FOD – DRY-HEAT STERILIZATION

THE PERFECT SOLUTION FOR DRY-HEAT STERILIZATION AND DEPYROGENATION NEEDS.
Applications Bio-pharmaceutical
Loads Tools, Glassware
Processes Depyrogenation, Sterilization
FOD_prodotto_fedegari

FOD ovens, such as autoclaves, run batch processes and are the ideal solution for the sterilization of all those production lines in which the variability of products, batches and formats do not allow the use of continuous sterilizers such as tunnels. FOD ovens main advantage lies on its particle contamination class assurance.

Fedegari guarantees the contamination level to remain under the established standards values for 100 class. This accuracy is verified also during the most critical phases such as heating and cooling, when the thermal expansion of the filters may release a great amount of particles.

Particulate contamination control originates from complex fluid dynamic studies and a close collaboration with Camfil, the world’s most respected filter manufacturer, with whom Fedegari works at the development of high-temperature filters.

DESIGN & TECHNICAL FEATURES

  • Sterilizing chamber: sealed welding, made of AISI 304 stainless steel 1,5 mm thick.
  • Single-leaf flush door on both sides, internal surface in AISI 304 stainless steel.
  • 100 mm thick rock-wool panels guarantee perfect thermal insulation: average temperature of 40 °C on the external surfaces at operating temperature of 250 °C.
  • Electric heating through AISI 321 stainless steel heating elements, assembled on a sliding frame for easy removal and maintenance.
  • Cooling by AISI 304 stainless steel heat exchanger.
  • Continuous automatic control and regulation of pressurization of the sterilizing chamber.
  • Continuous filtering of air in the sterilizing chamber, thanks to a system composed by 4 HEPA filters.
  • 5 RTD PT100 temperature probes.
  • Safety thermometer on non sterile front to prevent door opening if chamber temperature exceeds set value.
  • Stainless steel port for validation probe positioned on not sterile side.

KEY BENEFITS

  • Process performance particle contamination.
  • Temperature uniformity process repeatability.
  • The use of Fedegari standard components guarantees savings in training and maintenance thanks to standardized procedures.
  • Thema4 process controller pre-validated by Fedegari according to GAMP5.

COMPLIANT TO

  • ISO Standard: 9001:2015, 13485:2016
  • European directives: 2006/42/EC – Safety of machinery, 2014/30/EU – Electromagnetic compatibility, 2014/35/EU – Low-voltage device
  • European standard: EN ISO 12100, EN ISO 13857, EN 55011, EN 61000-4-2, EN 61000-4-4, EN 60204-1
  • 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 thepharmaceutical 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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