|Articles|December 4, 2019

Single-Use System Integrity

Author(s)Sartorius

-Higher integrity assurance is needed for single-use systems -An integrity-testing strategy may be required to meet regulatory expectations -New scientific and technological approaches offer stronger integrity


Related to this article

Regulatory Roundup—September 2026
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.