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FOF – SATURATED STEAM STERILISER

SATURATED STEAM STERILISER – The FOF Range

Applications: Bio-pharmaceutical

Loads: Sealed & unsealed containers, Filters, Machine parts, Tools, Wrapped tools, Garments, Glassware

Processes: Sterilisation


 The FOF Range – Saturated Steam Steriliser

Applications Bio-pharmaceutical
Loads Sealed & unseald containers, Filters, Machine parts, Tools, Wrapped tools, Garments, Glassware
Processes Sterilisation

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.
 

KEY BENEFITS


  • Innovation: control through pressure (less than 0.5 °C variation).
  • Total control: 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


  • 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
  • FDA
  • GMP

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For more information:

Contact us Here

Telephone SteriTech in Ireland: +353 (0) 7191 38920 

Telephone SteriTech in the UK:  +44 (0)1293 824 400