Endotoxin reagent Endosafe® LAL

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Traditional endotoxin testing has had a history of pain points, including long turnaround times, extensive training, and multiple steps for assay preparation. To make matters worse, an invalid LAL test result can potentially cripple your manufacturing timelines. The Endosafe LAL cartridge technology is the innovative response to the need for a more precise, objective, and faster quantitative results in the kinetic chromogenic method. A novel technology designed to optimize and refine the usage of LAL, our Endosafe LAL cartridges utilize 95% less horseshoe crab raw material and accessories than gel-clot and KTA methods. The disposable cartridges contain precise amounts of our FDA-licensed chromogenic LAL reagent, chromogenic substrate, and controls needed to measure color intensity directly related to the endotoxin concentration in a sample and obtain rapid, accurate results. Endosafe LAL Cartridges Are a Compendial BET Method FDA-licensed Endosafe LAL cartridges are a kinetic chromogenic LAL method as specified in the EP/USP. Automatically performing a duplicate sample and positive product control, they satisfy the harmonized BET chapters USP or Ph.Eur. 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.  As the cartridges are pre-filled, they eliminate the manual daily preparation of standards and reagents. Consolidating all the essential components in a self-contained cartridge reduces pipetting steps, decreases assay variability, cross-contamination, false positive risk, and retest rates.