What is endotoxin testing
Endotoxin testing is an important part of quality control for medical devices. We perform endotoxin analyses for your specific samples according to the European Pharmacopoeia chapter 2.6.32.
Endotoxins are highly pyrogenic bacterial structural components that can trigger immune responses. Because of its toxic effect, endotoxin testing is a fundamental safety requirement in the biomedical field. Ocean TuniCell offers endotoxin analysis via the PyroGeneTM Recombinant Factor C Endpoint Fluorescent Assay – a sustainable method that allows endotoxin detection in the range from 0.005-5 EU/ml.
The assay does not require using extract of blood cells from the horseshoe crabs. Hence, we contribute to the conservation of these marine organisms. Sustainability and conservation of marine life is a core value here at Ocean TuniCell.
How does it work?
Ocean TuniCell AS follows the European Pharmacopoeia guidelines for endotoxin analysis. Both the equipment (PyroWave™ XM Fluorescence Reader, Lonza) and kit (PyroGene ™ Recombinant Factor C Assay, Lonza) used for this service are certified and validated to follow the required quality standards for endotoxin testing. The customers are responsible to follow the regulations and pharmacopoeias of their country of interest. After the analysis has been completed for the selected samples, a report will be sent by email giving an overview of the assay setup, reagents used, and explanation of results from the analysis. The report serves as a helpful tool for future endotoxin analysis, and the documentation can be used and shared as required for QA and certifications.
Please contact us in the form below, and we will help you with setting up an endotoxin analysis for your samples.