Simply Sustainable Endotoxin Testing
Keeping pace with an industry characterized by progressive change, we continue to challenge the limits of conventional thinking and testing. Twenty years ago, our scientists pursued a vision of streamlining and optimizing the labor-intensive process of detecting pyrogen producing Gram-negative bacterial endotoxins through the design of our microfluidic Endosafe® LAL cartridge technology. Transforming benches and labs all over the world, the flagship proprietary technology eliminated much of the time, training, raw materials, and accessories by fusing all the essential components into a single disposable cartridge, to provide highly precise, real-time, quantitative endotoxin analysis.
Fast forward to today and elevating that approach, the next iteration integrates Endosafe Trillium recombinant cascade reagent (rCR) into the paramount cartridge technology to produce a rapid, animal-free solution to further propel the industry into the future of sustainable, quality control testing.
Endosafe® Cartridge Technology
This brochure provides detailed insights on endotoxin testing techniques, offering more streamlined, rapid, and precise solutions compared to traditional methods.
Simplify your BET
Synthesized and Simplified →
- Powered by a 3-Factor enzymatic cascade, curated to simulate the natural LAL reaction from the Limulus polyphemus species
- Eliminates the potential for 1,3-B-D-glucan induced false positives
- Reduces manual pipetting, diluting, reconstituting steps, and consumables which requires less glassware, plastic accessories, and eliminates reagent waste
Real-time, Robust Results →
- Delivers rapid, quantitative kinetic chromogenic rCR results in approximately 15 minutes
- Quantitative range of 0.5 to 0.005 EU/mL, 1 to 0.01 EU/mL, and 5 to 0.05 EU/mL
- Seamless integration with our existing suite of scalable, automated, Endosafe cartridge technology platforms
- Utilizes an archived standard curve, reducing human error in standard curve preparation
"We are diligently working on our sustainability initiatives and are very pleased that we’ll be able to offer an alternative to the horseshoe crab derived LAL with Endosafe Trillium rCR for our customers. The samples we test contain compounds that cause inhibition with the LAL test. However our experience with trialing Endosafe Trillium has reduced the inhibition, allowed us to remove the use of buffers in the assay, and work at a lower dilution. It’s great that both the Trillium rCR cartridges and vials can be used as a direct replacement for the traditional LAL with no need for additional equipment, training, or reagents."
Senior Microbiologist, Sub-contract Medical Device Testing Laboratory, UK
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Additional Testimonials
Using the Endosafe® Trillium™ rCR cartridges alongside our routine testing was straightforward for our technicians, as the test method remains identical, and the results are reported the same way. We were pleased with the technology implementation, quality of data, and onboarding as it was simple and seamless, which is ideal when introducing such an impactful change in the microbiology lab. We look forward to moving to Endosafe® Trillium™ rCR cartridges for routine testing later in the year as part of our environmental sustainability efforts.”
Greg White, Microbiology Laboratory Supervisor & Blackpool STEM Lead, DePuy Synthes International
The launch of Charles River’s Endosafe® Trillium™ cartridge revolutionizes the way the industry approaches endotoxin testing while strengthening our united commitment to sustainability initiatives."
Birgit Girshick, Corporate Executive Vice President & Chief Operating Officer, Charles River
Endosafe® Trillium™ rCR Technical Report
To further demonstrate the robustness and validity of our Trillium rCR matrix and formulation, we published a technical report detailing the results of our comprehensive beta test study program. The report highlights assay equivalency to our FDA-licensed kinetic LAL assay via our primary alternate method validation.
Download the Report
Engineered for an Effortless Endotoxin Testing Experience
The design of the cartridge technology was tailored around simplicity, flexibility, and sustainability. That approach continues with the integration of Trillium, elevating and aligning our sustainability mission with our customers. Endosafe cartridges significantly reduce the burden of creating a standard curve and sample preparation by eliminating the need for costly specialized training and excessive consumables, driving sustainability through operational efficiency.
