Dr Mary Collins
University of Cambridge
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Redefining quality assurance and performance for single-use systems (SUS)
SUS are disposable plastic components designed to replace traditional pharmaceutical equipment that requires cleaning, sterilization, or recycling. The shift toward these technologies is driven by process efficiency, reduced cross-contamination, and improved sterility assurance.
As adoption expands into commercial operations, manufacturers seek safe and reliable ways to industrialize their use. This transition changes quality ownership: part of the responsibility now lies with suppliers, requiring stronger collaboration and transparency. Because SUS can significantly impact drug quality, open communication between suppliers and end users is critical.
In this session, we will explore regulatory expectations and how Cytiva can help you mitigate risks and ensure compliance and performance, emphasizing a risk-based approach, robust supplier qualification, and integrity testing, as recommended by Annex 1.
We hope to see you there!
Your Cytiva team
Free Workshop
Quality matters: building trust in single-use systems
Shared responsibility for compliance and performance
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