Integrity assurance of Single-Use Systems accross the workflow from a supplier’s perspective

About the lecture

The latest revision to Annex 1 is driving higher global customer expectation for risk reduction for single-use systems – and this is driving additional interest in integrity testing for certain single-use assemblies used in high criticality applications.

At Thermo Fisher Scientific, we take a proactive approach to product integrity underpinned by our quality by design R&D process, our advanced manufacturing methods with robust process control, and our harmonized quality approach across our global manufacturing network. The presentation shows the focus of the Integrity assurance throughout our manufacturing process and the workflow.

About the speaker

Wouter is a passionate Senior Field Application Specialist focusing on optimal utilisation of appropriate Single-use systems in USP and DSP. He has been providing consultancy in Single-Use Technologies in Life Sciences over the last 20 years. He was technical support manager for Process filtration and Automation at Parker domnick hunter before joining Thermo Fisher Scientific in 2019. He holds a Master of Science Degree in Biochemistry from the KULeuven (Belgium)

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.