Safety assessment of endotoxin related to drug products and medical devices: A review.

Abstract

Endotoxin, also known as LPS, is the main component of the outer membrane of Gram-negative bacteria. It is released into the environment during cell division and cell death. Contamination of drug products and medical devices by endotoxin has been reported. Although endotoxin has been studied for its therapeutic uses treating diseases via the tolerance mechanism, more overwhelming evidence points to its toxicity. Extensive literature has reported its acute and chronic health effects and associati