Application of Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the Biopharmaceutical Sector - Pharmaceutical Technology

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Application of Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the Biopharmaceutical Sector
This paper examines the process of gamma irradiation of plastic materials used as part of single-use disposable systems in the pharmaceutical and biotechnology sectors, with a focus on validation requirements.


Pharmaceutical Technology
Volume 36, Issue 5, pp. s20-s30

References

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3. Radiation Sterilization Working Group (AAMI Sterilization Standards Committee). Radiation Sterilization—Material Qualification. Technical Information Report No. 17–1997. Association for the Advancement of Medical Instrumentation (Arlington, VA, 1998).

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10. M.A. Sebold, and J.A. Williams, "Radiation Sterilization" in M.R. Saghee, T. Sandle, and E.C. Tidswell (Eds.), Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices, Business Horizons, 841-872 (New Delhi, 2011).

11. E. Zandbergen and M. Monge, BioProcess Inter. Supplement 48-51 (June 2006).

12. R. Tykva and D. Berg, Man-Made and Natural Radioactivity in Environmental Pollution and Radiochronology, Kluwer Academic Publishers (Amsterdam, 2004).

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14. A. Booth, Sterilization of Medical Devices, Buffalo Grove: Interpharm Press, 1998.


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