Systems and approaches for sterilizing a drug delivery device

Abstract

A shielding member for use in sterilizing drug container assemblies includes a housing. The housing includes a first shielding portion and a second shielding portion. The first shielding portion includes a first and second surfaces and a plurality of first bore portions extending between. The second shielding portion having a first and second surfaces and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions. The first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing. The receptacles are sized and configured to receive drug container assemblies, each comprising a container with a container contact region and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each drug container assembly is exposed out of the housing through one of the openings.

What is claimed is: 
     
         1 . A system comprising:
 a drug container assembly including a container and a seal member, the container having an opening and the seal member at least partially covering the opening in the container;   an energy source configured to emit rays of energy towards a sterilization or disinfection region;   a barrier disposed adjacent to the sterilization or disinfection region and having an opening; and   wherein at least a portion of the drug container assembly is positioned adjacent to the opening in the barrier such that at least a portion of the seal member is disposed in the sterilization or disinfection region.   
     
     
         2 . The system of  claim 1 , wherein the barrier includes a wall and the opening is formed in the wall. 
     
     
         3 . The system of  claim 2 , wherein at least a portion of the container and the energy source are disposed on opposite sides of the wall. 
     
     
         4 . The system of  claim 3 , wherein the at least a portion of the seal member and the energy source are disposed on the same side of the wall. 
     
     
         5 . The system of  claim 3 , wherein the barrier includes a bore communicating with the opening, and wherein the at least a portion of the seal member is disposed in the bore. 
     
     
         6 . The system of  claim 5 , wherein the at least a portion of the container is disposed outside of the bore. 
     
     
         7 . The system of  claim 1 , wherein the opening in the container is coaxial with the opening in the barrier. 
     
     
         8 . The system of  claim 1 , wherein the drug container assembly includes a crimp ring coupling the seal member to the container, at least a portion of the crimp ring extending through the opening in the barrier and being disposed in the sterilization or disinfection region. 
     
     
         9 . The system of  claim 1 , wherein the energy source is configured to emit rays of radiation. 
     
     
         10 . The system of  claim 9 , wherein the energy source is an electron beam generator. 
     
     
         11 . The system of  claim 1 , wherein the barrier is a radiation shield. 
     
     
         12 . The system of  claim 1 , wherein the rays of energy emitted by the energy source penetrate the seal member to sterilize or disinfect a sealing interface between the seal member and the container. 
     
     
         13 . The system of  claim 1 , wherein the barrier limits exposure of at least a portion of the container to the rays of energy emitted by the energy source during a sterilization or disinfection process. 
     
     
         14 . The system of  claim 13 , wherein the barrier includes a shoulder configured to obstruct the rays of energy emitted by the energy source from interacting with the at least a portion of the container during the sterilization or disinfection process. 
     
     
         15 . The system of  claim 1 , wherein the barrier surrounds at least a portion of the sterilization or disinfection region.