Don't Let Seals Break Your Batch: A Risk-Based Approach To Column Maintenance

Effectively managing chromatography column seals is crucial in biopharmaceutical manufacturing to prevent contamination and ensure regulatory compliance. This article explores how a risk-based approach to seal maintenance can enhance efficiency and reliability, moving beyond generic, time-based replacement schedules. It delves into the use of risk assessment frameworks, such as those aligned with ICH Q9 guidelines, to classify seals based on factors like material compatibility, mechanical stress, and process criticality. The discussion also covers scenarios where per-batch seal changeovers are essential and highlights various condition-based monitoring tools, including visual inspection, pressure testing, and sensor-enabled monitoring, to predict and prevent seal failures.

Learn how to optimize your seal maintenance strategy for improved process integrity and operational uptime.