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Is Distillation Better Than Membranes To Produce Water for Injection?

Compiled by Mike Henley

EDI EP JP PHARMACEUTICALS PHARMACOPEIAS USP WFI

Abstract

Editor’s note: This column is based on a recent discussion on the LinkedIn Ultrapure Water Group. This column seeks to accurately reflect comments from each contributor. On occasion, there may be the need to edit contributor comments for clarity or length. Readers are invited to join the Ultrapure Water Group and to participate in discussions. An important purpose of the group is to provide a forum for practical discussion of issues facing endusers of high-purity water.

Pharmacopeias play an important role in the treatment of pharmaceutical water. Examples include the United States Pharmacopeia (USP), Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP), and the Chinese Pharmacopoeia Commission (ChP), among others. These respective documents provide the guidelines the manufacturers of pharmaceuticals and related products follow to treat their water. Some parts of the different pharmacopeia are harmonized so that facilities around the world can follow the same or similar treatment technology requirements.

But, much work is still needed to achieve uniform requirements for the production of pharmaceutical water. One example is the production of Water for Injection (WFI), which is an important ingredient in intravenous solutions. Thermal distillation has long been considered as the go-to technology to produce WFI. However, membrane technologies have advanced to the point that they are considered capable of producing WFI as well. So, now not all pharmacopeias hold the same requirements. This Ultrapure Water LinkedIn group discussion examines the merits of membranes or distillation to produce WFI.

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