Pyrogen Testing Services

The pyrogen test is a critical assay conducted in the pharmaceutical and biomedical industries to assess the presence of pyrogens in pharmaceutical products, medical devices, and biological substances. Pyrogens are substances, typically endotoxins derived from the outer membrane of Gram-negative bacteria, that can induce fever when introduced into the bloodstream.

Regulatory agencies mandate the pyrogen test as part of the safety evaluation process for pharmaceutical products and medical devices. Compliance with these regulations is essential for obtaining approval for product registration and market authorization.