Method for mixing and dispensing

Abstract

A method for sterilizing a concentrated composition and a diluent. The diluent is contained in a large container, and the concentrated composition is contained in a small container that is positioned within the large container. The combined containers are placed in at least one sealing layer that is hermetically sealed, and is also preferably placed in a second sealing layer that is also hermetically sealed. The bagged container is then placed in a carton, which preferably has a liner, and the carton is closed. The carton is then irradiation sterilized. The carton is delivered to the clean room. At a first staging area, the carton is opened and the bagged container is removed and brought to a second staging area. At the second staging area, the second sealing layer is removed and the container can be stored in the first sealing layer. The container is brought into the clean environment, where the first sealing layer is removed. At that point, the small container is opened and the chemical composition is released into the large container, so that the chemical composition mixes with the diluent. The container can then be shaken until the chemical composition is thoroughly mixed with the diluent.

1 . A method of sterilizing a chemical composition comprising the steps of:
 providing a first container with a first chemical composition and a second container with a second chemical composition, wherein the first container is positioned with respect to the second container so that the first chemical composition is maintained apart from said second chemical composition, but can be combined with the second chemical composition;   sealing the first and second containers in a first sealing layer to form a first sealed container enclosure;   enclosing said first sealed container enclosure in a shipping container to form a closed shipping package; and   externally irradiating said closed shipping package at a predetermined radiation level for a predetermined time interval to simultaneously sterilize said first and second chemical compositions, said first and second containers, said first sealed container enclosure, and said closed shipping package.   
     
     
         2 . The method of  claim 1 , wherein the second container is positioned inside the first container. 
     
     
         3 . The method of  claim 1 , wherein the second container is integral to the first container. 
     
     
         4 . The method of  claim 1 , wherein said second chemical composition comprises a disinfectant liquid. 
     
     
         5 . The method of  claim 1 , wherein said first chemical composition comprises a diluent. 
     
     
         6 . The method of  claim 1 , wherein said second chemical composition comprises phenol. 
     
     
         7 . The method of  claim 1 , wherein said irradiating step comprises subjecting the closed shipping package to gamma radiation in the range of about 20 to 50 kilograys. 
     
     
         8 . The method of  claim 7 , wherein the irradiating step comprises applying the gamma radiation to the closed shipping package in a plurality of directions. 
     
     
         9 . A method of storing a first and second chemical composition for use in a sterile environment, said first and second chemical compositions being respectively contained in a first and second container, said first and second containers being hermetically sealed in successive first and second hermetically sealed container enclosures, and a shipping enclosure to form a closed shipping package adapted to be transported, comprising the steps of:
 removing the first and second containers and the first and second hermetically sealed container enclosures from the shipping enclosure of the closed shipping package;   transporting the first and second containers and the first and second hermetically sealed container enclosures to the storage area;   storing the first and second containers enclosed in the first and second hermetically sealed container enclosures in the storage area for a period of time;   after the period of time, removing the second hermetically sealed container enclosure and transporting the first and second containers contained in the first hermetically sealed container enclosure to the sterile environment for use;   removing the first hermetically sealed container enclosure in the sterile environment for use of the first and second chemical compositions in the sterile environment; and,   releasing the first chemical composition from the first container into the second container to mix with the second chemical compositions in the sterile environment.   
     
     
         10 . The method of  claim 9 , wherein the storage area is a sterile storage area. 
     
     
         11 . The method of  claim 9 , wherein said first chemical composition is a diluent and the second chemical composition is a disinfectant, and the first and second chemical compositions are sterilized in said first and second containers by gamma radiation. 
     
     
         12 . The method of  claim 11 , wherein the gamma radiation is in the range of about 20 to 50 kilograys. 
     
     
         13 . The method of sterilization of  claim 9 , wherein said first container is located within the second container. 
     
     
         14 . The method of sterilization of  claim 9 , wherein each of said first and second sealing layers is formed of a single layer of closed cell polyethylene. 
     
     
         15 . The method of sterilization of  claim 9 , wherein said irradiating step comprises subjecting the closed shipping package to gamma radiation in the range of about 20 to 50 kilograys. 
     
     
         16 . A method of sterilizing a chemical composition comprising the steps of:
 providing a container having a first compartment for retaining a first chemical composition and a second compartment for retaining a second chemical composition, wherein the first compartment is positioned with respect to the second compartment so that the first chemical composition is maintained apart from said second chemical composition, but can be combined with the second chemical composition;   sealing the container in a first sealing layer to form a first sealed container enclosure;   enclosing said first sealed container enclosure in a shipping container to form a closed shipping package; and   externally irradiating said closed shipping package at a predetermined radiation level for a predetermined time interval to simultaneously sterilize said first and second chemical compositions, said container, and said first sealed container enclosure.   
     
     
         17 . The method of  claim 16 , wherein said second chemical composition comprises a disinfectant liquid. 
     
     
         18 . The method of  claim 16 , wherein said first chemical composition comprises a diluent. 
     
     
         19 . The method of  claim 16 , wherein said second chemical composition comprises phenol. 
     
     
         20 . The method of  claim 16 , wherein said irradiating step comprises subjecting the closed shipping package to gamma radiation in the range of about 20 to 50 kilograys. 
     
     
         21 - 22 . (canceled)