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Research ArticleTechnology/Application

Effects of Subzero Temperature Exposure and Supercooling on Glass Vial Breakage: Risk Management and Other Applications in Cold Chain Distribution

Ernest J. Chow, Ben Kitaguchi and Michael Trier
PDA Journal of Pharmaceutical Science and Technology January 2012, 66 (1) 55-62; DOI: https://doi.org/10.5731/pdajpst.2012.00772
Ernest J. Chow
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  • For correspondence: Ernest_Chow@Baxter.com
Ben Kitaguchi
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Michael Trier
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References

  1. 1.↵
    Technical Report No. 39. Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment; Parental Drug Association: Bethesda, MD, 2007.
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    Technical Report No. 46. Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User; Parental Drug Association: Bethesda, MD, 2007.
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    10. Freund E.
    Mechanistic studies of glass vial breakage for frozen formulations: II. Vial breakage caused by amorphous protein formulations. PDA J. Pharm. Sci. Technol. 2007, 61 (6),452–460.
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    7. Wadhwa M. S.,
    8. Jameel F.,
    9. Patro S.,
    10. Freund E.
    Mechanistic studies of glass vial breakage for frozen formulations: I. Vial breakage caused by crystallizable excipient mannitol. PDA J. Pharm. Sci. Technol. 2007, 61 (6),441–451.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  5. 5.↵
    1. Debenedetti P. G.,
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    Supercooled and glassy water. Physics Today 2003, 56 (6),40–46.
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    1. Heneghan A. F.,
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    Heterogeneous nucleation of supercooled water, and the effect of an added catalyst. Proc. Natl. Acad. Sci. U S A 2002, 99 (15),9631–9634.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 66 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 1
January/February 2012
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Effects of Subzero Temperature Exposure and Supercooling on Glass Vial Breakage: Risk Management and Other Applications in Cold Chain Distribution
Ernest J. Chow, Ben Kitaguchi, Michael Trier
PDA Journal of Pharmaceutical Science and Technology Jan 2012, 66 (1) 55-62; DOI: 10.5731/pdajpst.2012.00772
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    • Abstract
    • Introduction
    • Thermal Energy Quantification
    • Supercooling
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Effects of Subzero Temperature Exposure and Supercooling on Glass Vial Breakage: Risk Management and Other Applications in Cold Chain Distribution
Ernest J. Chow, Ben Kitaguchi, Michael Trier
PDA Journal of Pharmaceutical Science and Technology Jan 2012, 66 (1) 55-62; DOI: 10.5731/pdajpst.2012.00772

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