Abstract

Originally published in 2008, this paper has been recently updated following increasing number of pharmaceutical companies who are finding the presence of rouge in their high purity water storage and distribution systems.

Incidents of the presence of rouge seem to have increased significantly over the past decade, and this is giving cause for concern both in terms of the system engineering issues, and also in the system quality assurance and compliance areas. So much so, that the ISPE Guide recently introduced a chapter on Rouge.

This is a paper intended to summarise and collate observations of rouge and offer practical guidance from Honeyman Group’s own experiences in relation to rouge in pharmaceutical water systems.

Its purpose is to offer simple and basic guidance on what to do when rouge is found, what to consider in terms of its impact on the operation and use of high purity water systems, and suggestions as to how to proceed in a sensibl...

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