Product Description
Fedegari FCDV low temperature bio-decontamination units are designed to sterilise heat-sensitive materials that cannot be treated using conventional thermal sterilisation methods. Using vaporised hydrogen peroxide (H₂O₂), the system provides rapid and reliable surface bio-decontamination of instruments, materials and components before entry into controlled cleanroom environments.
Vaporised hydrogen peroxide is widely recognised as an effective sporicidal, antibacterial, antimycotic and antiviral agent, making it a trusted solution for pharmaceutical contamination control. Developed using a Quality-by-Design approach, the system aligns with evolving regulatory expectations from EMA and FDA for managing bioburden risks beyond traditional heat sterilisation methods.
• Rapid surface bio-decontamination cycles completed in approximately 30 minutes
• High process reliability through Fedegari-designed FHPV vaporisation system
• Flexible operation as a bio-decontamination unit or cleanroom pass-through hatch
• Simplified validation and integration through Thema4 process controller
• AISI 316L stainless steel chamber with sanitary finish (Ra < 0.4 μm)
• AISI 316L stainless steel doors with central glass viewing panel
• Dual inflatable door gaskets with integrated leak monitoring for complete airtightness
• Direct monitoring and control of hydrogen peroxide concentration in the chamber
• Integrated Fedegari hydrogen peroxide vaporiser with PID-based control loop
• Pass-through configuration with synchronised doors and pressure control capability
• EU Directives: 2014/30/EU (EMC), 2014/35/EU (Low Voltage), 2006/95/EC (Machinery Safety)
• European Standards: EN 55011, EN IEC 61000-4-2, EN IEC 61000-4-4, EN IEC 60204-1
• FDA compliant materials for non-metallic components in contact with process fluids
• GMP and GAMP5 guidelines
• 21 CFR Parts 210, 211 and 11
• UL 508A
• NFPA-79
• ASME BPE
FCDV – Bio-Decontamination Unit
The Fedegari FCDV Bio-Containment Unit is a low-temperature bio-decontamination system.