Fedegari Autoclavi SpA
Fedegari - Model FOF -Saturated Steam Sterilizers
FOF series is the synthesis of Fedegari’s approach: work hard to create simplicity to you, without compromising performance. Fedegari guarantees the highest performances thanks to its experience and daily work with customers: engineering solutions, developing software and components. FOF series is the most flexible solution for multi-purpose sterilization in bio-pharma industries. From solids and porous to liquids in open or non-hermetically sealed containers. FOF saturated steam sterilizer is suitable for tyndallization, pastorization and inactivation.
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Pt100 temperature probe
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NFPA standard
- 316Ti (316L upon request) stainless steel chamber, which can have a circular or square section, according to customer’s or process’ need.
- Chamber range from 200 to 6.800 liters, but loading capacity is fully customizable, according to customer’s need.
- Chamber internal surface is mechanically polished and complies with rigorous pharmaceutical standards, with a roughness Ra <0,4 μm.
- One or two doors in automatic sliding version (vertical or horizontal movement) or semi-automatic hinged version.
- 4 RTD PT100 temperature probes per chamber to monitor chamber and product temperature.
- Fedegari exclusive patented door gaskets that assure 100% tightness. These gaskets are FDA compliant and optionally also USP Class VI compliant.
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- Innovation: control through pressure (less than 0.5 °C variation).
- Total control: 4 RTD PT100 temperature probes per chamber, up to 200 alarms and monitoring messages.
- Easy validation & integration: pre-validated Thema4 process controller standardized.
- Complete flexibility: custom designed chambers are easily provided.
- Cost-effectiveness: smart maintenance and process optimization.
- 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 ISO 12100, EN ISO 13857, EN ISO 13849-1, EN IEC 60204-1, EN 61326-1, EN 61010-1, EN 61010-2-040, EN 4126-1, EN 12953-9
- USA electrical standards: NFPA 70 – National electrical code, UL 61010-1 – Safety requirement for electrical equipmentfor measurement, control and laboratory use – Part 1: general requirements
- Pressure vessel and electrical steam generator compliant to: 2014/68/EU – Pressure equipment directive (PED)
- FDA: compliance for non metallic component in contact with process fluids
- EN 285
- GMP
- GAMP5
- 21 CFR Part 210, 211 e 11
- UL 508A
- NFPA-79
- ATEX 94/4/EC
- ASME BPE
- DIN 58951-2
Optional
- ASME: Stamp R, Stamp S, Stamp U
- Chinese standard: SELO
- Swiss standard: SR 930.114
- Russian standard: CU TR 032
- PD 5000 code specification for unfired, fusion welded pressure vessels
- USP: compliance for non metallic component in contact with process fluids