Stainless Steel Lifecycle Management: Poster Presented at PDA Week 2026

Due to its chromium-enriched passive surface, stainless steel is a material of choice for drug product manufacturing equipment as it offers excellent corrosion resistance under standard use conditions. However, exposure to aggressive processing conditions and chemistries commonly used in drug manufacturing can compromise the integrity of the passive layer. The deterioration of the passive layer can lead to localized corrosion, pitting, and the formation of rouge. The presence of these corrosion forms on stainless steel can alter product-contact surface conditions, reducing equipment lifespan and compromising the effectiveness of validated cleaning procedures.To support lifecycle management, a risk-based, preventive maintenance approach is recommended to sustain the validated state of equipment cleaning procedures and to extend the operational lifespan of stainless-steel manufacturing equipment. Regulatory guidelines reinforce the importance of maintaining process equipment to limit contamination or mechanical failure modes that can impact drug product quality. This presentation will address the material properties of stainless steel, analyze the mechanisms of rouge formation and corrosion, present remediation strategies, and propose a scientifically sound, risk-based preventive maintenance framework as part of a comprehensive lifecycle management approach to stainless steel process equipment.