Services We Offer
Endotoxin / LAL TestingLAL testing (Limulus Amebocyte Lysate) is used to detect bacterial endotoxins on medical devices. Produced by gram-negative bacteria and found within the cell membrane, endotoxins account for an estimated 99% of the pyrogens found on the surface of medical devices.
Why you need it...
While there are no existing ISO standards regulating endotoxin presence, both American and European regulatory authorities require that samples from each manufacturing batch of sterile medical devices intended for contact with human blood or cerebro-spinal fluid during their routine use be tested for the presence of pyrogens.
SteriPro® Laboratories provides:
The Kinetic-Chromogenic Assay (North America and Europe)
The Gel-Clot Assay (Europe only)
SteriPro® Labs Brochure