Compendial FDA-Licensed Kinetic Chromogenic LAL Cartridges
Traditional endotoxin testing has had a history of pain points, including long turnaround times, extensive training, and multiple steps for assay preparation. To make matters worse, an invalid LAL test result can potentially cripple your manufacturing timelines.
The Endosafe LAL cartridge technology is the innovative response to the need for a more precise, objective, and faster quantitative results in the kinetic chromogenic method. A novel technology designed to optimize and refine the usage of LAL, our Endosafe LAL cartridges utilize 95% less horseshoe crab raw material and accessories than gel-clot and KTA methods. The disposable cartridges contain precise amounts of our FDA-licensed chromogenic LAL reagent, chromogenic substrate, and controls needed to measure color intensity directly related to the endotoxin concentration in a sample and obtain rapid, accurate results.
Endosafe LAL Cartridges Are a Compendial BET Method
FDA-licensed Endosafe LAL cartridges are a kinetic chromogenic LAL method as specified in the EP/USP. See the regulatory requirements here:
FDA Guidelines
USP BET <85> or BET <2.6.16> and Ph.Eur. <2.6.14>
Automatically performing a duplicate sample and positive product control, they satisfy 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.
As the cartridges are pre-filled, they eliminate the manual daily preparation of standards and reagents. Consolidating all the essential components in a self-contained cartridge reduces pipetting steps, decreases assay variability, cross-contamination, false positive risk, and retest rates.
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
Designed to optimize and refine our use of LAL, the FDA-licensed cartridge technology uses 95% less amount of the raw material and accessories than the traditional LAL testing methods while reducing time-consuming preparation and technician variability.
Is Your BET Program Sustainable?
We recognize every organization has their own directives on how to embrace the 3R principles while ensuring product quality and patient safety. Our extensive portfolio has transformed the way we approach endotoxin detection, each offering their own degree of sustainability while allowing us to further optimize our resources to reduce reliance on the horseshoe crab.
Go Animal-Free
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Engineered for versatility and precision
- Real-time quantitative endotoxin analysis in 15 minutes
- Scalability for our single sample nexgen-PTS™, 5-sample nexgen-MCS™, and fully automated Nexus 200™ Robot
- Proven USP/EP/JP-compliant BET method
- Built in archived standard curve to eliminate complexities
- FDA-licensed for in-process and final product release testing
- Detects between 0.005 and 10 EU/mL
- Reduction in manual pipetting, diluting, reconstituting steps, and accessories, reducing plastic usage and reagent waste
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Markets and Applications
In-process sample testing Biomedical products Final drug product testing Planetary protection (NASA) Dialysis water testing Compounded pharmaceutical products Stem cell materials R&D samples for in vivo studies Pharmaceutical water systems Environmental monitoring Cleaning validations Process validation Blood products Cell culture Cell & gene therapies STAT, PET & nuclear medicine samples MRNA Implantable medical devices -
Test Procedure
- Pipette 25 μL of a sample into each of the four sample reservoirs of the LAL cartridge
- Insert the cartridge into a Endosafe cartridge technology platform and press begin the test
- The system draws and mixes the sample with the LAL reagent in two channels (the sample channels) and the LAL reagent and positive product control in the other two channels (the spike channels)
- The sample is incubated and then combined with the chromogenic substrate
- After mixing, the optical density of the wells are measured and analyzed against an internally archived standard curve
- The quantitative results are then displayed within the software in approximately 15 minutes
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Product Codes
Product Type Description Product Code Multi-packs of 25 LAL test cartridges
(5/pouch) (FDA-licensed)Standard Curve Range: 1 to 0.01 EU/mL PTS5501F Standard Curve Range: 5 to 0.05 EU/mL PTS5505F 10 single packs of LAL test cartridges
(FDA-licensed)Standard Curve Range: 0.5 to 0.005 EU/mL Inquire for Product Code Standard Curve Range: 1 to 0.01 EU/mL PTS2001F Standard Curve Range: 5 to 0.05 EU/mL PTS2005F Standard Curve Range: 10 to 0.1 EU/mL PTS201F 10 single packs of inhibition/enhancement screening cartridges* PTS220 Blank Cartridges (quantity 2) (not licensed by the FDA) PTS200 * Inhibition/enhancement screening cartridges are not licensed by the FDA