Extractable/leachable chemistry testing can save, time, money, and animal life for certain classes of devices. Over the past decade, regulatory bodies have shifted their evaluation of biocompatibility from a strict linear approach to a less linear approach that includes in vitro tests and assessment using chemistry. Chemistry has the advantage of providing detailed information on the identity and amount of substances that can leave devices, while traditional biocompatibility tests are pass or fail. The challenge with chemistry can be that a deeper understanding of device materials and the science of extractable/leachable testing is required to correctly interpret results. Fortunately, for those companies without expertise in using chemistry to fulfill regulatory requirements, help is available through consulting services. The following are three frequently asked questions when consulting on these matters.
Published Article
PUBLISHED ARTICLE
Top 3 Questions About Extractable/Leachable Testing
Published In: MD+DI online
October 3, 2016
Matthew R Jorgensen, Ph.D.
Chemistry and Materials Scientist
Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. To characterize materials, Dr. Jorgensen has extensively used a wide variety of techniques including GC/MS, LC/MS, FTIR, UV/VIS, SEM, NMR, and several types of advanced spectroscopic techniques. His Ph.D. in Physical Chemistry from the University of Utah was based on the fabrication and analysis of titanium dioxide and silicon dioxide photonic crystals templated from the three-dimensional structure found in the exoskeleton of exotic weevils. During his time at the University of Utah, he received the Henry Eyring Research Fellowship, the DOW Chemical First Year Scholarship, and additional grants to travel and present his research at national and international conferences. His research has resulted in over 30 peer-reviewed publications.
