Application note: The Monocyte Activation Assay: The benefits of an animal-free test to show pyrogen-free pharmaceutical products
Posted: 29 June 2021 | Nelson Labs | No comments yet
Fever is something that most of us have experienced. However, when we use medicines or medical devices, we expect them to improve our health – not to cause a fever.
One of the culprits of fevers is the presence of pyrogens. Pyrogens are fever inducing substances that at a low dose may induce influenza-like symptoms. Exposure to high doses of these substances can even result in multiple organ failure or even death. Pyrogenic responses may be material-mediated, endotoxin-mediated, or mediated by other substances such as components of Gram-positive bacteria and fungi. Therefore, parenteral pharmaceuticals and medical devices that come into contact with the blood stream or cerebrospinal fluids should be free of pyrogens (EP 2.6.8, USP <151>, ISO 10993-11).
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