Abstract
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1–3, 2010
Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA)
Chlorine dioxide fumigation was successfully used to decontaminate a virally contaminated biotech manufacturing facility. Addressing safety, product quality, and corrosion risks were important factors in planning the building fumigation. Studies were performed to define the conditions in which minute mouse virus (MMV) is inactivated by chlorine dioxide and to understand equipment and facility risks. Written plans and procedures documented activities necessary to safely fumigate the building and requalify it to manufacture commercial product.
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- Article
- Abstract
- Introduction
- Re-Contamination Risk
- Chlorine Dioxide is an Effective Technology
- Scope of Decontamination
- Quality Considerations
- Documenting the Plans, Restoration, and Results
- Safety and Environmental Considerations
- The ClO2 Fumigation Was a Success but Had Unexpected Impacts on the Facility
- Acknowledgments
- References
- Figures & Data
- References
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