Since 1 April 2017, the European Pharmacopoeia (Ph.EU) has authorised the use of membrane technology to produce water for injection (WFI). This alternative to distillation is based on a cold treatment process that offers the same guarantees in terms of microbiological safety and meets the same purity requirements (absence of particles and suspended substances), while enabling manufacturers to make significant energy savings.

 

Performance of membrane technologies to produce WFI

Unlike the American and Japanese Pharmacopoeias, the European Pharmacopoeia has long authorised only the distillation mechanism as a process for producing water for injections (WFI), for reasons of microbiological safety. Since 1 April 2017, the Ph. EU has validated the use of membrane technologies, including reverse osmosis, coupled with electrodeionization (EDI), nanofiltration or ultrafiltration (UF).

In addition to the desire to harmonise the processes used to obtain WFI on a global scale, the doubts surrounding the risk of biofilm developing in the membranes, resulting in the contamination of water by micro-organisms, have been dispelled following a lengthy assessment process. Membrane technologies, although based on cold operation, incorporate a monitoring system throughout the WFI production stages, and particularly in the pre-treatment and storage areas where the risk of bacterial growth is greatest.

Membrane technologies: more economical and more ecological

For manufacturers, this change to the Ph.EU opens the way to significant savings, amounting to several hundred thousand euros a year. Membrane technologies, which operate cold, consume much less energy than distillation. They are also more economical, as distillation systems involve high investment and operating costs.

These energy savings are crucial at a time when industry as a whole is committed to using resources more responsibly. More economical and more environmentally friendly, the membrane system is appealing to manufacturers who consume large quantities of cold WFI. It has also won over the pharmaceutical industry, which produces dry forms, as well as the semi-conductor sector, which is subject to stringent water quality regulations.

Changes to the European Pharmacopoeia will undoubtedly have an impact on the design and performance of future WFI production systems. Depending on the needs of equipment manufacturers and installations, these changes will require support for pharmaceutical manufacturers in their water treatment processes.

 

Would you like more information on the benefits of membrane technologies for producing your WFI? Contact us now!