Case History: Manufacturer of Sents for Surgical Implants
Customer problem: Manufacturers of stents for surgical implantation. During manufacture a surfactant is used at one point but is later "flashed off" at 340 C. Customer needs to verify that all of the surfactant has been successfully removed by this procedure, and that stents are clean and ready for implantation.
What NHML did to solve the problem: We performed a solvent extraction on the stents and then analyzed the extract by Gas Chromatography-Mass Spectrometry. The resulting chromatograms showed surfactant peaks for all positive controls, no surfactant peaks for negative controls or for any of the actual test samples, thus verifying that all of the surfactant is removed by the 340 C flash off procedure.
Benefit to customer: QC department has proof as to the cleaniness of their medical devices
January 14, 2009 by Jeff Masse, Senior Chemist
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