Reverse osmosis for Water-for-Injections

The European Pharmacopeia is set to allow reverse osmosis to be used to manufacture Water-for-Injection (WFI) for the first time. Hitherto, only distillation has been permitted.

To explain what is involved, the European Commission has released a concept paper titled “Reverse osmosis in Ph. Eur. monograph Water for injections (0169).”

The introduction to the paper reads:

“The production of WFI is described in the European Pharmacopoeia (Ph. Eur.) monograph Water for injections (0169). In this monograph the method of production of WFI is limited to distillation only. This is currently distinct from the production methods described in the United States Pharmacopeia monograph, which allows for production of WFI by distillation or a purification process proven to be equal to or superior to distillation, and in the Japanese Pharmacopoeia, which allows for distillation or reverse osmosis (RO) followed by ultrafiltration (UF).

In the pharmaceutical industry, distillation has been the dominant method for producing WFI due to its ability to meet the required specifications and in part due to the regulatory environment. However, other industries with a requirement for high quality water, rather than distillation, employ RO and UF to produce water that is equivalent to or of a better quality than WFI described in the Ph. Eur.”

The paper can be accessed here.

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Posted by Tim Sandle