ x 2.1’ x 2.9’ )	2.0 m x 0.63 m x 0.84 m (6.6’ x 2.1’ x 2.9’ )
External Dimension (with one Pass Chamber) (W x D x H)	With Adjustable Base Stand (Min)	1.82 m x 0.92 m x 2.55 m (6.0’ x 3.0’ x 8.4’)	2.22 m x 0.92 m x 2.55 m (7.3’ x 3.0’ x 8.4’)	2.62 m x 0.92 m x 2.55 m (8.6’ x 3.0’ x 8.4’)
	With Adjustable Base Stand (Max)	1.82 m x 0.92 m x 2.85 m (6.0’ x 3.0’ x 9.4’)	2.22 m x 0.92 m x 2.85 m (7.3’ x 3.0’ x 9.4’)	2.62 m x 0.92 m x 2.85 m (8.6’ x 3.0’ x 9.4’)
External Dimension -Small Pass-through Chamber (W x D x H)		0.60 x 0.52 x 0.76 m
Glove Port Height (Min)		1000 mm	1000 mm	1000 mm
Glove Port Height (Max)		1300 mm	1300 mm	1300 mm
Chamber Environment		ISO Class 5 all chambers (Grade A)
Pre-filter	Process Chamber	G4, polyester media
	Pass-through Chamber	G4, polyester media
Filter Type - Chamber Inlet		HEPA (H14) Filter with Integral Mesh Guard and Gasket Seal
Filter Efficiency - Chamber Inlet		99.995% MPPS
Filter Type - Chamber Exhaust		HEPA (H14) Filter with Integral Mesh Guard and Gasket Seal
Filter Efficiency - Chamber Return and Exhaust		99.995% MPPS
Lighting Level		≥ 500 Lux (6000 K)
Sound Level		≤ 80 dBA
Airflow Type		Unidirectional/ Laminar Airflow
Chamber Operating Pressure		negative 125 Pa
Isolator Construction	Chamber	SS 316L
	Service Housing	SS 304
	Support Frame	SS 304
Isolator Finish	Chamber Internal	≤ 0.4 Ra
	Chamber External	≤ 0.6 Ra
	Serivce Housing External	≤ 0.6 Ra
	Support Frame	≤ 1.0 Ra
Electrical Requirements	220-240 VAC, 50/60 Hz, 1Ø	CBI-3-2G8	CBI-3-3G8	CBI-3-4G8
(by Client)	110-120 VAC, 50/60 Hz, 1Ø	CBI-3-2G9	CBI-3-3G9	CBI-3-4G9
Compressed Air Requirement (by Client) If no on-board compressor	2 Bar-g Pressure at 5 L/sec	✔	✔	✔
Exhaust Duct Requirements (by Client) unless Integral Catalytic Convertor is Included		10 “ Duct from Isolator to Outside
Air Change per Hour		1570 ACH	1570 ACH	1570 ACH
Volumetric Flow Rate		916 cmh	1225 cmh	1532 cmh
Downflow Velocity		0.4 m/s
Net Weight		TBD	TBD	TBD
Shipping Weight		TBD	TBD	TBD
Shipping Dimension (W x D x H)		TBD	TBD	TBD
Shipping Volume (Maximum)		TBD	TBD	TBD

Accessories

LIST OF OPTIONS for CBI Models		CBI-U	CBI - T	CBI-III	CBI-H
4" Split Butterfly Valve (for powder discharge of powder below isolator chamber)		✔	✔
Adjustable Hydraulic Stand (based on operator ID input)		✔		✔	✔
Exhaust Box (with automated dampers with inflatable seals or manual with valve)		✔		✔	✔
Anti-blow back damper box		✔	✔		✔
Automated Pressure Hold Test	with Client Supplied Compressed Air	✔	✔	✔	✔
Automated Pressure Hold Test	with On-board Air Compressor	✔	✔	✔	✔
Bag Welder with Table Bag-out Port		✔	✔	✔
Bio Dunk Tank Bag Out Port				✔	✔
Mobile Biodecontamination BioVap TM		✔		✔	✔
Carbon Filter		✔
Convertible to Class 1 cabinet					✔
Integration of small scale aseptic or potent tablet/capsule etc…		✔	✔	✔	✔
Double-sided access			✔	✔	✔
Manual Drain Ball Valve (for client controlled CIP/WP) must order with inner pass-through inflatable sealed doors.		✔	✔
Electrical Outlet (IP66)	IP 66	✔	✔	✔	✔
Electrical Outlet (IP66)	ATEX Zone 1/21 (only for internal environment)	✔	✔		✔
ATEX rating up to zone 1/21 internally only (ATEX fan, “IS” signals for internal door sensor/push button)		✔	✔
Glove Leak Tester		✔	✔	✔	✔
Formalin Vaporizer (auto neutralization and purge cycle)		✔		✔	✔
H₂O₂ Monitoring (sensor is not integrated with HMI)		✔		✔	✔
Liquid Water Entry / Exit Ports				✔	✔
N2 Purge for Process Chamber			✔
Ø250 mm Product Waste Bag Out Ports /				✔
Battery option to maintain EM interlock during power outage or E Stop		✔	✔	✔	✔
Particle Counter	Portable Paricle Counter (Non-viable)	✔		✔	✔
Particle Counter	Microbial Air Samples (Viable Particle Counter)	✔		✔	✔
Product Waste Entry / Exit Ports		✔			✔
RTPØ 105, 190, 270 - Alpha		✔	✔	✔	✔
RTPØ 105, 190, 270 - Beta Canister		✔		✔
RTPØ 105, 190, 270 - Beta Liner		✔		✔
RTPØ 350, 460 - Alpha, Beta Liner, Beta Canister			✔	✔	✔
Service Fixtures (Vacuum, Nitrogen, Compressed Air, Nozzle for BioVap)		✔	✔	✔	✔
Spray Ball (CIP) with Manual Ball Valve			✔
Spray Gun (WIP) with Manual Ball Valve		✔	✔
Sterile Continuous Liner		✔		✔	✔
Sterility Test Pump		✔
Temperature and Relative Humidity Monitoring (only for process chamber)		✔	✔	✔	✔
Rear view monitor		✔	✔	✔	✔
UV Lamp				✔	✔
Weighing Scale Granite Slab		✔	✔		✔
Sharps (inside)		✔