Bio-decontamination unit for heat-sensitive loads
Handling and bio-decontaminating heat-sensitive materials in bio-pharmaceutical environments pose significant challenges. Traditional thermal methods are not suitable for all materials, necessitating advanced surface decontamination technologies to ensure sterility without compromising the integrity of the materials.
Achieve rapid, reliable bio-decontamination
The FCDV bio-decontamination unit by Fedegari is engineered for low-temperature bio-decontamination using vaporized hydrogen peroxide (H2O2). It is designed to decontaminate heat-sensitive products and instruments that cannot be thermally sterilized. Featuring a stainless steel AISI 316L chamber with polished surfaces and 100% air-tight doors, the unit ensures surface bio-decontamination is achieved in as little as 30 minutes. The Fedegari hydrogen peroxide vaporizer with a PID-based control loop offers superior reliability and repeatability, facilitating easier validation. Moreover, the unit’s flexibility allows it to operate as a pass-through hatch with synchronized doors and pressure control, enhancing integration and functionality in cleanroom environments. Compliance with multiple regulatory standards, including EMA, FDA, and GMP, ensures adherence to strict bio-pharmaceutical requirements.
Benefits
- Rapid surface bio-decontamination in 30 minutes
- High reliability with PID-controlled hydrogen peroxide vaporizer
- Flexibility as a pass-through hatch with pressure control
- Easy validation through Thema4 process controller
- Compliance with stringent bio-pharmaceutical standards (EMA, FDA, GMP)