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Research ArticleResearch

Flexible Loading Pattern Approach in Overkill Steam Sterilization Based on the Physical Properties of Steam and Thermodynamics of Sterilization

Arnan Ben-David
PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 166-180; DOI: https://doi.org/10.5731/pdajpst.2021.012708
Arnan Ben-David
10AR – Sterile Engineering Solutions, 7 Yona Volach St., Rosh Haain, Israel
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References

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    Parenteral Drug Association Inc. PDA Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control; Bethesda, MD, 2007.
  2. 2.↵
    European Medicines Agency, Decision Tree for Sterilisation Choices for Aqueous Products. In Guideline on Sterilisation of the Medicinal Product, Active Substance, Excipient and Primary Container. EMA: London, 2015; Chapter 5, Figure 1, EMA/CHMP/CVMP/QWP/850374/2015.
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    U.S. Food and Drug Administration, Guidance for Industry and FDA Staff. Biological Indicator (BI) Premarket Notification [510(k)] Submissions. Center for Devices and Radiological health. U.S. Department of Health and Human Services: Rockville, MD, 2007.
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    U.S. Pharmacopeial Convention, General Chapter <1229.2> Moist Heat Sterilization of Aqueous Liquids. In USP 40—NF 35, USP: Rockville, MD, 2017.
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    A Tale of Two Sterilizers. PDA J. Pharm. Sci. Technol. 2020, 74 (1), 162–169.
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    World Health Organization. WHO Technical Report Series No. 961: Annex 6—WHO Good Manufacturing Practices for Sterile Pharmaceutical Products. WHO, 2011.
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    1. Agalloco J. P.,
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    1. Pavell A.,
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    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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    AISI 316 Stainless Steel Properties, SS 316 Grade Density, Composition, Yield Strength, Thermal Conductivity (theworldmaterial.com), https://www.theworldmaterial.com/316-stainless-steel/ (accessed April 26, 2023).
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    Phase Change Substance Property Tables in SI units for ME 201 section 001 Spring 2012. Department of Mechanical Engineering, Michigan State University: East Lansing, MI, 2012.
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    . “Laws of thermodynamics”. Encyclopedia Britannica, 6 Oct. 2022, https://www.britannica.com/science/laws-of-thermodynamics (accessed April 26, 2023).
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    1. Dion M.,
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  14. 14.
    Standard EN 285:2021 Sterilization. Steam Sterilizers. Large Sterilizers. (2021). https://www.en-standard.eu/bs-en-285-2015-sterilization-steam-sterilizers-large-sterilizers/, 13.3.2
  15. 15.
    1. Kaiser U.
    , Effectes of Non-Condensable Gasses (NCGs) on Steam Sterilization Processes, Central Service, Vol. 13, 2005, P 395.
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    Effects of Non-Condensable Gases (NCGs) on Steam Sterilisation Processes. Zentralsterilisation—Central Service 2005, 13 (1), 45–50.
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    Standard EN 285:2021 Sterilization. Steam Sterilizers. Large Sterilizers. (2021). https://www.en-standard.eu/bs-en-285-2015-sterilization-steam-sterilizers-large-sterilizers/, 8.3.1.2
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    What does the Survival/Kill Calculation on the Certificate of Analysis Really Indicate? Spore News 2005, 2 (3).
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    1. Agalloco J. A.
    Maximum and Minimum Loads in Steam Sterilization. PharmaManufacturing, February 19, 2018. https://www.pharmamanufacturing.com/articles/2018/maximum-and-minimum-loads-in-steam-sterilization/ (accessed February 19, 2018).
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PDA Journal of Pharmaceutical Science and Technology: 77 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 3
May/June 2023
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Flexible Loading Pattern Approach in Overkill Steam Sterilization Based on the Physical Properties of Steam and Thermodynamics of Sterilization
Arnan Ben-David
PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 166-180; DOI: 10.5731/pdajpst.2021.012708

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Flexible Loading Pattern Approach in Overkill Steam Sterilization Based on the Physical Properties of Steam and Thermodynamics of Sterilization
Arnan Ben-David
PDA Journal of Pharmaceutical Science and Technology May 2023, 77 (3) 166-180; DOI: 10.5731/pdajpst.2021.012708
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Keywords

  • Overkill
  • Saturated steam sterilization
  • PNSU
  • Lethality
  • Loading pattern
  • Steam properties
  • Thermodynamics

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