Within the article, we discuss the importance of maintaining quality and safety in endotoxin testing methods and the risks they may imply if inadequate.
Endotoxins are small, hydrophobic molecules that are part of the lipopolysaccharide complex that forms most of the outer membrane of Gram-negative bacteria (1).
They are released when the bacteria die and their outer membranes disintegrate, triggering the toxicity mechanism of the fractionated lipopolysaccharides.
To ensure patient safety, endotoxin testing must be carried out, not only on end-product medical devices or injectables, but also on the raw materials that are used to make them. Despite this requirement, endotoxin testing is often overlooked, and many manufacturers may rely too much on sterility testing.
As described in the harmonized European, United States, and Japanese pharmacopeias (2-4), sterility testing will detect live microorganisms, including Gram-negative bacteria. If these bacteria are destroyed during the sterilization process, however, endotoxin will be released and will remain undetected…