Risk-based qualification of X-ray sterilization for single-use systems
March 20 – 23, 2022
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 warrants consideration as an alternate sterilization technology. X-ray irradiation offers better penetration characteristics, improved dose uniformity ratio (DUR), and less environmental impact when compared to other sterilization modalities. We will share a risk based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization modalities.
Timo Neumann, Jessica Shea, Monica Cardona, and Paul Killian, "Risk-based qualification of X-ray sterilization for single-use systems" in "Single-Use Technologies V: Building The Future", Magali Barbaroux, Sartorius, France; Martina Micheletti, University College London, UK Eds, ECI Symposium Series, (2022). https://dc.engconfintl.org/sut_v/1