Pharm Res (2018) 35: 146 https://doi.org/10.1007/s11095-018-2421-6 RESEARCH PAPER Impact of Vial Washing and Depyrogenation on Surface Properties and Delamination Risk of Glass Vials 1,2,3 3 1 1 Dominique Ditter & Hanns-Christian Mahler & Linus Gohlke & Alejandra Nieto & 1 2 4 1 Holger Roehl & Joerg Huwyler & Michael Wahl & Andrea Allmendinger Received: 30 January 2018 /Accepted: 30 April 2018 /Published online: 23 May 2018 # Springer Science+Business Media, LLC, part of Springer Nature 2018 ABSTRACT and both the stressed solution and inner vial surface were Purpose The proper understanding of glass delamination is analyzed by a panel of conventional and advanced analytical important to glass manufacturers, pharmaceutical companies, techniques including 3D laser scanning microscopy. and health authorities to mitigate the occurrence of glass flakes Results The data showed that vial washing and from the vial when in contact with specific drug product solu- depyrogenation strongly influenced surface properties, in par- tions. The surface of glass vials is altered during glass cane- ticular those of uncoated vials. Surface characteristics such as and vial forming processes and is exposed to different stress pits increased depending on the process conditions, which es- conditions during drug product processing before coming
Pharmaceutical Research – Springer Journals
Published: May 23, 2018
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