Design & Technical Features

• AISI 316Ti (AISI 316L upon request) stainless steel chamber, which can have a circular or square section, according to customer’s or process’ need.
• Chamber range from 200 to 6.800 liters, but loading capacity is fully customizable, according to customer’s need.
• Chamber internal surface is electropolished and complies with rigorous pharmaceutical standards, with a roughness Ra <0,4 μm.
• Can have one or two doors with vertical or hinged opening systems to cope with available space in the smartest possible way.
• 4 RTD PT100 temperature probes per chamber to monitor chamber and product temperature.

Key Benefits

• Process optimization: The process is faster than the air-steam sterilization process. FOW is also an ideal sterilizer for <105 °C processing. Wet loads can be overcome using on automated drying extension with the installation of specific drying solutions downstream of the sterilization chamber.
• Easy validation & integration: Thema4 process controller is pre-validated according to GAMP5 and in compliance with 21 CFR Part 11, thus resulting in shortest qualification time and minimizing project risks. 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