Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma

Abstract

A vessel receives a liquid material, which is freeze-dried in situ within the vessel. A gas permeable material carried by the vessel provides gas transport for sublimation during drying. After freeze drying, an oxygen-free inert gas is introduced into the vessel through the gas permeable material, to occupy the interior of the vessel with the freeze-dried material. The gas permeable material is covered, to trap the oxygen-free inert gas within the vessel with the freeze-dried material. The freeze-dried material is stored in the entrapped oxygen-free inert gas within the vessel for a storage period. The vessel receives a reconstituting liquid for mixing with the freeze-dried material, and conveys the reconstituted freeze-dried material from the vessel for administration to an individual.

1 . Apparatus comprising:
 a dry freeze-dried material,   a reconstituting liquid for the freeze-dried material, and   a flexible container including first chamber sized and configured to hold the freeze-dried material in a dry state, a second chamber sized and configured to hold the reconstituting liquid in a wet state, a sealing wall within the flexible container sized and configured to form a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid, and at least one valve assembly in the sealing wall operative to open a region of the sealing wall to establish fluid flow communication between the first and second chambers.   
   
   
       2 . Apparatus according to  claim 1   wherein the valve assembly includes a pressure sensitive valve operative between a normally closed condition normally resisting fluid flow communication between the first and second chambers and an opened condition establishing fluid flow condition communication between the first and second chambers in response to a pressure differential applied across the valve.   
   
   
       3 . Apparatus according to  claim 2   wherein the pressure sensitive valve comprises a flap valve.   
   
   
       4 . Apparatus according to  claim 1   wherein the valve assembly includes a normally closed septum operative in a normally closed condition maintaining closure between the first and second chambers and an opened condition establishing fluid flow communication between the first and second chambers in response to at least a partially tearing of the septum.   
   
   
       5 . Apparatus according to  claim 4   wherein the septum includes a tear member coupled to a pulling member to at least partially tear the septum.   
   
   
       6 . Apparatus according to  claim 1   wherein the valve assembly includes a pressure sensitive valve operative between a normally closed condition normally resisting fluid flow communication between the first and second chambers and an opened condition establishing fluid flow condition communication between the first and second chambers in response to a pressure differential applied across the valve, and a normally closed septum associated with the valve operative in a normally closed condition maintaining closure between the first and second chambers independent of the valve and an opened condition establishing fluid flow communication between the first and second chambers in response to at least a partially tearing of the septum and a pressure differential applied across the valve.   
   
   
       7 . Apparatus according to  claim 6   wherein the pressure sensitive valve comprises a flap valve.   
   
   
       8 . Apparatus according to  claim 6   wherein the septum includes a tear member coupled to a pulling member to at least partially tear the septum.   
   
   
       9 . Apparatus according to  claim 1   further including an outer skirt overlaying an exterior wall of the container in a region of the sealing wall.   
   
   
       10 . Apparatus according to  claim 9   wherein the outer skirt includes a tear member coupled to a pulling member to tear the outer skirt for removal.   
   
   
       11 . Apparatus according to  claim 9   wherein at least a portion of the exterior wall of the container overlaid by the outer skirt includes placations.   
   
   
       12 . Apparatus according to  claim 9   wherein the flexible container includes an integral administration port for administering material from the container.   
   
   
       13 . Apparatus according to  claim 1   wherein the freeze-dried material includes freeze-dried human plasma.   
   
   
       14 . A method comprising
 providing a flexible container including first chamber holding a freeze-dried material in a dry state, a second chamber holds a reconstituting liquid for the freeze-dried material, the flexible container including an interior sealing wall sized and configured to form a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid, and at least one valve assembly in the sealing wall operative by manipulation to open a region of the sealing wall to establish fluid flow communication between the first and second chambers,   manipulating the valve assembly to open the region, and   expressing the reconstituting liquid from the second chamber through the valve assembly into the first chamber into contact with the freeze-dried material.   
   
   
       15 . A method according to  claim 14   further including reconstituting the freeze-dried material by successively expressing a mixture of the reconstituting liquid and freeze-drive material between the first and second chambers, thereby preparing a reconstituted product.   
   
   
       16 . A method according to  claim 15   further including administering the reconstituted product directly from one of the chambers to a recipient.   
   
   
       17 . A method according to  claim 14   wherein the freeze-dried material includes freeze-dried human plasma.   
   
   
       18 . A method comprising
 providing a flexible container including first chamber holding a freeze-dried material in a dry state, a second chamber holding a reconstituting liquid for the freeze-dried material, the flexible container including an interior sealing wall sized and configured to form a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid, at least one valve assembly in the sealing wall operative by manipulation to open a region of the sealing wall to establish fluid flow communication between the first and second chambers, and an outer skirt overlaying an exterior wall of the container in a region of the sealing wall and blocking manipulation of the valve assembly,   removing the outer skirt to expose the valve assembly to manipulation,   manipulating the valve assembly to open the region, and   expressing the reconstituting liquid from the second chamber through the valve assembly into the first chamber into contact with the freeze-dried material.   
   
   
       19 . A method according to  claim 18   further including reconstituting the freeze-dried material by successively expressing a mixture of the reconstituting liquid and freeze-drive material between the first and second chambers, thereby preparing a reconstituted product.   
   
   
       20 . A method according to  claim 19   further including administering the reconstituted product directly from one of the chambers to a recipient.   
   
   
       21 . A method according to  claim 18   wherein the freeze-dried material includes freeze-dried human plasma.   
   
