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A Novel MATLAB®-Algorithm-Based Video Analysis to Quantitatively Determine Solution Creeping in Intact Pharmaceutical Glass Vials

Molnar, Daniel ; Röhm, Martina; Wutz, Johannes; Rivec, Ingrid; Michel, Annika; Klotz, Gina 1; Hubbuch, Jürgen ORCID iD icon 1; Schindowski, Katharina; Presser, Ingo
1 Institut für Bio- und Lebensmitteltechnik (BLT), Karlsruher Institut für Technologie (KIT)

Abstract:

During the filling process of a biopharmaceutical drug product (DP), a liquid DP film might creep up the inner vial wall which is barely discernible, appears as milky-white haze after lyophilisation and is known as fogging. Creeping and fogging are mainly dependent on the primary packaging material surface and its hydration, vial preparation process as well as DP composition. The occurrence of both can impede visual inspection and might lead to DP rejection. Hence, our studies focused on the early detection of liquid solution and glass vial surface interaction directly after filling. For a fast and highly sensitive evaluation a novel video-based analysis was used. To our knowledge, this is the first time a MATLAB®-algorithm-based video analysis was applied to quantitatively determine creeping time-resolved. Furthermore, creeping in dependence of vial processing sites, surfactant type and concentration, filling temperature, and vial format were investigated. The results were verified using orthogonal conventional methods such as surface tension, wetting behaviour, and contact angle measurements, as well as ToF-SIMS, ICP-MS, and SEM. Additionally, the methods applied were assessed regarding their cross-validation capability. ... mehr


Verlagsausgabe §
DOI: 10.5445/IR/1000150366
Veröffentlicht am 08.09.2022
Cover der Publikation
Zugehörige Institution(en) am KIT Institut für Bio- und Lebensmitteltechnik (BLT)
Publikationstyp Zeitschriftenaufsatz
Publikationsmonat/-jahr 09.2022
Sprache Englisch
Identifikator ISSN: 0939-6411, 1873-3441
KITopen-ID: 1000150366
Erschienen in European Journal of Pharmaceutics and Biopharmaceutics
Verlag Elsevier
Band 178
Seiten 117–130
Nachgewiesen in Dimensions
Web of Science
Scopus
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