Product Description
FOD ovens, such as autoclaves, operate in batch mode and are ideal for sterilising production lines where variations in products, batch sizes and formats make continuous sterilisation systems, such as tunnels, impractical. Their key advantage is the ability to maintain strict particle contamination control throughout the sterilisation process.
Fedegari ensures particulate levels remain within the required ISO classification limits in accordance with ISO 14644-1, even during critical heating and cooling phases when filter expansion can release particles, supported by advanced fluid dynamic design and high-temperature filtration systems developed in collaboration with Camfil.
• Controlled particle contamination levels during sterilisation cycles
• High temperature uniformity and repeatable process performance
• Use of Fedegari standard components simplifies maintenance and training
• Thema4 process controller, pre-validated according to GAMP5
• Sterilising chamber with sealed welding in 304 stainless steel (optional 316L), 1.5 mm thickness
• Single-leaf flush doors on both sides with stainless steel internal surfaces
• Thermal insulation compliant with Euroclass A1 (EN 13501-1) for safe operation up to 250°C
• AISI 321 stainless steel electric heating elements mounted on sliding frame for easy maintenance
• Heating elements protected by Incoloy 800 tubes for high-temperature corrosion resistance
• High-temperature centrifugal fans with sealed bearings for air circulation
• Cooling system with 304 stainless steel heat exchanger
• Continuous chamber pressurisation control for depyrogenation processes
• Four HEPA filters providing continuous air filtration in the sterilisation chamber
• Five PT100 RTD temperature probes for process monitoring
• Safety thermometer preventing door opening above set temperature
• Stainless steel validation port for temperature probe placement
• Machinery Directive 2006/42/EC
• EMC Directive 2014/30/EU
• Low Voltage Directive 2014/35/EU
- EN ISO 12100, EN ISO 13857, EN ISO 13849-1, EN IEC 60204-1, EN IEC 61326-1, EN 61010-1, EN 61010-2-040, EN 13445-3, EN 4126-1.
FOD – Dry-Heat Steriliser
Engineered for dry-heat sterilisation and depyrogenation in biopharmaceutical manufacturing.