Depyrogenation

A process that removes or destroys pyrogens such as bacterial endotoxins. The most common method is dry heat at high temperature, for example 250 °C for at least 30 minutes, in an oven or tunnel for glassware and metal parts. Rinsing with WFI can remove endotoxin from some components. Depyrogenation is validated with endotoxin indicators placed in the coldest locations, and must show at least a 3-log reduction of endotoxin.