Tests Show Interface Catheter Solutions’ Extrusion Process is Pyrogen-Free

Interface Catheter Solutions, based in Laguna Niguel, Calif., reports that Independent statistically significant test results indicate 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 potentially may eliminate cleaning steps in their own manufacturing process.

LAL chromogenic, turbidimetric, and gel clot analyses were performed by an independent ISO-9001 laboratory—Torrance, Calif.-based Bioscreen Testing Services Inc.—that is registered with the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Agency. Multiple lots from three extrusion lines passed each method of testing. Pyrogens are readily detected by LAL testing systems. The test was accepted by the FDA in 1983 as a standard test for endotoxins. The FDA later established guidelines for LAL testing of pharmaceuticals and medical devices in 1987.

The LAL method is effective for measuring endotoxin levels in production processes, product releases, and water systems.

“For many manufacturers, independent testing of vendor tubing is required,” said Andre Noronha, director, medical extrusion for Interface Catheter Solutions. “Our customers count on us for endotoxin-free tubing, which is why we conduct our own rigorous outside testing. Endotoxin testing is necessary to confirm the safe manufacture and release of product. These 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 for our customers.”

Interface Catheter Solutions is a provider of outsourced solutions for balloon and catheter manufacturing. The company has focused on the balloon catheter market since 1995,  creating more than 2,100 balloon designs, and offers balloon design and development, balloon contract manufacturing, extruded balloon tubing, custom medical extrusion, and balloon catheter production and testing equipment.