|
Leachates which simulate body fluids can be tested for a variety of impurities using ICPMS for trace metals and GC, HPLC, GCMS, and IC for monomers, solvents, polymer additives, and other contaminants. In one project WCAS determined the leachability of a precious metal component encapsulated in silicone. In another, solvents used in assembling IV units were determined in IV saline. Test methods are developed, validated, and documented for FDA review. |
