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Article CommentaryCommentary

The Bugs Don't Lie

James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 615-621; DOI: https://doi.org/10.5731/pdajpst.2019.009894
James P. Agalloco
Agalloco & Associates Inc., 22 Carriage Trail, Belle Mead, NJ 08502
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References

  1. 1.↵
    European Medicines Agency. Annex I, Manufacture of Sterile Medicinal Products, draft revision; EMA: London, 2017.
  2. 2.↵
    MCA. Rules and Guidance for Pharmaceutical Manufacturers and Distributors; Her Majesty's Stationery Office: London, 1997.
  3. 3.↵
    Center for Drug Evaluation and Research and Center for Veterinary Medicine. Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products; U.S. Food and Drug Administration, 1994.
  4. 4.↵
    Ministry of Health, Labour and Welfare of Japan. Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing; MHLW, 2001.
  5. 5.↵
    Council of Europe. Chapter 5.1.1, Methods of Preparation of Sterile Products. In European Pharmacopoeia (Ph. Eur.), Council of Europe: Strasbourg, 2008.
  6. 6.↵
    Guide to Good Pharmaceutical Manufacturing Practice; U.K. DHSS, 1983.
  7. 7.↵
    1. Perkins J. J.
    Principles and Methods of Sterilization in Health Sciences, 2nd ed.; Charles C. Thomas: Springfield, IL, 1983.
  8. 8.↵
    1. Chick H.,
    2. Martin C. J.
    On the “Heat Coagulation” of Proteins. J. Physiol. 1910, 40 (5), 404–430.
    OpenUrlPubMedWeb of Science
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    1. Pflug I.
    Microbiology and Engineering of Sterilization Processes, Environmental Sterilization Laboratory, 14th ed; Environmental Sterilization Laboratory: Otterbein, IN, 2010.
  10. 10.↵
    U.S. Pharmacopeial Convention. Monograph: Biological Indicator for Steam Sterilization, Paper Carrier. In USP 21–NF 16; USP: Rockville, MD, 1985.
  11. 11.↵
    U.K. Department of Health and Social Security. Health Technical Memorandum 10, U.K. DHSS, 1980.
  12. 12.↵
    British Standards Institution. BS EN 554 – Sterilization of Medical Devices –Validation and Routine Control of Sterilization by Moist Heat; BSI, 1994.
  13. 13.↵
    U.S. Pharmacopeial Convention. General Chapter <1229,1> Steam Sterilization by Direct Contact. In USP 38–NF 33; USP: Rockville, MD, 2013.
  14. 14.↵
    U.S. Pharmacopeial Convention. General Chapter <1229.8> Dry Heat Sterilization. In USP 39–NF 34, USP: Rockville, MD, 2016.
  15. 15.↵
    1. Agalloco J.
    Steam Sterilization-in-Place Technology. J. Parenter. Sci. Technol. 1990, 44 (5), 253–256.
    OpenUrlPubMed
  16. 16.↵
    U.S. Food and Drug Administration. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice; Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services, 2004.
  17. 17.↵
    1. Akers J.,
    2. Agalloco J.
    A More Rational Approach to Sterile Product Manufacturing. Pharm. Technol. 2012, 36 (5), s48–50.
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  18. 18.↵
    1. Agalloco J.
    Confidential communications with clients, 1991–2019.
  19. 19.↵
    Parenteral Drug Association. Technical Report No. 1: (Revised) Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control; PDA: Bethesda, MD, 2007.
  20. 20.↵
    1. Agalloco J.
    Steam Sterilization and Steam Quality. PDA J. Pharm. Sci. Technol. 2000, 54 (1), 59–63.
    OpenUrlFREE Full Text
  21. 21.↵
    1. Agalloco J.
    Great Expectations, Wrong Parameters: Revaluating the Steam Quality Expectations. Pharma Manufacturing 2009, 6 (5), 38–42.
    OpenUrl
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 73 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 6
November/December 2019
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The Bugs Don't Lie
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 615-621; DOI: 10.5731/pdajpst.2019.009894

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James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 615-621; DOI: 10.5731/pdajpst.2019.009894
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Keywords

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

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