Endotoxin / LAL Testing

What it is
LAL 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.

The term "pyrogen," literally "heat generating," refers to any substance—microbial or otherwise—which would induce a temperature rise when introduced into a patient.

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.

To conform to current USP standards, blood-contacting devices must show <20 EU per device. Intrathecal devices must show <2.15 EU per device.

The proposed CE marking requirement will quantify this when a declaration of "Non-pyrogenic" is made on packaging.

How it is done
Copy deleted SteriPro® Labs employ two types of LAL testing:

• The Kinetic-Chromogenic Assay used in North America and Europe
• The Gel-Clot Assay used in Europe only

The Kinetic-Chromogenic Assay is more sensitive and less expensive than the Gel-Clot Assay. An additional advantage is that the Kinetic-Chromogenic Assay provides quantitative data for use in trend analysis and process monitoring.