Traditional endotoxin testing has long had pain points, including long turnaround times, extensive training, and multiple steps for assay preparation. To make matters worse, an invalid test result can potentially cripple your manufacturing timelines.
The Endosafe® cartridge technology is our innovative response to our customers’ need for higher sensitivity and faster quantitative 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 LAL methods while reducing time-consuming preparation and technician variability.
There’s no mistake that LAL is the gold standard for BET, and while conventional kinetic testing is a tried and trusted method, advances in science have allowed for improvement in how it’s utilized.
All of our highly flexible rapid testing platforms utilize our FDA-licensed cartridges as well as a variety of non-regulated cartridges for simple, 15-minute testing. The cartridges are pre-loaded with all of the reagents required to perform an LAL test, eliminating preparation of multiple reagents and reducing the opportunity for technician error.
FDA-Licensed LAL Cartridges
Our LAL cartridges use existing FDA-licensed Endosafe® chromogenic LAL reagent to measure color intensity directly related to the endotoxin concentration in a sample.
- Real-time quantitative endotoxin analysis in 15 minutes
- Proven USP/EP/JP-compliant BET method
- Licensed by the FDA in 2006 for in-process and final product release testing
- Detects between 0.005 and 10 EU/mL
Gram Identification Cartridges
Our Gram ID cartridge technology is a rapid assay that measures differences in the cell walls of microbial isolates. As a stain-free assay, the Gram ID cartridge eliminates procedure variability that occurs in traditional Gram stain determination.
- Reduces the need to subculture
- Capable of testing organisms <72 hours old
- Results in 3-7 minutes for Gram negative, Gram positive, and yeast and mold confirmation
The Beta-glucan assay is a rapid, in-process test designed for investigational purposes to ensure that products do not contain (1,3)-β-D glucans. Glucans are known to cause false-positive results in LAL assays, which could trigger an investigation.
- Designed to mimic kinetic chromogenic method by measuring color intensity
- Results in approximately 30 minutes
- Sensitivity range of 10-1,000 µg/mL
- The four reservoirs represent two pairs of sample and spike channels that allow the test to automatically run in duplicate. This design satisfies the harmonized USP/EP BET requirements for LAL testing.
- Each channel ends in an optical cell where the samples are analyzed by the reader. In the sample channels, the reader draws and mixes the sample with the LAL reagent.
- In the spike channels, the sample is mixed with the LAL reagent and positive control. Each sample is then combined with the chromogenic substrate and incubated.
- After mixing, the reader measures color intensity directly related to the endotoxin concentration and compares the reaction times to the ASC.
The human element can never be completely eliminated, but what can be done to mitigate errors and maintain your data’s integrity.