Bio Decontamination Hatch, Also known as VHP Pass Box
The Decontamination hatch allows monitoring material, tools, or bags with stoppers etc. to be transferred quickly between cleanrooms of different classes – C, B or A according to cGMP.
Fast and reliable microbiological surface decontamination is achieved using vaporized hydrogen peroxide (H2O2). The integrated LAF recirculation system guarantees the pressure cascade between the rooms and sterility is ensured also after the gassing process.
All safety-relevant functions are constantly monitored electronically.
Structures of the VHP Pass Box
Operating System:
Dedicated electronics with an operating panel for the control of the pass box, in laminar flow functioning mode and in sterilization, the software is comprised of the following functions.
Traceability
As the most important requirement of traceability, a paperless recorder is used to record real time parameters, store parameters and export data and other working conditions.
Important parameters are monitored and may be recorded: they can be either directly sent to a printer (option) or stored on a remote PC (Option).
Leak Test:
The chamber performs a separate fully automatic leak test prior to the decontamination cycle.
Automatic leak testing procedure fir the bio-decontamization airlock and for the whole work area.
At the beginning of each working routine the following steps will be automatically gone through.
According to ISO-14644-7 and ISO-10682-2 regulation, leakages testes are determined according to the requirements. Automatic leak test is carried out through PLC system, and clear results are obtained. If the technical requirements of leakage rate don’t meet the requirements, the subsequent transmission chamber cannot be sterilized.
Shut-off valves will be provided to permit leak testing by the pressure decay. These valves will be fitted ahead of the inlet HEPA filters and after the exhaust HEPA filters.
Inflatable Seal System:
The open windows and doors are sealed by an inflatable seal, and the windows and doors are made of silicone rubber, which is certified by the pharmaceutical industry.
When inflating, set pressure relief valve and pressure gauge to avoid the clean compressed air overcharging, when the pressure is insufficient, the alarm is carried out through the pressure gauge.
When running, design the safety valve, keep the constant pressure of the inflatable seal ring, the seal pressure will be monitored at all times, and the alarm system is equipped. The mechanical parts that protect the window seal are also used to ensure the safety of the failure.
Door of Chamber
The door opening of the transmission and operation chamber is controlled. The operation log must be formed through the PLC system in order to open the door.
When the door is opened or locked, transfer will not be able to enter the cabin run or, conversely, the same disinfection mode, when the transfer tank circulation disinfection, also cannot open the door.
The inner and outer doors of the Transfer hatch will be interlocked, so that only one door (of the door) can be open at any time.
Vaporized Hydrogen Peroxide Gas Generator
The Hydrogen peroxide generator is integrated with the chamber, vapors distribution and control system to provide automatic sporicidal gassing for the mode selected. It has the ability to use a number of different common bottle types, with the potential to execute dozens of cycles without the need for replenishment.
The generator will be provide with the hydrogen peroxide sensor to measure the peak vapors concentration during the disinfection cycle. Â
The VHP Sterilization cycle involves 4 Phases.
The above steps are performed automatically through the transmission of the cabin PLC system without human interface.
Filters:
To comply with the requirement of the air quality inside the work chamber, High Efficiency Particulate Air Filter (HEPA) H14 are used. These filters act as a particle barrier between the chamber and the surrounding room. The air in the work chamber is double filtered.
The relative environment of the transfer chamber is a positive pressure system, and the air distribution is laminar flow. Fresh air is collected from the high level area (B level) or HVAC system and the unidirectional laminar flow is formed through HEPA (H14).
The retention rate of H14 HEPA Filter is according ISO14644: retention rate>99.995% at 0.3 μm, The filter integrity test is done in compliance with ISO14644.
After the sterilization is completed, the automatic residue process is performed through the HMI, the MnO2 Filter can effectively degrade the hydrogen peroxide and discharge the cavity.
Shelves:
The Shelves are made of stainless steel AISI 316L and are used for an efficient loading of the basic chamber. They are installed at the back of the wall of the chamber. A shelve consists of 3 load surfaces. The Distance between the shelves are variable according to use.
Illumination:
A fluorescent tube illuminates the work chamber and is placed on the outside of the front door and can be replaced during production. The color of the tube is day light white.
Hydrogen Peroxide Sensor:
Hydrogen peroxide sensor, High concentration (max 1000ppm)
This option consists of a probe for H2o2 concentration measurement is the work chamber.
The sensor is placed inside the circulation air suction.
Contact Brinda Pharma India today to learn more about our high-quality Bio Decontamination Hatches (VHP pass box) and how they can help you achieve safe and efficient cleanroom operations. Don’t compromise on quality, trust the leading manufacturer in India for your bio decontamination needs.
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