In April 2017 the European Pharmacopoeia updated the monograph «Water for Injectables» (WFI). Since then, for the production of WFI the pharmaceutical industry can choose between distillation (hot WFI) or reverse osmosis (RO) based systems (cold WFI). This has presented the pharmaceutical industry with an opportunity for greater profitability and sustainability, as the production of cold WFI is more economical using proven technologies. Purified water production systems, most of which already exist in manufacturing plants, can be used for cold WFI production with very simple modifications, with the great advantage of reducing energy consumption and implementation space.
The adaptation of the European Pharmacopoeia was a significant change and finally brought Europe in line with other major pharmacopoeias, such as the United States Pharmacopoeia (USP) and the Japanese Pharmacopoeia (JP), which have long allowed methods beyond distillation, which has been a turning point especially for international companies.
Cold WFI production: Skepticism yields to technological innovations
The update in the European Pharmacopoeia regulation for cold WFI production was met with much skepticism from the Pharmaceutical Industry, even though the proposed solution based on RO+CEDI+UF was approved and proven in other Pharmacopoeias.
Part of the reluctance may be due to the increased risk of contamination in cold WFI systems if not properly maintained.
This concern has been significantly reduced by technological advances. Today’s operators also have a greater understanding of how to effectively reduce these risks and have the support and service of expert companies like Veolia.
Our Orion™ system combines RO, CEDI and UF technologies and is also thermally sanitizable with hot water at 80°C, providing a solution with minimal risk.
In addition, the connectivity of these systems with the HUBGRADE digital platform is a guarantee of effectiveness, as our digital services provide insight into WFI water quality in real time. This connectivity together with the management of alarms that warn as soon as any parameter is out of the control range, is a guarantee of compliance.
For all these reasons, since 2017 we have noticed a growing confidence in WFI production using this process. Not only large manufacturers in Europe are increasingly using membrane processes, the change is also suitable for smaller companies, especially due to the price of energy.
Membrane-based WFI generation: energy costs are driving the changeover
When the pharmaceutical industry makes a direct comparison of the permitted options, the savings achieved with cold WFI methods are clear. Since there is no need to heat the water, the energy costs associated with WFI production can be significantly reduced, which is especially important now that the price of energy has become significantly more expensive with the uncertainty of not knowing when it will stop.
It must be kept in mind that the pharmaceutical industry is going through a time of change, trying to be increasingly competitive in every way, implementing measures that allow for more cost-effective production.
In addition, it should be noted that membrane systems also have other advantages, such as lower investment costs, since the treatment for purified water production can also be used to produce WFI and can be easily scaled up. They also tend to have a smaller footprint, ideal where space is limited, and are much simpler to operate than distillation systems.
Any system for the production of water for injectables – regardless of the technology – must be well designed by an experienced company, in line with current regulatory standards, offering safe installation, continuous system monitoring and expert maintenance service.