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. While standard tap water is purified to a level sufficient for drinking, water standards for ingredient water are very high as drugs are injected directly into the bloodstream. WFI requires high purity water that has highly controlled endotoxin levels and minimal microbial contamination.

Global regulatory authorities have had to broaden the technology options to secure cost-effective and dependable access to WFI and sterile WFI.  The most widely used WFI method is distillation; however, this method is highly capital intensive and incurs high energy costs for heating the water. 

To address these barriers, many pharmacopeias have allowed or are evaluating alternative technologies such as reverse osmosis (RO). RO systems tend to have lower operating costs than distillation techniques, lower total capital costs, and require a smaller 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, and is more energy efficient than traditional RO. In addition to injectable drugs, WFI can be used to clean equipment and packing materials such as glass vials and syringes.