Rouging is a well-known but poorly understood phenomenon in the pharmaceutical industry. It involves
formation of red-brown to dark violet iron deposits on the inside surface of distillation columns, storage
vessels and distribution systems for hot WFI (Water For Injection). The affected systems are made from
stainless steel type AISI 316L as the primary construction material. The paper describes several cases of
rouging in WFI systems as to characteristics and distribution. Field observations are correlated with
published literature and experimental data obtained in the laboratory. Finally, theories of the mechanism
as well as approaches to preventing rouge are discussed.