   
       22 . A method comprising
 providing a flexible container including first chamber, a second chamber, and an interior sealing wall sized and configured to form a barrier between the first chamber and the second chamber, and at least one valve assembly in the sealing wall operative by manipulation to open a region of the sealing wall to establish fluid flow communication between the first and second chambers,   preparing a freeze-dried material comprising freeze-dried human plasma,   placing the freeze dried material in the first chamber of the container, and   placing a reconstitution liquid for the freeze dried material in the second chamber of the container.   
   
   
       23 . A method according to  claim 22   further including manipulating the valve assembly to open the region, and   expressing the reconstituting liquid from the second chamber through the valve assembly into the first chamber into contact with the freeze-dried material.   
   
   
       24 . A method according to  claim 23   further including reconstituting the freeze-dried material by successively expressing a mixture of the reconstituting liquid and freeze-drive material between the first and second chambers, thereby preparing a reconstituted product.   
   
   
       25 . A method according to  claim 24   further including administering the reconstituted product directly from one of the chambers to a recipient.   
   
   
       26 . A system comprising
 a vessel comprising a first end component comprising a rigid or semi-rigid material defining a first frame providing structural strength, the first end component including a gas impermeable material peripherally sealed to the first frame and spanning the frame to provide viewing into the interior space, a second end component comprising a rigid or semi-rigid material defining a second frame providing structural strength, the second end component including a gas permeable material peripherally sealed to the second frame and spanning the frame to provide gas transport to and from the interior space, a side wall component peripherally sealed to side edges of the first and second frames, the side wall component comprising a flexible, gas impermeable material, the first end component, the second end component, and the side wall component peripherally defining an interior space, and at least one port component on the side wall providing fluid communication with the interior space, and   a material introduced as a liquid through the at least one port and freeze-dried in situ within the interior space.   
   
   
       27 . A system according to  claim 26   wherein the vessel further includes a closure cover hinged to the second frame for movement between an opened condition exposing the gas permeable material of the second end component to gas transport and a closed condition covering the gas permeable material of the second end component to substantially block the gas transport.   
   
   
       28 . A system according to  claim 26   further including a gas-impermeable overwrap covering at least the hydrophic material of the second end component to substantially block gas transport to and from the interior space.   
   
   
       29 . A system according to  claim 26   further including a second port component on the side wall component providing fluid transport with the interior space, and   a reconstituting liquid introduced through the second port to reconstitute the freeze-dried material within the interior space.   
   
   
       30 . A system according to  claim 26   further including a rigid outer container for the vessel.   
   
   
       31 . A system according to  claim 26   further including an oxygen-free inert gas introduced into the interior space through the gas permeable material of the second end component.   
   
   
       32 . A system according to  claim 31   further including a closure cover covering the gas permeable material of the second end component to substantially block transport of the oxygen-free inert gas from the interior space.   
   
   
       33 . A system according to  claim 31   further including a gas-impermeable overwrap covering the gas permeable material of the second end component to substantially block transport of the oxygen-free insert gas from the interior space.   
   
   
       34 . A system according to  claim 26   wherein the freeze-dried material includes freeze-dried human plasma.   
   
   
       35 . A method comprising
 providing a vessel comprising a first end component comprising a rigid or semi-rigid material defining a first frame providing structural strength, the first end component including a gas impermeable material peripherally sealed to the first frame and spanning the frame to provide viewing into the interior space, a second end component comprising a rigid or semi-rigid material defining a second frame providing structural strength, the second end component including a gas permeable material peripherally sealed to the second frame and spanning the frame to provide gas transport to and from the interior space, a side wall component peripherally sealed to side edges of the first and second frames, the side wall component comprising a flexible, gas impermeable material, the first end component, the second end component, and the side wall component peripherally defining an interior space, and at least one port component on the side wall providing fluid communication with the interior space,   introducing a liquid material through the first port,   freeze-drying the liquid material in situ within the interior space, the gas permeable material of the second end component providing gas transport for sublimation during drying,   introducing a reconstituting liquid for mixing with the freeze-dried material within the interior space through the second port, to reconstitute the freeze-dried material, and   conveying the reconstituted freeze-dried material from the interior space through the third port.   
   
   
       36 . A method according to  claim 30   further including, after freeze drying, introducing an oxygen-free inert gas into the interior space through the gas permeable material of the second end component, to occupy the interior space with the freeze-dried material,   covering the gas permeable material of the second end component to trap the oxygen-free inert gas within the interior space with the freeze-dried material, and   storing the freeze-dried material in the entrapped oxygen-free inert gas within the vessel for a storage period prior to introduction of the reconstituting liquid.   
   
   
       37 . A method according to  claim 31   further including placing the covered vessel within an outer container during storage.   
   
   
       38 . A method according to  claim 30   further including, after freeze drying, introducing an oxygen-free inert gas into the interior space through the gas permeable material of the second end component, to occupy the interior space with the freeze-dried material,   sealing an overwrap of a gas-impermeable material over the vessel to trap the oxygen-free inert gas within the interior space with the freeze-dried material, and   storing the freeze-dried material in the entrapped oxygen-free inert gas within the vessel and overwrap for a storage period prior to introduction of the reconstituting liquid.   
   
   
       39 . A method according to  claim 33   further including placing the vessel within an outer container during storage.   
   
   
       40 . A method according to  claim 30   wherein the liquid material introduced through the first port comprises fresh human plasma.