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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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References

  1. 1.↵
    1. Dimbleby V.
    Glass for pharmaceutical purposes. J. Pharm. Pharmacol. 1953, 5 (12), 969–989.
    OpenUrlPubMed
  2. 2.↵
    Guidance for Industry. Container Closure Systems for Packaging Human Drugs and Biologics. Chemistry, Manufacturing, and Controls Documentation. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research: Rockville, MD, 1999.
  3. 3.↵
    1. Flynn C. R.,
    2. McMaster M.,
    3. Kraus D.,
    4. Hall M.
    Pharmaceutical glass containers: proven solution for primary parenteral packaging. American Pharmaceutical Review—The Review of American Pharmaceutical Business and Technology 2012, retrieved 6/4/2013 from http://www.americanpharmaceuticalreview.com/1488-White-Papers/38057-Pharmaceutical-Glass-Containers-Proven-Solution-for-Primary-Parenteral-Packaging/
  4. 4.↵
    1. Bloomfield J. E.
    Recalls and FDA Warning Letters Associated with Glass Issues for Sterile Drug Products. PDA/FDA Glass Quality Conference, Arlington, VA, 2011.
  5. 5.↵
    1. Degrazio F.,
    2. Paskiet D.
    The glass quandry: Glass breakage, delamination and compatibility with biologics have boosted interest in novel materials in pharma packaging. Contract Pharma 2012, Jan/Feb, http://www.contractpharma.com/issues/2012-01/view_features/the-glass-quandary/
  6. 6.↵
    1. Bacon F. R.,
    2. Burch O. G.
    Effect of time and temperature on accelerated chemical durability tests made on commercial glass bottles. J. Am. Cer. Soc. 1940, 23 (1), 1–9.
    OpenUrl
  7. 7.↵
    1. Iacocca R. G.,
    2. Allgeier M.
    Corrosive attack of glass by a pharmaceutical compound. J. Mater. Sci. 2007, 42 (3), 801–811.
    OpenUrl
  8. 8.↵
    1. Iacocca R. G.,
    2. Toltl N.,
    3. Allgeier M.,
    4. Dong X.,
    5. Foubert M.,
    6. Hofer J.,
    7. Peoples S.,
    8. Shelbourn T.
    Factors affecting the chemical durability of glass used in the pharmaceutical industry. AAPS PharmSciTech 2010, 11 (3), 1340–1349.
    OpenUrlPubMed
  9. 9.↵
    1. Guadagnino E.,
    2. Zuccato D.,
    3. Gloder C.,
    4. Mason D.
    An improved method to evaluate the quality of glass tubing as a raw material for pharmaceutical articles. Glass Technol.—Eur. J. Glass Sci. Technol., A 2011, 52 (6), 203–209.
    OpenUrl
  10. 10.↵
    1. Kucko N. W.,
    2. Keenan T.,
    3. Coughlan A.,
    4. Hall M. M.
    Fill volume as an indicator of surface heterogeneity in glass vials for parenteral packaging. J. Pharm. Sci. 2013, 102 (6), 1690–1695.
    OpenUrlPubMed
  11. 11.↵
    1. Akers M.
    Parenteral Preparations. In Remington: Essentials of Pharmaceutics; Pharmaceutical Press: London, 2013.
  12. 12.↵
    1. Hamilton J. P.,
    2. Brantley S. L.,
    3. Pantano C. G.,
    4. Criscenti L. J.,
    5. Kubicki J. D.
    Dissolution of nepheline, jadeite and albite glasses: toward better models for aluminosilicate dissolution. Geochimica et Cosmochimica Acta 2001, 65 (21), 3683–3702.
    OpenUrlCrossRefGeoRefWeb of Science
  13. 13.↵
    1. Franz H.
    Durability and corrosion of silicate glass surfaces. J. Non-Crystalline Solids 1980, 42 (1-3), 529–534.
    OpenUrl
  14. 14.↵
    1. Pye L. D.,
    2. Fréchette V. D.,
    3. Kreidl N. J.
    1. Adams P. B.,
    2. Evans D. L.
    Chemical Durability of Borate Glasses. In Borate Glasses: Structure, Properties, Applications; Pye L. D., Fréchette V. D., Kreidl N. J., Eds.; Plenum Press: New York, 1978, pp 525–537.
  15. 15.↵
    ASTM E438-92: Standard Specification for Glasses in Laboratory Apparatus, 2006.
  16. 16.↵
    National Toxicology Program. Report on Carcinogens, Twelfth Edition; U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program: Research Triangle Park, NC, 2011.
  17. 17.↵
    FactSage version 6.2, <www.factsage.com>, Ecole Polytechnique, Montreal, Canada and GTT Technologies, Herzogenrath, Germany, 2011.
  18. 18.↵
    1. Smith E. J.,
    2. Paskiet D. M.
    Essential Elements of Extractables and Leachables: From Material Selection to Final Report. In Training and Research Institute: #252; PDA: Bethesda, MD, 2013.
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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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Cited By...

  • Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials by Inductively Coupled Plasma Mass Spectrometry
  • Comparative Leachable Study of Glass Vials to Demonstrate the Impact of Low Fill Volume
  • Enhancing Patient Safety through the Use of a Pharmaceutical Glass Designed To Prevent Cracked Containers
  • Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial
  • Historical Review of Glasses Used for Parenteral Packaging
  • Performance Stability of Silicone Oxide-Coated Plastic Parenteral Vials
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  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
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Keywords

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

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