Integrated container for lyophilization, rehydration and processing of biological materials

• US 20040081588A1
• Filed: 10/23/2002
• Published: 04/29/2004
• Est. Priority Date: 10/23/2002
• Status: Active Grant

• Current Assignee: Blood Cell Storage, Inc.
• Original Assignee: Blood Cell Storage, Inc.
• Inventors: Schwartz, Stephen S., Hammerstedt, Roy H.
• Granted Patent: US 7,422,726 B2
• Time in Patent Office: Days
• US Class Current: 422/101
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0263 Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
• CPC Class Codes: A01N 1/0273 Transport containers A01N1/0268 takes precedence
• CPC Class Codes: B01L 3/505 flexible containers not provided for above
• CPC Class Codes: F26B 5/06 the process involving freezing

Abstract

An apparatus to lyophilize, store, transport, rehydrate, and process aqueous biological materials in a container which maintains sterility of its contents, allows container shrinkage after lyophilization, and optimally permits filtration or dialysis of the contents in situ, without the need for a second or series of additional containers. These benefits are met by a microporous container constructed of a membrane that is water vapor permeable, yet water impermeable.

Claims

1. An integrated container to lyophilize, store, transport, rehydrate, and process biological materials, comprising:

a) a closed construct, said closed construct defining a cavity therein, said cavity further comprising a lyophilization compartment having an upper face and a lower face and four lateral faces, wherein said upper face is fabricated with a flexible controlled pore membrane with hydrophobic surfaces that allows passage of water in a vapor but not liquid state, said lower face is fabricated with a rigid material, and said lateral faces are fabricated with a flexible material capable of maintaining a barrier between an internal vacuum and the external atmosphere; and

b) one of four said lateral faces having an access port therein to allow entry or removal of biological or other materials and water, said access port having a barrier to maintain sterility.

2. The integrated container according to claim 1, further comprising a vacuum-processing compartment having an upper face, a lower face, and four lateral faces, said controlled pore membrane of said lyophilization compartment and said lower face of said vacuum-processing compartment serving as a common wall between said lyophilization compartment and said vacuum-processing compartment, and said lateral faces and said upper face of said vacuum-processing compartment fabricated with a rigid material, wherein said upper face of said vacuum-processing compartment has an exit port therein having a barrier to maintain sterility, said exit port connected to a vacuum and condenser system (not shown) suitable for aseptic removal of water vapor.

3. The integrated container according to claim 2, wherein said lateral faces of said vacuum-processing compartment are fabricated with a flexible material capable of maintaining a barrier between an internal vacuum and the external atmosphere.

4. The integrated container according to claim 3, wherein each said lateral face of said vacuum-processing compartment contains a tabular structure that attaches to one of two ends of an external mechanical restraint, said restraints providing mechanical strength sufficient to retain said vacuum-processing compartment from collapse under vacuum pressure, whereby said restraints are released after lyophilization to allow collapse of said vacuum-processing compartment to a minimal volume.

5. The integrated container according to claim 3, wherein an internal mechanical restraint composed of a mesh is attached to said lower face of said vacuum-processing compartment, whereby mechanical strength is provided sufficient to prevent said upper face of said vacuum-processing compartment from coming in contact with said flexible controlled pore membrane.

6. The integrated container according to claim 3, wherein an internal mechanical restraint composed of a plurality of crisscrossing raised plastic “

bumps”

is attached to said lower face of said vacuum-processing compartment, whereby mechanical strength is provided sufficient to prevent said upper face of said first compartment from coming in contact with said flexible controlled pore membrane.

7. The integrated container according to claim 1, further comprising a first distal vacuum-processing compartment and a second distal vacuum-processing compartment, said distal vacuum-processing compartments having an upper face, a lower face, and four lateral faces, said upper face of said first distal vacuum-processing compartment, said lower face of said second distal vacuum-processing compartment, said lateral faces of said distal vacuum-processing compartments being fabricated with a rigid material, and said controlled pore membranes of said lyophilization compartment and said lower face of said first distal vacuum-processing compartment and said upper face of said second distal vacuum-processing compartment serving as common walls between said lyophilization compartment and said first distal vacuum-processing compartment and said lyophilization compartment and said second distal vacuum-processing compartment, wherein said upper face of said first distal vacuum-processing compartment and said lower face of said second distal vacuum-processing compartment has an exit port therein with a barrier to maintain sterility, said exit ports connected to a vacuum and condenser system (not shown) suitable for aseptic removal of water vapor.

8. The integrated container according to claim 7, further comprising a first external compartment and a second external compartment, said external compartments each having an upper face, a lower face, and four lateral faces, said upper face, said lower face, and a first and second lateral face being fabricated with a rigid material, an outer lateral face being fabricated with a flexible material, and an inner lateral face being fabricated from a porous surface having at least one pore formed therein, said pore being filled with an erodible substance, each said inner lateral face serving as a common wall between said external compartment and said lyophilization compartment, wherein each said outer lateral face of each said external compartment contains an access port therein.

9. The integrated container according to claim 7, wherein said lateral faces of said distal vacuum-processing compartments are fabricated with a flexible material capable of maintaining a barrier between an internal vacuum and the external atmosphere.

10. The integrated container according to claim 9, wherein each lateral face of said distal vacuum-processing compartment contains a tabular structure that attaches to one of two ends of an external mechanical restraint, said restraints providing mechanical strength sufficient to retain said vacuum-processing compartment from collapse under vacuum pressure, whereby said restraints are released after lyophilization to allow collapse of said distal vacuum-processing compartments to a minimal volume.

11. The integrated container according to claim 9, wherein each lateral face of said distal vacuum-processing compartment contains two tabular structures that attach to one of two ends of an external mechanical restraint, said restraints providing mechanical strength sufficient to retain said vacuum-processing compartments from collapse under vacuum pressure, whereby said restraints are released after lyophilization to allow collapse of said distal vacuum-processing compartments to a minimal volume.

12. The integrated container according to claim 9, wherein an internal mechanical restraint, composed of a mesh is attached to said lower face of said first distal vacuum-processing compartment and to said upper face of said second distal vacuum-processing compartment, whereby mechanical strength is provided sufficient to prevent said upper face of said first distal vacuum-processing compartment and said lower face of said second distal vacuum-processing compartment from coming in contact with said flexible controlled pore membrane.

13. The integrated container according to claim 9, wherein an internal mechanical restraint composed of a plurality of crisscrossing raised plastic “

bumps”

is attached to said lower face of said first distal vacuum-processing compartment and said upper face of said second distal vacuum-processing compartment, whereby mechanical strength is provided sufficient to prevent said upper face of said first distal vacuum-processing compartment and said lower face of said second distal vacuum-processing compartment from coming in contact with said flexible controlled pore membrane.

14. The integrated container according to claim 7, wherein said lateral faces of said lyophilization compartment are fabricated with a rigid material.

15. The integrated container according to claim 1, wherein the rigid material is selected from the group consisting of acrylic, polycarbonate, polypropylene and ABS.

16. The integrated container according to claim 1, wherein the flexible material is selected from the group consisting of polyethylene, polyurethane, and polyester/polyether block copolymers.

17. The integrated container according to claim 2, wherein said barrier of said access port and said barrier of said exit port is fabricated with a microporous hydrophobic membrane.