Pyrogen Testing Services

Pyrogen testing is a crucial procedure used to detect the presence of pyrogens—substances that can induce fever when introduced into the human body. These substances are most commonly bacterial endotoxins, which originate from the outer membrane of Gram-negative bacteria. However, pyrogens can also include non-endotoxin substances such as certain chemicals, metabolites, or contaminants introduced during manufacturing.

This testing is essential to ensure the safety of:

• Injectable pharmaceuticals – to prevent febrile reactions in patients.

• Biological products – such as vaccines and monoclonal antibodies, where sterility is critical.

• Medical devices – especially those intended to come into contact with blood or cerebrospinal fluid.

By identifying and eliminating pyrogens, manufacturers can meet regulatory standards and safeguard patient health. Pyrogen testing methods include the Rabbit Test, Bacterial Endotoxin Test (BET or LAL test), and Monocyte Activation Test (MAT), each with specific applications depending on the product type and regulatory requirements.