Qualification d'un procédé d'impression 3D résine pour la fabrication de guides chirurgicaux en laboratoire de proximité clinique : Caractérisation dimensionnelle, mécanique et physico-chimique

Details

Supervisors

Herman, Benoît

Faculty

Ecole polytechnique de Louvain

Degree label

Master [120] : ingénieur civil mécanicien, à finalité spécialisée
Master [120] : ingénieur civil mécanicien, à finalité spécialisée

Abstract

enThe rise of vat photopolymerisation 3D printing technologies, combined with the growing availability of medical-grade resins, is opening the way to the on-site production of personalised surgical devices within healthcare facilities. Realising this prospect in the form of a point-of-care 3D printing laboratory (PoC3DPL) nevertheless requires demonstrating that the resin/desktop 3D printer pairing, implemented within a controlled workflow, meets the safety, performance and accuracy requirements expected of a medical device. This thesis sets out to characterise such a workflow, built around the Loctite MED3394 White Sterilizable resin and the Anycubic Photon Mono M7 Max LCD printer. The approach is framed by Regulation (EU) 2017/745 (MDR) and draws on the applicable harmonised standards (ISO 10993, ISO/ASTM 52900:2021, ISO 527, ISO 178:2019) as an analytical framework, without claiming to constitute an industrial qualification process. The experimental characterisation is structured around three complementary axes. The degree of conversion is assessed by Raman spectroscopy for various post-curing times and print orientations. The mechanical properties are measured in tension and in three-point bending, on both as-printed and autoclave-sterilised specimens, across three print orientations. Dimensional accuracy is evaluated by three-dimensional optical scanning of calibration parts and a representative surgical guide. The results show that a conversion plateau approaching 90% is reached within a few minutes of post-curing, that the moduli measured in tension and in bending are consistent both with one another and with the values reported by the manufacturer, and that the process yields geometries whose deviations remain compatible with a surgical application. Comparing the two mechanical loading modes highlights the role of inter-layer interfaces in the sensitivity to print orientation. The effect of autoclave sterilisation, more pronounced in tension than in bending, constitutes a point of attention for clinical use. Taken together, these findings support the relevance of the studied workflow for use in a PoC3DPL, while identifying the critical operating conditions and the further lines of investigation required for any subsequent qualification.