Risk-Based Qualification of X-Ray Sterilization for Single-Use Systems
WEBINAR
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
Speakers
Monica Cardona
Merck
Global Senior Program Manager- Single Use & Integrated Platform Solutions
Monica Cardona is senior program manager for single-use and integrated platform solutions at our company, with 20+ years in life sciences across technical, strategic, and operational marketing roles. She leads cross-functional portfolio enhancement programs with quality, Emprove®, regulatory, operations, R&D, and commercial teams. She holds a B.S. from Hofstra and an M.S. from Adelphi, and is an active author, speaker, and industry member (PDA, BioPhorum, BPSA board).
Paul Killian, Ph.D.
Merck
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.
Pharma and biopharma manufacturing
- Classical pharma manufacturing
Duration:1h
Language:English
Session 1:presented May 5, 2022
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