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;
Michael O'driscoll
3Astellas Ireland Co. Ltd.; and
Kenji Nishiwaki
1Astellas Pharma Inc.;
Yuji Kawamoto
1Astellas Pharma Inc.;
Philip Gammell
3Astellas Ireland Co. Ltd.; and
Gerhard Schramm
4Wilco AG
Toni Wertli
4Wilco AG
Heino Prinz
4Wilco AG
Atsuhide Mori
1Astellas Pharma Inc.;
2Graduate School of Engineering, Kobe University;
Kazuhiro Sako
1Astellas Pharma Inc.;
2Graduate School of Engineering, Kobe University;

References
- 1.↵
FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice, 2004.
- 2.↵
EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 1 Manufacture of Sterile Medicinal Products, 2008.
- 3.↵
Japan Guidance for Industry Sterile Drug Products Produced by Aseptic Processing, 2011.
- 4.↵
- 5.↵
- Wolf H.,
- Stauffer T.,
- Chen SC,
- Lee Y.,
- Forster R.,
- Ludzinski M.,
- Kamat M.,
- Godorov P.,
- Guazzo D. M.
- 6.↵
- Wolf H.,
- Stauffer T.,
- Chen S. C.,
- Lee Y.,
- Forster R.,
- Ludzinski M.,
- Kamat M.,
- Mulhall B.,
- Guazzo D. M.
- 7.↵
- Kirsch L. E.,
- Nguyen L.,
- Kirsch A. M.,
- Schmitt G.,
- Koch M.,
- Wertli T.,
- Lehmann M.,
- Schramm G.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 5
September/October 2012
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
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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