High-Precision Medical Tube Extrusion in ISO 8 Cleanrooms

High-Precision Medical Tube Extrusion

MDE specializes in the extrusion of high-precision medical tubing using medical-grade materials. To ensure the highest standards of safety and quality, all extrusion activities take place in ISO 8 Cleanrooms with controlled pressure and constant monitoring of environmental parameters.

Advanced Processing Technologies

Our production lines are dedicated to a wide range of complex extrusion needs, ensuring a repeatable and validated process for every batch:

• Micro-extrusion: Precision tubing with diameters ranging from 0.2 to 10 mm.
• Multi-layer and Co-extrusion: Combining different materials to achieve specific stiffness, flexibility, and biocompatibility properties.
• Multi-lumen Tubing: Complex internal cross-sections for catheters and advanced medical components.
• Radiopaque Tubing: Inclusion of contrast agents for visibility during fluoroscopy.

Quality and Traceability

Precision is maintained through automated lines equipped with in-line laser control systems that constantly measure diameter, wall thickness, and lumen concentricity. We guarantee tight tolerances, material purity, and complete ISO 13485 traceability.

Certified Medical-Grade Materials

We exclusively use materials compliant with the ISO 10993 (biocompatibility) standard. Our expertise includes processing a variety of medical polymers, such as:

• Pebax®, Nylon (PA), and Polyurethane (PU)
• FEP, PFA, and PTFE
• Bioabsorbable Polymers
• Medical Silicone

Technical Validation

Every batch is accompanied by complete inspection reports. We provide full IQ/OQ/PQ validation documentation, rheological analysis of materials, and rigorous dimensional tests via optical microscopy to support your regulatory requirements.