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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 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.
- 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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Thema4
Thema4, developed to meet the most stringent requirements of thepharmaceutical industry, is installed on all Fedegari machines. It is able to integrate natively with SCADA and MES systems in use by the customer.
