Product Description
Fedegari’s Elastomeric Stopper Treatment Autoclave is designed for the processing and sterilisation of elastomeric closures used in pharmaceutical manufacturing. The system performs a complete treatment cycle including washing, rinsing, siliconising, sterilising, drying and automatic unloading of stoppers into a sterile area, all managed through the Thema4 process controller to ensure consistent and repeatable operation.
The unit incorporates a rotating drum with magnetic coupling, eliminating internal mechanical obstructions and maximising usable chamber space. Based on the same platform as the Fedegari Washer Steriliser (FOWS), the system can also operate as a standard moist-heat steriliser when not processing elastomeric closures.
• AISI 316L stainless steel chamber construction
• Chamber volumes from 200 to 6,800 litres, with customisable loading capacity
• Mechanically polished internal surfaces compliant with pharmaceutical standards (Ra < 0.4 μm)
• Six PT100 RTD temperature sensors for monitoring chamber and product temperature
• Dual hinged-door configuration for efficient loading and unloading
• Rotating drum with magnetic coupling to maximise chamber capacity
• Elastomeric stopper washing, siliconising and sterilisation
• Sterilisation of solid materials
• Sterilisation of porous materials
• Vial sterilisation
• GMP and GAMP5 guidelines
• 21 CFR Parts 210, 211 and 11
• ASME BPE
• FDA compliant materials for non-metallic components in contact with process fluids
• EU Directives: 2014/30/EU (EMC), 2014/35/EU (Low Voltage), 2014/68/EU (Pressure Equipment Directive)
• European safety and electrical standards including EN ISO and EN IEC series
• EN 285
• UL 508A, NFPA-79
Elastomeric Closures Treatment
Multi-process solution for washing, rinsing, siliconising, sterilising, drying, and automatic unloading of elastomeric stoppers in sterile environments.