Personalized medicine at the push of a button: printer design and implementation of SSE pharma printing in a hospital pharmacy.

The need for individualized dosages has led to the exploration of three-dimensional (3D) printing technology for producing personalized medicines. This technology allows for dosage, size, shape, and taste adjustments based on individual patient characteristics, yet its translation from research into routine pharmacy compounding remains limited. Practical guidance on implementation, validation, and integration into existing quality systems is lacking. This work provides a complete, implementation pathway for semi-solid extrusion (SSE) pharma printing in a (hospital) pharmacy or compounding facility. Our multidisciplinary consortium defined and applied the V-model as a quality framework encompassing User Requirements Specification (URS), functional and design specifications, and acceptance and qualification steps (FAT/SAT and IQ/OQ/PQ). Pharmacy staff were trained in the use of a custom-made 3D printer and related software, and evaluated the workflow, while test batches of placebo tablets were produced to assess reproducibility and inter-operator variability. After a two-day training session, operators consistently printed placebo tablets that met European Pharmacopoeia and national weight uniformity standards, supporting the feasibility of the 3D printing process for pharmaceutical preparations and provide preliminary evidence of its robustness with respect to operator-dependent variability. User feedback informed refinements to procedures and software, improving usability and traceability in line with ALCOA++++ principles. Critical Quality Attributes (CQAs) are described to validate the process and product. This work provides a practical and reproducible framework for integrating 3D printing into the extemporaneous preparation process within a (hospital) pharmacy environment, while outlining the key steps required to enable safely dispensing of 3D printed tablets.