Decontamination station for the pharmaceutical industry FCDV

for clean roomshydrogen peroxide

With the FCDV 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. Moreover, Fedegari has applied the Quality-by-design concept to the development of this innovative process equipment, in order to meet the current approach required by the EMA and FDA. DESIGN & TECHNICAL FEATURES Stainless steel AISI 316L chamber, polished to strict sanitary standards (Ra <0.4 μm). Doors are are made of AISI 316L stainless steel with a central glass panel 100% air-tight guaranteeed: 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.