Pfizer

Membrane-Based WFI

Water for Injection (WFI) is critical in biotech for producing sterile, safe pharmaceutical products and medical devices by providing a highly purified, pyrogen-free solvent and diluent for injectable drugs, and for cleaning/rinsing production and packaging equipment. The North Creek site relies on a single distillation-based WFI generation system, meaning a catastrophic failure could disrupt manufacturing by removing a critical source of highly purified, pyrogen-free water used for injectable drug production and for cleaning and rinsing equipment. The project developed a business case for adding a second WFI generation system and compared newer membrane-based purification technology with traditional distillation. The assessment was intended to define the problem and opportunity, evaluate potential benefits, costs, risks, feasibility, and success criteria, and support justification of a redundant WFI capability. To inform that comparison, the work included a process flow diagram, mass and heat balance, capital cost estimate, and annual operating expense tabulation, providing a structured basis for evaluating alternatives and improving system redundancy for manufacturing operations.