Abstract: Pharmaceutical additive manufacturing enables patient-specific solid dosage forms and supports distributed, on-demand production, yet its environmental performance remains insufficiently characterized. This research proposes a structured framework that couples Business Process Model and Notation (BPMN) with an ISO-aligned Life Cycle Assessment (LCA), mapping the cradle-to-gate operations of 3D-printed drug production and informing sustainability impact assessments. Drawing on the 3D-SustainDrugs project, the study models the end-to-end workflow for hot-melt extrusion (HME) filament preparation and Fused Deposition Modeling (FDM) printing, and uses the process map to define system boundaries, responsibilities, and data-collection points across material suppliers, primary manufacturing, secondary manufacturing, and distribution/healthcare services provision. The resulting life cycle inventory captures key inputs (e.g., materials, electricity, water), operational parameters (e.g., printing time, productivity, nozzle/bed temperature), and outputs (e.g., dosage forms, scrap/misprints, packaging mass), which are mapped to impact indicators, including Global Warming Potential and Cumulative Energy Demand, complemented by water footprint, resource depletion, human toxicity, and ecotoxicity. Even prior to full numerical reporting, the BPMN–LCA linkage enables systematic identification of environmental hotspots, indicating that energy-intensive thermal steps (HME/FDM), time-driven electricity use during printing, and material losses due to misprints or reprinting are likely the dominant contributors. Finally, the developed framework supports transparent “what-if” scenarios and sensitivity analyses (e.g., reject-rate reduction, productivity improvements, temperature and cycle-time adjustments, packaging and end-of-life alternatives), providing decision support to reduce sustainability impacts without compromising quality or operational performance.

Keywords: Additive Manufacturing, Pharmaceutical Production, Sustainable Manufacturing, Life Cycle Assessment (LCA), Process Modeling, Business Process Model and Notation (BPMN)

Pages: 1-10

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