Clean Room Assembly
ISO Class 7 for increased demand of single-use assemblies
Contract packaging of custom tubing sets, manifolds and sampling bottles
Call 1.866.434.5548 for more information
300 ft2 ISO 7 TerraUniversal Clean Room — 3500 ft2 White Room Storage
- Certified Clean Room – ISO 7 Certified, Classification ISO 14644-1:2015, compliant for airflow volume, velocity, characterization and room pressurization. Tested per IEST-RP-CC006.3 Specifications.
- 24/7 Environmental Control for temperature, humidity and light.
- Reduced Inventory Cost – Stock one Assembly part number rather than many individual component parts; authorize releases to ship units when required.
- 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 since 2007, Custom Tubing Sets, Manifolds and Bottle Assemblies.
- Stocked Components Include – Largest US Supplier with a variety of Oetiker Med/Pharma-Grade Clamps (sizes from 4.8mm to 25mm); also in stock Check Valves, Connectors, Gaskets, Seals and Tubing.
- 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.
Assembly Features Include:
- Product Lot Number Control
- Double Barrier Packaging
- Clear Product Identity Labeling
- Gamma Irradiation w/Indicator Label
- Material Certificate of Compliance