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Research ArticleResearch

Determining the Delamination Propensity of Pharmaceutical Glass Vials Using a Direct Stress Method

Christopher Sloey, Camille Gleason and Joseph Phillips
PDA Journal of Pharmaceutical Science and Technology January 2013, 67 (1) 35-42; DOI: https://doi.org/10.5731/pdajpst.2013.00900
Christopher Sloey
Department of Process and Product Development, Amgen Inc., Thousand Oaks, CA
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  • For correspondence: csloey@amgen.com
Camille Gleason
Department of Process and Product Development, Amgen Inc., Thousand Oaks, CA
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Joseph Phillips
Department of Process and Product Development, Amgen Inc., Thousand Oaks, CA
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References

  1. 1.↵
    1. Iacocca R. G.,
    2. Allgeier M
    . Corrosive attack of glass by a pharmaceutical compound. J. Mater. Sci. 2007, 42 (3), 801– 811.
    OpenUrl
  2. 2.↵
    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 processes on glass delamination. Pharm. Dev. Technol. 2001, 6 (3), 393– 405.
    OpenUrlPubMed
  3. 3.↵
    1. Iacocca R. G.,
    2. Toltl N.,
    3. Allgeier M.,
    4. Bustard M.,
    5. Dong X.,
    6. Foubert M.,
    7. Hofer J.,
    8. Peoples S.,
    9. Shelbourn T
    . Factors affecting the chemical durability of glass used in the pharmaceutical industry. AAPS PharmSciTech 2010, 11 (3), 1340– 1349.
    OpenUrlPubMed
  4. 4.↵
    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. Ceramic Soc. 1959, 42 (4), 200– 205.
    OpenUrl
  5. 5.↵
    Glass Containers for Pharmaceutical Use. European Pharmacopoeia, 7th ed.; Council of Europe: Strasbourg, France, 2011, Chapter 3.2.1, p 363.
  6. 6.↵
    1. Guadagnino E.,
    2. Zuccato D
    . Delamination propensity of pharmaceutical glass containers by accelerated testing with different extraction media. PDA J. Pharm. Sci. Technol. 2012, 66 (2), 116– 125.
    OpenUrlAbstract/FREE Full Text
  7. 7.↵
    1. Lanford W. A.,
    2. Davis K.,
    3. Lamarche P.,
    4. Laursen T.,
    5. Groleau R.,
    6. Doremus R. H
    . Hydration of soda-lime glass. J. Non-Crystalline Solids 1979, 33, 249– 266.
    OpenUrl
  8. 8.↵
    1. Bunker B. C
    . Molecular mechanisms for corrosion of silica and silicate glasses. J. Non-Crystalline Solids 1994, 179, 300– 308.
    OpenUrl
  9. 9.↵
    1. Wen Z.,
    2. Torraca G.,
    3. Masatani P.,
    4. Sloey C.,
    5. Phillips J
    . Nondestructive detection of glass vial inner surface morphology with differential interference contrast microscopy. J. Pharm. Sci. 2012, 101 (4), 1378– 1384.
    OpenUrlPubMed
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PDA Journal of Pharmaceutical Science and Technology: 67 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 1
January/February 2013
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Determining the Delamination Propensity of Pharmaceutical Glass Vials Using a Direct Stress Method
Christopher Sloey, Camille Gleason, Joseph Phillips
PDA Journal of Pharmaceutical Science and Technology Jan 2013, 67 (1) 35-42; DOI: 10.5731/pdajpst.2013.00900

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Determining the Delamination Propensity of Pharmaceutical Glass Vials Using a Direct Stress Method
Christopher Sloey, Camille Gleason, Joseph Phillips
PDA Journal of Pharmaceutical Science and Technology Jan 2013, 67 (1) 35-42; DOI: 10.5731/pdajpst.2013.00900
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  • Comparative Delamination Study to Demonstrate the Impact of Container Quality and Nature of Buffer System
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  • Comparison of Acid Titration, Conductivity, Flame Photometry, ICP-MS, and Accelerated Lamellae Formation Techniques in Determining Glass Vial Quality
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Keywords

  • Glass delamination
  • Glass lamellae
  • Accelerated lamellae formation
  • visual inspection
  • Hydrolytic resistance
  • Alkalinity
  • Type I borosilicate glass

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