FOF – SATURATED STEAM STERILIZER

THE MOST FLEXIBLE SOLUTION.
Applications Bio-pharmaceutical
Loads Sealed & unseald containers, Filters, Machine parts, Tools, Wrapped tools, Garments, Glassware
Processes Sterilization
FOF_prodotto_fedegari

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: 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

  • 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

 

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.
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