Automated PUPSIT For Drug Product Applications

Sterile filtration is the final safeguard in drug product manufacturing, ensuring patient safety and regulatory compliance before container filling. Recent updates to EU GMP Annex 1 mandate pre-use post-sterilization integrity testing (PUPSIT) as part of contamination control strategies. This application note demonstrates how an automated drug product filtration system integrates PUPSIT, post-use integrity testing, and in situ leak testing to verify barrier performance and maintain a closed sterile flow path. Using filter sizes from 1 to 10 inches in single and redundant configurations, 148 integrity tests and 65 leak tests were successfully completed, confirming system reliability. These automated methods reduce risk from damaged components and incomplete filter wetting, providing a robust approach to contamination control.

Explore how automation enhances compliance and patient safety through consistent, reproducible testing.