Two compartment syringe accessible package and method of using and making the same

Abstract

The system of a dispensing package and a piercing assembly is disclosed. The package has at least one compartment in which a flowable material is located and a fitment secured to the outside of the package at the fitment. The fitment includes a passageway extending therethrough, which is temporarily sealed by a cover. When the cover is removed a piercing assembly can be extended through the fitment and the underlying portion of the package for communication with the flowable material within the compartment. The piercing assembly includes a septum arranged to be pierced by a needle of a syringe to enable the flowable material to be drawn into the syringe. The package is arranged to be formed, filled with the flowable material and sealed on a form, fill and seal machine.

We claim: 
     
         1 . A packaging system comprising the combination of a package and a piercing assembly for enabling a needle to gain access to a flowable material held within the package, said package comprising a hollow body and a fitment, said hollow body being formed of a flexible material and including at least one compartment for holding a flowable material therein, said compartment comprising a wall panel having an outer surface to which said fitment is secured, whereupon a portion of said wall panel underlies said fitment, said fitment including a passageway extending therethrough and terminating at the portion of said wall panel underlying said fitment, said passageway being sealed but openable to isolate said passageway from the ambient atmosphere, said piercing assembly comprising a septum coupled to a tubular member having a piercing tip, said tubular member being arranged to be introduced through said passageway of said fitment after said passageway has been opened to enable said piercing tip to pierce through said portion of said wall panel underlying said fitment to enter the interior of said compartment to thereby provide access to the flowable material in said compartment, said septum being arranged to be pierced by said needle after said piercing tip has entered into the interior of the compartment to enable the flowable contents of said compartment to be withdrawn from said compartment through the needle. 
     
     
         2 . The system of  claim 1  wherein said package comprises at least two compartments separated from each other by a frangible interface, each of said compartments holding a material therein, with at least one of said materials being a liquid, said frangible interface being arranged to be breached to cause said liquid of one compartment to mix with the material of the other compartment to form said flowable material. 
     
     
         3 . The system of  claim 1  wherein said openable cover is removable from said fitment. 
     
     
         4 . The system of  claim 3  wherein said openable cover comprises a sheet of material releasably secured to said fitment by a releasably securable adhesive. 
     
     
         5 . The system of  claim 1  additionally comprising a crimped member fixedly securing said septum to said tubular member of said piercing assembly. 
     
     
         6 . The system of  claim 1  wherein said tubular member of said piercing assembly comprises a distal portion arranged to be locked into place within said passageway after said piercing tip has pierced through said portion of said wall panel underlying said fitment. 
     
     
         7 . The system of  claim 6  wherein said distal portion of said tubular member has at least one aperture therein adjacent said piercing tip. 
     
     
         8 . The system of  claim 1  wherein said needle has a tip and wherein said piercing assembly is sufficiently long so that when the tip of the needle is inserted through said septum, the tip of the needle is within the confines of said tubular member to prevent the tip from piercing any portion of the flexible material making up said package. 
     
     
         9 . The system of  claim 1  wherein said package additionally comprises an opposite wall panel portion located on the opposite side of said compartment from the side of said fitment and wherein said opposite side wall portion is reinforced to prevent the penetration thereof by said piercing assembly. 
     
     
         10 . The system of  claim 9  wherein said opposite wall panel portion comprises an inner surface contiguous with said compartment and an outer surface, and wherein said reinforcement of said opposite side wall portion is achieved by a layer of protective material located on at least one of said inner and said outer surface of said opposite wall panel portion. 
     
     
         11 . The package of  claim 1 , wherein said package is formed, filled with said material and sealed in said compartment on an automated form, fill and seal machine. 
     
     
         12 . A method of making a package for a packaging system, said system additionally comprising a piercing assembly having a septum and being arranged to be coupled to said package to enable one to withdraw the sterile flowable material from the package via a needle penetrating said septum, said method comprising:
 forming a package from a flexible material to result in at least one compartment in said package;   filling said at least one compartment with a sterile flowable material under aseptic conditions;   securing a fitment having a sterile passageway extending therethrough to said at least one compartment, said passageway being hermetically sealed to maintain its sterility; and   providing said piercing assembly so that it may be inserted into said passageway of said fitment.   
     
     
         13 . The method of  claim 12  additionally comprising:
 introducing said piercing assembly into said passageway of said fitment whereupon a portion of said piercing assembly penetrates said at least one compartment and into fluid communication with said flowable material therein, while maintaining the sterility of the flowable material within said package. 
 
     
     
         14 . The method of  claim 12  wherein said passageway in said fitment is maintained in said hermetically sealed state by a cover, said cover being removable to enable said piercing assembly to be introduced into said passageway of said fitment. 
     
     
         15 . The method of  claim 12  wherein said package is formed into said at least one compartment, said at least one compartment is filled with said flowable material, and said filled at least one compartment is sealed on an automated form, fill and seal machine. 
     
     
         16 . The method of  claim 15  wherein said package is formed into two compartments, with said fitment being secured to one of said compartments. 
     
     
         17 . A method of withdrawing a sterile flowable material by a needle from a flexible packaging system comprising a package and a piercing assembly, said piercing assembly comprising a septum, said method comprising:
 providing a package with a fitment secured thereto, said package being formed of a flexible material and having a compartment in which said flowable material is held under sterile conditions, said fitment being secured to said package at said compartment and having a sterile passageway extending therethrough hermetically sealed to maintain the sterility of said passageway;   inserting said piercing assembly in said passageway of said fitment so that a portion of said piercing assembly is located within said compartment and in fluid communication with said flowable material; and   inserting a needle through said septum and into fluid communication with said flowable material to withdraw said flowable material through said needle.   
     
     
         18 . The method of  claim 17  wherein said passageway in said fitment is maintained in said hermetically sealed state by a removable cover and wherein said method comprises removing said cover to enable said piercing assembly to be inserted into said passageway. 
     
     
         19 . The method of  claim 17  wherein said package comprises two compartments, wherein said compartments are separated from each other by a frangible interface and wherein each of said compartment comprises a material therein, said method additionally comprising causing said frangible interface to rupture whereupon said materials in said compartments mix together to form said flowable material.