Product Description
The Fedegari FOF series are saturated steam sterilisers designed for flexible, multi-purpose sterilisation in bio-pharmaceutical manufacturing. Suitable for a wide range of loads, the system supports sterilisation of solids, porous materials, filters, tools, machine parts and liquids in open or non-hermetically sealed containers, as well as wrapped instruments, garments and glassware.
FOF sterilisers can also be used for tyndallization, pasteurisation and inactivation processes, providing adaptable sterilisation solutions for different production requirements.
• Precise process control with temperature variation below 0.5°C
• Continuous monitoring with multiple temperature probes and alarm management
• Thema4 process controller, pre-validated for simplified validation and integration
• Flexible chamber design tailored to specific process requirements
• Reduced maintenance through optimised system design
• 316Ti stainless steel chamber (316L optional) with circular or square configuration depending on process requirements
• Chamber volumes from 200 to 6,800 litres with fully customisable loading capacity
• Mechanically polished chamber surface meeting pharmaceutical standards (Ra < 0.4 μm)
• Single or double door configurations with automatic sliding or semi-automatic hinged doors
• Four PT100 RTD temperature probes per chamber for product and chamber temperature monitoring
• Fedegari patented door gasket system ensuring complete chamber tightness (FDA compliant, optional USP Class VI)
• EU Directives: 2014/30/EU (EMC), 2014/35/EU (Low Voltage), 2006/95/EC (Machinery Safety)
• Pressure Equipment Directive 2014/68/EU (PED)
• EN 285
• GMP and GAMP5 guidelines
• 21 CFR Parts 210, 211 and 11
• UL 508A, UL 61010-1
• NFPA 70 and NFPA-79
• ATEX 94/4/EC
• ASME BPE
• DIN 58951-2
FOF – Saturated Steam Steriliser
Multi-purpose sterilisation solution for biopharmaceutical applications, suitable for a wide range of load types and processes.