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.
- 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.
- European directives: 2014/30/EU – Electromagnetic compatibility (EMC), 2014/35/EU – Low tension equipment (LVD), 2006/95/EC – Safety of machinery (MD)
- European standards: EN ISO 12100, EN ISO 13857, EN ISO 13849-1, EN IEC 60204-1, EN 61326-1, EN 61010-1, EN 61010-2-040, EN 4126-1, EN 12953-9
- USA electrical standards: NFPA 70 – National electrical code, UL 61010-1 – Safety requirement for electrical equipmentfor measurement, control and laboratory use – Part 1: general requirements
- Pressure vessel and electrical steam generator compliant to: 2014/68/EU – Pressure equipment directive (PED)
- FDA: compliance for non metallic component in contact with process fluids
- EN 258
- 21 CFR Part 210, 211 e 11
- UL 508A
- ATEX 94/4/EC
- ASME BPE
- DIN 58951-2
- ASME: Stamp R, Stamp S, Stamp U
- Chinese standard: SELO
- Swiss standard: SR 930.114
- Russian standard: CU TR 032
- PD 5000 code specification for unfired, fusion welded pressure vessels
- USP: compliance for non metallic component in contact with process fluids