Testing for bacterial endotoxins is regulated considerably less precisely for medical devices than the corresponding investigations for drugs or raw materials that are described in the Pharmacopoeias.
However, endotoxins can find their way into medical devices during the manufacturing process. It is therefore in the interest of every manufacturer to guarantee patient safety by performing appropriate monitoring.
As there are few binding regulations from the legislature, it is even more important that methods are developed and validated in close collaboration between the customer and the service laboratory and that their routine analysis are established.
Would you like to know which tests are suitable for your products?
We are a GMP-accredited and ISO 17025 certified contract laboratory in Switzerland with many years of experience in the testing of medical products. We would be pleased to provide support for any of your questions