The use of 3D printed medical devices is a growing field, due to product customizability, short lead times, and ability to create devices not possible with traditional manufacturing techniques. Despite this trend, there has been little study of the chemical constituents of 3D printed medical devices. Since 3D printing processes often involve the application of heat and contact with printer components, the extractable and leachable profiles of final products may be altered in comparison to the profiles of the original materials.
To gain a better understanding of the chemical profiles of 3D printed materials, four different 3D printed materials were extracted and analyzed for organic, metal, and particulate matter impurities. High resolution mass spectrometry data generated from a Waters Xevo G2-XS QTof provided the most useful platform for identifying unknown analytes. Results indicate that 3D printing design has a measurable effect on the extractable/leachable profiles of devices, and that material selection and treatment are important considerations in the production of 3D printed medical products.
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Joel Rindelaub, Ph.D.
Pace Analytical Life Sciences
Joel Rindelaub is a Principal Chemist at Pace Analytical Life Sciences in Oakdale, MN where he developed an Extractable & Leachable testing program within a GMP-compliant laboratory, focusing on support for the medical device and pharmaceutical industries.
Joel has extensive experience with mass spectrometry applications and chemical characterization techniques, receiving a Ph.D. in analytical chemistry from Purdue University. In addition to method development, scientific education and journalism, Joel is also a successful researcher and continues to publish his works in peer-reviewed literature.
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