Particulate Risk Mitigation in Single-Use Systems

WEBINAR

In this webinar, you will learn:

• Challenges in particulate detection and the regulatory landscape
• Key pillars of particulate risk mitigation for suppliers and end-users
• Examples of continuous particulate improvements in prevention as well as detection
• Tools such as a particulate library and use of analytical evaluation thresholds to navigate particulate contamination events
• Strategies for EU GMP Annex 1 considerations

As single-use technologies are increasingly being adopted, they are coming under heightened scrutiny from both regulators and industry stakeholders regarding particulate contamination. A structured understanding of particulate sources and behaviors is essential to maintaining process control.

In this webinar, we will present real-world examples of how continuous improvement strategies have been applied to both the prevention and detection of particulate matter in single-use processes. We will explore approaches to supplier and material qualification, process and equipment design, in-process monitoring, enhancements to visual inspection and analytical characterization, and practical tools.