Endotoxine Determination

For routine endotoxin determination, we have selected the Endosafe NexGen system from Charles River Laboratories.

The NexGen PTS system uses FDA-licensed LAL cartridges for rapid, sensitive endotoxin detection. This point-of-use test system delivers quantitative results in under 15 minutes with just two simple steps. Its design integrates licensed LAL reagents within disposable cartridges, enabling a fully contained, real-time endotoxin assay.

The NexGen PTS is 21 CFR Part 11 compliant, making it ideal for conventional quality control settings and seamlessly integrated into Elysia’s Turn-Key solutions. It employs LAL kinetic chromogenic methodology, which measures color intensity directly proportional to the endotoxin concentration in the sample.

Each cartridge contains precise amounts of LAL reagent, chromogenic substrate, and control standard endotoxin (CSE). Manufactured in an FDA-licensed cleanroom under cGMP standards, these cartridges ensure exceptional accuracy, consistency, and stability.