A system for validating a sealing of a pharmaceutical container, the system comprising:
- a pharmaceutical ferrule coupled to the pharmaceutical container comprising:
- a sealing region configured to secure a valve against a pharmaceutical container and having an upper boundary and a lower boundary;
- an engagement region configured to couple the pharmaceutical container to the pharmaceutical ferrule;
- and
- a coupling region comprising multiple tension members, wherein each tension member extends along a curvilinear path to connect the engagement region to the sealing region, and
- the multiple tension members are configured such that, when the engagement region is coupled to the pharmaceutical container and the coupling region is coupled to the valve, a tensile strength of the multiple tension members between the engagement region and the coupling region is at least equal to a predetermined value sufficient to retain the valve to the pharmaceutical container
- wherein gaps between the multiple tension members define flow paths through the pharmaceutical ferrule configured to enable gas leaking from the sealed interface to exit to be detected by a detection sensor;
- a valve assembly comprising the valve situated between the pharmaceutical ferrule and the pharmaceutical container, the valve extending along a central longitudinal axis of the pharmaceutical container and being fluidly communicative between the pharmaceutical ferrule and the pharmaceutical container;
- a gasket positioned between the valve assembly and the sealing region formed from the pharmaceutical container and the pharmaceutical ferrule, the gasket configured to form a gas-tight seal between the valve assembly and the pharmaceutical container;
- a vacuum chamber configured to apply a negative pressure to at least one pharmaceutical container within the vacuum chamber;
- a mass spectrometer comprising the detection sensor in fluid communication with the vacuum chamber;
- and,
- a controller configured to perform validation operations, the validation operations comprising:
- apply a negative pressure to the at least one pharmaceutical container;
- retrieve a spectrometer calibration profile, wherein the spectrometer calibration profile comprises a predetermined correlation between a molecule count of the spectrometer and a weight change in the pharmaceutical container over a predetermined period;
- and,
- determine, as a function of the spectrometer calibration profile and a detected molecule count by the mass spectrometer of a leaked substance from the pharmaceutical container, an equivalent weight change in the pharmaceutical container over the predetermined period.