Elastomeric stopper sterilization system
In bio-pharmaceutical manufacturing, ensuring sterile conditions for elastomeric closures is critical. Common issues include maintaining sterility during washing, siliconizing, and drying processes while preventing contamination through human handling.
Automates washing, siliconizing, and sterilizing
The Elastomeric Stopper Treatment System by Fedegari excels in processing elastomeric closures with precision and reliability. This system incorporates washing, rinsing, siliconizing, sterilizing, drying, and automatic unloading within a single unit, all managed by Thema4 process controller. Using a rotating drum with a magnetic coupling, it maximizes chamber space. It also doubles as a moist-heat sterilizer when not processing stoppers. The chamber is constructed from AISI 316L stainless steel, ranging from 200 to 6,800 liters, with customizable loading capacity. Its surface complies with pharmaceutical standards with a roughness Ra < 0.4 μm. Temperature is monitored by six PT100 RTD sensors, ensuring precise conditions. The dual-door system with semi-automatic unloading options supports sterile environments. Compliance with European and U.S. standards ensures safety and reliability.
Benefits
- Automated sterile unloading process
- Dual-purpose functionality for versatile use
- Minimized space requirements in chamber
- Customizable loading capacities for various needs
- Compliance with stringent industry standards