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 indicatethe 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.
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.
Pyrogens are readily detected by Limulus Amebocyte Lysate
(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,” says 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
949-448-7056; www.interfaceusa.com