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A Novel MATLAB®-Algorithm-Based Video Analysis to Quantitatively Determine Solution Creeping in Intact Pharmaceutical
Daniel Molnar1, Martina Röhm1, Johannes Wutz1
1Boehringer Ingelheim Pharma GmbH & Co. KG, Formulation and Process Development Biologicals Late Stage, 88397 Biberach, Germany.
Summary
Early detection of liquid drug product (DP) creeping on vial surfaces prevents fogging and rejection. A novel video analysis method quantifies creeping, revealing vial preparation impacts.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Analytical Chemistry
Background:
- Liquid drug product (DP) creeping on primary packaging vial walls can lead to fogging, impeding visual inspection and causing DP rejection.
- Creeping is influenced by primary packaging material, vial preparation, and DP composition, necessitating early detection methods.
- Current detection methods are limited, highlighting the need for sensitive, time-resolved analysis of liquid-glass interactions.
Purpose of the Study:
- To develop and apply a novel, rapid video-based analysis for early detection and quantitative assessment of liquid DP creeping.
- To investigate the influence of vial processing, surfactant properties, filling parameters, and vial format on creeping behavior.
- To validate the novel method using orthogonal analytical techniques and assess cross-validation capabilities.
Main Methods:
- A MATLAB®-algorithm-based video analysis was developed for time-resolved, quantitative measurement of liquid creeping.
- Experiments investigated creeping in relation to vial processing sites, surfactant type/concentration, filling temperature, and vial format.
- Orthogonal methods including surface tension, contact angle, ToF-SIMS, ICP-MS, and SEM were used for verification and cross-validation.
Main Results:
- The novel video analysis successfully quantified creeping time-resolved, offering high sensitivity for early detection.
- Vial preparation processes were found to significantly alter glass vial surface properties, impacting subsequent creeping behavior.
- Results demonstrated the influence of surfactants, filling temperature, and vial format on the observed creeping phenomena.
Conclusions:
- A novel video analysis method provides a sensitive and quantitative approach for early detection of liquid-glass interactions, specifically drug product creeping.
- Vial preparation is a critical factor influencing glass vial surface properties and the propensity for drug product creeping.
- This method aids in preventing fogging and potential drug product rejection by enabling early identification of detrimental surface interactions.
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