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PDA Journal of Pharmaceutical Science and Technology

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Article CommentaryCommentary

Wanted: Dead or Alive

James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology September 2021, 75 (5) 458-464; DOI: https://doi.org/10.5731/pdajpst.2020.011478
James P. Agalloco
Agalloco & Associates Inc., 22 Carriage Trail, Belle Mead, NJ 08502
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References

  1. 1.↵
    U.S. Pharmacopeial Convention. General Chapter <1229> Sterilization. In USP 42—NF 37, USP: Rockville, MD, 2013.
  2. 2.↵
    1. Agalloco J.
    Understanding Overkill Sterilization: An End to the Confusion. Pharm. Technol. 2007, Suppl. (2), S18–S25.
  3. 3.↵
    1. Pflug I. J.
    Microbiology and Engineering of Sterilization Processes, 14th ed.; Environmental Sterilization Laboratory: Otterbein, IN, 2010; p 683.
  4. 4.↵
    International Organization for Standardization, ISO 18472:2018 Sterilization of Health Care Products—Biological and Chemical Indicators—Test Equipment. ISO: Geneva, 2018.
  5. 5.↵
    Council of Europe. Methods of Preparation of Sterile Products, Chapter 5.1.1. In European Pharmacopoeia (Ph. Eur.), Council of Europe: Strasbourg, 2008; p 575.
  6. 6.↵
    1. Agalloco J. P.
    The Bugs Don't Lie. PDA J. Pharm. Sci. Technol. 2019, 73 (6), 615–621.
    OpenUrlAbstract/FREE Full Text
  7. 7.↵
    1. Agalloco J.
    Real-World Vapor Phase Hydrogen Peroxide Decontamination. Pharm. Technol. 2020, 44 (1), 53–57.
    OpenUrl
  8. 8.↵
    International Organization for Standardization. ISO 11137-2:2013 Sterilization of Health Care Products—Radiation—Part 2: Establishing the Sterilization Dose. ISO: Geneva, 2013.
  9. 9.↵
    Association for the Advancement of Medical Instrumentation. AAMI TIR33: Sterilization of Health Care Products—Radiation—Substantiation of a Selected Sterilization Dose—Method VDmax. AAMI: Arlington, VA, 2005; p 54.
  10. 10.↵
    U.S. Pharmacopeial Convention. General Chapter <1229.1> Steam Sterilization by Direct Contact. In USP 42—NF 37, USP: Rockville, MD, 2013; p 8079.
  11. 11.↵
    U.S. Pharmacopeial Convention. General Chapter <1229.14> Sterilization Cycle Development. In USP 42—NF 37, USP: Rockville, MD, 2017; p 8115.
  12. 12.↵
    1. Agalloco J.
    Kill the Bioburden, Not the Biological Indicator. BioPharm Int. 2017, 30 (4), 50–52.
    OpenUrl
  13. 13.
    Parenteral Drug Association Inc. Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control; Bethesda, MD, 2007.
  14. 14.↵
    1. Haberer K.,
    2. van Doorne H.
    Biological Indicators, Tools to Verify the Effect of Sterilisation Processes—Position Paper Prepared on Behalf of Group 1 (Biological Methods and Statistical Analysis). Pharmeur. Bio Sci. Notes 2011, 2011 (2), 26–39.
    OpenUrlPubMed
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PDA Journal of Pharmaceutical Science and Technology: 75 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 5
September/October 2021
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Wanted: Dead or Alive
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology Sep 2021, 75 (5) 458-464; DOI: 10.5731/pdajpst.2020.011478

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Wanted: Dead or Alive
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PDA Journal of Pharmaceutical Science and Technology Sep 2021, 75 (5) 458-464; DOI: 10.5731/pdajpst.2020.011478
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    • Limitations in Validation Practice
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Keywords

  • Terminal sterilization
  • Sterilization
  • Biological indicator
  • Bioburden
  • Probability of a nonsterile unit (PNSU)
  • Regulation
  • Sterility assurance

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