Access and vapor containment system for a drug vial and method of making and using same

Abstract

A safety vial system has a vial adapter subsystem irreversibly mountable to the top of a vial containing a hazardous medicament and a vial base subsystem sealingly engaging a lower portion of the vial adapter subsystem and telescopically movable therein from a first position providing a path for gas sterilization around the vial to a second position wherein the path is closed to form a sterilized expandable, neutral pressure bellows chamber around and below the vial. The device has a removable top cap, a pierceable barrier film, a normally closed needleless valve in fluid communication with a dual lumen spike initially disposed above the film and a frangible product integrity ring holding the activation housing in place for sealed telescopic movement on a main body that surrounds the vial. The user pulls the product integrity ring and removes it, and then pushes the activation housing axially downward until it clicks to lock the device in the activated position wherein both lumens of the spike are in communication with the inside of the vial. The user removes the top cap on the activation housing assembly, and then uses a needleless syringe with an adapter thereon to add diluent and mixes if needed and withdraw drug from the vial via the valve.