Charles River Endosafe® bacterial endotoxin testing equipment simplifies endotoxin detection from in-process to final lot release testing with flexible solutions, regardless of sample volume or industry. Easy-to-use Endosafe® endotoxin testing equipment will increase efficiency in the LAL laboratory by delivering rapid, accurate results. All of Charles River endotoxin testing solutions are backed by our skilled technical team who can provide training and maintenance.
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 and glucan concentration determination. With its small benchtop footprint, the Endosafe® nexgen-PTS™ is ideal for small to mid-size pharmaceutical companies and compounding pharmacies that want a portable, real-time testing option on the manufacturing floor. The enhanced features 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.
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This multi-cartridge benchtop LAL test equipment addresses the need for higher sample throughput while utilizing the same FDA-licensed LAL cartridge technology as the Endosafe® nexgen-PTS. The Endosafe® nexgen-MCS™ is proficient at concurrently testing up to five samples within 15 minutes for rapid, quantitative, and accurate endotoxin results. The Endosafe nexgen-MCS endotoxin testing system is comprised of five individual spectrophotometers built into a unit with a single Ethernet connector that links to your computer running EndoScan-V™ version 5.5.5 or higher, our 21 CFR Part 11 compliant-ready endotoxin measuring software.
Since each cartridge runs independently with the Endosafe nexgen-MCS, you can run your LAL testing samples as needed and not wait for a full batch of samples for testing, obtaining results in approximately 15 minutes.
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Endosafe® Nexus™ Automated Endotoxin Testing System
The Endosafe® Nexus™ delivers rapid, quantitative results in a low-maintenance, high-precision package as the first fully automated robotic system which eliminates high-volume testing variables and unlocks the full potential of our Endosafe® cartridge technology. 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.
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. Endotoxin automation is the most efficient standard of testing in your lab.
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BioTek® Plate Readers
We are able to provide an exceptional level of support for BioTek® endotoxin testing equipment due to our partnership with BioTek®. In addition to selling the BioTek® ELX808IU™ reader, our technical support department qualifies the instrument for compatibility with Endoscan-V™ software and the LAL test. Our onsite annual qualification of the instrument and software provides the assurance that it is operating correctly and fulfills the preventative maintenance requirements recommended by Charles River.
Your endotoxin detection platform requires testing software that generates accurate raw data analysis for reporting, tracking, and trending. Accurate and timely results are critical to ensuring your laboratory and manufacturing processes stay in a state of constant control. EndoScan-V is a validated endotoxin detection and measuring software used to generate and report quantitative LAL test data.
The endotoxin testing software performs requisite endotoxin calculations and generates secure data files and batch reports for product release as required by the FDA. All aspects of the software form the pillars of data integrity compliance according to 21 CFR Part 11: fully searchable audit trail, flexible user control and management, and reliable data generation and backup.
Charles River Cortex software
Charles River Cortex provides an integrated solution to securely consolidate, query, and analyze all real-time endotoxin test data for necessary internal QA and FDA trending reports. The decentralized, multi-client solution provides complete QA/QC instrument oversight. This allows remote PC access (with Cortex client software installed) to the same results database and server.
Customers can compile and manage data from any of the Endosafe rapid testing platforms, microplate readers, and tube readers into a unified data infrastructure to gain complete insight on their manufacturing operation and process in order to make informed, confident decisions.
Cortex allows users to proactively manage and monitor the operational integrity of the entire facility's endotoxin instrument equipment fleet including component effectiveness, calibration schedules, and system readiness within a single, end-to-end risk management environment. Cortex was designed in accordance with industry data integrity compliance guideline 21 CFR Part 11.