A pre-filled medical delivery
assembly configured to allow delivery of a single
dose of a therapeutic agent (e.g., vaccine,
drug, medicament, etc.) from a Blow-Fill-Seal (BFS)
vial to a patient. The delivery
assembly including a tear-activation valve that provides for an internal, mechanical BFS
vial opening, and defines an Auto-Disable (AD) feature that prevents refilling or re-use of the
assembly.