Pyrogen & Bacterial Endotoxin Testing for Medical Devices
Two different questions sit under 'pyrogens'. Bacterial endotoxin testing (LAL or recombinant methods, USP <85> and related device guidance) checks for endotoxin contamination, usually lot by lot. Material-mediated pyrogenicity is a biological endpoint considered within the ISO 10993 evaluation (ISO 10993-11 and the rabbit pyrogen test, USP <151>), and applies only where the device and contact warrant it.
What does it measure?
- Endotoxin level per device
- Material-mediated pyrogenic response where relevant
When is it used?
- Lot release of devices with endotoxin limits
- Biological evaluation of devices contacting blood, lymph or CSF, or implants
Laboratories with relevant capabilities
- Pace Analytical Life Sciences (Oakdale, MN) — Microbiology, Sterility Testing, Chemical Analysis
- Canyon Labs (Bluffdale, UT) — Microbiology Testing, Sterility Testing, Package Testing