The potentially devastating effects of endotoxins to humans have been widely reported. At sufficient concentrations in the bloodstream, it is possible for endotoxins to cause irreversible side effects and even death in severe cases. “Since its introduction, the LAL test has become one of the most important tools used in the pharmaceutical industry,” says Dubczak. “It has allowed for a level of bacteria and pyrogen monitoring that simply eluded manufacturers when the RPT was the only pyrogen test available. The LAL test has ensured the absence of pyrogens in raw materials, water for injection systems, in-process samples, and in the final products.