For the routine determination of endotoxins, Elysia has chosen the Endosafe NexGen from Charles River Laboratories.
The Nexgen PTS system utilizes FDA Licensed LAL Cartridges for sensitive and rapid endotoxin detection. It is a rapid point-of-use test system that provides quantitative test results in less than 15 minutes with only 2 simple steps. The technology utilizes licensed LAL reagents in a disposable cartridge using the Nexgen PTS for a completely contained, realtime endotoxin assay.
The Nexgen PTS is fully 21 CFR Part 11 compliant and perfect in a conventional quality control setting and is fully implemented in the Elysia Turn-Key solutions.
The Endosafe uses LAL kinetics chromogenic methodology that measures a colour intensity that is directly related to the endotoxin concentration in the sample. Each cartridge contains precise amount of LAL reagent, chromogenic substrate and control standard of endotoxin (CSE). The cartridges are manufactured in an FDA Licensed clean room environment according FDA cGMP standards ensuring test accuracy, consistency and product stability.
To perform the test, the user simply pipettes 25μl of a sample into each of the four sample wells of the cartridge. The Nexgen PTS Instrument draws and mixes the sample with the LAL reagent in two channels (sample channels 1 and 3) and with the LAL reagent and positive product control in the other two channels (spike channels 2 and 4). The sample is mixed with the chromogenic substrate and incubated. During the incubation period, the optical density of the wells is measured and analyzed against an internally-archived standard curve. By design, the PTS cartridge automatically performs a duplicate sample/ duplicate positive product control LAL test, thereby satisfying the harmonized USP and EP Bacterial Endotoxine Test (BET) and the FDA guideline for LAL testing.