Matthew DiPrima & James Coburn, US Food & Drug Administration
Additive Manufacturing (AM) has enabled medical device manufacturers to produce highly intricate and patient-matched devices more easily than in the past, leading to an increase in research interest and marketed AM medical products over the last decade. These intricate internal features and porous solids have particularly increased the consideration needed for processes such as cleaning. To be suitable for patient contact or implantation support materials, manufacturing residues, and debris must be sufficiently removed using pre-determined acceptance criteria for cleanliness of that AM device. These challenges are specific to the device and geometries produced, as well as the AM technique used. Test parts have been produced to characterize the resolution and build capabilities of 3D printers, but no test part has specifically challenged cleaning protocols with complex geometries relevant to AM medical devices. Ongoing research has designed a cleaning challenge part that mimics several relevant geometric features for medical devices. Preliminary tests have shown that it can be used to assess cleaning effectiveness and differentiate between cleaning cycles.