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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 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.
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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