Assessing the Potential of Ozonation in the Production of Water for Injection from a Sustainability, Legal, Cost and Feasibility Perspective

Sammanfattning

Water for Injection (WFI) is a critical utility in pharmaceutical manufacturing, traditionally produced through an energy-intensive distillation process. This thesis investigates the feasibility of a more sustainable alternative, ambient WFI production using membrane-based purification technologies combined with ozonation in the storage and distribution loop. Conducted in collaboration with AstraZeneca, the study compares the existing vapor compression distillation system at the Sweden Biomanufacturing Center with a proposed ambient-temperature system incorporating reverse osmosis (RO), electrodeionization (EDI), ultrafiltration (UF), and ozone-based sanitization. Using a combination of a literature review, expert interviews, and technical analyses, the two systems were evaluated with respect to energy and water consumption, CO2 emissions, economic viability, safety and compliance with pharmaceutical quality standards. Results indicate that the ambient system offers significant energy savings across various usage points and achieves comparable performance in terms of water efficiency and carbon footprint. Although not economically favorable as a retrofit, the ambient system presents a cost-effective solution for new installations. Safety assessments confirm that ozone can be safely integrated into pharmaceutical water systems when appropriate controls are in place. Importantly, the study presents strong evidence that an ambient membrane-based system with ozonation can reliably produce WFI that meets the quality requirements defined by major pharmacopoeias, including the USP, Ph. Eur., and JP. However, it should be noted that current Chinese regulations still mandate distillation for WFI production, limiting the global applicability of non-distillation systems. These findings support the ambient ozonation-based system as a sustainable and technically feasible alternative for future WFI production, aligning with AstraZeneca’s environmental goals and broader industry trends toward greener manufacturing practices.