Water for Injection (WFI) is the purest grade of bulk water used in the pharmaceutical industry.
With extremely low levels of bacteria, endotoxins and other contaminants, it’s an essential ingredient in products that are introduced directly into the bloodstream.
What’s the difference between Hot and Cold WFI?
WFI can be produced via distillation (Hot WFI) or a membrane system (Cold WFI). Until recently, the only permitted method within Europe was distillation. However, changes to the European Pharmacopeia in 2017 have now given pharmaceutical manufacturers the choice of producing WFI via either process:
1. Distillation (Hot WFI)
This traditional hot process involves a phase change of water into steam to remove bacteria and endotoxins, before condensing the steam back into liquid. High operating temperatures ensure optimal water purification with low contamination risks. On the other hand, there are significant downsides like high energy costs and large system footprints.
2. Membrane systems (Cold WFI)
Cold WFI production methods include reverse osmosis combined with a secondary membrane such as ultrafiltration. Compared to distillers, membrane systems often have lower costs and take up less space. The drawbacks are greater contamination risks and monitoring needs due to ambient (“cold”) operating temperatures, but these can be mitigated with periodic hot water sanitisation.
Which WFI option is right for your pharmaceutical business?
The trade-off between cost and risk can make it difficult to decide whether Hot or Cold WFI is best for your business. With over 80 years within the industry, Veolia Water Technologies can help you make these kind of decisions.
Speak to a Veolia Water Technologies expert today through the form below: