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Clean Room Molding

To protect the end-user of medical-grade products, medical device companies seek out clean room manufacturing and assembly services. One of the most common versions of these services is clean room molding. These clean room environments meet strict standards for sanitary manufacturing, according to the number of particles (sized 0.5µm or larger) in one cubic foot of air. At MDI, we offer clean room molding for various medical device companies. We adhere to the ISO 13485 standard for organizations involved in the design, production, installation and servicing of medical devices. Depending on the unique needs of your product, we offer ISO cleanroom molding classifications 1-9, with 1 being the most sanitary. This could mean you require the surrounding air to have as little as 100 particles per cubic foot of air, or as many as 100,000 particles per cubic foot. We offer several clean room manufacturing services, including:

  • Molding

  • Extrusion (single, multi, and co-extrusion)

  • Bonding (UV and Solvent)

  • Decorating

  • Flaring

  • Tipping

  • Packaging (Pouch and Tray)

  • Force Testing (Pull force, burst, and torque)

  • IQ/OQ/PQ Validations

To provide comprehensive clean room manufacturing services, we partner with a variety of 3rd party vendors. Sourcing medical-grade components like needles, hypotubes, and trocar shafts helps MDI maximize our capabilities for our customers. We have demonstrated experience producing devices like catheters, tubing, medical balloons, and cannulas. Combing both our in-house capabilities and quality vendors, we are proud to offer turnkey medical device production services at a global scale. Prototype to production – MDI will make it happen. Call us today at 1-800-211-9897, or use our contact page and we will respond within one business day.