Water for Injection (WFI) Preparation By Membrane May Become Possible
Recent regulatory developments, particularly within the European Pharmacopoeia (Ph. Eur.), are accelerating the acceptance of membrane-based technologies for producing Water for Injection (WFI). The Ph. Eur. now explicitly permits non-distillation methods — such as reverse osmosis (RO), electrodeionization (EDI), and ultrafiltration — provided they achieve performance equivalent to traditional distillation in removing chemical impurities, microorganisms, and endotoxins.
Experimental data using a Cobetter 6 kD hollow-fiber membrane show promising results, achieving endotoxin levels <0.02 EU/mL under high-load challenge conditions. As additional regions, including China, consider aligning with European guidance, membrane-based WFI generation is emerging as a scientifically robust and regulatory-supported alternative for pharmaceutical manufacturing.