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

1. T. Sandle and M. Saghee, Jrnl of Comm. Biotechnol. (2011).

2. G. Rao, A. Moreira, and K. Brorso, Biotechnology and Bioengineering 102 (2) 348–356 (2008).

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).

4. W. Wozniak-Parnowska and A. Najer, Acta Microbiol. Pol. 27 161–168 (1978).

5. W.A. Rutala, M.F. Gergen, and D.J. Weber, American Jour. of Infection Control 26 (4) 393-398 (1998).

6. A.G. Chmielewskia, M. Haji-Saeida, and S. Ahmedb, "Progress In Radiation Processing Of Polymer," Nuclear Instruments and Methods in Physics Research 236 (1-4) 44-54 (2005).

7. S. Baloda, BioProcess Inter. Supplement 10-22 (May 2008).

8. K.J.R. Clark and J. Furey, BioProcess Inter. 4 (6) S16-S20 (2006).

9. H. Pora, and B. Rawlings, BioProcess Int. 7 (14): 9-16 (2009).

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).

13. E.R.L. Gaughran, and R.F. Morrissey, Sterilization of Medical Products, Volume 2, Multiscience 35-39, (Montréal, 1981).

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


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