Radiation Sterilization of Aseptically Manufactured Products

References

1. 1.↵
   Guidance for Industry. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. Center for Drug Evaluation and Research, Food and Drug Administration (FDA): Rockville, MD, September 29, 2004.
2. 2.↵
   US Department of Health and Human Services, FDA. Use of aseptic processing terminal sterilization in the preparation of sterile pharmaceuticals for human and veterinary use. Federal Register 56: 51354 51358, October 11, 1991.
3. 3.↵
   1. Farrington J. K.

   Environmental monitoring in pharmaceutical manufacturing—a product risk issue. American Pharmaceutical Review 2005, 8 (5), 26–30

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4. 4.↵
   1. Jimenez L.

   Microbial diversity in pharmaceutical product recalls and environments. PDA J. Pharm. Sci. Technol. 2007, 61 (5), 383–399

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5. 5.↵
   1. Davis W. K.,
   2. Strawderman E. W.,
   3. Masefield J.

   Proceedings of the International Kilmer Memorial Conference on the Sterilization of Medical Products; Multiscience Publications Ltd.: Montreal, 1981; Vol. II, p. 34

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6. 6.↵
   Sterilization of Health Care Products—Radiation—Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices, International Organization for Standardization, ANSI/AAMI/ISO 11137-1:2006.
7. 7.↵
   Sterilization of Health Care Products—Radiation—Part 2: Establishing the Sterilization Dose, International Organization for Standardization, ANSI/AAMI/ISO 11137-2:2006.
8. 8.↵
   Sterilization of Medical Devices—Microbiological Methods—Part 1: Determination of a Population of Microorganisms on Products, International Organization for Standardization, ANSI/AAMI/ISO 11737-1.
9. 9.↵
   Sterilization of Medical Devices—Microbiological Methods—Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process, International Organization for Standardization, ANSI/AAMI/ISO 11737-2.
10. 10.↵
    1. Stumbo C. R.,
    2. Murphy J. R.,
    3. Cochran J.

    Nature of thermal death time curves of PA 3679 and Clostridium botulinum. Food Technol. 1950, 4, 293–302

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