Independent statistically significant test results by a leading laboratory have shown that Interface Extrusion extruded solely in a clean room environment is free of pyrogens. Results from three different methods of Limulus Amebocyte Lysate (LAL) testing for endotoxins indicate the extrusion lines can be classified as "pyrogen free." The implications of these test results are that catheter manufacturers may potentially eliminate cleaning steps in their own manufacturing process, saving time and cost.

LAL chromogenic, turbidimetric, and gel clot analyses were performed by an independent ISO-9001 laboratory registered with the United States Food and Drug Administration (FDA) and the Drug Enforcement Agency. Multiple lots from three extrusion lines passed each method of testing. The LAL method is effective for measuring endotoxin levels in production processes, product releases, and water systems.

Interface recognizes that customers can benefit from endotoxin-free tubing, which is why we conducted our own rigorous third party testing. Endotoxin testing is necessary to confirm the safe manufacture and release of product. Latest results confirm Interface Catheter Solutions manufactures pyrogen-free tubing directly from our extrusion process and clean room facility, providing higher confidence in our extrusion capabilities.