Optimization of nucleation and crystallization for lyophilization using gap freezing
First Claim
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1. 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 comprising a tray surface;
a thermal conduction insulator disposed between the heat sink surface and the tray surface; and
a spacer disposed between the heat sink surface and the tray surface and supporting the tray;
wherein the heat sink surface and tray surface are separated by a fixed distance greater than 1 mm.
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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.
57 Citations
18 Claims
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1. An article adapted for use in a lyophilization chamber comprising:
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a heat sink comprising a heat sink surface in thermal communication with a refrigerant; a tray comprising a tray surface; a thermal conduction insulator disposed between the heat sink surface and the tray surface; and a spacer disposed between the heat sink surface and the tray surface and supporting the tray; wherein the heat sink surface and tray surface are separated by a fixed distance greater than 1 mm. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. 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 during freezing to thereby freeze the solution from the top and bottom surfaces at approximately the same rate.
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17. 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. - View Dependent Claims (18)
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Specification