Portable Endotoxin Testing System
The Endosafe nexgen-PTS is a rapid, point-of-use handheld spectrophotometer. Supporting both Endosafe® LAL and Trillium™ recombinant cascade reagent (rCR) cartridges, it provides accurate and effortless endotoxin detection and glucan concentration determination. Its compact and lightweight footprint makes it optimal for small to mid-size pharmaceutical companies and compounding pharmacies requiring fast and simple testing right on the manufacturing floor.
The Endosafe nexgen-PTS exponentially elevates assay efficiency, offering dramatically faster run times than traditional methods, streamlined data entry, and reduced user variability. With user management functionality, it ensures compliance with 21 CFR Part 11, enhancing administrative control and maintaining high data integrity.
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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Whether you need to test water right at the sampling port, off-batch samples in the QC lab, in-process buffers, or STAT samples at the point of sample collection, the simplicity, portability, and reliability of the Endosafe nexgen-PTS can streamline your programs and accelerate your manufacturing quality control processes while preserving confidence in your testing method.
Check out the Endosafe nexgen-PTS Video
Did you know Endosafe LAL cartridges are a compendial BET method?
FDA-licensed Endosafe LAL cartridges are a kinetic chromogenic LAL method as specified in the Ph.Eur./USP and JP. See the regulatory requirements here:
FDA Guidelines
USP BET <85> or EP BET <2.6.14>
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PRODUCT CODES
Product Code Endosafe® nexgen-PTS™ instrument
Ethernet cable
One-year warranty
Power supply
USB cable adapter
StylusPTS150K Endosafe® EndoScan-V™ software M1260 -
ENDOSAFE® ENDOTOXIN TESTING CARTRIDGES
Endosafe® FDA-licensed LAL Cartridge Technology
Increase your speed, while decreasing variability.
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 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, curated to simulate 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
The Beta-glucan assay is a simple, 30 minute, in-process test that mimics kinetic chromogenic method by measuring color intensity. As glucans are known to cause false-positive results in the LAL test, our cartridges are used for investigational purposes to ensure that products do not contain (1,3)-β-D glucans.
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DATA INTEGRITY
As manufacturing and technologies evolve, regulators expect organizations to adopt robust systems with built-in features that inhibit data integrity failures and modern processes designed to reduce risk, such as human error. Traditional bacterial endotoxin tests using a duplication method to mitigate human risk, such as the "four eyes principle," are the least effective at preventing human error, while systems that employ a form of automation are less reliant on subjective data, leading to greater confidence in product quality, setting a new standard of excellence.
The user management function in the nexgen-PTS system allows for controlling user access and authority of how data is generated and stored enabling they system to be CFR Part 11 compliant ready.
Every action is recorded to ensure data integrity adherence with the searchable audit trail. Results are displayed on the LCD screen and can be exported via WiFi or Ethernet for printing and analysis in LIMS or Charles River Cortex™.
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TECHNICAL RESOURCES
Assay Guides
- FDA-Licensed LAL and nexgen-PTS Assay Guide
- rCR and nexgen-PTS Assay Guide
- Beta-Glucan and nexgen-PTS Assay Guide
- Inhibition and Enhancement (I/E) and nexgen-PTS Assay Guide
Case Study
Pfizer: Increasing Operational Efficiencies with the Endosafe System
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.
- TUTORIALS
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Frequently Asked Questions (FAQs) About Endosafe nexgen-PTS
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Is the Endosafe nexgen-PTS enabled for 21 CFR Part 11 compliance?
Yes, the Endosafe nexgen-PTS is 21 CFR Part 11 compliant-ready. However, it is up to the end user to ensure compliance.
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Are there additional instruments that utilize Endosafe cartridges?
Yes, we offer a suite of scalable Endosafe cartridge testing platforms, including the Endosafe® nexgen-MCS™, a multi-cartridge benchtop system ideal for more than 10 samples per shift, and the Endosafe® Nexus 200™, a fully automated robotic system capable of testing up to 120 samples and performing serial dilutions in a fully enclosed system.
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How is sensitivity determined for cartridges?
We supply cartridges 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].