Customers may benefit from use of 300 ft ISO 7 Clean Room and Services:
• Reduced Inventory Cost – Stock one Assembly part rather than many individual component parts; authorize releases to ship units when needed.
• Proven Process – Design Support, Documentation, Controlled Manufacturing Operating Procedures, Assembly Work Instructions, Material Certificate of Compliance, Product Record Retention.
• Proven Experience – Assembling Single-Use Fluid Path Kits, Custom Tubing Sets, Manifolds and Bottle Assemblies.
• Certified Facility – ISO 7 Certified, Classification ISO 14644-1:2015, compliant for airflow volume, velocity, characterization and room pressurization. Tested per IEST-RP-CC006.3 Specifications.
• Stocked Components Include – Largest US Supplier of Oetiker Med/Pharma-Grade Clamps; also in stock Check Valves, Connectors, Gaskets, Seals and Tubing.
• 24/7 Environmental Control for temperature, humidity and light.
• Post Packaging Gamma Irradiation Services available.
• Trained Personnel for Clean Room gowning, entry/exit, line prep/clearance, manufacturing operating procedures, self-inspection, non-conforming identification, disposition and product handling.