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;
Ken Choju
2Nippon Electric Glass Co., Ltd. Otsu Plant Otsu, Shiga, Japan;
Carol Rea Flynn
3Glass Standards and Technical Services Manager, Corning Incorporated, One Riverfront Plaza, Corning, NY, USA;
Ludovico Gavioli
4Bormioli Rocco S.p.A., Via Garibaldi Bergantino (RO), Italy;
Ron Iacocca
5Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA;
Amy Meysner
6Glass Technology Services Ltd., Chapeltown, Sheffield, South Yorkshire, UK;
Joachim Pfeifer
7Amgen Research, Staffelseestr, Munich, Germany;
Holger Roehl
8F. Hoffmann-La Roche Ltd., Basel, Switzerland;
Volker Rupertus
9Schott AG, Hattenbergstr, Mainz/Germany;
Martina Scarpa
10Stazione Sperimentale del Vetro, Venice, Italy;
Huimin Sun
11National Institutes for Food and Drug Control, Dongcheng District, Beijing, China;
Jingwei Zhang
12SGD Group, Rue Eolis – Pôle d'Activités Bresle Maritime Saint Quentin La Motte Croix au Bailly, France;
Daniele Zuccato
13Stevanato Group, SGLab, Via Molinella, Piombino Dese (PD), Italy; and
Massimo Guglielmi
14Dipartimento di Ingegneria Industriale, University of Padova, Via Marzolo, Padova, Italy
Reference
- 1.↵
- 2.↵
- Bacon F. R.,
- Burch O. G.
- 3.↵
- Schaut R. A.,
- Weeks W. P.
- 4.↵
- Dimbleby V.
- 5.↵U.S. Food and Drug Administration. Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs. 2011. https://wayback.archive-it.org/7993/20170113073826/http://www.fda.gov/Drugs/DrugSafety/ucm248490.htm. Accessed March 25, 2011.
- 6.↵Glass Containers for Pharmaceutical Use. European Pharmacopoeia 7th ed., Council of Europe: Strasbourg, France, 2011, Chapter 3.2.1, p 363.
- 7.↵
- Guadagnino E.,
- Zuccato D.
- 8.↵
- Sloey C.,
- Gleason C.,
- Phillips J.
- 9.↵
- Scheumann V.,
- Klause M.,
- Rothhaar U.
- 10.↵
- 11.↵
- Rehm K.
- 12.↵
- Hang P. T.,
- Brindley G. W.
- 13.↵
- 14.↵
- Ramkumar J.,
- Chandramouleeswaran S.,
- Sudarsan V.,
- Vatsa R.K.,
- Shobha S.,
- Shrikhande V.K.,
- Kothiyal G.P.,
- Mukherjee T.
- 15.↵Schott Newsletter No. 14, 2011.
- 16.↵
- Ditter D.,
- Nieto A.,
- Mahler H. C.,
- Roehl H.,
- Wahl M.,
- Huwyler J.,
- Allmendinger A.
- 17.↵
- 18.↵
- Ogawa T.,
- Miyajima M.,
- Wakiyama N.,
- Terada K.
- 19.↵
- Rothaar U.,
- Klause M.,
- Hladik B.
- 20.↵
- Rupertus V.,
- Hladik B.,
- Rothhaar U.,
- Scheumann V.
- 21.↵
- Jiang G.,
- Goss M.,
- Li G.,
- Jing W.,
- Shen H.,
- Fujimori K.,
- Le L.,
- Wong L.,
- Wen Z.Q.,
- Nashed-Samuel Y.,
- et al
- 22.↵
- Biavati A.,
- Poncini M.,
- Ferrarini A.,
- Favaro N.,
- Scarpa M.,
- Vallotto M.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 6
November/December 2018
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
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
Jump to section
Related Articles
- No related articles found.
Cited By...
- No citing articles found.