Water systems and
rouging
Rouging,
which describes the presence of a surface layer of iron oxide, is a phenomenon
that often affects pharmaceutical and hospital water systems constructed from stainless
components. Rouging presents a particular risk to high-purity water systems,
such as Water-for-Injections or Purified Water (produced by either distillation
or reverse osmosis.)
The
risk that arises from rouging is that product contamination, through the
presence of particulates, could occur. To add to this, there is an impact on
water quality for rouge may be the source of contaminants that lead to the
chemical deterioration of water quality. Furthermore, buildups of rouge
byproducts can lead to operational problems including blockages in filters. If
more severe localized corrosion (pitting) occurs, this can lead to more serious
operational issues.
With
regard to this subject, Tim Sandle has written an article for the Journal of
GXP Compliance.
The
reference is:
Sandle,
T. (2015) The Rouging Effect in Pharmaceutical Water Systems: Causes and
Strategies for Prevention, Journal of GXP Compliance, Vol. 19, Issue 1, 1-10
Posted by Tim Sandle
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