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Research ArticleResearch

Delamination Propensity of Glass Containers for Pharmaceutical Use: A Round Robin Activity Looking for a Predictive Test

Juan Cerdan-Diaz, Ken Choju, Carol Rea Flynn, Ludovico Gavioli, Ron Iacocca, Amy Meysner, Joachim Pfeifer, Holger Roehl, Volker Rupertus, Martina Scarpa, Huimin Sun, Jingwei Zhang, Daniele Zuccato and Massimo Guglielmi
PDA Journal of Pharmaceutical Science and Technology November 2018, 72 (6) 553-565; DOI: https://doi.org/10.5731/pdajpst.2018.008599
Juan Cerdan-Diaz
1Nipro Pharma Packaging Americas Corporation, Millville, NJ, USA;
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Ken Choju
2Nippon Electric Glass Co., Ltd. Otsu Plant Otsu, Shiga, Japan;
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Carol Rea Flynn
3Glass Standards and Technical Services Manager, Corning Incorporated, One Riverfront Plaza, Corning, NY, USA;
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Ludovico Gavioli
4Bormioli Rocco S.p.A., Via Garibaldi Bergantino (RO), Italy;
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Ron Iacocca
5Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA;
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Amy Meysner
6Glass Technology Services Ltd., Chapeltown, Sheffield, South Yorkshire, UK;
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Joachim Pfeifer
7Amgen Research, Staffelseestr, Munich, Germany;
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Holger Roehl
8F. Hoffmann-La Roche Ltd., Basel, Switzerland;
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Volker Rupertus
9Schott AG, Hattenbergstr, Mainz/Germany;
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Martina Scarpa
10Stazione Sperimentale del Vetro, Venice, Italy;
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Huimin Sun
11National Institutes for Food and Drug Control, Dongcheng District, Beijing, China;
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Jingwei Zhang
12SGD Group, Rue Eolis – Pôle d'Activités Bresle Maritime Saint Quentin La Motte Croix au Bailly, France;
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Daniele Zuccato
13Stevanato Group, SGLab, Via Molinella, Piombino Dese (PD), Italy; and
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Massimo Guglielmi
14Dipartimento di Ingegneria Industriale, University of Padova, Via Marzolo, Padova, Italy
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  • For correspondence: Massimo.guglielmi@unipd.it
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Article Information

vol. 72 no. 6 553-565
DOI 
https://doi.org/10.5731/pdajpst.2018.008599
PubMed 
29954923

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online December 4, 2018.

Article Versions

  • previous version (June 27, 2018 - 21:50).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2018

Author Information

  1. Juan Cerdan-Diaz1,
  2. Ken Choju2,
  3. Carol Rea Flynn3,
  4. Ludovico Gavioli4,
  5. Ron Iacocca5,
  6. Amy Meysner6,
  7. Joachim Pfeifer7,
  8. Holger Roehl8,
  9. Volker Rupertus9,
  10. Martina Scarpa10,
  11. Huimin Sun11,
  12. Jingwei Zhang12,
  13. Daniele Zuccato13 and
  14. Massimo Guglielmi14,*
  1. 1Nipro Pharma Packaging Americas Corporation, Millville, NJ, USA;
  2. 2Nippon Electric Glass Co., Ltd. Otsu Plant Otsu, Shiga, Japan;
  3. 3Glass Standards and Technical Services Manager, Corning Incorporated, One Riverfront Plaza, Corning, NY, USA;
  4. 4Bormioli Rocco S.p.A., Via Garibaldi Bergantino (RO), Italy;
  5. 5Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA;
  6. 6Glass Technology Services Ltd., Chapeltown, Sheffield, South Yorkshire, UK;
  7. 7Amgen Research, Staffelseestr, Munich, Germany;
  8. 8F. Hoffmann-La Roche Ltd., Basel, Switzerland;
  9. 9Schott AG, Hattenbergstr, Mainz/Germany;
  10. 10Stazione Sperimentale del Vetro, Venice, Italy;
  11. 11National Institutes for Food and Drug Control, Dongcheng District, Beijing, China;
  12. 12SGD Group, Rue Eolis – Pôle d'Activités Bresle Maritime Saint Quentin La Motte Croix au Bailly, France;
  13. 13Stevanato Group, SGLab, Via Molinella, Piombino Dese (PD), Italy; and
  14. 14Dipartimento di Ingegneria Industriale, University of Padova, Via Marzolo, Padova, Italy
  1. ↵* Corresponding Author: Dipartimento di Ingegneria Industriale, University of Padova, Via Marzolo 9, 35135 Padova, Italy; e-mail: Massimo.guglielmi{at}unipd.it
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PDA Journal of Pharmaceutical Science and Technology: 72 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 6
November/December 2018
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Delamination Propensity of Glass Containers for Pharmaceutical Use: A Round Robin Activity Looking for a Predictive Test
Juan Cerdan-Diaz, Ken Choju, Carol Rea Flynn, Ludovico Gavioli, Ron Iacocca, Amy Meysner, Joachim Pfeifer, Holger Roehl, Volker Rupertus, Martina Scarpa, Huimin Sun, Jingwei Zhang, Daniele Zuccato, Massimo Guglielmi
PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 553-565; DOI: 10.5731/pdajpst.2018.008599

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Delamination Propensity of Glass Containers for Pharmaceutical Use: A Round Robin Activity Looking for a Predictive Test
Juan Cerdan-Diaz, Ken Choju, Carol Rea Flynn, Ludovico Gavioli, Ron Iacocca, Amy Meysner, Joachim Pfeifer, Holger Roehl, Volker Rupertus, Martina Scarpa, Huimin Sun, Jingwei Zhang, Daniele Zuccato, Massimo Guglielmi
PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 553-565; DOI: 10.5731/pdajpst.2018.008599
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Keywords

  • Glass delamination
  • Glass corrosion
  • ICP-OES
  • Round robin test
  • Type I borosilicate glass

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