Containment Barrier Isolator (CBI) – Unidirectional

Your Practical Solution to cGMP Compliance

The Containment Barrier Isolator – Unidirectional (CBI-U) is designed to deliver a controlled ISO Class 5 (Grade A) environment through unidirectional (laminar) airflow, ensuring optimal protection for sterile and aseptic processing. By physically separating the operator from the critical process zone, the CBI-U safeguards personnel, product, and the surrounding environment within a fully enclosed barrier system. The unit can be factory-configured to operate under positive or negative pressure, with either single-pass or recirculating airflow, allowing it to be tailored to specific process requirements and containment strategies.

Engineered for small-scale aseptic operations involving non-hazardous or hazardous materials, the CBI-U provides robust containment performance and is pressure-tested to Class II according to ISO 10648-2. To further ensure chamber integrity, an optional automated pressure decay test is available for routine verification. The system can also be equipped with an integrated automated biodecontamination solution (BioVap™), achieving a validated 6-log reduction of bioburden using hydrogen peroxide, supporting rapid and reproducible decontamination cycles.

Applications:

Pharmacy Compounding (Chemotherapy/TPN)
Small-Scale Potent Material Handling
Aseptic Processing
Sterility Testing
Research and Development
Cell Processing

Request for Quotation

Features

Unidirectional (laminar) airflow compliant with sterile product handling standards, supported by H14 HEPA supply filters (>99.995% efficiency at 0.1–0.3 µm) delivering ISO Class 5 (Grade A) air cleanliness and double-stage H14 HEPA exhaust filtration for enhanced room protection.
Rapid recovery time of less than 60 seconds to re-establish and maintain ISO Class 5 conditions.
Class II containment performance in accordance with ISO 10648-2 leak tightness requirements.
Type D pass-through chambers with dedicated H14 HEPA supply filters, featuring electromagnetic interlocking and time-delay control for safe material transfer.
Safe multi-piece glove change system with 200 × 200 mm circular glove ports to maintain barrier integrity during replacement.
FDA-grade static seals for both inner and outer doors to ensure reliable sealing performance.
Integrated HMI/PLC control system with optional 21 CFR Part 11 compliance for electronic records and electronic signatures.

Principle

Total Exhaust/Single Pass Airflow	Recirculating Airflow

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 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 70% 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 30% 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

Containment Barrier Isolator - Unidirectional		2G		3G		4G
External dimension of Process Chamber *		1200 x 920 x 2650 mm		1600 x 920 x 2650 mm		2000 x 920 x 2650 mm
Internal dimension of Process Chamber		1196 x 560 x 765 mm		1596 x 560 x 765 mm		1996 x 560 x 765 mm
External dimension of 1-glove Pass Chamber		610 x 780 x 1325 mm
Internal dimension of Pass chamber		606 x 450 x 700 mm
Glove port height **		1135 mm
Glove port dimension		Circular (200 x 200 mm) Note: Oval (200 x 300 mm) is available as optional
Chamber Environment		ISO Class 5 in Process Chamber (Grade A)
Chamber Pressure		Factory-Configured Either Positive or Negative Pressure
Airflow Type		Unidirectional/ Laminar Airflow Factory-Configured Recirculating or Single-Pass/Total Exhaust Model
Filter Type - Chamber Inlet		HEPA (H14) Filter with Integral Mesh Guard and Gasket Seal
Filter Efficiency - Chamber Inlet		> 99.995% at Most Penetrating Particle Size (MPPS) as per EN 1822:2009
HMI Type		HMI Siemens/ Allen Bradley 7" Note: Industrial PC upgrade is available as optional
Control System		Industrial Grade PLC Siemens/ Allen Bradley
Lighting Level		≥ 500 Lux (6000 K)
Sound Level		≤ 80 dBA
Isolator Construction	Internal Chamber	SS316L
	Service Housings	SS304
	Support Frame	SS304
	Control Panel	In-house SS304 (IP-20)
	Chamber Door	10 mm (0.39") Tempered Glass
Isolator Surface Finish	Internal Chamber	≤ 0.4 Ra
	External Chamber	≤ 0.6 Ra
Electrical Requirement		220-240 VAC, 50/60 Hz, 1Ø or 110-120 VAC, 50/60 Hz, 1Ø Note: 3Ø is available upon request
Compressed Air Requirement		Min 6 Bar-g, max 12 Bar-g with 200 Liter per Minute Flow
Exhaust Duct Requirements (by Client) unless Integral Catalytic Convertor is Included		250 mm (10") Duct from Isolator to Outside
Estimated Weight		850 kg	1000 kg		1200 kg
Shipping Dimension (W x D x H)		Contact Esco for more information

