Endotoxin Testing
Microtest provides an array of superior endotoxin testing services to meet all regulatory demands for products to be labeled endotoxin-free or nonpyrogenic.
Causing fever, septic shock, and other disease symptoms, the gastrointestinal tract bacteria known as endotoxins attract considerable regulatory scrutiny. Examples range from USP 85 through U.S. FDA guidelines are used as primary methods for manufacturing release of medical devices to the ISO bacterial endotoxin test (BET).
• FDA/USP gel clot
• Chromogenic
• Turbidimetric
 No other laboratory can match our expertise in testing of both pharmaceutical products and medical devices. We’re specialists in endotoxin testing even of challenging combinations such as drug-coated stents, and of clinical trial materials.
Our technicians are highly trained in specialized endotoxin testing, including procedures utilizing smaller mandated limits for materials that may contact cerebrospinal fluids. We’re experienced in the use of reagents from all current U.S. manufacturers. And our facilities maintain a large array of testing equipment, to prevent delays and deliver faster throughput.
|