Cartridge Functionality
- The four reservoirs represent duplicate sample and spike channels that allow the test to automatically run in duplicate as is the requirement for standard BET testing
- In the sample channels, the reader draws and mixes the sample with the rCR reagent
- In the spike channels, the sample is mixed with the rCR reagent and positive control
- Each sample is then combined with the chromogenic substrate drawn into the optical cell and incubated
- Each channel ends in an optical cell where the samples are analyzed by the cartridge instrument
- The instrument measures color intensity directly related to the endotoxin concentration and compares the reaction times to the archived standard curve
Replace, Reduce, Refine: Achieving Sustainability
Today, organizations worldwide are pursuing animal-free options to ensure the longevity of their supply chains and business operations while maintaining a strong commitment to corporate citizenship.
Discover our Dedication
A Step-By-Step Process to Validating rCR Endotoxin Testing
In this webinar you'll learn how we beta tested and validated our animal-free Endosafe® Trillium™ recombinant cascade reagent (rCR) to surpass even the most stringent sustainability standards, setting the bar in QC for endotoxin testing and easy implementation.
WATCH NOW
Additional Support and Product Information
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Alternative Method Validation Support
As with our original Trillium reagent, Trillium cartridges are recognized as a cogent alternative testing method to traditional, compendial endotoxin testing methods. Regulators expect to see a full alternative method validation and its relevant data for review before approval is given. We provide a pathway to faster submission and implementation with a validation support package that includes protocols and a primary validation summary report. With over 40 years of endotoxin testing, troubleshooting, and methods development experience, our skilled technical teams are an extension of your team, providing guidance and support throughout your implementation.
- Validation documentation: including protocols and a validation summary report
- Contract testing services: Trillium rCR interference screen and product specificity
- Technical teams: experience in successfully validating alternative microbiological methods (Celsis®)
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Product Codes and Ordering Information
Product Type Description Product Code Multi-packs of 25 Trillium™ rCR cartridges
(5/pouch)Standard Curve Range: 1 to 0.01 EU/mL RCRC5501 Standard Curve Range: 5 to 0.05 EU/mL RCRC5505 10 single packs of Trillium™ rCR cartridges Standard Curve Range: 0.5 to 0.005 EU/mL Inquire for Product Code Standard Curve Range: 1 to 0.01 EU/mL RCRC3001 Standard Curve Range: 5 to 0.05 EU/mL RCRC3005 Documentation Primary Validation Documentation performed on Trillium™ rCR Cartridges VALRCR3200 Contract Testing Services One Sample Interference Screen TSRCR3500 One Batch Product Specificity, includes interference screen TSRCR3601 Three Batch Product Specificity, includes interference screen TSRCR3603 One Batch Precision and Accuracy TSRCR3800
Best Practices for rCR Vial and Cartridge Adoption
Uncover how to standardize your testing, reduce invalid results, and stay compliant with Trillium™ recombinant cascade reagents (rCR) vials and cartridges.
View the Guide
Frequently Asked Questions (FAQ) for Endosafe Trillium rCR Cartridges
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Which endotoxin testing instruments can be used with Endosafe Trillium cartridges?
We offer several highly flexible rapid testing platforms to meet the needs of a variety of sample throughputs and different lab sizes and configurations. All Endosafe instruments support the same test cartridges for accurate, convenient, and real-time endotoxin testing, and glucan concentration determination.
- Endosafe® nexgen-PTS™ for point-of-sample testing
- Endosafe® nexgen-MCS™ for higher sample throughput
- Endosafe® Nexus 200™ for the central QC lab
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How do I store Endosafe Trillium cartridges?
Store cartridges between 2 – 25° C. Do not open the pouch until you are ready to use the cartridge. If using a pack that contains more than one cartridge, be sure to keep the pouch sealed between uses.
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Do I need any special reagents to run my sample with Endosafe Trillium cartridges?
In most cases just the sample and water for BET will be needed. Some samples may require buffers or other intervention to overcome interference, as determined during the test for interfering factors. Most samples require dilution in water for BET to overcome interference.
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How is sensitivity determined for the Endosafe Trillium cartridges?
We supply Trillium cartridges with different 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 to [email protected].
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What software do you need to run Trillium Cartridges?
Use of Nexgen 11.1.1 or above is mandatory for Trillium cartridge technology.