With the bio-decontamination unit you can bring inside the clean rooms all those products and instruments that cannot be thermally sterilized. Surface bio-decontamination of the load is carried out with vaporized hydrogen peroxide – H2O2.

Among the most reliable sporicidal agents, vaporized hydrogen peroxide (H2O2) is nowadays one of the most popular: its antibacterial, antimycotic and antiviral properties are well known and scientifically documented.

This solution is becoming increasingly relevant as the regulators shift their focus away from traditional moist- and dry-heat sterilization processes to address all other bioburden risks. This innovative process equipment meets the current approach required by the EMA and FDA.

• Stainless steel AISI 316L chamber, polished to strict sanitary standards (Ra <0.4 μm).
• Doors are made of AISI 316L stainless steel with a central glass panel
• 100% air-tight guaranteed: thanks to two separate inflatable gaskets seating in two slots mechanically machined all around the door with an additional leak-monitoring system.
• Direct control of hydrogen peroxide in the chamber.
• Optimized process: surface bio decontamination is achieved in 30 minutes.
• Fedegari hydrogen peroxide vaporizer with control loop (PID based), which provides superior reliability and repeatability for easier validation.
• Great flexibility: FCDV can be used as a pass-through hatch aired with synchronized doors and pressure control.

• Process optimization: surface bio-decontamination in 30 min.
• Reliability: FHPV hydrogen peroxide vaporizer totally engineered and manufactured by Fedegari.
• Flexibility: the unit can be used as a pass-through hatch aired with synchronized doors and pressure control.
• Easy validation & integration: all processes managed by Thema4 process controller.