Rouge and Elastomer Management in Biopharma: Hidden Risks, Smarter Strategies
The foundation of biopharmaceutical operations lies in process accuracy, system robustness, and regulatory adherence.Yet two often-overlooked areas underappreciated in their operational impact – Rouge formation in stainless steel systems and elastomer asset management—can silently threaten process integrity and regulatory readiness.
The good news? With the right strategy, these challenges can be transformed into strengths.
A Closer Look at Rouge in Biopharma Systems
Rouge is a type of corrosion that forms on stainless steel surfaces, commonly seen in high-purity water systems and steam lines. Appearing as reddish or black discoloration, it reflects various stages of stainless steel degradation. Because biopharma environments rely heavily on clean-in-place (CIP) and steam-in-place (SIP) systems, they are particularly vulnerable.
But rouge doesn’t have to be a major compliance risk—if it’s proactively understood and managed. With science-based techniques like water sampling and surface integrity evaluations ((like those SCRI-IS conducts), rouge can be treated more as a maintenance concern than a compliance failure. One such method of rouge monitoring would be water sampling, where SCRI-IS have developed a sampling programme SOP to assist their clients with Rouge Managment.
In the SCRI-IS Corrosion Management course, participants gain practical skills including:
- Differentiating between rouge types (I, II, III)
- assess risk based on system type and material of construction (using tools like the PREN number)
- Performing rouge inspection and conduct a mock surface integrity and rouge assessment
- Evaluating asset criticality and corrosion risk
The result? A well-informed, proactive approach that turns rouge from a red flag into a manageable variable.
A 2-hour workshop at the Pharmaceutical Maintenance Symposium will highlight key concepts from this course—ideal for anyone seeking innovative Rouge Management strategies.
Elastomer Change-Outs: Biopharma’s Hidden Resource Drain
Elastomer components—diaphragms, gaskets, O-rings—are essential for maintaining sterile conditions in biopharma operations. Yet, they are also one of the biggest maintenance burdens on biopharma sites. Change-outs of elastomer components account for up to 50% of all planned maintenance activities, drawing heavily on-site resources and manpower.
Too often, elastomer management is treated as a routine task, when in fact, it should be a tightly controlled process. Errors in installation, material selection, or staff training can lead to premature failure, process downtime, and quality deviations.
That’s where SCRI-IS’s dedicated Elastomer Change-Out Team comes in. Not only are our teams trained directly by OEMs, but they also go further—aligning practices with global engineering standards like:
- DIN standards for fastener condition and re-use evaluation
- ASME BPE for polymer surface integrity
- Mechanical Joint Integrity (MJI10) training, a best practice borrowed from the Oil & Gas industry where no technician is allowed on site without formal joint integrity certification.
Think about that: in Oil & Gas, you can’t open a clamp without certification. But in biopharma? Anyone can break and remake critical joints—with no formal training. That’s a practice SCRI-IS is helping the industry leave behind.
Our Elastomer Asset Management course includes:
- Diaphragm valve design and failure modes
- Sealing criticality and change-out (ECO) procedures
- Hands-on installation on purpose-built rigs
Join our 2-hour workshop at the Symposium to experience the theoretical core of this training—an excellent first step in improving elastomer reliability and maintenance effectiveness.
Moving from Reactive to Proactive
Both rouge and elastomer degradation are inevitable realities of biotech manufacturing. But with a proactive, science-based approach to inspection, training, and change-out execution, their impact can be minimised—ensuring product quality, regulatory compliance, and operational uptime.
SCRI-IS is responding to problems and helping its clients build the capabilities to prevent them in the first place.
Meet us and SCRI-IS’ teams at the Pharmaceutical Maintenance Symposium
🗓 May 22–23, 2025
📍 Amara Hotel, Singapore
🎤 Hosted by No Deviation
We’ll be delivering the Rouge and Elastomer workshops featured above and will be available for one-on-one discussions. Whether you’re exploring a Rouge Assessment or building a tailored Elastomer Change-Out Program, our team is ready to help.
Don’t miss this opportunity to gain practical insights and level up your facility’s reliability strategy.
