What Is The Difference Between Pyrogens And Bacterial Endotoxins In Medical Devices?

Pyrogen refers to the pyrogenic substances that can cause abnormal body temperature rise, including bacterial pyrogens, high-molecular-weight endogenous pyrogens, low-molecular- weight endogenous pyrogens, and chemical pyrogens, etc., which are generally classified as endogenous pyrogens and exogenous pyrogens. The pyrogens of medical devices mainly refer to exogenous pyrogens. Bacterial endotoxin is the most important aspect of pyrogens. Bacterial endotoxin is the lipopolysaccharide component released from the cell wall after the death and autolysis of Gram-negative bacteria. It is generally derived from biological contamination introduced during production. It is a quality control indicator of the product and does not belong to the biological evaluation endpoint. Pyrogens cannot be eliminated by sterilization and pyrogenic substances other than endotoxins can also cause pyrogenic reactions. Therefore, bacterial endotoxins belong to pyrogens, but pyrogens are not necessarily bacterial endotoxins. It is not possible to determine whether there is a potential risk of pyrogenic reaction simply by testing the limit of endotoxins. This risk needs to be reduced through production processes and process control.