Stainless Steel Lifecycle Management: Poster Presented at PDA Week 2026

Area of Science:

• Materials Science
• Chemical Engineering
• Pharmaceutical Manufacturing

Background:

• Stainless steel's passive layer provides corrosion resistance but can degrade under aggressive pharmaceutical manufacturing conditions.
• Deterioration leads to localized corrosion, pitting, and rouge formation, impacting equipment and cleaning validation.

Purpose of the Study:

• To analyze stainless steel corrosion mechanisms in drug manufacturing.
• To present remediation strategies for corrosion and rouge.
• To propose a risk-based preventive maintenance framework for lifecycle management.

Main Methods:

• Analysis of stainless steel material properties.
• Investigation of corrosion and rouge formation mechanisms.
• Development of a risk-based preventive maintenance framework.

Main Results:

• Identified mechanisms of passive layer deterioration and rouge formation.
• Outlined strategies for corrosion remediation.
• Proposed a framework for lifecycle management of stainless steel equipment.

Conclusions:

• A risk-based, preventive maintenance strategy is crucial for sustaining validated cleaning procedures.
• Implementing this framework extends equipment lifespan and ensures drug product quality and safety.