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Research ArticleTechnology/Application

A Quick Test To Monitor the Delamination Propensity of Glass Containers

Volker Rupertus, Bernhard Hladik, Uwe Rothhaar and Volker Scheumann
PDA Journal of Pharmaceutical Science and Technology July 2014, 68 (4) 373-380; DOI: https://doi.org/10.5731/pdajpst.2014.00990
Volker Rupertus
1Schott Pharmaceutical Packaging; and
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  • For correspondence: volker.rupertus@schott.com
Bernhard Hladik
1Schott Pharmaceutical Packaging; and
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Uwe Rothhaar
2Schott Pharma Services, Schott AG, Mainz, Germany
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Volker Scheumann
2Schott Pharma Services, Schott AG, Mainz, Germany
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  • Article
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References

  1. 1.↵
    U.S. Food and Drug Administration (FDA). Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs. FDA: Rockville, MD, March 2011 (http://www.fda.gov/Drugs/DrugSafety/ucm248490.htm).
  2. 2.↵
    Rx-360, an International Pharmaceutical Supply Chain Consortium, has recently commented on this issue of delamination (http://www.rx-360.org).
  3. 3.↵
    1. Iacocca R. G.,
    2. Toltl N.,
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    Factors affecting the chemical durability of glass used in the pharmaceutical industry. AAPS PharmSciTech 2010, 11 (3), 1340–1349.
    OpenUrlPubMed
  4. 4.↵
    1. Sloey C.,
    2. Gleason C.,
    3. Phillips J.
    Determining distance of the delamination propensity of pharmaceutical glass vials using a direct stress method. PDA J. Pharm. Sci. Technol. 2013, 67 (1), 35–42.
    OpenUrlAbstract/FREE Full Text
  5. 5.↵
    1. Guardagnino E.,
    2. Zuccato D.
    Delamination propensity of pharmaceutical glass containers by accelerated testing with different extraction media. PDA J. Pharm. Sci. Technol. 2012, 66 (1), 116–125.
    OpenUrlAbstract/FREE Full Text
  6. 6.↵
    1. Paul A.
    Chemistry of Glasses, 2nd ed.; Chapman & Hall Ltd: London, 1990; pp 180–204.
  7. 7.↵
    1. Ennis R. D.,
    2. Pritchard R.,
    3. Nakamura C.,
    4. Coulon M.,
    5. Yang T.,
    6. Visor G. C.,
    7. Lee W. A.
    Glass vials for small volume parenterals: influence of drug and manufacturing process on glass delamination. Pharm. Dev. and Technol. 2001, 6 (3), 393–405.
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  8. 8.↵
    1. Bacon F. R.,
    2. Raggon F. C.
    Promotion of attack on glass and silica by citrate and other anions in neutral solution. J. Am. Ceram. Soc. 1959, 42 (4), 199–205.
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  9. 9.↵
    1. Cahn J. W.,
    2. Charles R. J.
    The initial stages of phase separation in glasses. Phys. Chem. Glasses 1965, 6 (5), 181–191.
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  10. 10.↵
    1. Haines D.,
    2. Scheumann V.,
    3. Rothhaar U.
    Glass flakes. Pre-testing stops a big problem before it even starts. Contract Pharma June 5, 2013, 2–7.
  11. 11.↵
    International patent of Schott AG, Mainz, Germany; Rapid test method for evaluating the delamination tendency of glass packaging means; WO 2013/060728 A1; disclosure date May 2, 2013.
  12. 12.↵
    1. Kreski P.,
    2. Varshneya A.
    Microstructural Phase Separation and Delamination in Glass for Pharma Applications. In Processing, Properties, and Applications of Glass and Optical Materials; John Wiley & Sons, Inc.: Hoboken, NJ, 2012.
  13. 13.↵
    1. Friedbacher G.,
    2. Bubert H.
    Surface and Thin Film Analysis: A Compendium of Principles, Instrumentation, and Applications, 2nd ed.; Friedbacher G., Bubert H. , Eds.; Wiley-VCH: Weinheim, Germany, 2011.
  14. 14.↵
    1. Du W. F.,
    2. Kuruoka K.,
    3. Akai T.,
    4. Yazawa T.
    Study of Al2O3 effect on structural change and phase separation in Na2O-B2O3-SiO2 glass by NMR. J. Mater. Sci. 2000, 35, 4865–4871.
    OpenUrlCrossRef
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PDA Journal of Pharmaceutical Science and Technology: 68 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 4
July/August 2014
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A Quick Test To Monitor the Delamination Propensity of Glass Containers
Volker Rupertus, Bernhard Hladik, Uwe Rothhaar, Volker Scheumann
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 373-380; DOI: 10.5731/pdajpst.2014.00990

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A Quick Test To Monitor the Delamination Propensity of Glass Containers
Volker Rupertus, Bernhard Hladik, Uwe Rothhaar, Volker Scheumann
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 373-380; DOI: 10.5731/pdajpst.2014.00990
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Keywords

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  • Primary packaging

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