* Including exhaust collar for ducting and fixed stand with caster wheels and leveling feet

** With fixed stand with caster wheels and leveling feet

Building Exhaust Requirement	2G	3G	4G
Total exhaust (Single Pass) with 1PTC	750 cmh	1100 cmh	1500 cmh
Recirculating	150 cmh	220 cmh	300 cmh

Note:The values stated above are based on standard building exhaust requirements with a ±30% tolerance and may vary for customized dimensions or specific airflow configurations. Please contact Esco to confirm the exact building exhaust requirements for the proposed or selected configuration.

Accessories

The Esco Containment Barrier Isolator – Unidirectional (CBI-U) is a versatile system designed to accommodate a wide range of applications, supported by various optional features and customization configurations as outlined below. Contact Esco to learn how the CBI-U can be tailored to meet your specific process and containment requirements.

List of Options		CBI-U	CBI-T	CBI-III
4” Split Butterfly Valve (for powder discharge of powder below isolator chamber)		✓	✓	✓
Raised and Lower Height Adjustable Support Stand		✓
Anti-blow Back Damper Box		✓	✓	✓
Automated Pressure Hold Test	With Client-supplied Compressed Air	✓	✓	✓
Automated Pressure Hold Test	With Mobile Air Compressor (Esco-supplied)	✓	✓	✓
Bag Welder with Table Bag-out Port		✓	✓	✓
Mobile Biodecontamination BioVap		✓		✓
Integrated Biodecontamination BioVap		✓		✓
Carbon Filter		✓		✓
Integration of Small Scale Aseptic or Potent Tablet/Capsule		✓	✓	✓
Double-sided Access			✓
Manual Drain Valve		✓	✓	✓
Electrical Outlet	IP-66	✓	✓	✓
	IP-54	✓	✓	✓
	Non-IP rated	✓	✓	✓
	ATEX Zone 21 (only for internal chamber)	✓	✓	✓
ATEX rating up to zone 1/21 internally only		✓	✓	✓
Glove Leak Tester	Integrated	✓	✓	✓
Glove Leak Tester	Wireless*	✓	✓	✓
H2O2 Monitoring System (integrated to HMI/PLC)		✓		✓
Entry / Exit Ports	Liquid/ Water Waste	✓		✓
Entry / Exit Ports	Product Waste	✓	✓	✓
N2 Purge for Process Chamber			✓
Product Waste Bag Out Ports		✓	✓	✓
Particle Counter Integration		✓		✓
Air Sampler Integration		✓		✓
RTPØ 105, 190, 270 - Alpha		✓	✓	✓
RTPØ 105, 190, 270 - Beta Canister		✓	✓	✓
RTPØ 105, 190, 270 - Beta Liner		✓	✓	✓
RTPØ 350 - Alpha, Beta Liner, Beta Canister		✓	✓	✓
Spray Ball (CIP) with Manual Ball Valve			✓
Spray Gun (WIP) with Manual Ball Valve			✓
Sterility Test Pump	Tabletop	✓		✓
Sterility Test Pump	Integrated	✓		✓
Temperature and Relative Humidity Monitoring (only for process chamber)		✓	✓	✓
Rear View Monitor		✓	✓	✓
UV Lamp		✓		✓
Weighing Scale Granite Slab with SS316L Frame and Leveling Feet		✓	✓	✓