Endotoxin testing is a vital component of pharmaceutical, biologic, and medical device quality control, with a direct impact on medication safety. As detection technologies have advanced, the ...

Endotoxin refers to a component of the outer cell membrane of Gram-negative bacteria called lipopolysaccharide (LPS). LPS is the biologically active portion of naturally occurring endotoxin complexes.

Bacteria can be found everywhere—even sometimes in clean rooms. That’s a problem for manufacturers of drugs and medical devices that are injected or implanted. Even if manufacturers can remove the ...

The presence of harmful bacteria in parenteral drugs or implantable devices can cause inflammatory responses such as fever and, in some cases, may even be fatal. As a result, robust bacterial ...