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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.
DESIGN & TECHNICAL FEATURES
- 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.
KEY BENEFITS
- 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.
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 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
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 the pharmaceutical industry, is installed on all Fedegari machines. It is able to integrate natively with SCADA and MES systems in use by the customer.
