COUNTERPRESSURE STERILIZATION THROUGH SUPERHEATED WATER
FOW Superheated Water sterilizers are able to perform counterpressure sterilization of large volume parenteral solutions through a superheated water spray system.
In compliance with cGMP and FDA standards for LVP products, FOW autoclaves are suitable for treating loads in containers that may be deformed due to the difference in pressure between the chamber and the container itself.
Where the product is liable to separation or for accelerating thermal transition phases, the whole load can be rotated during the entire sterilization process.
- 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.
- FOW superheated water sterilizer is equipped with 316Ti – 1.4571 (316L – 1.4404 upon request) stainless steel chamber.
- Besides the standard versions from 830 to 14.800 liters, loading capacity is fully customizable according to customer needs.
- Chamber internal surface mechanically polished with a roughness Ra <0,4 μm.
- One or two doors with vertical or hinged opening systems to cope with available space in the smartest possible way.
- 5 RTD PT100 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 RTD PT100 temperature probe.
- 2 validation ports.
- Fedegari exclusive patented door gaskets assure 100% tightness, compliant to FDA and USP Class VI.
- Piping and valves in 316L – 1.4435 and 316L – 1.4404 stainless steel.
- Sterilization of parenteral solutions, liquids in sealed containers not deformable (eg. glass vials) and liquids in heat sensitive sealed containers (eg. plastic bags or bottles).
- Terminal sterilization of pre-filled syringes (PFSs).
The load is held in rotation thanks to a special rotating drum inside the chamber. The rotation drum has a magnetic coupling and is adjustable in speed, direction of rotation and intermittently. This system finds application in the treatment of suspensions and emulsions and ensures a better performance of the tightness tests for ampoules under vacuum and a more homogeneous heat transmission in the load.
Robotic handling with FOW for the pharmaceutical industry.
- 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)
- FDA: compliance for non metallic component in contact with process fluids
- EN 285
- 21 CFR Part 210, 211 e 11
- UL 508A
- ATEX 94/4/EC
- ASME BPE
- DIN 58951-2
- ASME: Stamp R, Stamp S, Stamp U
- Chinese standard: SELO
- Swiss standard: SR 930.114
- Russian standard: CU TR 032
- PD 5000 code specification for unfired, fusion welded pressure vessels
- USP: compliance for non metallic component in contact with process fluids