Materials Science and Analytical Challenges in Biomedical Product Development
Dr. D. Chuck Dunbar, Sr. Scientist III, Alcon Laboratories
Materials used in the products, packaging and the manufacture of pharmaceuticals and biomedical devices introduce many challenges in their development. There is increased awareness of the unintended health effects attributed to unintentional exposure to toxic compounds. As the sensitivity of analytical techniques improves, the regulatory requirements for the approval of new products have also become more stringent. An overview of the applicable regulations will be presented as well as real world examples of analytical challenges in biomedical product development.