Blow fill sealed container with twist off top operated by overcap and method of making the same

Abstract

A container assembly includes a container body having a port or aperture adapted for use with a luer end of a needleless syringe. The aperture is sealed to a closure top by a first frangible seal. An overcap has a cap base sealed to the container body and an upper cap connected to the cap base by a second frangible seal, providing a sterile barrier surrounding the first frangible seal. The second frangible seal is broken by depressing the upper cap toward the container body. Alternatively, the second frangible seal is a removable tear strip broken by tugging on the tear strip. The upper cap includes a detent portion frictionally securing the upper cap to the closure top when the upper cap is depressed toward the container body. The upper cap and secured closure top are removed from container body by twisting the upper cap to break the first frangible seal and open the port.

1 .- 26 . (canceled)  
     
     
         27 . A method of forming container assembly, comprising: 
 forming a unitary container body and closure top assembly, the container body holding fluid and including a port having an aperture therein, the closure top being attached over the aperture of the container body by a first frangible seal; and    forming an overcap having a second frangible seal therein;    sealing the overcap to the container body to form the container assembly, the overcap surrounding the first frangible seal; and    sterilizing the container assembly, the overcap providing a sterile barrier surrounding the first frangible seal.    
     
     
         28 . The method of  claim 27 , wherein the unitary container body and closure top assembly are formed by a blow/fill/seal method.  
     
     
         29 . The method of  claim 27 , wherein the overcap is fusion welded to the container body.  
     
     
         30 . The method of  claim 27 , wherein the container assembly is sterilized by autoclaving.  
     
     
         31 . The method of  claim 28 , wherein the overcap is not fixed to the closure top during a first sterilization of the filled container body.