BioPass™ Pass Through

BioPass™ Pass Through is floor standing airtight transfer chamber with onboard ventilation and integrated atomized or vaporized hydrogen peroxide (AHP/VHP, H₂O₂) based bio-decontamination system designed for passing large equipment into a ISO Class 5 cleanroom in an aseptic manner.

BioPass™ Pass Through provides a flush threshold enclosure to allow materials to be wheeled into the enclosure with minimum effort. Full stainless steel assembly in compliance with cGMP's design requirements.

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Industries Served:

Hospital
Food, Beverages & Confectionary
Manufacturing Facilities
Veterinary Surgeries

Dentist
Primary Healthcare Facilities
Pharmaceutical Industry

Features

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 0.8 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 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:

Touch screen HMI/PLC: Enables intuitive operation and cycle monitoring with password protection and data logging
Selection from ticket roll printer or PDF file via HMI for biodecontamination cycle

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.

GENERAL SPECIFICATIONS (AHP Cycle)
Air Injection Pressure	4 bar ± 10%
Air Injection Flow Rate	32 lpm ± 10%
Injection Time	30 sec – 20 mins
Dwell Time	15 – 45 mins
Aeration Time	20 – 90 mins
Total Decontamination	30 mins – 2 hrs
Sterilant Used in One Cycle	10 – 150 mL
Sterilant Injection Flow Rate	200 – 1000 µL/sec
Sterilant	30% Hydrogen Peroxide

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.

Principle

Airflow Pattern

During operation, room air is drawn through the top of the unit via HEPA H14 knife edge gel sealed filter with ≥ 99.995% efficiency in the primary side resulting in a unidirectional stream of clean air projected vertically over the internal work zone. All airborne contaminants are flushed and diluted, resulting in a particulate-free mobile work environment.
During bio-decontamination process, the air will run through via HEPA H14 knife edge gel sealed filter with single-pass flow to remove hydrogen peroxide concentration inside the chamber during aeration stage.
A nominal filter face velocity (client scope) of 0.45 m/s (90 fpm) ensures that there are a sufficient number of air changes within the enclosed area of the laminar flow unit in order to maintain cleanliness.
HMI system monitors the airflow and other critical parameters such as chamber pressure, H₂O₂ concentration, temperature and relative humidity and provides alarms related to the critical parameters that out of the tolerance limit.

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.

Models

STANDARD INTERNAL DIMENSIONS
W x D x H (mm)	700 x 700 x 700 mm	800 x 800 x 800 mm	900 x 900 x 900 mm	1000 x 1000 x 1000 mm	1200 x 1200 x 1200 mm
W x D x H (in)	27.6” x 27.6” x 27.6”	31.5” x 31.5” x 31.5”	35.5”x 35.5” x 35.5”	39.4” x 39.4” x 39.4”	47.3” x 47.3” x 47.3”
W x D x H (ft)	2.30’ x 2.30’ x 2.30'	2.63' x 2.63' x 2.63'	2.96' x 2.96' x 2.96'	3.3' x 3.3' x 3.3'	3.94' x 3.94' x 3.94'

GENERAL SPECIFICATIONS
Air Classification		ISO Class 5 as per ISO-14644-1 (Grade A as per EU GMP)
Aiflow Pattern	During normal operation	Single Pass
	During biodecontamination	· Recirculatory (During gassing and dwelling) · Single Pass (During aeration)
Operating Pressure		+50Pa with respect to ambient environment
Leak Tightness		The acceptable leakage rate of the chamber will be no greater than 10^-2/h, Refer to ISO 10648-2, Class 3 Containment Enclosure.
Lighting		≥600
Noise Level		≤75 dBA
Temperature		Monitored (not controlled)
Humidity		Monitored (not controlled)
Filtration Elements	Pre-Filter	G4
	Supply Filter	HEPA (H14) filter with typical efficiency of ≥ 99.995% at MPPS
	Exhaust Filter
Biodecontamination		BioVap™ (Hydrogen peroxide-based) capable of achieving a minimum of log 6 reduction in spore forming micro-organisms validated using a BI challenge validation