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

Abstract

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.

Popular Abstract

In today’s world, where sustainability is becoming increasingly important, even the way we produce water for medicines is under review. One of the most critical types of water in the pharmaceutical industry is called Water for Injection (WFI). This ultra-pure water is used to clean equipment and to make injectable drugs like vaccines and intravenous treatments. Since it goes directly into the body, WFI must meet extremely strict quality standards to ensure patient safety.

Traditionally, WFI is produced by boiling water and collecting the steam in a process known as distillation. While this method is effective and reliable, it consumes large amounts of energy and water, posing challenges for an industry that is striving to reduce its environmental footprint.

This thesis, conducted in collaboration with AstraZeneca, explores a greener alternative: producing WFI at room temperature using advanced filtration and ozone, a powerful form of oxygen already used to disinfect drinking water. The idea is to purify the water using technologies such as reverse osmosis, electrodeionization, and ultrafiltration, and then use ozone to keep it clean during storage and distribution, without the need for heat.

The study compares AstraZeneca’s current distillation-based system at its Södertälje facility with the proposed ambient-temperature, ozone-based system. It evaluates both approaches in terms of energy use, water consumption, carbon emissions, safety, cost, and compliance with pharmaceutical quality standards. The results are promising: the ambient system significantly reduces both energy use and costs, while still reliably producing WFI that meets international quality standards (including those from the U.S., Europe, and Japan). However, some countries, such as China, still require WFI to be produced by distillation, which limits the global adoption of this alternative method.

Although not yet cost-effective as a replacement for existing systems, the ozone-based approach could be a smart, sustainable choice for new installations. It also supports AstraZeneca’s environmental goals and the pharmaceutical industry’s broader shift toward greener manufacturing.

In short, this research shows that with the right setup and safety measures, producing WFI using ozone and membrane filtration is a safe, sustainable, and technically sound alternative, offering a meaningful step toward more environmentally friendly medicine production.

• author: Ljungman, Siri
• supervisor: Niklas Andersson; Walter Deltin
• organization: Chemical Engineering (M.Sc.Eng.)
• course: KETM05 20251
• year: 2025
• type: H2 - Master's Degree (Two Years)
• subject: Technology and Engineering
• keywords: Water for Injection, Ozonation, Membrane filtration, Pharmaceutical water systems, Ambient WFI production, Sustainability, Energy efficiency, Ozone sanitization, Chemical engineering
• language: English
• id: 9196414
• date added to LUP: 2025-06-12 11:47:49
• date last changed: 2025-06-12 11:47:49