October 12, 2017

Leachable Studies of Medical Devices in Complex Biological Environments


 Thursday, October 12, 2:10 p.m. EST

Adam Kozak, a senior research scientist at Cambridge Polymer Group, presents "Leachable Studies of Medical Devices in Complex Biological Environments" at Eurofins Lancaster Laboratories' Extractables and Leachables Symposium for Drugs and Devices in Pennsylvania.

Detailed Extractables/Leachables Studies

Extractables and leachables studies usually follow a two-step program. In the first step, an exaggerated extraction is conducted using simple solvent conditions more aggressive than those anticipated to be realized in a clinical setting in order to determine to determine the complete extraction profile and to identify the potential extraction compounds, desired or undesired. In the second step, a leaching study is conducted that attempts to simulate the clinical environment of the target application. The simulated leaching environment often comprises a more complex biological matrix than those used for extraction, which in turn complicates the chemical analysis assays used to identify and quantify the leaching materials. In this presentation, we show examples of studies that required a more detailed testing assay to identify and quantify compounds coming from implanted medical devices.



Adam Kozak specializes in the chemical and mechanical analysis of polymer materials and medical devices. He has substantial experience in the use of gas chromatography-mass spectroscopy (GC-MS) for leachables and extractables analysis, trace impurity/contaminant analysis, residual monomer content, unknown compound identification, migration levels, deformulation, and odor analysis by headspace GC-MS and other chromatographic techniques.