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Review ArticleReview

Historical Review of Glasses Used for Parenteral Packaging

Robert A. Schaut and W. Porter Weeks
PDA Journal of Pharmaceutical Science and Technology July 2017, 71 (4) 279-296; DOI: https://doi.org/10.5731/pdajpst.2016.007377
Robert A. Schaut
Corning Incorporated, Corning, NY
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  • For correspondence: schautra@corning.com
W. Porter Weeks
Corning Incorporated, Corning, NY
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Article Figures & Data

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  • Figure 1
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    Figure 1

    Photo of glass vials used in 1795 near Alexandria, Virginia (15).

  • Figure 2
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    Figure 2

    Limousin's drawing of a glass ampoule (24).

  • Figure 3
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    Figure 3

    Evolution of pharmaceutical container shape, size, color, and glass composition from 1600s through today. From left to right: (a) manually free-blown soda-lime bottle circa 1600–1699, (b) manually mold-blown soda-lime bottle circa 1700–1799, (c) manually mold-blown soda-lime vial circa 1840–1860, (d) manually mold-blown soda-lime bottle circa 1865–1915, (e) semi-automatically mold blown soda-lime bottle circa 1880–1920, and (f) borosilicate vials: mold blown amber and tubular converted clear circa 2013–2016. Objects a–e are from the collection of the Corning Museum of Glass, Corning, NY.

  • Figure 4
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    Figure 4

    Illustration of different corrosion processes on a glass surface (51). (A) Congruent dissolution releases all elements at a single rate, (B) incongruent dissolution releasing elements at different rates, (C) corrosion of surface by chemical reaction of solvent with solid, and (D) leaching of alkali without affecting network elements.

  • Figure 5
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    Figure 5

    Timeline of USP revisions and key milestones regarding the use of glass in parenteral packaging. The tests indicate when they were included in the USP containers chapter(s) and are grouped to illustrate the tests that distinguish each glass types.

  • Figure 6
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    Figure 6

    Electron microscope image of the interior heel region of a vial which exhibited delaminated flakes after exposure to a liquid solution. The figure shows several thin flakes that have not yet released from the container surface and regions where the flakes have already been released.

Tables

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    TABLE I

    Normalized Cost of a Gallon of Expensive Liquids, All Stored in Glass Containers

    LiquidPrice/Gallon
    Soliris (Treatment of rare blood cell disorder)5$46,251,271
    Scorpion Venom6$38,858,507
    Copaxone (MS Medication)4$27,476,736
    Thailand Cobra Venom6$152,835
    Chanel No. 56$25,600
    Insulin6$9,411
    • View popup
    TABLE II

    Analyzed Glass Compositions for Ancient and Modern Glass Containers, Showing Similar Ratios from 1500 BC to Modern Times

    Weight %Egypt 1500 BC (10)Roman 1st Century AD (11)Window Glass 8th–9th Century (12–13)Naples 17th Century (12–13)Beverage Bottle 2013 (14)
    SiO26869706973
    Al2O334211
    B2O3
    Na2O1619151712
    K2O2<113<1
    MgO31122
    CaO476911
    Fe2O3111<1<1
    • View popup
    TABLE III

    Glass Composition for Several Commercial Borosilicates between 1900 and 2016. (A) Pyrex 33-expansion Borosilicate, (B) Schott Jena Fiolax Glass, and (C) Kimble's 51-expansion Borosilicate

    A
    Weight%Pyrex 191833Pyrex 194734Pyrex 198535Pyrex 201136
    SiO280.580.680.581.5
    Al2O32.02.22.22.3
    B2O311.812.812.912.3
    Na2O4.43.53.83.9
    K2O0.20.40.4
    B
    Weight%Jena 191833Jena 193724Fiolax 201136Fiolax 201637
    SiO2656574.675
    Al2O34.245.65.4
    B2O310.71110.910.5
    Na2O7.87.56.97.1
    CaO0.61.51.5
    ZnO10.911
    As2O30.20.1
    C
    Weight%Kimble N.C. 193024Kimble N-51-A 195838Kimble N51A 196839Gerresheimer N51A 201436
    SiO273.874.074.672.7
    Al2O35.55.45.56.6
    B2O39.69.19.411.3
    Na2O6.56.46.26.0
    K2O0.90.62.6
    MgO0.50.20.3
    CaO0.60.90.90.5
    BaO32.92.2
    ZnO0.6
    As2O30.1
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 71 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 4
July/August 2017
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Historical Review of Glasses Used for Parenteral Packaging
Robert A. Schaut, W. Porter Weeks
PDA Journal of Pharmaceutical Science and Technology Jul 2017, 71 (4) 279-296; DOI: 10.5731/pdajpst.2016.007377
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  • Article
    • Abstract
    • Introduction: Why Is Glass an Ideal Material for Packaging Pharmaceutical Products?
    • Glass Composition Evolution
    • Manufacturing Methods Advances
    • Test Methods
    • Problems Associated with Glass Packaging
    • What's Next: Advances in Glass Composition, Performance, and Testing
    • Conflict of Interest Declaration
    • Acknowledgements
    • Reference
  • Figures & Data
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  • Info & Metrics
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Cited By...

  • Creating an evidence-based economic model for prefilled parenteral medication delivery in the hospital setting
  • Measurement of Solution Composition as an Alternative to Titration for Evaluating the Hydrolytic Resistance of Glass
  • Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials by Inductively Coupled Plasma Mass Spectrometry
  • Creating an evidence-based economic model for prefilled parenteral medication delivery in the hospital setting
  • Investigating the Effects of the Chemical Composition on Glass Corrosion: A Case Study for Type I Vials
  • An Evaluation of the Glass Vial Hydrolytic Resistance Method
  • Inhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral Vials
  • Enhancing Patient Safety through the Use of a Pharmaceutical Glass Designed To Prevent Cracked Containers
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More in this TOC Section

  • The Role of Microbiologists in Drug Product Development
  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
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Keywords

  • Glass
  • Delamination
  • hydrolytic
  • packaging
  • Parenteral
  • review

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Historical Review of Glasses Used for Parenteral Packaging
Robert A. Schaut, W. Porter Weeks
PDA Journal of Pharmaceutical Science and Technology Jul 2017, 71 (4) 279-296; DOI: 10.5731/pdajpst.2016.007377

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