Identification of Contaminants in Medical Devices
When an unknown material is suspected in a medical device, manufacturers need to know the source of contamination. Medical device contamination projects may involve the determination of components at low concentrations such a ppm or ppb levels.
A strategic technical approach is required to identify the unknown device contamination by using a comparison study between a control and suspect sample. The technical approach is dependent on the sample matrix and the suspected level of contamination. Often, we start with a general screen of the control and suspect sample using GC/MS and LC/MS. Depending on the test results, we may need to isolate the contaminant from a large amount of sample to allow analysis using FT-IR and NMR spectroscopy. Once identification is complete, we can further quantify the contaminant in the sample matrix.
Medical device contamination identification projects have involved foreign particles, trace metals, and degradants. Some sources of contaminants have been from the medical device manufacturing, production process, or degradation. We work closely with our clients to trace the source of contamination and develop a realistic corrective action program.
