Sterilization fluid path with barrier removal

Abstract

A device and method is disclosed for assembling a container holder in a clean environment, aseptically adding a solution to a primary container, inserting the primary container into the container holder, applying a first barrier to the container holder, sterilizing the container holder comprising the primary container and the applied first barrier to provide a sterilized container holder, assembling a fluid path module in a clean environment, the assembling comprising applying a second barrier to a first end of the sterilized fluid path module, sterilizing the fluid path module to provide a sterilized fluid path module and assembling a delivery device comprising the sterilized container holder and the sterilized fluid path module.

What is claimed is: 
     
         1 . A delivery device comprising:
 a sterilized container holder comprising:   a sterilized primary container comprising an aseptically added solution;   a first barrier; and   a sterilized fluid path module comprising:   a sterilized penetration needle;   a sterilized channel;   a sterilized user needle; and   a second barrier at a first end of the sterilized fluid path module.   
     
     
         2 . The delivery device of  claim 1 , further comprising a third barrier at a second end of the sterilized fluid path module. 
     
     
         3 . The delivery device of  claim 1 , wherein the sterilized fluid path module is configured to connect to the sterilized container holder via the sterilized penetration needle. 
     
     
         4 . The delivery device of  claim 1 , wherein at least one of the first barrier and the second barrier is a septum material. 
     
     
         5 . The delivery device of  claim 4 , wherein the septum material is at least one of an aluminum foil, Tyvek and a thermoplastic elastomer (TPE). 
     
     
         6 . A sterilized fluid path module comprising:
 a sterilized penetration needle;   a sterilized channel;   a sterilized user needle; and   a second barrier at a first end of the sterilized fluid path module.   
     
     
         7 . The sterilized fluid path module of  claim 6 , further comprising a drive module. 
     
     
         8 . The sterilized fluid path module of  claim 6 , further comprising a third barrier at a second end of the sterilized fluid path module.