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
- AISI 316Ti (AISI 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 electropolished and complies with rigorous pharmaceutical standards, with a roughness Ra <0,4 μm.
- Can have one or two doors with vertical or hinged opening systems to cope with available space in the smartest possible way.
- 4 RTD PT100 temperature probes per chamber to monitor chamber and product temperature.
- 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.
- ISO Standard: 9001:2015, 13485:2016
- European directives: 2014/68/EU – Pressure Equipment Device (PED), 2006/42/EC – Safety of machinery, 2014/30/EU – Electromagnetic compatibility, 2014/35/EU – Low-voltage device, 2007/47/EC – Medical device
- European standard: EN ISO 12100, EN ISO 13857, EN ISO 13849-1 EN 55001, EN 61000-4-2, EN 61000-4-4, EN 61000-6-2, EN 61000-6-4, EN 60204-1
- ASME: Stamp R, Stamp S, Stamp U
- Chinese standard: SELO
- Swiss standard: SR 930.114