Sustainability Presentations

Wednesday November 06, 2024 from 11:30 to 12:45

Room: Guanacaste

PL7.1 Coupling sustainability assessments with business continuity strategies for implementation of multiple sterilization technologies

James J Hathcock, United States

Sr Director, Regulatory and Validation Strategy
Cytiva

Abstract

Coupling Sustainability Assessments with Business Continuity Strategies for Implementation of Multiple Sterilization Technologies

James Hathcock1, Lan Luo1, Lacy Linney1.

1Cytiva, Weestborough, MA, United States

Major sterilization strategies for medical and bioprocess equipment are facing unprecedented challenges related to business continuity and environmental sustainability, which are encouraging the implementation of multiple-sterilization technology/modality approaches to ensuring potential risks are mitigated.  In qualifying alternative sterilization technologies or modalities for the same product, product lifecycle and environmental sustainability assessments are increasingly expected by both regulators and corporate sustainability initiatives that include comprehensive assessment of all key contributing steps in the manufacturing value chain.   In evaluating dimensions of environmental sustainability, risk dimensions that are more easily measured or have a greater abundance of data, such as carbon footprint analysis are typically emphasized, whereas other risk dimensions are frequently invisible or neglected.  In evaluating X-ray as an alternative sterilization strategy for gamma-irradiated materials, where there is an inherent low efficiency conversion of electrons to photons, engineering solutions can be implemented that mitigate or offset conversion inefficiencies to improve the overall impact assessment.  Herein we share holistic approaches to assessing the environmental sustainability of multiple ionizing radiation sterilization technologies, including X-ray and gamma, and the extent to which mitigation strategies can minimize the impact assessment.    


If you have any questions, please email us (info@imrp2024.com) or come to the onsite registration desk.
© 2024 IMRP