Containment Barrier Isolators - H: Hybrid (CBI-H)
Your Practical Solution to cGMP Compliance
Containment Barrier Isolator - Convertible Class III/Class I Biosafety Cabinet (CBI-H) builds on Esco Pharma’s success of CBI-III. It allows operators to work via a removable glove visor to convert the cabinet and function as a Class III or a Class I Biosafety Cabinet as per EN 12469 standards. In BSC Class III mode, the operator works through a glove port attached to a removable panel. It can be converted to a BSC Class I by removing the closure panel and attaching a blanking plate over the inlet HEPA filter.
To ensure maximum performance, commissioning and preventive maintenance of the cabinet must be done in both modes.
Applications:
Laboratory containment for handling biological agents of up to level 4
Research and development
Fully welded stainless steel 316L internal chambers with stainless steel 304 external housing
Designed to operate as a Class III BSC to Class IIII BSC or as Class I BSC
In Class III BSC mode, access to the work zone is through the gloves/gauntlets set into a removable panel
Converted to Class I BSC by removing the panel and closing the air inlets on both sides
Easy to clean inside and out; easy to maintain
Class I BSC Mode
Cabinet can be converted to a Class I BSC Mode by simply removing the front glove port attachment panel. Ambient air is pulled inside the work zone and is exhausted out of the cabinet by passing through a HEPA (H14) filter prior to exhaust.
Class III BSC Mode
Ambient air is pulled through the inlet pre-filter and HEPA (H14) filter located at the both sides of the cabinet. The HEPA (H14) filter provides particle-free ISO Class 5 air cleanliness as per ISO 14644-1. Air from both the pass-through chamber and main chamber is pulled to the top portion through a HEPA (H14) filter and is 100% exhausted out of the cabinet through a dedicated ducting system.
GENERAL SPECIFICATIONS Containment Barrier Isolator - Hybrid |
CBI-H-2G |
CBI-H-3G |
CBI-H-4G |
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Main Chamber Nominal Size (Width) |
1.2 meter (4’) |
1.6 meter (5.2’) |
2.0 m (6.6’) |
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Working Chamber Dimensions - Min (W x D x H) |
1.20 m x 0.55 m x 0.77 m (3.9’ x 1.8’ x 2.5’) |
1.60 m x 0.55 m x 0.77 m (5.2’ x 1.8’ x 2.5’) |
2.0 m x 0.55 m x 0.77 m (6.6’ x 1.8’ x 2.5’) |
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Working Chamber Dimensions - Max (W x D x H) |
1.20 m x 0.63 m x 0.84 m (3.9’ x 2.1’ x 2.8’) |
1.60 m x 0.63 m x 0.84 m (5.2’ x 2.1’ x 2.8’) |
2.0 m x 0.63 m x 0.84 m (6.6’ x 2.1’ x 2.8’) |
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External Dimension |
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 3.9’ 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 3.9’ x 9.4’) |
2.62 m x 0.92 m x 2.85 m (8.6’ x 3.0’ x 9.4’) |
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External Dimension of Pass-through Chamber (W x D x H) |
0.62 x 0.66 x 0.58 m |
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Glove Port Height (Min) |
1200 mm |
1200 mm |
1200 mm |
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Glove Port Height (Max) |
1500 mm |
1500 mm |
1500 mm |
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Chamber Environment |
ISO Class 5 all chambers (Grade A) |
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Airflow |
Class III |
Turbulent |
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Class I |
Unidirectional (Positive) |
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Pre-filter |
Process Chamber |
G4, polyester media |
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Pass-through Chamber |
G4, polyester media |
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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% MPPS |
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Filter Type - Chamber Exhaust - 1st Stage |
HEPA (H14) Filter with Integral Mesh Guard and Gasket Seal |
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Filter Type - Chamber Exhaust - 2nd Stage |
HEPA (H14) Filter with Integral Mesh Guard and Gasket Seal or Carbon Filter |
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Filter Efficiency - Chamber Exhaust - 1st Stage |
99.995% MPPS |
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Filter Efficiency - Chamber Exhaust - 2nd Stage |
99.995% MPPS |
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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, 50/60 Hz, 1Ø |
CBI-H-2G8 |
CBI-H-3G8 |
CBI-H-4G8 |
(by Client) |
110-120 VAC, 50/60 Hz, 1Ø |
CBI-H-2G9 |
CBI-H-3G9 |
CBI-H-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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Net Weight |
TBD |
TBD |
TBD |
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Shipping Weight |
TBD |
TBD |
TBD |
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Shipping Dimension (W x D x H) |
TBD |
TBD |
TBD |
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Shipping Volume (Maximum) |
TBD |
TBD |
TBD |
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) | ✔ |