Bacterial endotoxins can trigger severe inflammation and death if they enter the bloodstream, cerebrospinal fluid, or intraocular fluid. Accurate detection of endotoxin levels in medical products is therefore an important part of the sterility testing process. This article provides an overview of how endotoxins can contaminate injectable drugs and biologics and examines the common methods used in the detection and removal of endotoxins from materials, manufacturing equipment, and final medical products. The authors provide guidance from the US Food and Drug Administration (FDA) for setting acceptable limits of endotoxins and give examples of FDA warning letters issued to sponsors of medical products for endotoxin-related concerns.
