Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion
This standard provides a guide for validating cleaning processes performed on additive manufactured parts. Techniques we offer include extraction of residual particles, morphological characterization, composition analysis and total particulate quantity estimation. Samples are processed through ultra-sonication in an appropriate extraction fluid to loosen and remove any manufacturing particulate. This extraction fluid is then filtered to isolate the particles for further analysis. Using custom, automated particle characterization, particle parameters (area, aspect ratio, form factor, roundness, length, perimeter, ferret average and equivalent circular diameter) are measured. Using SEM-EDS, a compositional analysis may be performed on a selection of particles to verify composition. Quantity of total particulate can also be estimated by performing counts on the filtered particles.