A syringe system for accommodating lyophilization of a liquid drug, storing the lyophilized drug, separately storing a diluent, combining the lyophilized drug and diluent to reconstitute the lyophilized drug to solution form for administration, and dispensing the solution, said system comprising:
- a first syringe barrel for initially containing a liquid drug and having (1) a delivery end defining a delivery passage, (2) an opposite open end, (3) an interior surface, and (4) a venting portion including at least one longitudinal channel in said venting portion;
- a removable closure sealing closed said delivery passage;
- a reciprocable stopper that has (1) an outer side facing said first syringe barrel open end, and (2) an inner side facing said first syringe barrel delivery passage, said reciprocable stopper being initially locatable in said first syringe barrel adjacent said longitudinal channel at a first position which permits passage of vapor around said reciprocable stopper through said channel out of said first syringe barrel during lyophilization, said reciprocable stopper subsequently being movable to positions inward of said channel of the venting portion wherein said interior surface is sealingly engaged for sealing the lyophilized drug in said first syringe barrel;
- a sterility maintenance sleeve that is located at the outer side of said reciprocable stopper for movement with said reciprocable stopper and that has (1) an outlet end defining an outlet passage, (2) an opposite open end, (3) an interior female thread, and (4) at least one deflectable, anti-rotation tab which
- (a) projects into the longitudinal channel of said first syringe barrel to prevent rotation of said sterility maintenance sleeve relative to said first syringe barrel when said sterility maintenance sleeve is located at a predetermined longitudinal position in said first syringe barrel, and
- (b) deflects out of said longitudinal channel when said sterility maintenance sleeve is moved inward beyond said longitudinal channel during subsequent administration of the solution;
- a removable plug for temporary insertion into said sterility maintenance sleeve through the open end of said sterility maintenance sleeve, said plug having (1) an engaging member for threadingly engaging the interior female thread of said sterility maintenance sleeve, (2) a nozzle-shaped distal end seal for sealing the outlet passage of said sterility maintenance sleeve and (3) an exterior seal wall for temporarily sealing the open end of said first syringe barrel outwardly of the longitudinal channel;
- a diluent syringe for being inserted into said sterility maintenance sleeve after removal of said plug, said diluent syringe comprising
- (1) a diluent syringe barrel that holds a liquid diluent and includes
- (a) an exterior engaging member for threadingly engaging the interior female thread of said sterility maintenance sleeve, and
- (b) a discharge end defining a discharge passage, and
- (2) a movable piston plunger slidably and sealingly disposed in said diluent syringe barrel;
- and
- fluid transfer connector means for selectively accommodating transfer of liquid diluent from said diluent syringe barrel through said reciprocable stopper from the outer side of said reciprocable stopper to the inner side of said reciprocable stopper whereby the movable piston plunger of said diluent syringe can be moved toward the discharge end of said diluent syringe barrel for expressing said liquid diluent through the discharge passage of said diluent syringe barrel, through the outlet passage of said sterility maintenance sleeve, and through said reciprocable stopper via said fluid transfer connector means to combine said liquid diluent with said lyophilized drug for reconstitution of said drug in solution form whereby said removable closure can be subsequently removed from the delivery passage of said first syringe barrel and then the movable piston plunger of said diluent syringe, the diluent syringe barrel, the sterility maintenance sleeve, and the reciprocable stopper can together be moved inward so that said reciprocable stopper forces said drug solution through the delivery passage of said first syringe barrel for administration to a patient.