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

• An overview of definitions, regulatory requirements and the basics of polymer stabilization and degradation • The concepts for designing and executing extractables and leachables studies of container closure systems • A discussion of the benefits of extractables and leachables testing for understanding the influence of materials used in (bio)pharmaceutical processes • Case studies of different type of materials like plastics, rubbers and inks as potential sources of extractables/leachables • A discussion of suitable techniques like spectroscopy and surface analysis for the identification of unknown impurities and material failure investigations •Case studies demonstrating successful strategies employed in ‘real world’ impurity and failure investigations