Sterile Water for Injection (WFI)

Biologic drugs, including mAbs and peptides, have seen tremendous growth over the past two decades, resulting in an increase in the number of injectable drug formulations. Because drugs are injected directly into the bloodstream, water standards for the ingredient water are very high. While standard tap water is purified to a level sufficient for drinking, WFI requires high purity water without bacteriostat, antimicrobial agents, or added buffer. 

As injectable drugs have become an increasingly common part of patient treatment, global regulatory authorities have had to broaden the scope for cost-effective access to secure and dependable sterile WFI. The most widely used WFI method is distillation; however, this method is highly capital intensive and incurs high energy costs due to the heating of water.

To address these barriers, many pharmacopeias have allowed or are evaluating alternative technologies such as reverse osmosis (RO). Reverse osmosis systems tend to have lower operating costs than distillation techniques, lower total capital costs, and require less footprint in the facility. HSRO (Heat-Sanitizable RO) is one of the most popular options because it eliminates the need for sanitizing chemicals, uses less labor to sanitize, and is much more energy-efficient than traditional RO.