Material Mediated Pyrogen

Material Mediated Pyrogen

Material-Mediated Pyrogen (Rabbit Pyrogen) testing detects the febrile response provoked by device extracts when administered intravenously — a critical endpoint for products with circulatory or implant contact. Per ISO 10993-11 and USP 151, it screens for both endotoxin and chemical pyrogens that bacterial-endotoxin testing alone may miss.

We perform pyrogen testing on saline and oil extracts using validated rabbit colonies, with full thermal-response curves and acceptance criteria aligned to current pharmacopoeial expectations.