Endotoxins are part of the cell membrane of gram-negative bacteria and are released when the organism dies or the cell wall dissolves. They are very heat-stable and cannot be removed by sterilization. They belong to the group of so-called pyrogens and, even in the smallest concentrations, can trigger fever reactions, drop in blood pressure, coagulation disorders and life-threatening shock states in both humans and animals.
For this reason, it is extremely important, especially for medical devices, to ensure endotoxin-free production and packaging. According to the European Pharmacopoeia (Ph. Eur. 2.6.14), medical devices must be tested for endotoxins, and < 20 EU per product is considered the standard for medical devices. For the quantitative determination, the so-called chromogenic-kinetic Limulus Amoebocyte Lysate Test (LAL test) is used, among others.
- Detection of endotoxins in the eluate in endotoxin units (EU) after rinsing your medical device
Further information can be found here.