Intended for multi-purpose sterilization in bio-pharma industries. From solids and porous to liquids in open or non-hermetically sealed containers. Fedegari’s saturated steam sterilizer is suitable for tyndallization, pastorization and inactivation.

• 316Ti (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 mechanically polished and complies with rigorous pharmaceutical standards, with a roughness Ra <0.4 μm.
• One or two doors in automatic sliding version (vertical or horizontal movement) or semi-automatic hinged version.
• 4 RTD PT100 temperature probes per chamber to monitor chamber and product temperature.
• Fedegari exclusive patented door gaskets that assure 100% tightness. These gaskets are FDA compliant and optionally also USP Class VI compliant.

Benefits:

• Innovation: control through pressure (less than 0.5 °C variation).
• Total control: 4 RTD PT100 temperature probes per chamber, up to 200 alarms and monitoring messages.
• Easy validation & integration: pre-validated Thema4 process controller standardized.
• Complete flexibility: custom designed chambers are easily provided.
• Cost-effectiveness: smart maintenance and process optimization.

• European directives: 2014/30/EU – Electromagnetic compatibility (EMC), 2014/35/EU – Low tension equipment (LVD), 2006/95/EC – Safety of machinery (MD)
• European standards: EN ISO 12100, EN ISO 13857, EN ISO 13849-1, EN IEC 60204-1, EN 61326-1, EN 61010-1, EN 61010-2-040, EN 4126-1, EN 12953-9
• USA electrical standards: NFPA 70 – National electrical code, UL 61010-1 – Safety requirement for electrical equipmentfor measurement, control and laboratory use – Part 1: general requirements
• Pressure vessel and electrical steam generator compliant to: 2014/68/EU – Pressure equipment directive (PED)