Product Description
The Fedegari FOA steam–air sterilizer is designed for the counterpressure sterilisation of aqueous solutions in sealed containers, including large volume parenterals (LVPs), vials, pre-filled syringes (PFS), blood bags and other packaged liquids. By controlling both temperature and chamber pressure (steam + air), the system prevents deformation of sealed containers while delivering reliable thermal sterilisation.
Uniform heat distribution is achieved through a flow deflector and magnetic drive mixing system, while the process is optimised so loads exit dry and ready for downstream processing. Sterilisation cycles are managed through the Fedegari Thema4 process controller, which is GAMP5 aligned and compliant with 21 CFR Part 11, enabling straightforward validation and integration with facility SCADA systems.
• Chamber volumes from 830 to 14,800 litres, with customisable loading capacity
• Pharmaceutical-grade chamber finish (Ra < 0.4 μm)
• Single or double door configurations with automatic sliding or hinged doors
• Five PT100 RTD probes for chamber and load temperature monitoring
• Automatic sterilisation of air filters
• Patented Fedegari door gaskets ensuring full chamber tightness
• Stainless steel piping and valves in 316L
• Magnetic drive mixing system reducing seal wear and maintenance
• EU Directives: 2014/30/EU (EMC), 2014/35/EU (Low Voltage), 2014/68/EU (Pressure Equipment Directive – PED)
• European Standards including EN ISO 12100, EN ISO 13849-1 and EN IEC 60204-1
• EN 285
• 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, UL 61010-1
• NFPA 70 (National Electrical Code) and NFPA-79
• ATEX 94/4/EC
• ASME BPE
• DIN 58951-2
FOA – Steam Air Steriliser
Precise counterpressure sterilisation for aqueous solutions in sealed containers such as LVPs, vials, pre-filled syringes, and blister packs.