FCDV – BIO-DECONTAMINATION UNIT

LOW TEMPERATURE BIO DECONTAMINATION UNITS (H2O2).
Applications Bio-pharmaceutical
Loads Heat sensitive
Processes Bio-decontamination
FCDV_prodotto_fedegari

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 chmaber.
  • 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.

KEY BENEFITS

  • 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.

COMPLIANT TO

  • European directives: 2014/30/EU – electromagnetic compatibility (EMC), 2014/35/EU – Low tension equipment (LVD), 2006/95/EC – Safety of machinery (MD)
  • European standards: EN 55011, EN IEC 61000-4-2, EN IEC 61000-4-4, EN IEC 60204-1
  • FDA: compliance for non metallic component in contact with process fluids
  • GMP
  • GAMP5
  • 21 CFR Part 210, 211 e 11
  • UL 508A
  • NFPA-79
  • ASME BPE

 

Optional

  • US electrical norms: NFPA 70 – National electrical code,  UL 61010-1 – Safety requirement for electrical equipment for measurement, control and laboratory use – Part 1: general requirements.

 

Want to know more about our certifications? Please visit the dedicated section or do not hesitate to contact us.

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