Fedegari FOD ovens, are the ideal solution for the batch depyrogenation of production lines which do not allow the use of continuous sterilisers such as tunnels. FOD oven's main advantage lies on its particle contamination class assurance.
As is required by Federal standard 209E the Fedegari system is one of very few batch ovens able to guarantee repeatable Class 100 conditions throughout the complete cycle
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.
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.
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
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