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The washer sterilizer is an absolute unique and original solution, designed for improving and simplifying all cleaning requirements when the loads need to enter a controlled-contamination environment. The FOWS washer sterilizer is a hybrid solution suitable for washing, decontaminating, sterilizing and drying various types of loads as no traditional machine can ever do.
These multipurpose machines, totally managed by Thema4 process controller, represent the most cost-effective solution in terms of CAPEX as well as operating costs while combining the high-performance of a steam sterilizer into a jet washer.
This new concept presents many advantages when compared with a traditional solution of two different machines (washer + steam sterilizer): FOWS requires less space in a plant, less time to complete the process, less training, and reduced maintenance and validation costs.
To carry on the washing cycle, FOWS washer sterilizer benefits from the emollient effect of steam on greasy and sticky dirt such as ointment, cream, gel etc. Thanks to this, the consumption of detergents, water and energy is significantly reduced presenting a trully eco-friendly solution. Additionaly, vacuum can be used for drying loads, reducing process duration with lower operating costs.
DESIGN & TECHNICAL FEATURES
- FOWS steam sterilizer is equipped with a AISI 316L stainless steel chamber.
- Chamber’s inner surface mechanically polished until a roughness of less than Ra <0,4 μm, in order to avoid any water stagnation.
- 6 RTD PT100 probes positioned in chamber for constant monitoring and immediate of washing and sterilization cycles. The probes are located in some critical points of the chamber, such as the interspaces of the door and water drain, in order to have the assurance of the uniformity of temperature.
- Additional space for two validation probes, to ensure greater ease of data checking.
- The hydraulic system and the valves are made of AISI 316L steel with sanitary finishing.
- Chamber 100% air-tight guaranteed by two inflatable gaskets, with an original solution patented by Fedegari.
KEY BENEFITS
- Process optimization: 4 processes in 1 machine.
- Cost-effectiveness: reduction of installation, qualification, maintenance, revalidation and personnel training costs.
- Flexibility: you can run the unit as a washer, as an autoclave or as a combined unit. The load will be washed, sterilized and dried at once in 110 minutes.
- Highly-efficient & Eco-friendly: use of steam for improving washing/degreasing performances, expecially for sticky ointments/creams.
COMPLIANT TO
- 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
- GMP
- GAMP5
- 21 CFR Part 210, 211 e 11
- UL 508A
- NFPA-79
- ATEX 94/4/EC
- ASME BPE
- DIN 58951-2
Optional
- 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
Want to know more about our certifications? Please visit the dedicated section or do not hesitate to contact us.
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THEMA4
Thema4, developed to meet the most stringent requirements of thepharmaceutical industry, is installed on all Fedegari machines. It is able to integrate natively with SCADA and MES systems in use by the customer.
