Endotoxin / Pyrogen Testing

The Endotoxin Detection Assay tests for gram-negative endotoxins. The assay follows current USP chapter <85> and AAMI ST72 guidelines to qualify that products are below specified levels of endotoxin. Passing lots are accompanied with a certificate of conformity.

Endotoxins/pyrogens are ubiquitous as they are components of lysed bacterial cell walls. Bacteria will be present in any laboratory or manufacturing environment. Stringent control of manufacturing environments and human personnel is required to keep endotoxin/pyrogen levels low.