Operator Protection
Product Protection
Environmental Protection
Clean Air
BioPass™ Pass Through
BioPass™ Pass Through, a floor standing airtight transfer chamber, is an all-in-one automated hydrogen peroxide (H2O2) based biodecontamination solution functioning as a pass through cabinet to facilitate in the transfer of materials or specimen in and out of controlled environments such as cleanrooms or biosafety laboratories.
This is equipped with onboard ventilation, and built-in/ integrated Esco BioVap™ biodecontamination system with automated pressure testing capabilities.
Unlike ordinary pass through boxes or cabinets intended only for small material transfers, the BioPass™ Pass Through allows passing of large equipment into an ISO Class 5 cleanroom in an aseptic manner.
BioPass™ Pass Through cabinet is designed in compliance with cGMP requirements, and is constructed as a full 316L stainless steel pass through; therefore, making it suitable for extensive laboratory and/or cleanroom applications.
Industries Served:
- Hospital
- Food, Beverages & Confectionary
- Manufacturing Facilities
- Veterinary Surgeries
- Dentist
- Primary Healthcare Facilities
- Pharmaceutical Industry
Easy-to-clean construction
The interior and cleanroom side face of the pass through cabinet/ chamber is made of 316 L stainless steel with a smooth interior and coved corners to ensure easy cleaning and biodecontamination
- The interior surface is polished to 0.6 Ra μm or better and external surfaces exposed to cleanrooms 1.2 Ra μm or better
- The cleanroom wall interface allows a flush finish with the surface for cleanliness
Interlocked inflatable seal doors
Pass through chamber doors are constructed with FDA-approved silicone inflatable seal. This removes the need for external mechanical latch and ensures maximal airtight containment, and high leakage resistance.
- Doors shall give > 90° opening for full access
- Interlocking doors preventing cross-contamination by not allowing sterile unloading doors from opening until after biodecontamination
Chamber pressure monitoring
Direct reading pressure gauges are provided to both sides of the pass through cabinet to give indication of the chamber pressure
H2O2 biodecontamination system
Integrated with Esco BioVap™ biodecontamination system with:
- PLC control
- HMI operator interface
- Ticket roll printer for biodecontamination cycle result
Safe exhaust of air
Optional on-board catalytic converter to allow air to be taken from the room, then exhausting it back, with interlocked safety exhaust H2O2 sensor. This avoids costly HVAC ducting.
Clean Air, Purging and Biodecontamination Capabilities
BioPass™ Pass Through cabinet provides a flush threshold enclosure to allow large materials to be wheeled into the enclosure with minimum effort.
The pass through chamber’s onboard ventilation system ensures all materials passing through are purged off of contaminants, and together with its biodecontamination system, aseptic process in an ISO Class 5 cleanroom is guaranteed.
Standard Internal Dimensions
|
W x D x H (meters) |
1.2 m x 0.9 m x 1.2 m |
0.9 m x 1.6 m x 1.5 m |
1.6 m x 1.6 m x 2 .5 m |
2 m x 2 m x 2.7 m |
2 m x 3 m x 2.7 m |
3 m x 4 m x 2.7 m |
|
W x D x H (inches) |
48 in x 35 in x 47 in |
35 in x 66 in x 59 in |
63 in x 63 in x 98 in |
79 in x 79 in x 107 in |
79 in x 119 in x 107 in |
119 in x 158 in x 107 in |
|
W x D x H (feet) |
4 ft x 3 ft x 3 ft 11 in |
2 ft 11.4 in x 5 ft 6 in x 4 ft 11 in |
5 ft 3 in x 5 ft 3 in x 8 ft 2 in |
6 ft 7 in x 6 ft 7 in x 8 ft 11 in |
6 ft 7 in x 9 ft 10 in x 8 ft 11 in |
9 ft 10 in x 13 ft 2 in x 8 ft 11 in |
GENERAL SPECIFICATIONS
|
Air Classification: |
ISO Class 5 (EUGMP Grade A) |
|
Airflow Pattern: |
Single Pass uni-directional airflow (not laminar) |
|
Operating Pressure: |
Chamber +50Pa with respect to the grey side area |
|
Leak Tightness |
The acceptable leakage rate of the chamber will be no greater than 0.5% vol/hr, equivalent to a class 3 Isolator |
|
Lighting |
Internal lighting shall be provided giving average 200 lux illumination over the whole area of the chamber when measured at 1 m above the floor level. |
|
Noise Levels: |
Less than 65dBA |
|
Temperature: |
Uncontrolled |
|
Humidity: |
Uncontrolled |
|
Inlet Filtration: |
HEPA H14 Filtration |
|
Exhaust Filtration: |
HEPA H14 Filtration |
|
Pre-Filter: |
G4 Pre-filters. |
|
Bio-decontamination: |
A minimum of log 6 reduction in spore forming micro-organisms validated using a BI challenge validation |
Integrated Biodecontamination System
Esco Pharma has developed an effective hydrogen peroxide based Biodecontamination system capable of achieving a log 6 reduction in bio-burden. The spore log reduction has been validated by biological indicator challenge using biological indicator stainless steel ribbons populated with Geobacillus stearothermophilus spores.
