As biopharmaceutical manufacturing evolves, there is debate as to whether a company needs an in-house water system. This white paper examines the strategic and operational considerations of buying high-purity Water for Injection (WFI) versus building traditional water infrastructure. With the rise of single-use technologies, purchasing pre-treated WFI offers reduced capital costs, increased flexibility, and simplified compliance, making it a compelling option for new builds and retrofits alike.

How robust environmental controls and validated testing methods offer a safer, more stable solution than lowering endotoxin thresholds in drug and biologic production.