Fedegari's - Elastomeric Stopper Processing Equipment
 

DESIGN AND TECHNICAL FEATURES

• AISI 316L stainless steel chamber.
• Chamber range from 200 to 6.800 liters, but loading capacity is fully customisable, 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)

KEY BENEFITS

• Dual-purpose unit: saturated steam steriliser or elastomeric stopper processing. 
• Double option for unloading in sterile area.
• Rotating drum with magnetic coupling: no obstruction in the chamber.
• Clean, sterile, and dry stoppers and closures delivered to the filling machine without breaking containment in pharmaceutical production.

APPLICATION FIELDS

• Stopper washing, siliconizing and sterilising.
• Solids material sterilisation.
• Porous material sterilisation.
• Vial sterilisation.

BASKET

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-sterilising chute, positioned on unloading door.

UNLOADING OPTIONS

Unloading in heat-sealed bags: the autoclave is equipped with an auto-sterilising 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-sterilising chute connected with a stainless steel tank, which is sterilised 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.

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