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Research ArticleTechnology/Application

A New Glass Option for Parenteral Packaging

Robert A. Schaut, John S. Peanasky, Steven E. DeMartino and Susan L. Schiefelbein
PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 527-534; DOI: https://doi.org/10.5731/pdajpst.2014.00998
Robert A. Schaut
Corning Incorporated, Sullivan Park Science and Technology, Corning, NY, 14831
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  • For correspondence: schautra@corning.com
John S. Peanasky
Corning Incorporated, Sullivan Park Science and Technology, Corning, NY, 14831
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Steven E. DeMartino
Corning Incorporated, Sullivan Park Science and Technology, Corning, NY, 14831
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Susan L. Schiefelbein
Corning Incorporated, Sullivan Park Science and Technology, Corning, NY, 14831
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Article Figures & Data

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  • Figure 1
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    Figure 1

    Hydrolytic testing results (USP <660> Surface Glass Test, EP3.2.1 Test A) of ion-exchanged alkali aluminosilicate 3 mL vials and three different alkali borosilicate 3 mL vials. Error bars indicate typical measurement variation in a control population.

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    Figure 2

    Estimated loss of boron and alkali species from a Type 1B alkali borosilicate glass and the alkali aluminosilicate glass over a range of temperature in a stoichiometric flame. Plot shows the elemental fraction of boron and alkali in the gas phase at equilibrium.

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    Figure 3

    Plot of ICP-MS solution concentrations for metals extracted from alkali borosilicate and alkali aluminosilicate glass vials into WFI after autoclaving and 8 weeks of storage at 50 °C. Error bars represent the pooled standard deviation.

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    Figure 4

    Product degradation kinetics under accelerated storage conditions for one stability-indicating assay when stored in standard alkali borosilicate vials (Historical Mean) and alkali aluminosilicate vials.

Tables

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    Table II

    Thermal, Physical, Mechanical, and Optical Properties and Associated Test Methods of a Few Alkali Borosilicate Glasses and the Alkali Aluminosilicate Glass

    unitsTEST METHODType 1BType 1AAluminosilicate
    Borosilicate ABorosilicate BBorosilicate CBorosilicate H
    Strain Point (1014.5 P)°CASTM C336-71/2010525530537525556
    Anneal Point (1013 P)°CASTM C336-71/2010560565576560608
    Softening Point (107.6 P)°CASTM C338-93/2008780785767825870
    Working Point (104 P)°CASTM C965-96/20121164116012601292
    (0–300°C) Thermal Expansion10−7 K−1ASTM E228-115249533369
    Densityg/cm3ASTM C693-93/20082.342.342.412.232.39
    Refractive Index@ 589nmvarious methods1.491.4921.4731.493
    Stress-Optic Coefficient10−6 mm2.N−1ASTM C770-98/20083.44.03.05
    Young's modulusGPaASTM C623-92/2010736371
    Poisson's ratio-ASTM C623-92/20100.20.20.2
  • Table III
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    Table IV

    Average ICP-MS Concentrations for Vials Autoclaved and Stored in Water for Injection (WFI) at 25°C for 8 Weeks

    Values shown in italics indicate the detection limit of the ICP-MS method; in those cases, standard deviation values are not applicable. Sn is not included in the table because it was not detected in any of the samples at any temperature (detection limit for Sn is 0.01 ppm).

    ug/gAluminosilicateBorosilicate A Vial ABorosilicate B Vial BBorosilicate B Vial EBorosilicate B Vial F
    MeanPooled SDMeanPooled SDMeanPooled SDMeanPooled SDMeanPooled SD
    Al0.070.020.710.130.120.010.030.010.070.01
    B0.201.820.120.200.200.20
    Ca0.160.060.200.030.120.060.080.020.190.05
    K1.130.050.450.020.050.070.010.060.02
    Mg0.100.010.100.000.010.010.080.00
    Na0.700.043.180.123.790.062.480.051.200.04
    Si1.210.118.610.431.750.150.370.010.950.16
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PDA Journal of Pharmaceutical Science and Technology: 68 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 5
September/October 2014
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A New Glass Option for Parenteral Packaging
Robert A. Schaut, John S. Peanasky, Steven E. DeMartino, Susan L. Schiefelbein
PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 527-534; DOI: 10.5731/pdajpst.2014.00998

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A New Glass Option for Parenteral Packaging
Robert A. Schaut, John S. Peanasky, Steven E. DeMartino, Susan L. Schiefelbein
PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 527-534; DOI: 10.5731/pdajpst.2014.00998
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Keywords

  • Glass
  • Parenteral
  • Extractables
  • Borosilicate
  • Aluminosilicate
  • stability

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