Portable Endotoxin Testing System

The enhanced features of the Endosafe® nexgen-PTS™ address your needs for decreased assay run time, simplified data entry, reduced user variability, and enhanced administration control in your endotoxin testing. The addition of a User Management functionality allows the system to be 21 CFR Part 11 compliant-ready.

Did you know Endosafe® LAL cartridges
are a compendial BET method?

Charles River's comprehensive biologic testing solutions includes stability testing.

FDA-licensed Endosafe® LAL cartridges are a kinetic chromogenic LAL method as specified in the EP/USP and JP. See the regulatory requirements here:

FDA Guidelines
USP BET <85> or EP BET <2.6.14>

Whether you choose to perform endotoxin testing at the point of sample collection or in the central QC lab, the portability and exceptionally fast results of the Endosafe nexgen-PTS™ can enhance your LAL testing programs and accelerate your manufacturing quality control processes.

Watch the Endosafe® nexgen-PTS™ Video


    Product Code
    Endosafe® nexgen-PTS™ instrument
    Ethernet cable
    One-year warranty
    Power supply
    USB cable adapter

    FDA-Licensed LAL cartridge Technology

    Reduce Retest Rates. Decrease Variability in Your Endoxin Testing.

    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 LAL testing 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 endotoxin testing 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. 

    Each FDA-licensed LAL 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.

    View the Cartridge Schematic

    • The User Management function allows for controlling user access and authority of how data is generated and stored making the nexgen-PTS 21 CFR Part 11 compliant ready.
    • Results are displayed on the LCD screen and can be exported via Wi-Fi or Ethernet for printing and analysis in LIMS or Charles River Cortex™.
    • Searchable audit trail, with every action recorded to ensure data integrity. Add Charles River Cortex for an integrated solution to securely consolidate, query, and analyze all real-time endotoxin data for necessary internal QA and FDA trending reports.

    Assay Guides

    The Endosafe® nexgen-PTS™ endotoxin testing instrument 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

Microbial Solutions Customer Portal

Lab analyst performing Quality Control on Endosafe LAL reagent for endotoxin testing

Easily access Endosafe® and Celsis® reagent kit inserts, print user guides, consult operator manuals, review Safety Data Sheets (SDS), and download Certificates of Analysis (CoA) and Certificates of Quality (CoQ).

Frequently Asked Questions (FAQs) About Endosafe® nexgen-PTS