Analytical Services : In Vitro / In Vivo
The goal of shelf life stability studies is to obtain objective evidence that the absorbable device/component maintains its mechanical and physical properties over a selected period of time (typically ≤ 3 years). The main output of this type of testing is an expiration date. Typically both real-time (25C @ 40% RH) and accelerated aging (40C @ 65% RH) conditions are tested against the release specification.
For absorbable polymers, in-vitro degradation studies are imperative to analyze the change in material properties in a simulated and controlled environment. ASTM standards, such as ASTM F1635, are followed to characterize the degradation rates and changes in material, and physical properties. Any of the tests above can be modeled to characterize material loss profiles. Common test modes include mass loss and strength loss over time.
In Vivo studies may be performed in conjunction with Godley-Snell Animal Research Center. This often includes feasibility trials to determine tissue response of an implanted device, or degradation kinetics of a prototype in various small animal models.