BACTERIAL & ENDOTOXIN TESTING
The Bacterial Endotoxins Test (BET) is an in-vitro assay for detection and quantitation of bacterial endotoxins, a component of the cell wall of Gram negative bacteria. The BET is performed as part of the lot release testing for medical devices with direct or indirect contact to the cardiovascular system, lymphatic system or cerebrospinal fluid. Injectable pharmaceutical products must also be tested for bacterial endotoxins. Routine monitoring of water systems and incoming materials can help to ensure that the process does not contribute endotoxins to the final product.
There are three methods for this test:
Method A. The gel-clot technique, which is based on gel formation
Method B. The turbidimetric technique, based on the development of turbidity after cleavage of an endogenous substrate
Method C. The chromogenic technique, based on the development of color after cleavage of a synthetic peptide-chromogen complex
The test is carried out in a manner that avoids endotoxin contamination.
We provide these options from a source company with FDA-licensed products for rapid and traditional bacterial endotoxin testing. In this case, it decreases repeated tested and you will be sure about the safety of your products.