Albumin in a flexible polymeric container

Abstract

A flexible polymeric container for holding albumin. The container is made of a sheet of flexible polymeric film formed into a bag having a cavity enclosed by a first wall, an opposing second wall, and seals about a periphery of the first and second walls. The seals join an interior portion of the opposing first and second walls and create a fluid-tight chamber within the cavity of the container for storing a concentration of the albumin.

What is claimed is:  
     
         1 . A container for holding albumin comprising: 
 a flexible polymeric film formed into a bag having a cavity enclosed by a first wall, an opposing second wall, and seals about a periphery of the first and second walls, the seals joining an interior portion of the opposing first and second walls and creating a fluid-tight chamber within the cavity of the container, wherein a concentration of albumin is stored within the fluid-tight chamber.    
     
     
         2 . The container of  claim 1 , wherein a solution of sterile water and stabilizers is mixed with the concentration of albumin in the container.  
     
     
         3 . The container of  claim 1 , wherein the bag has a plurality of peripheral edges that are sealed, and another peripheral edge that contains a fold.  
     
     
         4 . The container of  claim 3 , wherein three of the peripheral edges are sealed with heat, and one of the peripheral edges contains the fold that separates the first wall from the opposing second wall.  
     
     
         5 . The container of  claim 3 , wherein a fitment is connected to the container, the fitment having a passageway that cooperates with the fluid-tight chamber of the container.  
     
     
         6 . The container of  claim 5 , wherein the fitment is adjacent the fold.  
     
     
         7 . The container of  claim 3 , wherein the peripheral edge opposing the fold contains a first longitudinal seal and a second longitudinal seal, the first and second longitudinal seals joining the first and second opposing walls, and wherein an aperture is located between the first longitudinal seal and the second longitudinal seal, the aperture extending through the first and second opposing walls.  
     
     
         8 . The container of  claim 3 , further comprising an aperture adjacent an edge opposing the fitment.  
     
     
         9 . The container of  claim 3 , further comprising at least one chevron seal in the fold.  
     
     
         10 . The container of  claim 5 , further comprising a chevron seal in the fold on opposing sides of the fitment.  
     
     
         11 . The container of  claim 1 , wherein the flexible polymeric film comprises a laminate having an outside layer of linear low density polyethylene, a gas barrier layer, a core layer of polyamide, and an inside layer of linear low density polyethylene.  
     
     
         12 . The container of  claim 11 , wherein the layers comprising the flexible polymeric film are bonded together with a polyurethane adhesive.  
     
     
         13 . A container for albumin comprising: 
 a flexible polymeric film formed into a bag having a cavity enclosed by a first wall, an opposing second wall, and seals about a periphery of the first and second walls, the seals joining an interior portion of the opposing first and second walls and creating a fluid-tight chamber within the cavity of the container, and a concentration of albumin being stored within the fluid-tight chamber.    
     
     
         14 . A flexible polymeric container for holding a concentrate of water-soluble albumin, comprising: 
 a bag made from a sheet of flexible polymeric material initially converted into a tube, the tube being subsequently converted into a series of adjacent bags in an aseptic area, the bags having a first side member, a second side member peripherally sealed to the first side member, and a cavity between an interior of the first and second side members, wherein a quantity of a concentration of water-soluble albumin is located within the cavity of the bag following filling of the albumin into the cavity of the bag through an opening of the bag with a filler in the aseptic area, the opening of the bags being sealed within the aseptic area of the to create a fluid-tight chamber containing the albumin.    
     
     
         15 . The flexible polymeric container of  claim 14 , wherein the flexible polymeric sheet material comprises a laminate film having an outside layer of linear low density polyethylene, a gas barrier layer, a core layer of polyamide, and an inside layer of linear low density polyethylene.  
     
     
         16 . The flexible polymeric container of  claim 15 , wherein the layers are bonded together with a polyurethane adhesive.  
     
     
         17 . The flexible polymeric container of  claim 15 , wherein the gas barrier layer is a polyvinylidene chloride.  
     
     
         18 . The flexible polymeric container of  claim 15 , wherein the core layer of polyamide is a nylon.  
     
     
         19 . The flexible polymeric container of  claim 15 , wherein the gas barrier layer is constructed from SARAN.  
     
     
         20 . A flexible polymeric container filled with albumin, comprising: 
 an outer shell made of a laminate having an outside layer of linear low density polyethylene bonded together to a first side of a polyvinylidene chloride layer, a second side of the polyvinylidene chloride layer being bonded together to a first side of a layer of SARAN, the second side of the layer of SARAN being bonded together to an inside layer of linear low density polyethylene, the outer shell having a first side and an opposing second side sealed together at a periphery of the outer shell, and a cavity located between the first and second sides, the cavity forming a fluid-tight chamber having a concentration of albumin stored therein, wherein a fitment extends from the outer shell, the fitment having a sealed passageway extending into the cavity of the container to allow the albumin to be released from the fluid-tight chamber.    
     
     
         21 . The flexible polymeric container of  claim 20 , wherein the layers of the laminate are bonded together with a polyurethane adhesive.