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PDA Journal of Pharmaceutical Science and Technology

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Review ArticleReview

A Tale of Two Sterilizers

James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 162-169; DOI: https://doi.org/10.5731/pdajpst.2019.009993
James P. Agalloco
Agalloco & Associates Inc., 22 Carriage Trail, Belle Mead, NJ 08502
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References

  1. 1.↵
    1. Garvey W.
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    1. Sutton S. V. W.,
    2. Tirumalai R.
    Activities of the USP Microbiology and Sterility Assurance Expert Committee during the 2005–2010 Revision Cycle. Am. Pharm. Rev. 2011, 14 (5), 12–29.
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  4. 4.↵
    U.S. Pharmacopeial Convention. General Chapter <1229> Sterilization of Compendial Articles. In USP 36—NF 31; USP: Rockville, MD, 2013.
  5. 5.
    U.S. Pharmacopeial Convention. General Chapter <1229.2> Moist Heat Sterilization of Aqueous Liquids. In USP 36—NF 31; USP: Rockville, MD, 2013.
  6. 6.
    U.S. Pharmacopeial Convention. General Chapter <1229.1> Sterilization by Direct Contact. In USP 36—NF 31; USP: Rockville, MD, 2013.
  7. 7.
    International Society for Pharmaceutical Engineering. Good Practice Guide: Commissioning & Qualification of Pharma Water & Steam Systems; ISPE: Tampa, FL, 2011.
  8. 8.
    International Organization for Standardization. ISO 17665: Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. ISO: Geneva, 2006.
  9. 9.
    1. Agalloco J.
    Empty Chamber Studies (aka Much Ado About Nothing). Pharma Manuf. [Online] 2018. https://www.pharmamanufacturing.com/articles/2018/empty-chamber-studies-aka-much-ado-about-nothing/ (accessed Month Date, Year).
  10. 10.
    1. Agalloco J.
    Loaded Chamber Temperature Distribution Studies. Pharma Manuf. [Online] 2018. https://www.pharmamanufacturing.com/articles/2018/loaded-chamber-temperature-distribution-studies/ (accessed Month Date, Year).
  11. 11.
    1. Pavell A.,
    2. Hughes K.
    A Risk-Based Approach to Variable Load Configuration Validation in Steam Sterilization: Application of PDA Technical Report 1 Load Equivalence Topic. PDA J. Pharm. Sci. Technol. 2010, 64 (2), 124–136.
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    U.S. Food and Drug Administration. 21 CFR Part 212—Current Good Manufacturing Practices in Manufacturing, Processing, Packing or Holding of Large Volume Parenterals, and Request for Comments regarding Small Volume Parenterals. U.S. Department of Health and Human Services. Government Publishing Office: Washington, DC, 1976.
  13. 13.
    1. Agalloco J.
    Kill the Bioburden, Not the Biological Indicator. BioPharm. Int. 2017, 30 (4), 50–52.
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  14. 14.
    1. Agalloco J.
    Understanding Overkill Sterilization: Putting an End to the Confusion. Pharm. Technol. 2007, 30 (5, Suppl.), S18–S25.
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    U.K. Department of Health and Social Services. Health Technical Memorandum 10 Sterilization. DHSS: London, 1980.
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    U.K. Department of Health and Social Services. Health Technical Memorandum 2010 Sterilization. DHSS: London, 1994.
  17. 17.↵
    Centers for Disease Control and Prevention. Biosafety in Microbiological and Biomedical Laboratories, 5th ed., CDC, 2007.
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 74 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 1
January/February 2020
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A Tale of Two Sterilizers
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 162-169; DOI: 10.5731/pdajpst.2019.009993

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A Tale of Two Sterilizers
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 162-169; DOI: 10.5731/pdajpst.2019.009993
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  • Article
    • Abstract
    • Introduction
    • Other Steam Sterilization Usage
    • Multipurpose Sterilizers
    • Conclusion
    • Conflict of Interest Declaration
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Cited By...

  • Flexible Loading Pattern Approach in Overkill Steam Sterilization Based on the Physical Properties of Steam and Thermodynamics of Sterilization
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More in this TOC Section

  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management
Show more Review

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Keywords

  • Steam sterilization
  • Terminal sterilization
  • Porous loads
  • Non-porous loads
  • Sterilizer design
  • United States Pharmacopeia

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