Single-Use Systems And Drug Product Manufacturing Challenges

EU GMP Annex 1 is prompting drug manufacturers to look beyond individual control points and evaluate contamination risk across the entire sterile manufacturing process. Although Pre-Use Post-Sterilisation Integrity Testing (PUPSIT) helps verify sterile filter performance, it is only one part of an effective contamination control strategy.

A comprehensive approach also considers the integrity of single-use fluid paths, biocontainers, tubing assemblies, connections, and other components that support sterile operations. Understanding how these elements interact can help manufacturers identify vulnerabilities, strengthen process controls, and protect product quality.

Explore how regulatory expectations are encouraging a more connected view of contamination risk and learn why assessing the complete manufacturing ecosystem can improve compliance, operational confidence, and patient safety.