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.
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 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.
Watch the video here.
Endosafe® nexgen-MCS™
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.
Watch the video here.
Advancing Endotoxin Testing with Robotics
Automation through robotics represents a new paradigm for bacterial endotoxin testing, streamlining QC processes and providing widespread operational benefits across many organizations. Since the launch of the first fully automated robotic Endosafe® Nexus™ in 2014, transformations in technology and innovation have inspired our Research and Product Development team to reimagine the next iteration of our automated endotoxin testing system.
The Endosafe® Nexus™ 200 is a fully enclosed, data integrity compliant, walkaway robotic instrument, capable of testing up to 120 samples per run and performing complex and serial dilutions via Endosafe® cartridge technology.
The advantages of implementing automation are no longer just for high-volume, large manufacturing organizations. Robotics help minimize variation, time, and resources of performing both laboratory and out of specification investigations. Improved agility and shorter testing times can reduce lead times for quality control labs by 60-70% and could eventually lead to real-time product releases. By using automated endotoxin testing designed for a GMP laboratory, lab analysts are free to perform high-value activities such as interpreting data, analyzing trends, and proactively addressing risks, all aspects that are highly stressed in Annex 1.
Introducing Endosafe® Nexus 200™ video.
- Streamlined automation: A fully automated, walkaway system that reduces manual intervention, enhancing operational efficiency.
- Integrated, secure design: Completely enclosed platform mounted on an integrated cabinet with locking door and caster wheel safety features
- Exceptional sample throughput: Increases sample throughput capability, testing up to 120 diluted and undiluted samples per run
- Complex dilution capability: Expertly handles complex serial dilutions for a broad range of testing requirements for water, in-process, and final product testing
- Adaptable testing compatibility: Supports both Endosafe® Trillium® rCR and FDA-licensed LAL cartridge technology for precise, quantitative results.
- Enhanced data protection: Reliable backup and restore features ensure the security of vital testing data.
- Seamless system integration: Facilitates improved traceability, security, and data management through LIMS integration.
- Adherence to data integrity standards: Meets global data integrity requirements with digital signatures, comprehensive audit trails, and robust user management.
- Continuous monitoring and control: Real-time tracking and trending enabled via Charles River Cortex™ software to maintain a complete state of control.
| Product | Code |
|---|---|
| Endosafe® Nexus™ 200 Robotic System | MR750020K |
| Next generation Nexus™ Platform | |
| Endosafe® nexgen-MCS™ | |
| 3 cartridge dispensers | |
| 6 20-position racks | |
| Endoscan-V™ software | |
| Cabinet |
| Feature | Endosafe® Nexus™ | Endosafe® Nexus™ 200 |
|---|---|---|
| Sample capacity per automation session | Maximum of 60 undiluted samples or 48 diluted samples | Maximum of 120 samples, diluted or undiluted |
| Dilution ratios | Simple dilution up to 1:300 | Serial dilutions up to 1:32,768 |
| Number of pipette heads | 1 | 4 (increases speed of sample handling) |
| Number of pipette tips | 96 per tip style (300μL and 1000μL) | Over 700 total tips (480-300μL and 288-1000μL) |
| Sample rack | 2 x 24 or 2 x 32 position racks | 6 x 20 sample tube racks |
| Bar Code | 1D barcode | 1D and 2D barcode options |
| Operating system compatibility | Windows 10 and 11 | Windows 10 and 11 |
| Controller | External PC | External PC |
| Application | Integrated Nexus™ 2.7 software | EndoScan-V™ version 6.2 and above |
| Hardware Configuration | Single benchtop configuration with baskets for waste | Closed unit with integrated cabinet, waste chute |
| Data Integrity features | Validated software with audit trails |
|
| Safety | Third party enclosure available for purchase |
|
Endosafe® PRS 3 Microplate Reader
The Endosafe ® PRS 3 microplate reader offers streamlined testing with existing Endosafe reagents from Charles River on a flexible platform. Users enjoy a seamless and intuitive user experience combined with the Endosafe ® EndoScan-V™ software version 6.2 and above. Paired with our premier global service and support network, our clients can confidently rely on a collaborative partner dedicated to providing solutions and helping customers achieve success.
Endosafe EndoScan-V
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.
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