Optimization of nucleation and crystallization for lyophilization using gap freezing
AssigneesBaxter Healthcare S.A., Baxter International Inc.
InventorWei Y. Kuu
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Abstract
This application discloses devices, articles, and methods useful for producing lyophilized cakes of solutes. The devices and articles provide for a method of freezing liquid solutions of the solute by the top and the bottom of the solution simultaneously. The as frozen solution then provides a lyophilized cake of the solutes with large and uniform pores.
Claims29
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In a method of freezing a liquid solution for subsequent lyophilization, the liquid comprising top and bottom surfaces and disposed in a container, and the container disposed in a lyophilization chamber comprising a heat sink, the improvement comprising separating the container from direct contact with the heat sink to thereby freeze the solution from the top and bottom surfaces at approximately the same rate.
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An article adapted for use in a lyophilization chamber comprising:
- a heat sink comprising a heat sink surface in thermal communication with a refrigerant;
- a tray surface;
- and
- a thermal insulator disposed between the heat sink surface and the tray surface.
A lyophilization device comprising:
- a plurality of heat sinks that individually have a heat sink surface in thermal communication with a refrigerant, at least one of said heat sinks being disposed above another to thereby form upper and lower heat sinks;
- wherein the lower heat sink surface is disposed between the upper and lower heat sinks;
- a tray surface disposed between the upper heat sink and a lower heat sink surface;
- and
- a thermal insulator disposed between the tray surface and the lower heat sink.
A sample container comprising
- a vial comprising top and a bottom;
- and
- a thermally insulating support affixed to the bottom of the vial, the thermally insulating support having a thermal conductivity less than about 0.2 W/m·K at 25° C.
Dependencies are inferred from the claim text.