Endotoxin Testing
Endotoxin testing is a crucial process used to detect the presence of endotoxins, which are toxic substances found in the outer membrane of certain bacteria. These endotoxins can trigger severe immune responses in humans and animals, making it essential for industries like pharmaceuticals and medical devices to ensure their products are free from contamination. Common methods for testing include the Limulus Amebocyte Lysate (LAL) test, which uses a substance derived from horseshoe crab blood.
The testing process typically involves taking samples from products or surfaces and analyzing them for endotoxin levels. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), set strict guidelines for acceptable endotoxin limits to ensure safety and efficacy. By conducting thorough endotoxin testing, manufacturers can protect public health and maintain compliance with industry standards.