Automated Endotoxin Testing System

Performing endotoxin testing on large numbers of samples using traditional methods can be both time-consuming and susceptible to outside influences, such as technician errors and standard curve anomalies. The time required to prepare standards and samples can often exceed the assay time while simultaneously tying up valuable resources.

nexus instruments

As manufacturing and technology evolve, your organization should be looking at changing methods that are heavily dependent on human interaction. Moving to automated endotoxin testing will help to lower your coefficient of variations, reduce ergonomic issues, save lab analyst time, and reduce standard curve variability.

Traditional bacterial endotoxin tests using a duplication (i.e., repeating the same task or effort in order to identify or avoid error) method to mitigate human risk, such as the "four eyes principle," are the least effective at preventing human error, while automation is the most effective, as it is less reliant on subjective data.

By reducing human error in processes, they are not only more efficient, but they also increase the quality of products produced, thus positively impacting patients and their safety.


The Endosafe® Nexus Process

 

User Benefits Endosafe® Nexus™ Automated Endotoxin Testing System

  • Data Integrity
    • Bar-coding technology enhances data management and reduces input errors and the need for subsequent investigations.
    • Full, searchable audit trail, with every action recorded to ensure data integrity.
    • Addresses increased focus on data integrity by regulators, minimizing risk of most commonly cited events.
  • Lab Efficiency
    • Hands-off rapid automated endotoxin testing system with the ability to test up to 60 samples per run.
    • Automated dilution and sample handling with the ability to suspend current run.
    • Can be utilized for central lab water testing and product testing.
  • Product Codes
    Product Code
    Nexus™ robotic system 24-tube racks
    nexgen-MCS™ instrument
    Nexus™ integrated software
    Computer
    Anti-static mat
    MR65024K
    Nexus™ robotic system 32- tube racks
    nexgen-MCS™ instrument
    Nexus™ integrated software
    Computer
    Anti-static mat
    MR65032K
    Sterilized conductive 300 μL tips case
    (5,760 per case)
    MR300
    Sterilized conductive 1 mL tips case
    (3,840 per case)
    MR1000

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>

Frequently Asked Questions (FAQs) About Endosafe® Nexus™