Webinar: WFI Production with Membrane Technology

In Europe it has become possible to produce water for injection (WFI) using non-distillation methods since March 2017. The change in the European Pharmacopoeia allows WFI production by means of suitable methods such as reverse osmosis. However, the EU Commission has also pointed out that in order to ensure the quality of a “cold-produced” WFI, other measures have to be taken than those required previously for the mandatory distillation.

The robustness of this new process has to be demonstrated. The Q&A document prepared for this purpose by the EMA provides further assistance in some areas, but also leaves many questions unanswered. In addition, the monograph on Highly Purified Water (HPW) will be suppressed as of April 2019. Now, the most obvious question is: how will HPW - after its suppression from the European Pharmacopoeia - become Water for Injection (WFI)?

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