Integrated container for lyophilization, rehydration and processing of biological materials
First Claim
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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 first 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 second flexible controlled pore membrane, and said lateral faces are fabricated with a rigid material, a flexible material, or any combination thereof;
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;
c) a first distal vacuum-processing compartment and a second distal vacuum-processing compartment, said first distal vacuum-processing compartment having an upper face and four lateral faces, said first controlled pore membrane of said lyophilization compartment serving as a lower face of said first distal vacuum-processing compartment and as a common wall between said lyophilization compartment and said first distal vacuum-processing compartment, said second distal vacuum-processing compartment having a lower face and four lateral faces, said second controlled pore membrane of said lyophilization compartment serving as an upper face of said second distal vacuum-processing compartment and as a common wall between said lyophilization compartment and said second distal vacuum-processing compartment, and 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, a flexible material or any combination thereof, 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 suitable for aseptic removal of water vapor; and
(d) 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.
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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.
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Citations
7 Claims
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1. An integrated container to lyophilize, store, transport, rehydrate, and process biological materials, comprising:
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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 first 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 second flexible controlled pore membrane, and said lateral faces are fabricated with a rigid material, a flexible material, or any combination thereof; 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; c) a first distal vacuum-processing compartment and a second distal vacuum-processing compartment, said first distal vacuum-processing compartment having an upper face and four lateral faces, said first controlled pore membrane of said lyophilization compartment serving as a lower face of said first distal vacuum-processing compartment and as a common wall between said lyophilization compartment and said first distal vacuum-processing compartment, said second distal vacuum-processing compartment having a lower face and four lateral faces, said second controlled pore membrane of said lyophilization compartment serving as an upper face of said second distal vacuum-processing compartment and as a common wall between said lyophilization compartment and said second distal vacuum-processing compartment, and 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, a flexible material or any combination thereof, 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 suitable for aseptic removal of water vapor; and (d) 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. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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Specification