Getting Ready For SUT X-Ray Irradiation

The use of single-use technology (SUT) in bioprocessing is expected to increase at a compound annual growth rate (CAGR) of 16.0% from 2021 to 2028*.

This means the market demand for gamma irradiation, the current primary method for the sterilization in SUT, will soon significantly exceed supply, creating an urgent need for alternatives.

Watch industry expert Christelle Marcoux from GSK Vaccines (BioPhorum workstream member on alternatives to gamma sterilization) and James Hathcock, PhD from Pall Corporation (Bio-Process Systems Alliance X-Ray Committee Co-Chair) as they discuss the introduction of X-ray sterilization technology. They explain how bioprocessing companies, suppliers, and regulators need to work together to explore the opportunities for process improvements, as well as present a unified approach to the validation work required to gain regulatory approval.

By attending the session, you will learn more about:

• Why this is a critical change for industry and the responsibilities of each stakeholder
• Key questions to address for biomanufacturers
• How gamma and X-ray irradiation compare
• What testing has been completed and key milestones for readiness for industry
• An example of how to qualify a SUS sterilized with X-ray irradiation

*source: Single-use Bioprocessing Market Size, Share & Trends Analysis Report By Product (Probes & Sensors, Simple & Peripheral Elements), By Workflow (Downstream, Upstream), By End-use, By Region, And Segment Forecasts, 2021 - 2028