Liner-based shipping and dispensing containers for the substantially sterile storage, shipment, and dispense of materials

Abstract

A liner-based assembly including an overpack, a liner disposed within the overpack, and a filling connector securable to at least one of the overpack and the liner and ineloding a membrane for substantially aseptic filling. The membrane may be an elastomeric stopper, which may be configured, for re-sealing with or without the assistance of heat The liner-based assembly may further include a dispense connector that is operably connected with the overpack and/or the liner. The dispense connector may comprise or be operably connected to a one-way valve, the one-way valve having —an elastomeric portion defining an opening and generally operably coupled with a plug member positioned within the—opening. In a closed position, the elastomeric portion may be sealed against the plug member, and when a pressure is applied against the elastomeric portion, the elastomeric portion may flex in a manner configured —to permit only one—way flow through the opening.

What is claimed is: 
     
         1 . A liner-based assembly for use with pressure dispense comprising:
 an overpack;   a liner disposed within the overpack; and   a filling connector that is securable to at least one of the overpack and the liner, the connector including a membrane for substantially aseptic filling.   
     
     
         2 . The liner-based assembly of  claim 1 , wherein the membrane comprises a re-sealable elastomeric stopper. 
     
     
         3 . The liner-based assembly of  claim 2 , wherein the re-sealable elastomeric stopper is configured for re-sealing with the assistance of heat. 
     
     
         4 . The liner-based assembly of  claim 2 , wherein the liner and overpack are irradiated. 
     
     
         5 . The liner-based assembly of  claim 1 , further comprising a dispense connector operably connected with at least one of the overpack and the liner, over the filling connector, the dispense connector at least one of comprising or operably connected to a one-way valve. 
     
     
         6 . The liner-based assembly of  claim 5 , wherein the liner is collapsible away from the overpack. 
     
     
         7 . The liner-based assembly of  claim 6 , further comprising a portable pressure source for pressurizing an annular space between the overpack and liner for collapsing the liner and dispensing the contents thereof. 
     
     
         8 . The liner-based assembly of  claim 5 , wherein the one-way valve comprises an elastomeric portion defining an opening and generally operably coupled with a plug member positioned within the opening, the plug member being relatively stiff as compared to the elastomeric portion, wherein in a closed position, the elastomeric portion is sealed against the plug member, and wherein when a pressure is applied against the elastomeric portion, the elastomeric portion is flexes in a manner configured to permit only one-way flow through the opening. 
     
     
         9 . A method for providing a sterile transporting and pressure dispense system, the method comprising:
 providing an overpack and a liner disposed within the overpack;   irradiating the overpack and liner for sterility; and   securing a connector to at least one of the overpack and the liner, the connector including a membrane for substantially aseptic filling.   
     
     
         10 . The method of  claim 9 , wherein the membrane comprises a re-sealable elastomeric stopper. 
     
     
         11 . The method of  claim 10 , further comprising filling the liner by piercing the elastomeric stopper with a needle and passing a material through the needle into the liner. 
     
     
         12 . The method of  claim 11 , further comprising removing the needle upon completion of filling and applying heat to assist in re-sealing the elastomeric stopper. 
     
     
         13 . The method of  claim 11 , further comprising removing headspace gas from the interior of the liner upon completion of filling the liner. 
     
     
         14 . The method of  claim 13 , wherein the connector comprises a one-way valve for permitting headspace gas to pass in one direction out of the liner. 
     
     
         15 . The method of  claim 9 , further comprising providing a dispense connector that is operably connected with at least one of the overpack and the liner, the dispense connector at least one of comprising or operably connected to a one-way valve. 
     
     
         16 . The method of  claim 15 , wherein providing a dispense connector comprises providing a portable pressure source for pressurizing an annular space between the overpack and liner. 
     
     
         17 . The method of  claim 16 , wherein the portable pressure source comprises a disposable compressed gas cartridge. 
     
     
         18 . A liner-based assembly for use with pressure dispense comprising:
 an overpack;   a liner disposed within the overpack, the liner configured for collapsing away from the overpack upon the introduction of a gas or fluid into an annular space between the overpack and liner; and   a dispense connector that is securable to at least one of the overpack and the liner, the dispense connector comprising a passage in fluid communication with the annular space and at least one of comprising or operably connected to a one-way dispense valve in fluid communication with an interior of the liner.   
     
     
         19 . The liner-based assembly of  claim 18 , wherein the one-way valve comprises an elastomeric portion defining an opening and generally operably coupled with a plug member positioned within the opening, the plug member being relatively stiff as compared to the elastomeric portion, wherein in as closed position, the elastomeric portion is sealed against the plug member, and wherein when a pressure is applied against the elastomeric portion, the elastomeric portion is flexes in a manner configured to permit only one-way flow through the opening. 
     
     
         20 . The liner-based assembly of  claim 8 , wherein the liner and overpack irradiated.