Fedegari BIO-DECONTAMINATION UNIT – FCDV

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 <0.4μm).
  • Doors are made of AISI 316L stainless steel with a central glass panel
  • 100% air-tight guarantee: 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 a 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.

To acquire further information or to request a special quote, please call our office at 800-829-5741.

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