Sterilization Validation

Manufacturing

• Manufacturing Overview
• Product Design and Development
• Tooling Design and Fabrication
• Process Design and Validation
• Device Packaging
• Device Manufacturing & Assembly
• Microscopic Medical Device Assembly
• Sterilization Validation
• Regulatory Assistance for FDA, CE and SFDA
• Supply Chain Management

Devon Medical has three EtO Chambers (10m³, 15m³, 20m³) onsite and has local partners for Gamma applications. ISO 11135 estimated 3^rd quarter ‘09

• Sterilization validation
• Residual analysis
• Pyrogen testing