Regulatory (Healthcare/Pharmaceutical/Phytosanitary)

Thursday November 07, 2024 from 11:30 to 12:30

Room: Guanacaste

Alan Montgomery, United States

Senior Scientist - Radiation Processing
Johnson & Johnson

Abstract

Assessing the Most Appropriate Radiation Source For Healthcare Products

Alan Montgomery1.

1MQSA, Johnson & Johnson, Raritan, NJ, United States

The recent shift in industry towards X-ray irradiation promised increased sterilization capacity to supplement the traditional radiation sources used. This strategic move aimed to reduce the reliance on existing technologies to strengthen the supply chain.  However, emerging practical experience shows there are additional considerations in the areas of capacity, cost, and regulatory timeline. This presentation will provide a review of our journey, highlighting the challenges and limitations encountered in the addition of X-ray approved products. We discuss the challenges, including validation requirements (both time and cost), regulatory hurdles, and operational complexities. Our findings underscore the need to understand end-to-end supply chain, including transportation costs, to deliver the most appropriate solutions.  Based on these insights, we advocate for an assessment of current strategy, proposing a more balanced approach that utilizes a dual-submission for Sterile R product with multiple radiation sources.


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