Stability tests are used to check how a diagnostic/pharmaceutical product changes under certain conditions (temperature, humidity, light, storage conditions, freeze-thaw process, matrices ...) over a certain period of time.
Biomex plans and implements stability studies for assays and samples, taking into account the EP25 guidelines of the Clinical and Laboratory Standards Institute (CLSI) and the stability aspects listed in Annex II, Section 6.3 of the IVDR, such as the shelf life of the product, the shelf life (e.g. of the reagents) after opening, the transport stability and storage conditions.
Biomex also provides services for determining and checking calibration stability, onboard stability, as well as module and device precision. Contact us!