Volume 3, Issue 5 (May 2006)
Residue Analysis on Implants
Process agent residues on implant surfaces have become the center of attention after implant failures that were clearly attributed to problems of contamination and cleanliness during manufacturing. The success of modern implants depends strongly on the quality control after manufacturing since a minor degree of contamination may generate increased inflammation of the wound. Therefore, process and quality control requires tools to identify and quantify contaminations on implant surfaces. We evaluated a series of analytical methods, including gas chromatography and mass spectrometry analysis, thin layer chromatography, total organic carbon, and x-ray photoelectron spectroscopy, regarding their suitability for the different type of residues. The focus was put on extraction of soluble non-polar organic agents and subsequent analysis. All methods were assessed with internal standard contamination oil that contains a variety of surface-active agents used in common commercial cutting oils and emulsions for medical device machining.