A pyrogen is a substance that induces a febrile response (elevation of body temperature, fever) in humans and animals, which can be fatal. The causative substance is usually a bacterial endotoxin, a lipopolysaccharide complex associated with the outer membrane of Gram-negative pathogens such as E. coli, Salmonella, and Shigella. Pyrogen Testing is associated with microbiological contamination of sterilised parenteral products, biosynthetically produced materials, vaccines and adjuvants, and medical devices introduced into the fluid path. Regulatory agencies require these products to be evaluated for pyrogenic potential, either in vitro or in vivo, as a means of limiting the acceptable risk of febrile reaction in humans to injection of the specified product.
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