Drinking water is the basis for producing water for pharmaceutical purposes in all national pharmacopoeias. What was long prohibited in the EU has been a reality for the past two years.Since the revision of WFI monograph 0169 in the European Pharmacopoeia, water for injection (WFI) can also be produced using the cold membrane process. This includes the membrane processes reverse osmosis and electrodeionization in combination with an additional ultrafiltration step.
In comparison to distillation, these membrane processes are economically and ecologically more efficient, since they eliminate the need for additional equipment, for the energy required to generate hot steam, and the associated costs. Currently, pharmaceutical companies are testing different cold membrane processes. The challenge: although there are official requirements for safe WFI, they do not apply to the manufacturing process.
It takes courage and foresight
Which WFI production process is best suited for pharmaceutical manufacturers depends on the projected microbiological risk and the highest possible operational safety. What’s more, switching to a new process requires courage and foresight – which pays off in the long run. Provided all steps in the WFI manufacturing process are optimally planned and coordinated, pharmaceutical companies can benefit from immense energy savings, not to mention an improved environmental balance.
If the cold membrane process proves to be a success in Europe, transcontinental companies are sure to expand it to other regions as well. However, that is still a long way off. To turn this vision into reality, pharmaceutical manufacturers will need a reliable partner who can not only supply the right equipment, but also has many years of process know-how and can support them with risk assessment, planning, validation and documentation. Please feel free to contact us!
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