Advancing Drug Product Manufacturing With A Risk-Based Approach To Single-Use System Integrity

Single-use systems are the default for most biopharmaceutical processes, yet maturity has not settled on how much control is enough. Best practice and regulatory expectations keep evolving, with a sharper focus on understanding and managing risks to quality. Examine the many points of control across the lifecycle of a single-use system and consider what changes when system integrity is approached as a connected whole rather than a series of separate checks. The emphasis falls on building a contamination control strategy that is well documented and ready for regulatory scrutiny.

See how this broader view of integrity can inform your own strategy.