This white paper introduces Aquabiliti’s innovative approach to single-use systems (SUSs) for the delivery and filling of Water for Injection (WFI) and aqueous solutions for the ever-evolving needs of the biopharmaceutical, pharmaceutical, and medical device industries. By controlling the entire supply chain within a dedicated single-use facility, Aquabiliti ensures superior product quality, operational efficiency, and cost-effectiveness. Leveraging state-of-the-art cleanrooms, rigorous quality control, and over 30 years of expertise, Aquabiliti delivers customized, high-purity SUS solutions. This paper outlines the company’s infrastructure, vertical integration strategy, and deep technical capabilities that position us as a trusted leader in single-use technology.

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.