Overview Of Single-Use System Integrity Assurance

By Patrick Evrard, Contamination Control and Sterility Assurance Senior Principal Scientist, Quality and Regulatory Affairs

Single-use systems support sterility assurance, contamination control, and patient safety across biopharmaceutical manufacturing. Protecting their integrity requires more than testing at the point of use. It calls for an end-to-end strategy grounded in quality risk management and a clear understanding of how materials, components, packaging, transport, installation, handling, and operating conditions can introduce risk.

As single-use technologies have evolved from basic biocontainer bags to complex bioreactors with mixers and sensors, the potential points of failure have also expanded. A loss of integrity at any stage can affect product quality, operator safety, production schedules, and business continuity.

Learn how a holistic, life cycle approach can help manufacturers identify vulnerabilities, strengthen controls, and align integrity assurance programs with regulatory expectations and industry best practices.