Endotoxinkontrollen

Endotoxinkontrollen, also known as endotoxin testing or pyrogen testing, is a critical process in the pharmaceutical and medical device industries to ensure the safety of products intended for parenteral administration. Endotoxins are lipopolysaccharides found in the outer membrane of Gram-negative bacteria. When introduced into the bloodstream, even in very small amounts, they can trigger a severe inflammatory response, leading to fever, shock, and potentially death. Therefore, controlling endotoxin levels in injectable drugs, intravenous fluids, and medical devices that come into contact with the bloodstream or cerebrospinal fluid is paramount.

The most widely used method for endotoxin detection is the Limulus Amebocyte Lysate (LAL) test, which utilizes the blood cells of the horseshoe crab (Limulus polyphemus). These cells contain enzymes and proteins that react with endotoxins, causing a cascade of reactions that result in gel formation, a color change, or the emission of light. Different variations of the LAL test exist, including the gel-clot, chromogenic, and fluorogenic assays, each offering varying levels of sensitivity and quantitative accuracy. Regulatory agencies worldwide, such as the FDA and EMA, mandate strict limits for endotoxin contamination and require manufacturers to implement robust endotoxin control strategies throughout the manufacturing process, from raw material sourcing to final product release. This includes rigorous environmental monitoring, validated sterilization processes, and routine product testing to prevent endotoxin-related adverse events.