Abstract
Purpose Pharmaceutical three-dimensional (3D) printing is an innovative production technique which enables the manufacturing of personalized medicine at the point-of-care. A reliable 3D printer is paramount for the successful implementation in clinical practice. In this paper, the design strategy of a pharmaceutical semi-solid extrusion 3D printer is described, where the concept of quality-by-design is applied. Methods The technical design stages are divided in the conceptual design and detailed design stage. The minimal viable product, critical process parameters and implemented control strategies were defined. Results The critical process parameter with the highest impact is the temperature of the cartridge during preheating, i.e. prior to the production process. The temperature is controlled with an accurate thermistor, closed feedback loop and thermal isolation. The temperature can be monitored at all times using the graphical user interface and there is an audit trail using the logging system. Software was developed conforming to GAMP5. Conclusions Build-in control strategies in the design of the pharmaceutical 3D printer can mitigate risks during the production process of personalized medicine. The regulatory landscape surrounding 3D-printed drug products remains challenging. By using this design approach, relevant guidelines were taken into account during the design of a pharmaceutical 3D printer. Future development of the 3D printer should include the incorporation of process analytical technology tools and upscaling of feedstock production to further support the implementation of personalized medicine 3D-printed at the point-of-care.