EN ISO 12100, EN ISO 13857, EN ISO 13849-1, EN 60204-1, EN 55011, EN IEC 61000-4-2, EN IEC 61000-4-4
Product Description
The Fedegari FOW series are superheated water sterilizers designed for counterpressure sterilisation of liquids in sealed containers, including large volume parenterals (LVPs), blood bags, syringes and packaged liquid products. Using a superheated water spray system, FOW sterilizers ensure controlled heat transfer while balancing internal container pressure to prevent deformation during sterilisation.
Designed in accordance with cGMP and FDA requirements for LVP processing, the system supports reliable sterilisation of heat-sensitive products and packaged liquids. Optional load rotation can be applied during sterilisation to improve heat transfer and prevent product separation where required.
Key Benefits
• Counterpressure sterilisation protecting container integrity during processing
• Faster cycle times compared with traditional air-steam sterilisation processes
• Suitable for low-temperature processing (<105°C)
• Optional load rotation for improved heat transfer and product stability
• Simplified validation and system integration through the Thema4 process controller (GAMP5 aligned, 21 CFR Part 11 compliant)
Design Features
316Ti stainless steel chamber (316L optional) with pharmaceutical-grade finish (Ra < 0.4 μm)
• Chamber volumes from 830 to 14,800 litres, with fully customisable loading capacity
• Single or double door configurations with vertical sliding or hinged opening systems
• Five PT100 RTD probes for chamber and load temperature monitoring
• Automatic sterilisation of the air filter with dedicated temperature probe
• Two validation ports for probe placement during qualification
• Fedegari patented door gasket system ensuring complete chamber tightness (FDA compliant, optional USP Class VI)
• Sanitary piping and valves in 316L stainless steel
Compliance
- 2006/42/CE Safety of machinery,
- 2014/30/UE Electromagnetic compatibility (EMC),
- 2014/35/UE Low tension equipment (LVD),
- FDA: compliance for non-metallic component in contact with process fluids
- GMP
- GAMP5
- 21 CFR Part 210, 211 e 11
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FOW – Superheated Water Steriliser
Designed for counterpressure sterilisation of large-volume parenteral and other sealed containers.