Sterile products

Endotoxin- and pyrogen testing

To exclude pyrogenic substances in sterile formulations, the determination of the absence of endotoxins or pyrogens is mandatory. This applies to both sterile pharmaceuticals as well as sterile medical devices. Labor LS offers a comprehensive range of biological purity tests in this field. All common LAL methods (A, C, D) are established for the detection of endotoxins of Gram-negative bacteria (LPS, lipopolysaccharides). Testing for fever-inducing signals of Gram-positive bacteria (LTA, lipoteichoic acid) is conducted with the classical pyrogen test. The MAT (monocyte activation test) and the rFC assay (recombinant factor C) round off the test portfolio.