Cooling element, shipping box with a cooling element, method for temperature stabilisation, and use of a cooling element

Abstract

A cooling element includes a container, the container defining an internal volume within one or more walls of the container. The volume is air-tight sealed, and the container is configured for containing dry ice (solid carbon dioxide), releasing carbon dioxide gas from the volume and blocking ingress of ambient gas into the volume. Additionally, a shipping box includes a thermally insulated volume therein, and is configured for holding a receptacle and one or more cooling elements, wherein the one or more cooling elements are arranged to enclose the receptacle. Further, a method is disclosed for thermal stabilisation of such a receptacle by using the cooling element or shipping box. The receptacle is arranged for holding a product such as a (bio)pharmaceutical substance and/or advanced therapy medicinal product(s).

1 . A cooling element comprising a container, the container defining an internal volume within one or more walls of the container; the volume being air-tight sealed, wherein the container contains dry ice, and is configured for releasing carbon dioxide gas from the volume and blocking ingress of ambient gas into the volume. 
     
     
         2 . The cooling element according to  claim 1 , wherein the material of the container walls is selectively permeable for carbon dioxide gas. 
     
     
         3 . The cooling element according to  claim 1 , wherein the container comprises a one-way valve for releasing gas from the internal volume. 
     
     
         4 . The cooling element according to  claim 3 , wherein the one-way valve is an overpressure release valve. 
     
     
         5 . The cooling element according to  claim 1 , wherein the internal volume of the container is configured for containing between about 50 grams and about 20 kilograms of carbon dioxide dry ice. 
     
     
         6 . A shipping box comprising a thermally insulated volume therein, and configured for holding at least one receptacle and one or more cooling elements according to  claim 1 , wherein the one or more cooling elements are arranged to enclose the receptacle. 
     
     
         7 . The shipping box according to  claim 6 , wherein the shipping box is configured with thermally insulating walls and cover surrounding the thermally insulated volume. 
     
     
         8 . The shipping box according to  claim 6 , wherein the thermally insulated volume is configured to have an internal pressure equal to external air pressure. 
     
     
         9 . The shipping box according to  claim 6 , wherein the thermally insulated volume is an air-tight volume and the shipping box comprises a pressure relief valve or passage for releasing gas from the thermally insulated volume. 
     
     
         10 . The shipping box according to  claim 6 , wherein the receptacle comprises a vial containing a (bio)pharmaceutical substance or advanced therapy medicinal product, and the vial is provided with a rubber stopper. 
     
     
         11 . The shipping box according to  claim 10 , wherein the (bio)pharmaceutical substance or advanced therapy medicinal product comprise one or more substances selected from a group comprising small molecules, oligonucleotides, nucleic acids, peptides, proteins, antibodies, protein or antibody-drug conjugates, gene therapy, cell therapy, vaccines, blood or blood-derived components and microbiota derived products. 
     
     
         12 . A method for temperature stabilisation of a product contained in one or more receptacles during shipment in dry ice, comprising:
 providing a shipping box comprising a thermally insulated volume therein;   placing one or more cooling elements and the one or more receptacles in the thermally insulated volume, while arranging the one or more cooling elements to enclose the one or more receptacles,   in which each cooling element comprises a container, the container defining an internal volume within one or more walls of the container; the internal volume being air-tight sealed and filled with dry ice, wherein the container is configured for releasing carbon dioxide gas from the volume and for blocking ingress of ambient gas into the volume;   the method further comprising:
 releasing carbon dioxide gas from the internal volume of the container at a predetermined overpressure of the carbon dioxide gas relative to ambient pressure. 
   
     
     
         13 . The method according to  claim 12 , wherein the method comprises:
 maintaining a pressure in the thermally insulated volume at ambient pressure. and/or the method comprises:
 providing the thermally insulated volume as an air-tight volume and 
 providing the shipping box with a pressure relief valve or passage for releasing gas from the thermally insulated volume for maintaining a constant pressure in the thermally insulated volume. 
   
     
     
         14 . The method according to  claim 12 , wherein the method comprises:
 preceding the placement of one or more cooling elements and the one or more receptacles in the thermally insulated volume:
 providing the container of the cooling elements with an opening for access to the internal volume of the cooling elements; 
 filling the internal volume of the cooling elements with dry ice through the opening; 
 air-tight sealing the opening after filling the internal volume with dry ice 
 providing the container of the cooling elements with a pressure regulation means ( 25 ). 
   
     
     
         15 . A method of shipping a product in dry ice, the method comprising:
 arranging a cooling element in accordance with  claim 1  in a shipping box, the shipping box comprising a thermally insulated volume therein; and   arranging at least one receptacle holding the product in the shipping box, the product comprising a (bio)pharmaceutical substance or advanced therapy medicinal product.