Bacterial endotoxin contamination on certain orthopedic devices can result in adverse regulatory and patient impact, and considerable product cost. Understanding the potential sources of endotoxin and regular monitoring in the manufacturing process are key to preventing negative outcomes. In this presentation, we will discuss what types of devices need to be tested for product release, sources of endotoxin, primary endotoxin test methods, including recombinant reagents and the monitoring of processes to prevent endotoxin contamination. Presented by STERIS, Booth 861
