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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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).

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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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