You will benefit from a detailed discussion on extractables and leachables testing concepts of packaging and materials used in pharmaceutical processes to hands-on experience demonstrated by several case studies. The seminar will also include strategies and practical examples of the identification of impurities and the investigation of material failures

Definitions, regulatory requirements and the basics of polymer stabilization and degradation • Concepts for designing and executing extractables and leachables studies of container closure systems • Illustrative examples including printing and adhesives, pharmaceutical interaction studies, barrier effects of packaging materials, and more. • Case studies of different types of materials including plastics, rubbers and inks as potential sources of extractables/leachables • Suitable techniques such as spectroscopy and surface analysis for the identification of unknown impurities and for material failure investigations • Case studies demonstrating successful strategies employed in the field of extractables and leachables