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


21. E. Eisenberg and G.P. Jacobs, "The Development of a Formulation for Radiation Sterilizable Urea Broth," J. Appl. Bacteriol. 58 (1), 21–25 (1985).

22. Health Industry Manufacturers Association, Radiation Compatible Materials (Report No. 78–4.9), (HIMA, Washington, DC, 1978).

23. Association for the Advancement of Medical Instrumentation, AAMI Technical Information Report 17, Radiation Sterilization-Material Qualification, (AAMI, Arlington, VA, 1998).

24. S. Shang et al., "Radiation Sterilization Compatibility of Medical Packaging Materials." J. Vinyl and Additive Technol. 4 (1), 60–64 (1998).

25. L. Massey, The Effect of Sterilization Methods on Plastics and Elastomers, (William Andrew, Norwich, NY, 2nd ed., 2005).

26. A. Tallentire, J. Dwyer and F.J. Ley, "Microbiological Control of Sterilized Products. Evaluation of Model Relating Frequency of Contaminated Items with Increasing Radiation Treatment," J. Appl. Bact. 34 (3), 521–534 (1971).

27. A. Tallentire and A.A. Kahn, "Tests for the Validity of a Model Relating Frequency of Contaminated Items and Increasing Radiation Dose," in Radiosterilization of Medical Products 1974 (International Atomic Energy Agency, Vienna, 1975), pp. 3–14.

28. AAMI, AAMI Technical Information Report, TIR 27, Radiation Sterilization—Substantiation of 25 kGy as a Sterilization Dose—Method VDmax (AAMI, Arlington, VA, 2001).

29. J. Kowalski and A. Tallentire, "Substantiation of 25 kGy as a Sterilization Dose: A Rational Approach to Establishing Verification Dose," Radiat. Phys. Chem. 54 (1), 55–64 (1999).


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