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Research ArticleResearch

Development of a Nondestructive Leak Testing Method Utilizing the Head Space Analyzer for Ampoule Products Containing Ethanol-Based Solutions

Hirotaka Sudo, Michael O'driscoll, Kenji Nishiwaki, Yuji Kawamoto, Philip Gammell, Gerhard Schramm, Toni Wertli, Heino Prinz, Atsuhide Mori and Kazuhiro Sako
PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 434-444; DOI: https://doi.org/10.5731/pdajpst.2012.00882
Hirotaka Sudo
1Astellas Pharma Inc.;
2Graduate School of Engineering, Kobe University;
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Michael O'driscoll
3Astellas Ireland Co. Ltd.; and
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Kenji Nishiwaki
1Astellas Pharma Inc.;
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Yuji Kawamoto
1Astellas Pharma Inc.;
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Philip Gammell
3Astellas Ireland Co. Ltd.; and
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Gerhard Schramm
4Wilco AG
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Toni Wertli
4Wilco AG
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Heino Prinz
4Wilco AG
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Atsuhide Mori
1Astellas Pharma Inc.;
2Graduate School of Engineering, Kobe University;
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Kazuhiro Sako
1Astellas Pharma Inc.;
2Graduate School of Engineering, Kobe University;
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Article Information

vol. 66 no. 5 434-444
DOI 
https://doi.org/10.5731/pdajpst.2012.00882
PubMed 
23035027

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 3, 2012.

Copyright & Usage 
© PDA, Inc. 2012

Author Information

  1. Hirotaka Sudo1,2,
  2. Michael O'driscoll3,
  3. Kenji Nishiwaki1,
  4. Yuji Kawamoto1,
  5. Philip Gammell3,
  6. Gerhard Schramm4,
  7. Toni Wertli4,
  8. Heino Prinz4,
  9. Atsuhide Mori1,2 and
  10. Kazuhiro Sako1,2
  1. 1Astellas Pharma Inc.;
  2. 2Graduate School of Engineering, Kobe University;
  3. 3Astellas Ireland Co. Ltd.; and
  4. 4Wilco AG
  1. Corresponding author: Hirotaka Sudo, Astellas Pharma, Inc. hirotaka.sudo{at}astellas.com
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PDA Journal of Pharmaceutical Science and Technology: 66 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 5
September/October 2012
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Development of a Nondestructive Leak Testing Method Utilizing the Head Space Analyzer for Ampoule Products Containing Ethanol-Based Solutions
Hirotaka Sudo, Michael O'driscoll, Kenji Nishiwaki, Yuji Kawamoto, Philip Gammell, Gerhard Schramm, Toni Wertli, Heino Prinz, Atsuhide Mori, Kazuhiro Sako
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 434-444; DOI: 10.5731/pdajpst.2012.00882

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Development of a Nondestructive Leak Testing Method Utilizing the Head Space Analyzer for Ampoule Products Containing Ethanol-Based Solutions
Hirotaka Sudo, Michael O'driscoll, Kenji Nishiwaki, Yuji Kawamoto, Philip Gammell, Gerhard Schramm, Toni Wertli, Heino Prinz, Atsuhide Mori, Kazuhiro Sako
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 434-444; DOI: 10.5731/pdajpst.2012.00882
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Keywords

  • Container/closure integrity
  • Integrity tester
  • Leak tester
  • Head space analysis

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