Thanks to a wide experience in the pharmaceutical industry, Fedegari has developed a special sterilizer addressed to elastomeric closures treatment. This process equipment can perform washing, rinsing, siliconizing, sterilizing, drying and automatic unloading of stoppers in a sterile area. All these processes are managed by Thema4 process controller.
The stopper treatment autoclave uses a drum with a special magnetic coupling, which guarantees more space in the chamber.
As for Fedegari washer sterilizer (FOWS) this is a dual-purpose unit: when is not running as a stopper treatment it can be used as a normal moist-heat sterilizer.
DESIGN AND TECHNICAL FEATURES
- AISI 316L stainless steel chamber.
- 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.
- 6 PT100 RTD temperature sensors to monitor chamber and product temperature (3 flexible, 2 fixed + 1 located in the door-chamber jacket).
- Two doors with hinged opening systems to cope with available space in the smartest possible way (unloading side comes with semi-automatic door when chute is installed).
- Dual-purpose unit: saturated steam sterilizer or elastomeric stopper processing.
- Double option for unloading in sterile area.
- Rotating drum with magnetic coupling: no obstruction in the chamber.
- Stopper washing, siliconizing and sterilizing.
- Solids material sterilization.
- Porous material sterilization.
- Vial sterilization.
Thanks to a special engineering, rotating AISI 316L stainless steel drum guarantees the best performance when running washing, siliconizing and drying cycles. The automatic unloading phase is performed by inverting the rotating way and due to the auto-sterilizing chute, positioned on unloading door.
Unloading in heat-sealed bags: the autoclave is equipped with an auto-sterilizing chute on the unloading side and with an external trolley for the weighing and heat-sealing of the bags. Operators action is limited to putting on the bags on the chute and to switching on the heat-sealing system. Customers can configure the desired bags weight, so that the machine can regulate the amount of the unloaded stoppers.
Unloading in stainless steel tanks: the stoppers treatment autoclave is equipped with a rotating auto-sterilizing chute connected with a stainless steel tank, which is sterilized thanks to the direct link with the chamber. Operators action is limited to external clamp removal. The tank is linked to the chamber thanks to a special lifting column, or in alternative with a lifting trolley.
- 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
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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.
Internal and external trolleys
Cassettes for vials and bottles
Built-in electric steam generator
Suitable filter on industrial steam line
Condensate drain cooler
Second filter in series on compressed air line
“Air detector” system
Steam sampling system
Hot air drying
Specific decontamination cycles
Additional HMI panels
Graphic User Interface (GUI) for remote control
Thema4 external recorder