Clean Room Assembly

ISO Class 7 for increased demand of single-use assemblies

Contract packaging of custom tubing sets, manifolds and sampling bottles

clean room assembly

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.

Customer benefits

  • 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