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Research ArticleResearch

An Evaluation of the Glass Vial Hydrolytic Resistance Method

Christopher Sloey, Camille Gleason, Michael Akers, Yasser Nashed-Samuel and Joseph Phillips
PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 212-219; DOI: https://doi.org/10.5731/pdajpst.2018.008896
Christopher Sloey
1Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA 91320;
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  • For correspondence: csloey@amgen.com
Camille Gleason
2Tanvex Biopharma USA, Inc., 10394 Pacific Center Court, San Diego, CA 92121; and
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Michael Akers
1Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA 91320;
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Yasser Nashed-Samuel
1Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA 91320;
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Joseph Phillips
3ArmaGen, 26679 Agoura Road Suite 100, Calabasas, CA 91302
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References

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    Historical Review of Glasses Used for Pharmaceutical Packaging. PDA J. Pharm. Sci. Technol. 2017, 71, 279–296.
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    1. Iacocca R.G.,
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    Corrosive Attack of Glass by a Pharmaceutical Compound. J. Mater. Sci. 2007, 42, 801–811.
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    1. Lanford W.A.,
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    Hydration of Soda-Lime Glass. J. Non-Crystal. Solids 1979, 33, 249–266.
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    Molecular Mechanisms for Corrosion of Silica and Silicate Glasses. J. Non-Crystal. Solids 1994, 179, 300–308.
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    Glass Containers for Pharmaceutical Use. European Pharmacopoeia, 9th ed.; Council of Europe: Strasbourg, France, 2016; Chapter 3.2.1.
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    Containers – Glass. United States Pharmacopeia 41 – National Formulary 36, 2018; General Chapter <660>.
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    1. Sloey C.,
    2. Gleason C.,
    3. Phillips J.
    Determination of Delamination Propensity of Pharmaceutical Glass Vials Using a Direct Stress Method. PDA J. Pharm. Sci. Technol. 2013, 67 (1), 35–42.
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    1. Fujimori K.,
    2. Lee H.,
    3. Sloey C.,
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    5. Wen Z,
    6. Phillips J.,
    7. Nashed-Samuel Y.
    Comparison of Acid Titration, Conductivity, Flame Photometry, ICP-MS, and Accelerated Lamellae Formation Techniques in Determining Glass Vial Quality. PDA J. Pharm. Sci. Technol. 2016, 70, 248–255.
    OpenUrlAbstract/FREE Full Text
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    Evaluation of the Inner Surface Durability of Glass Containers. United States Pharmacopeia 41 – National Formulary 36, 2018; General Chapter <1660>.
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    1. Watjen U.,
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    The Certification of A Reference Material for the Determination of The Alkali Leaching from Pharmaceutical Glass Containers; European Commission JRC 38013, 2007.
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    1. Fujimori K.,
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    4. Nashed-Samuel Y.
    Development of Conductivity Method as an Alternative to Titration for Hydrolytic Resistance Testing Used for Evaluation of Glass Vials Used in Pharmaceutical Industry. PDA J. Pharm. Sci. Technol. 2017, 71, 50–58.
    OpenUrlAbstract/FREE Full Text
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PDA Journal of Pharmaceutical Science and Technology: 73 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 3
May/June 2019
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An Evaluation of the Glass Vial Hydrolytic Resistance Method
Christopher Sloey, Camille Gleason, Michael Akers, Yasser Nashed-Samuel, Joseph Phillips
PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 212-219; DOI: 10.5731/pdajpst.2018.008896

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An Evaluation of the Glass Vial Hydrolytic Resistance Method
Christopher Sloey, Camille Gleason, Michael Akers, Yasser Nashed-Samuel, Joseph Phillips
PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 212-219; DOI: 10.5731/pdajpst.2018.008896
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Keywords

  • Glass vials
  • surface hydrolytic resistance
  • alkalinity

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