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EU24CEMAR1/SES301 - Seal Tightness Drones to Support Container Closure Integrity Assurance

‐ Mar 12, 2024 11:15am

Seal Tightness Drones to Support Container Closure Integrity Assurance|A novel method for monitoring vial sealing and container handling using 'drones' (sensor-enabled replica containers) that measure seal force, pressure, and shock will be explained. This new technology gives insights into the process variability inherent in the capping and crimping process and throughout the filling and packaging process. Data will be shared that focuses on the interrelationships of components and crimping performance. Anticipated applications will be presented including data generated that gives insights into material properties and how they impact seal tightness.

The management of the capping and crimping process for vials has always faced challenges due to the lack of a suitable method to monitor the process with the absence of an in-process analytical monitoring tool. Residual Seal Force (RSF) is sometimes used but adoption of RSF is not uniform in industry due to limitations with reproducibility. Industry practice still often relies on rudimentary checks carried out by operators that are not quantitative. The method under development with project partner SmartSkin to monitor this assembly process will be explained as well as the progress made toward integrating this method as a GMP application. Integrating these new seal tightness measurements into a control plan which supports the holistic approach and assurance of container closure integrity (CCI).