Design & Technical Features

• Standard versions from 830 to 14.800 liters with fully customizable loading capacity
• Chamber internal surface electropolished with a roughness Ra <0,4 μm.
• One or two doors with vertical or hinged opening systems
• 5 PT100 RTD probes for temperature control (2 fixed – in the filter and discharge – and 3 flexible for the load).
• Automatic sterilization of the air filter with fixed temperature probe.
• Fedegari exclusive patented door gaskets assure 100% tightness.
• Piping and valves in stainless steel AISI 316L.
• Patented magnetic drives remove any tightness problem deriving from seal wear, and minimizes maintenance, without requiring any lubrication.

Key Benefits

• Flexibility: control of critical process parameters designed to prevent any undesired deformation/damage of the containers, while providing the desired thermal treatment.
• Total control: temperature and pressure control (air + steam) using magnetic fan drives to guarantee a uniform mixture spread.
• Process optimization: load emerges dry and ready for the next process steps.
• Easy validation: Thema4 process controller pre-validated according to GAMP5 and in compliance with 21 CRF Part 11
• Integration: Open system architecture that can be integrated with SCADA system and other Fedegari machines.
• Highest productivity: Fedegari R&D laboratory is available to develop the best treatment solution for your specific needs. We run tests with different loads and requirements.

Compliant to

• 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
• FDA
• GMP

Porous Load autoclaves

Pure water generation systems by Stilmas represent the simplest, safest and most reliable water purification method for the production of ultra-pure water when high bacterial and chemical quality is required

Pure Steam Generators

Pure water generation systems by Stilmas represent the simplest, safest and most reliable water purification method for the production of ultra-pure water when high bacterial and chemical quality is required