ROUGE, The Intrinsic Phenomenon in 316L Stainless Steel ( WEBROUGE )
This presentation establishes a solid foundation as to what is currently understood about rouge. Rouge is an everyday occurrence. The amount of money invested in reacting to this phenomenon is very high, but may not be necessary. Key ways to assess are a successful risk-analysis and answering the right question; does it affect the quality of the product.
This webinar provides a knowledge structure consisting of science-based concepts, science-based risk analyses, research results, and practical experiences. Rouge is worthy of attention but not of universal need to remediate. This presentation is designed for individuals who want to have a better understanding of the available treatment alternatives when addressing the presence of rouge in 316L stainless steel biopharmaceutical systems.
Rouge is an electrochemical phenomenon; its chemistry is understood; and its formation is the subject of theories that are as diverse as there are the colors for identification. It is generally agreed under what conditions it is more likely to appear and progress, but what it is not quite well known or understood is where it originates and the specific causes for its appearance. The industry utilizes an alloy that offers all the best observed advantages for use in the biotechnology and pharmaceutical processes; it is not supposed to corrode, it is naturally protected by a “passive layer” that can be enriched with chemical treatments, but unfortunately can be compromised by welding, mechanical stresses, airborne impurities, chlorides, elevated temperatures, and contact with solutions that contain aggressive acids. However, there are various processes to counteract those threats even though it is also known that rouge will soon reappear if the product contact surface is exposed to similar pre-existing conditions.
The risk of rouging must be estimated and the risk of rouge remediation must also be estimated, and ultimately, those two risks must be compared and educated decisions be made.
At the conclusion of this session, participants will be able to: