- 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) |
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Chamber Pressure |
Factory-Configured Either Positive or Negative Pressure |
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Airflow Type |
Unidirectional/ Laminar Airflow |
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Filter Type – Chamber Inlet |
HEPA (H14) Filter with Integral Mesh Guard and Gasket Seal |
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Filter Efficiency – Chamber Inlet |
99.995% |
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Filter Type – Chamber Exhaust |
HEPA (H14) Filter with Integral Mesh Guard and Gasket Seal |
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Filter Efficiency – Chamber Exhaust |
99.995% |
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Lighting Level |
≥ 500 Lux (6000 K) |
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Sound Level |
≤ 80 dBA |
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Isolator Construction |
Chamber |
SS 316L |
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Service Housing |
SS 304 |
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Support Frame |
SS 304 |
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Isolator Finish |
Chamber Internal |
≤ 0.4 Ra |
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Chamber External |
≤ 0.6 Ra |
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Serivce Housing External |
≤ 0.6 Ra |
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Support Frame |
≤ 1.0 Ra |
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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 |
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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 |
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Shipping Weight |
979 kg |
1320 kg |
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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) | ✔ |