Integrity RedefinedConsistent Robustness and Integrity Testing Lead to Enhanced Process Integrity and Patient Safety

摘要

For more than 20 years, single-use technologies (SUTs) have had widespread application in the biopharmaceutical industry, initially for buffer and media storage. Because of their recognized advantages and numerous technological advances (e.g., bioreactors, mixers, probes, and needles), SUTs now are considered increasingly for critical steps such as formulation, bulk drug-substance storage, bulk transport, and final drug-product filling. Thus, integrity assurance is becoming a major concern for biomanufacturers.