Apparatus for manipulating pre-sterilized components in an active sterile field

Abstract

The connection, assembly, or fill of two or more pre-sterilized components 10, 12 having at least one terminal end 14 each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components 10, 12 together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field 60. Using a low-voltage electron beam instrument 54, such as the MIN-EB™, a suitable sterile field sphere can be created. The terminal ends 14 of the multiple components 10, 12 remain within the sterile field sphere 60 until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

1 . A sterilization system comprising: 
 a. a housing defining a sterilization chamber;    b. a low energy electron beam tube configured to emit an electron beam out an end thereof forming a reactive volume within the sterilization chamber and supported within the housing; and,    c. a robotic manipulating device disposed within the housing and configured to manipulate objects to be sterilized within the reactive volume formed within the sterilization chamber by the electron beam emitted from the electron beam tube.    
     
     
         2 . A sterilization system comprising: 
 a. a housing defining a sterilization chamber;    b. at least one low energy electron beam tube configured to emit an electron beam out an end thereof forming a reactive volume within the sterilization chamber; and    c. a gas distribution system disposed adjacent to the emitting end of the electron beam tube and configured to direct gas away from the emitting end of the electron beam tube and toward the reactive volume.    
     
     
         3 . The sterilization system of  claim 2  including a manipulating device disposed at least in part within the sterilization chamber for grasping an object to be sterilized and manipulating the object within the reactive volume.  
     
     
         4 . The sterilization system of  claim 3  wherein the manipulating device is a robotic member.  
     
     
         5 . The sterilization system of  claim 3  wherein the manipulating device is a glove box.  
     
     
         6 . A sterilization apparatus, comprising: 
 a. at least one low energy electron beam tube configured to emit and electron beam out an end thereof forming a reactive volume; and    b. a gas distribution system disposed adjacent the emitting end of the electron beam tube and configured to direct gas away from the emitting end of the electron beam tube and toward the reactive volume formed by the electron beam to expand the reactive volume.    
     
     
         7 . The sterilization apparatus of  claim 6  wherein the gas distribution system includes a source of helium or argon.  
     
     
         8 . The sterilization apparatus of  claim 6  including a manipulating device for grasping one or more objects to be sterilized and manipulating the object within the reactive volume.  
     
     
         9 . The sterilization apparatus of  claim 8  wherein a plurality of beam tubes are provided having electron beams forming the reactive volume.  
     
     
         10 . The sterilization apparatus of  claim 8  wherein the manipulating device is a robotic member.  
     
     
         11 . The sterilization apparatus of  claim 8  wherein the manipulating device is a robotic arm.  
     
     
         12 . The sterilization apparatus of  claim 8  wherein the manipulating device is a glove box hand.  
     
     
         13 . The sterilization apparatus of  claim 12  wherein the glove box hand is capable of moving in any direction and is capable of manipulating a variety of objects including different sized objects.  
     
     
         14 . A sterilization system comprising: 
 a. a station comprising a sterilization field within;    b. a low energy electron beam tube configured to emit an electron beam out an end thereof forming a reactive volume within the sterilization field and supported within the station; and,    c. a robotic manipulating device disposed within the station and configured to manipulate objects to be sterilized within the reactive volume formed within the sterilization field by the electron beam emitted from the electron beam tube.    
     
     
         15 . A sterilization system comprising: 
 a. a station comprising a sterilization field within;    b. at least one low energy electron beam tube configured to emit an electron beam out an end thereof forming a reactive volume within the sterilization field; and    c. a gas distribution system disposed adjacent to the emitting end of the electron beam tube and configured to direct gas away from the emitting end of the electron beam tube and toward the reactive volume.    
     
     
         16 . The sterilization system of  claim 15  including a manipulating device disposed at least in part within the sterilization field for grasping an object to be sterilized and manipulating the object within the reactive volume.