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.

Key Benefits

• 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.

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

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