Testing Medical Devices for Endotoxin (pyrogens)

References:

ANSI/AAMI ST72:2011 Bacterial endotoxin - Test methods, routine monitoring and alternatives to batch testing

USP <85> Bacterial Endotoxins Test

Endotoxin concentration limits are specified for sterile medical devices used in invasive procedures.

We can provide endotoxin product validations and routine endotoxin testing for medical devices and sterilised re-usable instrumentation using LAL Kinetic Chromogenic techniques.