Endotoxin Test

BURECO conducts turbidimetric or chromogenic kinetic Limulus Amebocyte Lysate (LAL) tests compliant with EU and U.S. guidelines. The test can be applied for release and in process control testing of active pharmaceutical ingredients (API) and final products, as well as for environmental monitoring. A project specific validation of the LAL test may be conducted as needed according to the relevant guidelines by inhibition and enhancement testing.

BURECO has established a proprietary extraction protocol to assess the endotoxin load of medical devices, e.g. implants. The method is capable to solubilise endotoxins bound to the surface of implants and detects concentrations below the requirement of 20 endotoxin units (EU) on the surface of metallic implants. This detection limit can usually not be reached by applying the standard LAL protocol for medical devices. BURECO’s LAL Test is validated and reaches a sensitivity of 0.01 EU/mL. BURECO offers a project specific validation of the method in accordance with the listed guidelines that enables testing of medical devices. Testing of samples can be performed under GMP compliance after a project specific validation.

The quantification of the endotoxin contamination on implants by BURECO´s LAL assay is based on a kinetic-turbidimetric measurement. The method is compliant with USP <161> Transfusion and Infusion Assemblies and Similar Medical Devices, the European Pharmacopoeia (2.6.14) and associated guidelines.