Mechanical performance was tested with two (2) quantitative techniques, Vertical CompressionTest (VT) and Burst Test (BT), measuring the maximum mechanical stress that a single vial can withstand before generating a failure; the configurations tested showed no statistically significant difference before and after conditioning.

CCIwas tested with a deterministic technique, Laser-based Headspace-Gas Analysis, measuring the concentration of CO2 gas present in the headspace of the vial. In this study, the analysis was conducted on manually and automatically assembled vials with multiple stopper configurations, at multiple timepoints after storage at room temperature and at -80°C. Seven (7) combinations were tested, each with 30 samples at T0 and T6 months, and all configurations passed, showing that CCI was maintained.

Given that final container closure configuration is process and material dependent, a dedicated study is mandatory to ensure the suitability of the selected configuration for the required application.

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Stevanato Group S.p.A. published this content on 19 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 19 April 2024 09:49:03 UTC.