Radiation Sterilization of Parenterals - Pharmaceutical Technology

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Radiation Sterilization of Parenterals
Irradiation is an established method of sterilization for pharmaceutical products. Radiation sterilization can be achieved with gamma rays, electron beams, and X-rays. Each of these techniques has its advantages and disadvantages. The author describes these methods, the ways to find the correct sterilization doses, and the regulatory and safety concerns about irradation sterilization.


Pharmaceutical Technology


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6. N.G.S. Gopal, "Radiation Sterilization of Pharmaceuticals and Polymers," Radiat. Phys. Chem. 12 (1), 35–50 (1978).

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9. G.O. Phillips, "Medicines and Pharmaceutical Base Materials," in Manual on Radiation Sterilization of Medical and Biological Materials, (International Atomic Energy Agency, Vienna, 1973), pp. 207–228.

10. R. Schnell and W. Bogl, "Teil VI and VII, Bericht des Instituts fur Strahlenhygiene des Bundesgesundheitsamtes," in Der Einfluss der Strahlenbehandlung auf Artzneitmittel und Hilfstoffe. Eine Literaturstudie, (Dietrich Reimer Verlag, Berlin, 1984).

11. C. Schuttler, W. Bogl, and K. Stockhausen, "Teil II and III," in Der Einfluss der Strahlenbehandlung auf Artzneitmittel und Hilfstoffe. Eine Literaturstudie, (Dietrich Reimer Verlag, Berlin, 1979).

12. C. Schuttler and W. Bogl, "Teil IV and V," in Der Einfluss der Strahlenbehandlung auf Artzneitmittel und Hilfstoffe. Eine Literaturstudie, (Dietrich Reimer Verlag, Berlin, 1982).

13. H.Trutnau, W. Bog, and K. Stockhausen, "Teil I," in Der Einfluss der Strahlenbehandlung auf Artzneitmittel und Hilfstoffe. Eine Literaturstudie, (Dietrich Reimer Verlag, Berlin, 1978).

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15. C. Boess and W. Bogl, "Influence of Radiation Treatment on Pharmaceuticals—A Review: Alkaloids, Morphine Derivatives, and Antibiotics," Drug Dev. Ind. Pharm. 22 (6), 495–529 (1996).

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17. T.A. DuPlessis, The Radiation Sterilization of Pyrogen-Free Water in Polyethylene Sachets, (Atomic Energy Board, Pretoria, South Africa, Report PER-17-1, 1977).

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19. G.P. Jacobs et al., "The Use of Gamma-Irradiation for the Sterilization of Water for Injections and Normal Saline Solution for Injection," Acta Pharma. Suec. 14 (3), 287–292 (1977).

20. G.P. Jacobs and E. Eisenberg, "The Reconstitution of Powders for Injection with Gamma-Irradiated Water," Intl. J. Appl. Radiat. Isotopes 32 (3), 180–181 (1981).


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