WFI membrane process: soon a global standard?

May 1, 2026 | 2 min read

The harmonization of all major pharmacopoeias with regard to the production of water for injection (WFI) opens up new possibilities. Membrane processes are becoming the preferred method.

Key takeaways
              Since October 1, 2025: all major pharmacopoeias are aligned with regard to WFI
Membrane processes are becoming increasingly established; global share is approaching the 30 percent mark
Clear advantages over distillation: lower energy and floor space requirements, reduced operating costs
Prerequisite for success: precise planning, coordinated system design, consistent minimization of contamination risk
Strategic partnerships with experienced suppliers increase efficiency, scalability, and regulatory security

            

The production of WFI has changed significantly since 2017. Until then, European regulations differed significantly from comparable pharmacopoeias, for example in the U.S. or Japan. In the EU, distillation was the only permitted process for producing WFI. Although this method fully complies with the stringent pharmaceutical requirements, it is associated with high energy consumption. Considering higher sustainability requirements and rising energy costs especially in Europe, the revision of the European pharmacopoeia can be seen as a small revolution.

For WFI production, the EU pharmacopoeia now also permits methods equivalent to distillation, including membrane processes based on reverse osmosis and electrodeionization in combination with an additional ultrafiltration step. In 2020, the World Health Organization (WHO) recognized membrane processes as a suitable method for WFI production in Annex 3 of the WHO Technical Report Series (TRS) 1025. The guideline describes the key principles that should be applied worldwide and can be supplemented by additional regulatory frameworks.

Alignment now also in China

Since then, membrane processes have gained increasing acceptance. Estimates suggest that they already account for nearly 30 percent of WFI produced globally. This is particularly noteworthy given that the process had not previously been approved for the Chinese market. The revision of the Chinese Pharmacopoeia on October 1, 2025, has now brought all major pharmacopoeias into regulatory alignment, increasing the chances that membrane processes could become a new global standard in the future.

There are good arguments in favor of membrane-based processes: They are more economical and environmentally friendly compared to distillation, as they eliminate the need for additional equipment, the energy required to generate heating steam, and the associated costs. Close collaboration between planners, equipment suppliers, and pharmaceutical companies is crucial for ensuring compliance with the strict requirements.

Process steps at a glance
              Pre-treatment
Softening
Sanitization
Reverse osmosis
Electrodeionization
Ultrafiltration
Continuous monitoring

            

Strategic partnership as equals

Recent years and the increasing establishment of membrane-based processes have shown that if all steps along the WFI manufacturing process are optimally planned, coordinated, and monitored, pharmaceutical manufacturers can realize substantial energy savings and improve their environmental impact while benefitting from lower investment costs and a reduced machine footprint. Choosing the right partner is crucial for success, as close collaboration is necessary to define the optimal system design and effective measures to minimize microbial contamination risks.

Partnering with a strategic supplier like Syntegon means gaining access to advanced system concepts and in-depth process consulting. We offer turnkey membrane-based systems that are modular and can be easily adapted and expanded to meet individual requirements. Long-standing practical experience with pure media systems provides the foundation for consulting services and collaboration on equal footing. Under these conditions, membrane-based processes can become a valuable long-term asset – and establish themselves as the preferred method for WFI production.

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WFI membrane process: soon a global standard?

Key takeaways

Alignment now also in China

Process steps at a glance

Strategic partnership as equals

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