Endotoxins are part of the cell membrane of gram-negative bacteria and are released when bacteria die or the cell wall dissolves. They are very heat stable and cannot be removed by sterilization. They are allocated to the so-called pyrogens and can cause fever reactions, low blood pressure, coagulation disorders and life-threatening shock states in even the lowest concentrations in both humans and animals.
Because of this, 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 checked upon endotoxins. For medical devices <20 EU per product are considered as standard. Among others, the so-called chromogen-kinetic limulus amoebocyte lysate test (LAL test) can be used for the quantitative determination.