Portable Endotoxin Testing System
The enhanced features address your needs for decreased assay run time, simplified data entry, reduced user variability, and enhanced administration control. The addition of a User Management functionality allows the system to be 21 CFR Part 11 compliant-ready.
Whether you choose to perform testing at the point of sample collection or in the central QC lab, the portability and exceptionally fast results of the nexgen-PTS™ can enhance your testing programs and accelerate your manufacturing quality control processes.
|Endosafe® nexgen-PTS™ instrument
USB cable adapter
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The Endosafe® nexgen-PTS™ utilizes disposable cartridges for accurate, convenient, and real-time endotoxin detection, glucan concentration determination, and Gram identification.
- FDA-Licensed LAL Assay Guide
- Beta-Glucan Assay Guide
- Gram ID Assay Guide
- Inhibition and Enhancement (I/E) Assay Guide
A Pfizer Case Study: Increasing Operational Efficiencies with the Endosafe® Systems
In this webinar, Jeffrey Weber from Pfizer discusses options for endotoxin and compendial testing of pharmaceutical products, with a specific emphasis on the Endosafe® endotoxin testing platforms.
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Reduce Retest Rates. Decrease Variability.
There’s no mistake that the LAL assay is the gold standard for endotoxin testing, and while conventional kinetic testing is a tried and trusted method, advances in science have allowed for improvement in how it’s utilized. The Endosafe® cartridge technology is our innovative response to our customers’ need for higher sensitivity and faster quantitative results. Designed to optimize and refine our use of LAL, the cartridge technology eliminates a significant amount of the raw material and accessories required for traditional LAL methods while reducing time-consuming preparation and technician variability.
Each cartridge contains precise amounts of our FDA-licensed 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 EP<2.6.14> for LAL testing. Understand how our FDA-licensed LAL cartridge technology is compliant with existing global harmonized regulatory guidelines.
Each FDA-licensed LAL cartridge is manufactured according to rigid quality control procedures to ensure test accuracy and product stability.