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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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Article Information

vol. 67 no. 1 35-42
DOI 
https://doi.org/10.5731/pdajpst.2013.00900
PubMed 
23385562

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 5, 2013.

Copyright & Usage 
© PDA, Inc. 2013

Author Information

  1. Christopher Sloey*,
  2. Camille Gleason and
  3. Joseph Phillips
  1. Department of Process and Product Development, Amgen Inc., Thousand Oaks, CA
  1. ↵* Correspondence author: One Amgen Center Dr., Thousand Oaks, CA 91320. csloey{at}amgen.com
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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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  • 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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