Pyrogen testing methods have been successfully inspected by the Regierungspräsidium Tübingen as GMP compliant (Regional Council Tübingen)
TentaMedix GmbH is pleased to announce the extension of its GMP relevant testing portfolio. Already in the year 2019, TentaMedix GmbH received the official certificate of recognition from the ZLG and the listing as an officially recognised testing laboratory for medical devices in accordance with the requirements of Directives 93/42/EEC, 90/385/EEC, and DIN ISO/IEC 17025 for biological and microbiological testing of medical devices.
The extension of the GMP compliant portfolio now also includes the methods already accredited by ZLG for in vitro testing for bacterial endotoxins using the Limulus amebocyte lysate test (LAL; Ph. Eur. 2.6.14; methods C & D) as well as detection for pyrogens using the monocyte activation test (MAT; Ph. Eur. 2.6.30) for medicinal products.
Managing Director Dr. Dominik Herzog commented: “The extension of the GMP testing methods is a great achievement by every single employee of our contract laboratory. Our focus remains on the 3Rs (reduce, replace, refine) to reduce the number of unnecessary animal experiments. Implementing additional testing methods helps us to investigate the biosafety of medical devices and drugs for manufacturers and ultimately for patient safety.”
The authorised signatory of TentaMedix GmbH Dr. Wolfgang Rudy is also pleased: “Having the pyrogenicity tests GMP compliant is a great success. Now we can also carry out drug testing in this area in addition to medical devices. We are constantly working on improving ourselves. For example, we are planning to expand the existing ISO 10993 services to include the in vitro micronucleus test. In combination with the already accredited AMES test, we will be able to completely offer the required in vitro genotoxicity testing of ISO 10993-3 or ISO 10993-33 in the near future.”
TentaMedix GmbH already offers a wide range of ISO 17025 accredited and ZLG recognised test methods for biocompatibility testing according to ISO 10993 for medical devices. With the extension of the GMP compliant portfolio, TentaMedix GmbH further establishes itself as a relevant testing laboratory for medical devices and pharmaceuticals.
Would you like to learn more about TentaMedix‘ services? Please feel free to contact our expert directly, we will be happy to support you.
Dr. Nicolas Danylec
Sales & Marketing TentaMedix GmbH
+49 721 957 919 531