Multi-Cartridge Endotoxin Testing System
The Endosafe® nexgen-MCS™ supports the ability to test multiple endotoxin samples at once, via both Endosafe® LAL and Trillium™ recombinant cascade reagent (rCR) cartridges. The benchtop system houses five individual spectrophotometers in a single unit and is capable of testing 5 samples in approximately 15 minutes, reducing downtime by allowing random access of samples by not having to wait for a full batch before testing. Linked through a single Ethernet connector, the system is powered through an external PC with our 21 CFR Part 11 compliant-ready endotoxin measuring and analysis software, Endosafe® EndoScan-V™.
Speed and Efficiency
- Simultaneously test up to 5 samples for higher throughput testing
- Run samples independently allowing for random access and less delays
- Real-time, quantitative endotoxin detection results in 15 minutes
- Simple and easy to use technology that requires no microbiology training
Robust Flexibility
- Supports both LAL or Trillium recombinant cascade reagent (rCR) cartridges
- Quantitative range of 0.5 to 0.005 EU/mL, 1 to 0.01 EU/mL, and 5 to 0.05 EU/mL for Endosafe Trillium rCR cartridges and four levels of sensitivity 0.005, 0.01, 0.05 and 0.10 EU/ml for Endosafe LAL cartridges
- System qualification and validation support is available
Data Integrity Compliance
- Powered by EndoScan-V endotoxin measuring software for analysis (version 5.5.5 or higher)
- Sophisticated endotoxin detection data management and reporting capabilities
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DATA INTEGRITY
The nexgen-MCS runs with version 5.5.5 or higher, our FDA 21 CFR Part 11 compliant-ready endotoxin measuring software. Data integrity-enabling features include: secure data records with digital signatures, automated data backup for easy recovery, and detailed audit trails for investigation
Find out more about EndoScan-V to increase your confidence in the accuracy and security of your release testing data.
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PRODUCT CODES
Product Code Endosafe® nexgen-MCS™ instrument
Power supply
Ethernet cable
One-year warrantyMCS150K Endosafe® nexgen-MCS™ package
nexgen-MCS™ instrument
EndoScan-V™ software
Power supply
One-year warranty
Ethernet cableMCS650K EndoScan-V™ software M1260 -
ENDOSAFE® ENDOTOXIN TESTING CARTRIDGES
Increase your speed, while decreasing variability.
Endosafe cartridge technology is our innovative response to our customers’ need for higher sensitivity and faster quantitative LAL testing results. Refined to optimize and minimize the use of LAL, cartridge technology eliminates a significant amount of the raw materials and test consumables required for traditional endotoxin testing methods, all while reducing time-consuming preparation and technician variability.
Each cartridge contains precise amounts of our FDA-licensed Endochrome-K™ chromogenic 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 Ph.Eur.<2.6.14> for LAL testing.
Each 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.
Endosafe® Trillium™ rCR Cartridges
Our rCR test cartridges are powered by a 3-factor enzymatic cascade, by simulating the natural LAL reaction from the Limulus polyphemus species. The formulation and composition of Trillium includes the 3 critical biological proteins (recombinant Factor C, recombinant Factor B, and recombinant proclotting enzyme) and a specific concentration of key components.Beta-Glucan Cartridges
Glucans are notorious drivers of interference and false positives. Our Beta-Glucan cartridges employ a simple 30-minute kinetic chromogenic assay to detect these problematic (1,3)-β-D substances during method development.
Are you confident that you are using the best BET method to reach your organization's goals?
With companies looking for ways to increase their data integrity compliance and operational efficiencies, simply answer these 5 questions to see which endotoxin test method is best for your organization’s testing requirements.
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Frequently Asked Questions (FAQs) About the Endosafe nexgen-MCS
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When would you use Endosafe nexgen-MCS over a Endosafe nexgen-PTS™ for endotoxin testing?
Both the Endosafe nexgen-MCS and the Endosafe nexgen-PTS utilize Endosafe cartridge technology for endotoxin testing. However Endosafe nexgen-MCS is a better option for a processing up to 5 samples at once. Endosafe nexgen-PTS can process only one sample at a time.
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How many product samples can you run on Endosafe nexgen-MCS per 8-hour shift?
Endosafe nexgen-MCS can run at least 120 samples depending on sample composition and sensitivity in an 8-hour shift if continuously running.
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Is the LAL cartridge technology utilized by Endosafe nexgen-MCS a compendial method?
The LAL cartridge technology utilized is a kinetic chromogenic method which is a compendial method per the USP<85> or Ph.Eur.<2.6.14>.
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What is the difference between the Endosafe-MCS and the Endosafe nexgen-MCS?
The Endosafe nexgen-MCS is the next generation of the Endosafe-MCS. While both utilize Endosafe cartridge technology, the Endosafe nexgen-MCS is able to store all assay information for data integrity compliance and has advanced optics that help the sample to center in the optical well to ensure accurate readings.
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How is sensitivity determined for cartridges?
Cartridges are offered with various sensitivities as the level of endotoxin that is allowed in specific products vary. Your choice of cartridge sensitivity will depend on the type of sample being tested, the endotoxin limit, and level of interference (how much dilution is required). The Charles River Technical Support Team is here to help you choose the correct cartridge sensitivity. Please reach out with any questions: [email protected].