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Stevanato: 2R vials and deep cold storage – mechanical & CCI performances

Evaluating the performance of containers on a case-by-case basis is always recommended. But increased assurance about the compatibility of glass containers with cold storage conditions is key for pharmaceutical companies facing development issues with mRNA vaccines. In this increasingly complex application, Stevanato Group glass vials are a proven solution to make life easier for customers.

This study aims to demonstrate experimentally the Mechanical & Container Closure Integrity (CCI) performance of 2R Fina® quality glass vials in multiple conditions.

Mechanical performance was tested with two quantitative techniques, Vertical Compression Test (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.

CCI was tested with a deterministic technique, Laser-based Headspace-Gas Analysis, measuring the concentration of CO2 gas present in the head-space of the vial. In this study, the analysis was conducted on manually and automatically assembled vials with multiple stopper configurations, at multiple time points after storage at room temperature and at below 80 degrees Celsius. 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.

Climatic chamber with 2R vials inside for DF cycle

The study analysed and verified the behaviour of 2R Fina® quality glass vials from Stevanato Group after being conditioned at below 80 degrees Celsius for a prolonged period of time.

The results of such analysis show that 2R vials can be processed under such conditions without impacting their mechanical performance; moreover, vial geometry, in combination with different closure systems, can maintain CCI for a prolonged period of time under the testing conditions.

Stevanato Group’s 2R Fina® quality glass vials are therefore suitable for sensitive molecules that require deep-cold storage to keep the drug stable until it is used – mRNA and DNA vaccines, for example, as well as viral vector and gene therapies.

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