Rouge, as you know, is a big deal in biopharmaceutical companies. At this time, they are only derouging and passivating based on non-scientific assessments of color or “QC queasiness”. The industry is spending a tremendous amount of money on derouging/passivation, chemicals, acid waste neutralization and using WFI and PW waters to rinse up the systems. The amount of water wasted in these operations is huge. Singapore, being extremely water conscious, understands the need for accurate usage of water for these “rinsing” operations. If we have scientific data to show exactly when a derouging/passivation is needed, then getting rid of these prophylactic approaches is paramount to saving the Singapore Water Authority thousands of cubic meters of excellent water every year.
Among many accolades and achievements, Nissan is Co-Chairman, Contributing author and Chapter Leader of ISPE “Baseline Guide for Pharmaceutical Water and Steam Systems” and Revisions 1-3, Co-chairman and Coordinating Author of ISPE Good Practice Guide - “Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems”.