An Overview of Risk Assessment Strategies for Extractables and Leachables - The author describes several approaches for risk assessment of extractables and leachables. - BioPharm International


An Overview of Risk Assessment Strategies for Extractables and Leachables
The author describes several approaches for risk assessment of extractables and leachables.

BioPharm International
Volume 25, Issue 1, pp. 39-45


As scientific progress continues to be made, methodologies are advanced, sources are better controlled, materials improve, and processes are upgraded and better measured and controlled, the best practice to assess the risk of leachables will further evolve. Science and understanding are not static. However, the fundamental understanding of all the technical issues regarding leachables and toxicological safety will continue to be applied to achieve a knowledge-based risk assessment.

Thomas E. Stone, PhD, is a principal scientist in the analytical technologies group at EMD Millipore,


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