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A rapid FDA-licensed endotoxin detection system Endosafe-PTS is a rapid, point-of-use test system providing quantitative LAL results in about 15 minutes

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Charles River Laboratories’ revolutionary FDA-licensed endotoxin detection system, the Endosafe®-PTS, is a rapid, point of use test system that provides quantitative LAL results quickly. The PTS utilizes LAL reagents in a disposable test cardridge with a handheld reader for a completely contained, real-time endotoxin testing system. The PTS is in line with the FDA’s initiative for Process Analytical Technology (PAT) contributing to improved quality, safety, and efficiency to the pharmaceutical manufactering process.
The Endosafe®-PTS is licensed by the FDA as testing method for in-process and final release testing of pharmaceutical procucts.

Test technology:

The PTS utilizes LAL kinetic chromogenic methodology to measure color intensity directly related to the endotoxin concentration in a sample. Each cartridge contains precise amounts of licensed LAL reagent, chromogenic substrate, and control standard endotoxin (CSE).

Product Applications:

Endosafe®-PTS Non-licensed Products:

The PTS technology is being employed in numerous other applications. Two products, the Endosafe®-PTS Gram ID (gram identification) and Endosafe®-PTS BCA (protein determination) are available presently. Other applications are currently in development.

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