Apparatus and Methods for Making, Storing, and Administering Freeze-Dried Materials Such as Freeze-Dried Plasma

Abstract

A flexible container receives a liquid material, which is freeze-dried in situ within the flexible container. A gas permeable material that is separate from the flexible container provides gas transport for sublimation during drying and lyophilization. The gas permeable portion of the system can be isolated and removed from the flexible container post-lyophilzation The freeze-dried material is stored in the flexible container until administration is necessary. The flexible container receives a reconstituting liquid for mixing with the freeze-dried material, and conveys the reconstituted freeze-dried material from the flexible container for administration to an individual.

1 . An apparatus for freeze-drying a liquid material, said apparatus comprising:
 a first collapsible container;   a tubing connected to said first collapsible material; and   a permeable membrane in fluid-tight, vapor connection with said tubing, said membrane being separate from said first collapsible container.   
     
     
         2 . The apparatus according to  claim 1 , further comprising a second container connected to said tubing, said second container supporting said permeable membrane. 
     
     
         3 . The apparatus according to  claim 2 , wherein said second container is flexible. 
     
     
         4 . The apparatus according to  claim 1 , further comprising a fluid intake port for receiving a liquid. 
     
     
         5 . The apparatus according to  claim 4 , wherein said fluid intake port is located on the first collapsible bag. 
     
     
         6 . The apparatus according to  claim 4 , wherein said fluid intake port is located on the tubing. 
     
     
         7 . The apparatus according to  claim 1  further comprising an administration port located on said first collapsible container. 
     
     
         8 . The apparatus according to  claim 1  further comprising a reconstitution port located on said first collapsible container. 
     
     
         9 . The apparatus according to  claim 1  wherein said permeable membrane comprises a PTFE material. 
     
     
         10 . The apparatus according to  claim 1  wherein said permeable membrane comprises a polypropylene, polyester, polyethylene, polyurethane, polyvinylidene fluoride or polytetrafluoroethylene material. 
     
     
         11 . The apparatus according to  claim 1  wherein said liquid comprises plasma. 
     
     
         12 . The apparatus according  claim 1  further comprising a port for receiving a pH adjustment solution, said located on said first collapsible container. 
     
     
         13 . The apparatus according  claim 1  further comprising a port for receiving a reconstituting liquid, said located on said first collapsible container. 
     
     
         14 . The apparatus of according to  claim 1  further comprising a pouch for storing said first collapsible container. 
     
     
         15 . The apparatus according to  claim 14  wherein said pouch further comprises a low moisture vapor transfer rate (MVTR) material. 
     
     
         16 . The apparatus according to  claim 15  further comprising an oxygen absorber located in said pouch. 
     
     
         17 . The apparatus according to  claim 15  further comprising a water absorber located in said pouch. 
     
     
         18 . A method of freeze-drying a liquid comprising the steps of:
 providing an apparatus for receiving a liquid, said apparatus comprising:
 a first flexible container; 
 a tubing connected to said first flexible container; 
 a permeable membrane attached to said tubing, said membrane being separate from said first flexible container; and 
 a first liquid port for receiving said liquid; 
 a second liquid port for receiving a pH adjusting solution; 
   filling said first flexible container with said liquid; and   freeze-drying said liquid within said first flexible container.   
     
     
         19 . The method according to  claim 18  further comprising the step of vacuum packing said first flexible container. 
     
     
         20 . The method according to  claim 18  wherein said liquid comprises human plasma. 
     
     
         21 . A method comprising the steps of:
 providing an apparatus for receiving a liquid, said apparatus comprising:
 a first flexible container; 
 a tubing connected to said flexible container; 
 a separate permeable membrane attached to said tubing; 
 a liquid port for introducing said liquid; 
   a second liquid port for introducing a pH adjusting solution;
 an administration port; and 
 a reconstitution port; 
   introducing liquid into said apparatus through said liquid port; and   freeze-drying said liquid within said first flexible container during a lyophilization process.   
     
     
         22 . The method of  claim 21  further comprising the step of:
 permanently sealing said tubing after freeze-drying said liquid; and 
 removing said permeable membrane from said apparatus. 
 
     
     
         23 . The method of  claim 22  wherein said step of sealing further includes:
 providing a device to pinch shut the tubing during lyophilization; and 
 pinching shut the tubing. 
 
     
     
         24 . The method of  claim 23  wherein said step of sealing further comprises heat sealing said tubing. 
     
     
         25 . The method of  claim 23  wherein said step of sealing further comprises heat sealing said tubing. 
     
     
         26 . The method of  claim 21  further comprising the step of vacuum packing said first container. 
     
     
         27 . The method of  claim 21  wherein said apparatus further comprises a second collapsible container, said second collapsible container supporting said permeable membrane. 
     
     
         28 . The method of  claim 21  further comprising the steps of:
 removing said second collapsible container from said apparatus after freeze-drying said liquid; and 
 sealing said tubing. 
 
     
     
         29 . The method of  claim 22  further comprising the step of:
 attaching said reconstitution port to a liquid source; and 
 reconstituting the freeze drying plasma. 
 
     
     
         30 . The method of  claim 29  further including the step of administering the reconstituted product directly from the first collapsible container through the administering port to a recipient. 
     
     
         31 . The method of  claim 29  wherein said liquid comprises plasma. 
     
     
         32 . The method of  claim 22  further comprising the step of:
 storing said first flexible container within a pouch, said pouch comprising a low moisture vapor transfer rate (MVTR) material. 
 
     
     
         33 . The method of  claim 32  further comprising the step of:
 providing an oxygen absorber with said pouch. 
 
     
     
         34 . The method of  claim 32  further comprising the step of:
 providing a water absorber within said pouch.