Water for Injection (WFI) Preparation By Membrane May Become Possible
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.