- Laminar / Unidirectional airflow that complies to standards for sterile product handling
- HEPA (H14) filters with a typical efficiency of > 99.999% at 0.3 microns provide superior ISO Class 5 air cleanliness (Grade A)
- Recovery Time to maintain ISO Class 5 environment is less than 60 seconds
- Class II Containment as per ISO 10648-2 leak tightness
- Type D Passthrough Chambers equipped with electromagnetic interlocking mechanism and time-delay effect
- Safe glove change and low contamination filter change
- FDA-grade static seals

- 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 100 as per US Fed Std 209E) inside the isolator to protect the work material inside the main chamber and pass-thru. Air fromthe 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.
GENERAL SPECIFICATIONS Containment Barrier Isolator – Unidirectional | CBI-U-2G | CBI-U-3G | CBI-U-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 0.550 m x 0.77 m | 1.6 m x 0.55 m x 0.77 m | 2.0 m x 0.55 m x 0.77 | |
Working Chamber Dimensions – Max (W x D x H) | 1.2 m x 0.626 m x 0.84 m | 1.6 m x 0.626 m x 0.84 m | 2.0 m x 0.626 m x 0.84 m | |
External Dimension | With Adjustable Base Stand (Min) | 1.815 m x 0.92 m x 2.26 m | 2.215 m x 0.92 m x 2.26 m | 2.615 m x 0.92 m x 2.26 m |
With Adjustable Base Stand (Max) | 1.815 m x 0.92 m x 2.56 m | 2.22 m x 0.92 m x 2.56 m | 2.615 m x 0.92 m x 2.56 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) | |||
Chamber Pressure | Factory-Configured Either Positive or Negative Pressure | |||
Airflow Type | Unidirectional/ Laminar Airflow | |||
Filter Type – Chamber Inlet | HEPA (H14) Filter with Integral Mesh Guard and Gasket Seal | |||
Filter Efficiency – Chamber Inlet | 99.995% | |||
Filter Type – Chamber Exhaust | HEPA (H14) Filter with Integral Mesh Guard and Gasket Seal | |||
Filter Efficiency – Chamber Exhaust | 99.995% | |||
Lighting Level | ≥ 500 Lux (6000 K) | |||
Sound Level | ≤ 80 dBA | |||
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, | CBI-U-2G8 | CBI-U-3G8 | CBI-U-4G8 |
(by Client) | 110-120 VAC, | CBI-U-2G9 | CBI-U-3G9 | CBI-U-4G9 |
Compressed Air Requirement (by Client) | 2 Bar-g Pressure at 5 L/sec | ✔ | ✔ | ✔ |
Exhaust Duct Requirements (by Client) | 10” Duct from Isolator to Outside | |||
Estimated Weight of Cabinet (1 PTC) | 721 kg | 900 kg | 1121 kg | |
Estimated Weight of Cabinet (2 PTC) | 851 kg | 1030 kg | 1209 kg | |
Net Weight | 929 kg | 1260 kg | ||
Shipping Weight | 979 kg | 1320 kg | ||
Shipping Dimension (W x D x H) | 1550 X 950 X 1760 mm | 2500 X 1080 X 2400 mm | 3370 X 1100 X 2420 mm | |
Shipping Volume (Maximum) | 2.59 | 6.48 | 8.97 | |
| 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 | ✔ | ✔ | ✔ | ✔ | ||
| 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 | ✔ | ✔ | ✔ | ✔ | ||
| 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) | ✔ | ✔ | ✔ | |||
| 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) | ✔ | ||||||





