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Review ArticleReview

Increasing Patient Safety by Closing the Sterile Production Gap—Part 1. Introduction

James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology July 2017, 71 (4) 261-268; DOI: https://doi.org/10.5731/pdajpst.2016.007104
James P. Agalloco
Agalloco & Associates Inc., 22 Carriage Trail, Belle Mead, NJ 08502
BE, MS, MBA
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Reference

  1. 1.↵
    U.S. Food and Drug Administration. Current Good Manufacturing Practice in the Manufacture, Processing, Packaging or Holding of Large Volume Parenterals, Proposed Rule. Federal Register 1976, 41 (106) 22202–22219. Withdrawn 1991.
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    Sterilization General Chapter. United States Pharmacopeia, XII, 1942.
  3. 3.↵
    <1229> Sterilization. United States Pharmacopeia, 36, 1st supplement, 2013.
  4. 4.↵
    U.S. Food and Drug Administration. Use of Aseptic Processing and Terminal Sterilization in the Preparation of Sterile Pharmaceuticals for Human and Veterinary Use, Proposed Rule. Federal Register 1991, 56 (198), 51354–51358.
    OpenUrl
  5. 5.↵
    1. Thiboutot R.,
    2. et al
    . Aseptic Processing and Terminal Sterilization. J. Parenteral Sci. Technol. 1991, 45 (6) 254–258.
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  6. 6.↵
    Parenteral Drug Association. PDA Response. FDA Proposal to Amend cGMPs—Use of Aseptic Processing and Terminal Sterilization in the Preparation of Sterile Pharmaceuticals for Human and Veterinary Use. J. Parenteral Sci. Technol. 1992, 46 (3), 65–68.
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  7. 7.↵
    European Medicines Agency. Decision Trees for the Selection of Sterilisation Methods (CPMP/QWP/054/098), February 1999.
  8. 8.↵
    U.S. Food and Drug Administration. Preliminary Concept Paper—Sterile Drug Products Produced by Aseptic Processing, 2002.
  9. 9.↵
    Product Quality Research Institute. Aseptic Processing Working Group Final Report, http://pqri.org/wp-content/uploads/2015/12/FinalReport.pdf, 2003.
  10. 10.↵
    U.S. Food and Drug Administration. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice, Draft Guidance, 2003.
  11. 11.↵
    U.S. Food and Drug Administration. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice, 2004.
  12. 12.↵
    Ministry of Health, Labour and Welfare of Japan. Guidance on the Manufacture of Sterile Pharmaceutical Products Produced by Terminal Sterilization, 2007.
  13. 13.↵
    1. Izumi M.,
    2. Fujifuru M.,
    3. Okada A.,
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    6. Udagawa T.,
    7. Miyake M.,
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    9. Tokuda H.,
    10. Nishioka G.,
    11. Yoden H.,
    12. Aoki M.
    Evaluation of Bacillus oleronius as a Biological Indicator for Terminal Sterilization of Large-Volume Parenterals. PDA J. Pharm. Sci. Technol. 2016, 70 (1), 30–38.
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  14. 14.↵
    1. Agalloco J.,
    2. et al
    . Post-Aseptic Fill Lethal Treatment TF Looks at Safety and Operational Improvements in Injectable Drug Manufacturing. PDA Letter 2011, 47 (4), 14, 16.
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  15. 15.↵
    1. Agalloco J.,
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    Achieving Balance in Sterile Product Manufacturing. Pharm. Technol. 2015, 39 (12), 36–41.
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  16. 16.
    1. Pflug I.
    Microbiology and Engineering of Sterilization Processes, 14th ed.; Environmental Sterilization Laboratory: Otterbein, IN, 2010; Table 13.7.
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PDA Journal of Pharmaceutical Science and Technology: 71 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 4
July/August 2017
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Increasing Patient Safety by Closing the Sterile Production Gap—Part 1. Introduction
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology Jul 2017, 71 (4) 261-268; DOI: 10.5731/pdajpst.2016.007104

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Increasing Patient Safety by Closing the Sterile Production Gap—Part 1. Introduction
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology Jul 2017, 71 (4) 261-268; DOI: 10.5731/pdajpst.2016.007104
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Keywords

  • Terminal sterilization
  • Aseptic processing
  • Sterilization
  • Biological indicator
  • Bioburden
  • Probability of a non-sterile unit (PNSU)
  • Regulation
  • Sterility assurance

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