Bacterial Endotoxin / LAL Testing
Lucideon provides comprehensive endotoxin testing services using the Kinetic Turbidimetric Method, a highly sensitive test using Limulus Amebocyte Lysate (LAL). This method detects endotoxins, the fever-inducing components known as pyrogens. Endotoxins most often originate from the cell walls of gram-negative bacteria but are also found as leachates from certain chemicals and materials.
Endotoxin testing is essential to ensure product safety and regulatory compliance of healthcare products and medical devices, where contamination can lead to severe responses in the end user.
How the Kinetic Turbidimetric Method Works
The Kinetic Turbidimetric Method is one of three established LAL methodologies (alongside gel-clot and chromogenic methods). This method monitors an increase in turbidity as endotoxins react with LAL reagent derived from the blood of the horseshoe crab. The presence of endotoxins triggers a clotting response that causes a measurable increase in turbidity that is proportional to the concentration of endotoxins.
This approach is extremely sensitive and is capable of detecting very low endotoxin levels, making it suitable for rigorous pharmaceutical and medical device standards.
Applications of Endotoxin Testing
Endotoxin testing is a critical safety assessment for a range of products including, but not limited to:
- Parenteral medicines - drugs administered by injection
- Irrigation fluids and dialysis solutions - sterile solutions used directly in or around the body
- Medical devices - those that come into direct or indirect contact with blood and body tissues
- Purified water - a crucial component in many pharmaceutical and medical processes
Our endotoxin tests are conducted in line with the European Pharmacopoeia 2.6.14 and United States Pharmacopoeia (USP) 85.
Using an extraction process, our testing detects any endotoxins that may have adhered to device surfaces or entered solutions throughout the manufacturing process.
Why Choose Lucideon?
Our endotoxin/LAL testing services offer reliable, pharmacopoeia-compliant analysis to ensure your products are safe and comply with industry regulations. Key benefits of our solutions include:
- Compliance and accuracy: with expertise in pharmacopeial methodologies, Lucideon delivers trusted results that align with Ph. Eur., USP, and JP standards
- High sensitivity: our testing can detect low levels of endotoxin, even in highly diluted solutions to ensure precise results
- Partnership: at Lucideon we don't simply provide you with analytical results, we work with you to truly understand the results and their meaning
Ensuring your products are endotoxin-free is essential for product safety and regulatory compliance. Partner with Lucideon to access endotoxin testing solutions tailored to your needs. Contact us today to learn more about how our endotoxin testing can support your product development.