Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
Who Will Benefit
- Engineering personnel - all levels from junior engineers to directors and VPs
- Maintenance personnel for Critical Utilities and Water
- QA/QC personnel involved with critical utilities
- Water system operators
- Types of rouge and its classifications
- Corrosion mechanics caused by rouge
- Images of different rouge type
- Chemistry of different Ferric Oxides identified as rouge
- Actual costs of derouging and passivation
- Placement of on-line rouge monitors in distribution piping system
- Data analysis of installed rouge monitors
- Environmental and operational Influences on rouge development
Key Learning Objectives
- Understanding the different classifications of rouge in biopharmaceutical water
- How to determine limits for rouge
- Trending information on rouge development
- Chemistry of rouge development
- The use of online rouge monitoring connected to a DCS, SCADA, BMS, and other computer programs.
- The advantages of on-line rouge monitoring
- Comparison with Auger Electron Spectroscopy
- The difference between rouge rate and rouge accumulation
- Problematic areas for rouge development in pharmaceutical water systems.
Rouge is a phenomenon of the oxidation of stainless steel materials used in pharmaceutical manufacturing. Rouge is exacerbated by high temperatures used in pharmaceutical water production and delivery systems. Hot Water for Injection (HWFI) is typically maintained at 80°C nominal to enhance the microbial destruction and prevention of microbial proliferation. These hot temperatures exacerbate the chemical instances of oxidation resulting in corrosion and unsightly formations of discoloration on pristine stainless steel surfaces.
Rouge is prevalent in all stainless steel components in contact with the hot water, including: pumps, piping, vessels, filter housings, valves, etc. Rouge may be unsightly, but if rouge particulates are found in the end product, the product is deemed unusable.
Online rouge monitors are available in the industry to monitor the rouge development over time. This scientific approach allows the pharmaceutical company to determine, accurately, when derouging and passivation activities are needed. The use of online rouge monitoring instrumentation can mitigate unnecessary applications of derouging and passivation chemicals and procedures by showing the actual rouge development over months and years. This prevents unnecessary downtime, chemical applications, rinsing operations, acid waste neutralization, cost and increases product uptime, throughput, and revenues.
Why Should You Attend
Rouge can be a contentious issue between engineering and QA/QC. Often derouging frequency determination is based on QC bias and a dislike of the rouge discoloration. Prophylactic applications of chemicals to derouge the piping and vessels are not based on science but QC comfort levels. This prophylactic application of derouging and passivation chemicals causes undue downtime, costs, and shutdown of the water system from 2-5 days depending piping loops and systems. The use of an online rouge monitor can determine the frequency for derouging and passivation by monitoring the actual rouge development. In almost every installation, derouging and passivation frequency has been reduced significantly to once every 3-5 years instead of once a year. Your attendance will help the needed understanding of rouge, its development, mitigation ideas, setting limits to determine derouging and passivation frequency, and scientific determination and data of rouge development.
By participating in the webinar you will learn about rouge, its development, possible liabilities for pharmaceutical products, science-based rouge monitoring, rouge limit determination, and the value of data to refute QC/QA misunderstandings about rouge and their insistence on frequent derouging and passivation.
Course Instructor Nissan Cohen
A recognized worldwide expert, with over 40 years’ experience, in high purity, ultrapure, reclaim and recycle water systems, and Total Organic Carbon (TOC) with profound expertise in instrumentation, automation, and organic contamination oxidation systems using ozone, UV, ion exchange and catalysts. Accomplished author of over 40 technical articles and major industry and regulatory publications published by Ultrapure Water, Pharmaceutical Technology, Pharmaceutical Engineering, Semiconductor International, the International Society for Pharmaceutical Engineering (ISPE), ASTM, and The Journal of the Institute of Environmental Sciences and Technology.