Evaluation of degradable materials

Development of product-specific test plans in accordance with relevant standards, including:

•     Test design
•     Test solutions and conditions
•     Number & dimensions of test specimens
•     Real-time and accelerated degradation

• Viscoelastic properties (rheology)
• Molecular weight (chromatographic, e.g., GPC)
• Optical evaluation (macroscopic/microscopic, e.g., SEM)
• Change in mass balance (gravimetry)
• Identity (e.g., MALDI-TOF-MS, LC-MS/MS, HPLC, XPS, FTIR, ICP-MS)
• Thermal properties (DSC)
• Mechanical properties (based on ISO 25539; rheology)
• Particle size & charge (DLS, zeta potential)

Detection of degradation products (based on DIN EN ISO 10993-13 and -15), including:

• Definition of suitable release parameters
• Degradation in simulated body fluids
• Separation & analysis (sample, fragments, solution)
• Release kinetics / active substance analysis (e.g., photometric, HPLC)

• Determination of in vitro cytotoxicity (based on ISO 10993-5)
• Evaluation of cell behavior
• Histological analysis