STELEC H2O2 BIODECONTAMINATION SYSTEM
- Stainless steel AISI 304 case
- HMI – Color touch screen
- PLC Siemens, Schneider Electrics or Rockwell Automation
- Printer + USB port
- RJ45 socket interface and remote maintenance (in option)
- Self-locking castors
- The volumes to be bio decontaminated can be programmed
- The time of the aeration phase can be programmed
- The volume of H2O2 injected is measured by a flow meter
- The pressure and air flow are controlled and monitored
- The temperature is controlled and monitored
- Built-in dehumidifier (in option)
- Integrated Catalytic Filter for H2O2 abatement (in option)
- H2O2 Sensor for High Concentration
- H2O2 Sensor for operator safety
Bio-decontamination is a validated process used to ensure that the environment of an isolator or any other closed system is viably exempt from micro-organisms, by using an anti-microbial gas.2The product used is hydrogen peroxide solution (H2O2), with a concentration of 35%.Surface bio-decontamination is considered as compliant after a reduction of 6 Log Geobacillus Stearothermophilus ATCC7953/ATCC12980 for H2O2.2), concentrazione 35%. Il processo è conforme a valle di una riduzione pari a 6 Log utilizzando Geobacillus Stearothermophilus ATCC7953/ATCC12980 per H2O2.
There are 4 phases in the bio-decontamination cycle:
- Leak Test Phase
- Conditioning phase by relative humidity control (only with dehumidifier option)
- Vaporization phase
- Aeration phase.
The stage of sterilization or bio-decontamination can be done only once the conditions filled and controlled by the user.
You have to control the electrical power supply, the connections to your equipment in compliance with your procedures, then control the parameters of the generator. Introduce the sterilizing gas, check the bio-decontamination and ventilation parameters and then start the cycle. During the cycle, all events are monitored and can be saved due to various sensors (temperature, flow rate, time) to ensure that the cycle is performed correctly, controlled by a Schneider or Siemens PLC, and the parameters are displayed on a touch screen and can be collected via the USB port or RJ45 socket (as per CFR 21 part 11 with Siemens PLC).
- Cycle name
- RFID control of sterilizing agent bottle container
- Cycle number
- Date and time of start and finish of cycle
Bio-decontamination phase cycle time
- Rinsing phase cycle time
- Volume of sterilizing agent
- Check of the flow rate, pressure, time
- Cycle result: pass or failed.