Endosafe® nexgen-PTS™

The Endosafe® nexgen-PTS™ is a rapid, point-of-use handheld spectrophotometer that uses USP/BET-compliant disposable cartridges for accurate, convenient, and real-time endotoxin testing, glucan concentration determination, and Gram identification. 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.

Assay Guides

The Endosafe® nexgen-PTS™ utilizes disposable cartridges for accurate, convenient, and real-time endotoxin detection, glucan concentration determination, and Gram identification.

Case Studies

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.
View the Replay »

Implementation of the Endosafe® Rapid Endotoxin Testing Platform at Pfizer
Pfizer has assessed the Endosafe® rapid test methods on dozens of applications and gathered extensive data to support comparability to USP<85> and PharmEur 2.6.14 Bacterial Endotoxin.
View the PDA Poster »

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.
Learn More About Cartridge Compliance »

Each FDA-licensed LAL cartridge is manufactured according to rigid quality control procedures to ensure test accuracy and product stability.
View the Cartridge Schematic »

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. 

Interested in Improving your Lab Efficiency? »

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