Fedegari horizontal high pressure steam sterilizer FOB5-TS (400 liters) in Autoclaves

Fedegari FOB5-TS series horizontal high pressure steam sterilizers

Design and Technical Features:

• Chamber volume: 650 liters (FOB5-TS) - 670 liters (FOB5S-TS) - 837 liters (FOB5/L-TS) - 830 liters (FOBS5/L-TS)
• Free standing single or recessed with double doors for pass-through application
• Vertically automatic sliding doors effortless pneumatically operated
• Built-in, external or combined steam source
• Massive, long-lived pressure vessels PED certified, exclusive pneumatic valves and hydraulic components made of high corrosion resistant AISI 316 L stainless steel, sanitary grade
• Internal high-efficiency jacket by 316 L stainless steel plate heat exchanger for steam preheating/drying
• Unique door closing system with patented pneumatic gasket seal for perfect airtight, safety and maximum reliability
• Ergonomic loading height
• Special execution with single or double stainless steel sealing flange (BIOSEAL) for laboratory risk category L3 and L4 and operating theater
• Operation of the unit from both ends by operator panel and display fitted on loading and unloading sides
• Operation of the unit from both ends
• DCS PLUS 10 process controller with large touch-screen color video-graphic display
• Fully programmability: 30 standard sterilization programs easy to customize in a multi-user environment
• Operating software fully validated and documented to conform with the rigorous pharma standards for reproducibile processes
• GLP compliant

Advantages and Key Benefits:

• Superior quality of materials with first class finishing and components all rigorously tested at Fedegari's, for long term reliability and process safety
• High-tech chamber and door system construction
• Improved performances thanks to more efficient and faster processing
• Short batch time and optimum drying
• Ergonomic positioning of adjustable
• Wide variety of transport and loading trolleys, internal racks, shelves, trays and containers, customized solutions for individual needs
• Full and easy accessibility to technical area from the front and lateral side for service and regular maintenance
• High level of programming and application flexibility with fully configurable cycles
• Multilevel password management for authorized access only
• Special stadndard test programs (i.e. Bowie Dick, vacuum, pressure leak test, heating programs, etc.) for routine check of sterilizer efficiency
• GMP / GLP compatible data management offering full traceability and documentation, meeting the most stringent worldwide safety and quality standards

Optional Kits and Accessories:

• Integrated 316 L stainless steel electric steam generator fully automatic with independent operation and control
• Pre- and post-vacuum processes, single or fractionated with high-output water-ring vacuum pump
• Exclusive high-efficiency fast cooling module for liquid programs with magnetic propeller type fans
• Decontamination cycle for high-risk pathogenic wastes
• Sterilization program with complete cycle by steam/air mixture in counterpressure for delicate treatment of small batches as blister packs, contact lenses, carpules, syringes, solutions in glass/plastic bottles or bags (PVC, PP, PE), etc
• Effluent discharge air filtration kit for wastes treatment with automatic filter sterilization
• Automatic in-line air filter sterilization program
• Air detector and steam quality kit in compliance with CFPP01-01
• Automatic program for pharmacopea cycle on hydrolytic resistance of glass containers
• DCS LINK for remote data archiving on a PC over the 21 CFR Part 11 protocol
• DCS LOGGER for managing data according to the 21 CFR Part 11 protocol
• MDD certification possible using optional kit conforming to EU medical directives