HomeWebinarsRisk-Based Qualification of X-Ray Sterilization for Single-Use Systems

Risk-Based Qualification of X-Ray Sterilization for Single-Use Systems


The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation is being considered an additional sterilization technology for business and supply continuity. We will share a risk-based qualification testing strategy including extractables and data generated to support the comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization methods.

In this webinar, you will learn about:

  • The comparison of gamma and X-ray irradiation sterilization
  • A risk-based qualification test strategy
  • Data evaluation of gamma versus X-ray sterilized single-use components


Monica Cardona

Monica Cardona


Senior Program Manager

Monica Cardona is a senior program manager for single-use and integrated systems at Merck. She has worked in life sciences for more than 20 years. She has had several global roles in technical, strategic, and operational marketing.

Monica holds a B.S. in Biology from Hofstra University and an M.S in Biology from Adelphi University. She has published and lectured internationally on a wide range of filtration, validation, and single-use bioprocessing topics. Monica is a member of the Parenteral Drug Association (PDA), BioPhorum, and a founding member of Bio-Process Systems Alliance (BPSA).

Paul Killian, Ph.D.

Paul Killian, Ph.D.


R&D Director, Analytical Technologies

Paul F. Killian, Ph.D., is an R&D director with more than 30 years of experience as an analytical chemist. He manages the analytical technologies team which provides bioanalytical, imaging, polymer characterization, small molecule analytics, and spectroscopy support to new product development, including performing extractable studies on new products. He has a Ph.D. in chemistry from the University of Massachusetts and an M.S. in public health from Boston University.

Webinar Information

Pharma and biopharma manufacturing

  • Classical pharma manufacturing
  • Duration:1hr

  • Language:English

  • Presented:Thu, May 5, 2022

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