Ensuring Single-Use Systems Integrity in Aseptic or Closed-Process Applications

TAKEAWAY

If you are working with single-use systems, this article shows you in concrete terms how to design a defensible, risk-based leak and integrity test strategy that actually protects your batches and uptime.

ARTICLE AT A GLANCE

Based on Hogreve et al. (2024) and Sartorius integrity science, you learn how to translate MALL, microbial ingress data, and validated physical test methods into a robust SUS concept rather than isolated tests. This gives you immediately usable arguments and design principles to challenge suppliers, refine your SUS set-up, and align your contamination control strategy with current regulatory expectations.

LINK

https://www.sartorius.com/download/1524236/bpi-ensuring-susi-in-aseptic-or-cp-applications-publication-1--data.pdf