A European processor with more than 60 years of experience molding, extruding, and assembling medical parts is setting up an operation to do just that in the U.S. Raumedic AG, headquartered in Helmbrechts, Germany, recently announced plans to build a 60,000 ft² facility in Mills River, N.C. The building will house 22,000 ft² of cleanroom (ISO Class 7) manufacturing space.
Raumedic specializes in micro extrusion of tubing with I.D. down to 0.004 in. (0.1 mm), multilayer structures that encapsulate radiopaque stripes, injection molding with hard/soft combinations, blown film, and automated assembly using 100% camera control.
Raumedic Inc. plans to start production next January with medical tubing and injection molding. It will have about 50 employees, gradually increasing to 100 as production ramps up. Raumedic will produce medical tubing and other products in a variety of materials, including a novel PTFE (photo) developed by ElringKlinger Kunststofftechnik in Germany, an automotive molder of gaskets, housing modules and shielding systems. Called Moldflon, the material is billed as a biocompatible thermoplastic with properties very similar to standard PTFE.
Raumedic has been using it in Europe since 2012.
While conventional PTFE is processed on a ram extruder in a batch process, Moldflon can be run continuously on single-screw extruders. This makes it suitable for long tubing production runs and for coextrusion, notes Steve Maxson, technical sales manager at Raumedic Inc. Maxson adds that while traditional PTFE has limitations with regard to minimum wall thickness, Moldflon can be extruded for catheters at wall thickness down to 0.0005 in.
Additional applications for Moldflon include single-lumen tubing as thin as 0.001 in., multi-lumen tubing, IV catheter tubing with radiopaque stripes, micro cannulas for insulin delivery, and spooled beading (rod) for lumen support. ElnringKlinger USA is located in Buford, Ga.