H2O2 Monitoring System - (One per Biopass Needed)
H2O2 sensor 0-100ppm to ensure the concentration of hydrogen peroxide inside the chamber to confirm end of aeration.
Remote Catalytic Converter
Allows aeration of the system and operation without the need for site ducting. The system can be exhausted to the room following aeration.
How does BioPass™ Pass Through differ from other transfer chambers in the market?
With greater than 40 years of experience in the industry, Esco simply provides more comprehensive features that reflect in its withstanding core technologies and innovations that have been tested through time.
BioPass™ Pass Through, one of Esco’s developments under the Cross-Contamination Facility Integrated Barrier product line, caters to large equipment/material transfer needs in order to lessen personnel traffic while ensuring integrity of controlled environments during the transfer process.
One of its main advantages is its all-in-one comprehensive design, made with stainless steel for cGMP compliance, which includes the following:
- Onboard ventilation with HEPA filtered air
- Integrated H2O2 based BioVap™ biodecontamination system
- Catalytic converter for safe exhaust of air out of the chamber to avoid costly HVAC ducting on site
- HMI controller for 21 CFR Part 11 Compliance
How does BioPass™ Pass Through differ from other pass through cabinets offered by Esco?
Esco Pharma offers 4 types of pass through cabinets/ hatches with distinct qualities which differentiate it from one another, namely:
- Static pass boxes
These pass through cabinets and hatches are utilized and installed for aseptic transfer of materials into and out of cleanroom areas.
- Dynamic pass boxes and Dynamic Floor Laminar Hatches (DPB/DFLH)
DPB/DFLH, unlike static ones, are aseptic architectural systems that are maintained with an ISO Class 5 as per ISO 14644-1 (Grade A as per EU GMP) clean air supply within its internal chambers. This is made possible by built-in prefilter, HEPA filter and blower within the DPB/DFLH unit.
Difference between DPB/DFLH is that DPB is wall-mounted and is either provided with/ without a floor stand while DFLH is floor mounted.
- Esco air shower pass boxes (EAS-PB)
EAS-PB is similar to DPB/DFLH such that air is provided to the unit but air is supplied only for a limited duration.
EAS-PB is constructed with built in air showers and is provided with an array of stainless nozzles and high velocity air jets running at 18-30 m/s. Robustly-designed to scrub off potential surface particulate contaminants from materials being transferred between controlled environments.
- BioPass™ Pass Through
BioPassTM Pass Through is similar to dynamic floor laminar hatches such that it is floor mounted and is maintained with an ISO Class 5 as per ISO 14644-1 (Grade A as per EU GMP) clean air supply within.
Distinctly, it is equipped with an integrated biodecontamination system, and is designed to relatively wheel-in large equipment/ materials into the enclosure.
- Static pass boxes
How is BioPass Pass Through cGMP compliant?
cGMP requires surfaces used to be easily cleanable. BioPass™ Pass Through utilizes stainless steel 316L which is easy to clean, non-particulate generating, resistant to API, and less prone to corrosion.
