We are happy to announce that the SYNLAB pharma institute is now ISO 17025 accredited for cytotoxicity of medical devices according to ISO 10993 and LAL test.
Lab testing for device registration and for routine monitoring of production with outstanding quality is provided. Clients are assisted in the decision process, finding the right strategy. Biocompatibility testing is performed in accordance with GMP, GLP and ISO 17025 and analytical services (according to ISO 10993) are offered for:
- Chemical characterization of materials
- Determination of Endotoxins
Besides that, extractables and leachables studies are performed for medical devices and packaging materials as well as ageing studies.
In addition, microbiological testing is provided for facility and product monitoring.