USP 151 Standard Method for Pyrogen Test

EUROLAB laboratory provides testing and compliance service within the scope of USP 151 standard. A pyrogen is a fever-inducing substance when injected into human subjects. Pyrogen testing is based on similar pyrogenic thresholds in humans and rabbits.

The methods and requirements in this section apply to assemblies or devices labeled sterile and non-pyrogenic that are in direct or indirect contact with the cardiovascular system, lymphatic system, or cerebrospinal fluid.

The pyrogen test is designed to limit to an acceptable level the risks of febrile reactions in the patient associated with the administration of the product of interest by injection. The test involves measuring the rise in temperature of rabbits following intravenous injection of a test solution and is intended for products that can be tolerated by the test rabbit at a dose of up to 10 mL/kg intravenously injected.

For products that require preliminary preparation or are subject to special application conditions, follow the additional instructions provided in the individual monograph or, in the case of antibiotics or biologics, the additional instructions provided in the federal regulations.

EUROLAB assists manufacturers with USP 151 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.