The Endosafe nexgen-PTS is a rapid, point-of-use handheld spectrophotometer. Supporting both Endosafe® LAL and Trillium™ recombinant cascade reagent (rCR) cartridges, it provides accurate and effortless endotoxin detection and glucan concentration determination. Its compact and lightweight footprint makes it optimal for small to mid-size pharmaceutical companies and compounding pharmacies requiring fast and simple testing right on the manufacturing floor.
The Endosafe nexgen-PTS exponentially elevates assay efficiency, offering dramatically faster run times than traditional methods, streamlined data entry, and reduced user variability. With user management functionality, it ensures compliance with 21 CFR Part 11, enhancing administrative control and maintaining high data integrity.
Whether you need to test water right at the sampling port, off-batch samples in the QC lab, in-process buffers, or STAT samples at the point of sample collection, the simplicity, portability, and reliability of the Endosafe nexgen-PTS can streamline your programs and accelerate your manufacturing quality control processes while preserving confidence in your testing method.
Endosafe® FDA-licensed LAL Cartridge Technology
Increase the speed, while decreasing variability.
The Endosafe cartridge technology is Charles River Laboratories innovative response to their customers’ need for higher sensitivity and faster quantitative LAL testing results. Designed to optimize and refine the use of LAL, the cartridge technology eliminates a significant amount of the raw material and accessories required for traditional endotoxin testing methods while reducing time-consuming preparation and technician variability.
Each cartridge contains precise amounts of FDA-licensed chromogenic LAL reagent, chromogenic substrate, and controls needed to obtain rapid, accurate results. The cartridges automatically perform a duplicate sample and positive product control, thereby satisfying the harmonized BET chapters USP <85> or Ph.Eur. <2.4>2.4 for LAL testing.
Each cartridge is manufactured according to rigid quality control procedures to ensure test accuracy and product stability and is compliant with existing global harmonized regulatory guidelines.
Endosafe® Trillium™ rCR Cartridges
Their rCR test cartridges are powered by a 3-Factor enzymatic cascade, curated to simulate the natural LAL reaction from the Limulus polyphemus species. The formulation and composition of Trillium includes the 3 critical biological proteins (recombinant Factor C, recombinant Factor B, and recombinant proclotting enzyme) and a specific concentration of key components.
Beta-Glucan Cartridges
The Beta-glucan assay is a simple, 30 minute, in-process test that mimics kinetic chromogenic method by measuring color intensity. As glucans are known to cause false-positive results in the LAL test, our cartridges are used for investigational purposes to ensure that products do not contain (1,3)-β-D glucans.
Accessed from: Endosafe® nexgen-PTS™ Endotoxin Testing | Charles River
