Method of inducing nucleation of a material
First Claim
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1. A method of inducing nucleation of freezing in a material within a chamber comprising the steps of:
- bringing the material to a temperature near or below a phase transition temperature in an atmosphere within the chamber pressurized above ambient pressure; and
decreasing the pressure of the atmosphere within the chamber proximate the material in 40 seconds or less or at a pressure rate drop, Δ
P/Δ
t, greater than about 0.2 psi per second, to uniformly induce nucleation of the phase transition in the material.
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Abstract
Methods of inducing nucleation of a material is provided. The disclosed methods comprise the steps of bringing the material to a temperature near or below a phase transition temperature and altering the pressure to induce nucleation of the material. The disclosed methods are useful in freeze-drying processes, particularly pharmaceutical freeze-drying processes.
16 Citations
21 Claims
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1. A method of inducing nucleation of freezing in a material within a chamber comprising the steps of:
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bringing the material to a temperature near or below a phase transition temperature in an atmosphere within the chamber pressurized above ambient pressure; and decreasing the pressure of the atmosphere within the chamber proximate the material in 40 seconds or less or at a pressure rate drop, Δ
P/Δ
t, greater than about 0.2 psi per second, to uniformly induce nucleation of the phase transition in the material. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A method of controlling the freezing process of a material in a plurality of vials or containers within a chamber comprising the steps of:
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cooling the material at a prescribed cooling rate in the chamber pressurized above ambient pressure; decreasing the pressure in the pressurized chamber in 40 seconds or less or at a pressure rate drop, Δ
P/Δ
t, greater than about 0.2 psi per second, to uniformly nucleate freezing within the material in the plurality of vials or containers; andcontinuing cooling of the nucleated material in the plurality of vials or containers to a prescribed final temperature to further freeze the material. - View Dependent Claims (17, 18)
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19. A solidification process of a material disposed in a plurality of vials or containers within a chamber comprising the steps of:
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bringing the material in the plurality of vials or containers to a temperature near or below a phase transition temperature in the chamber pressurized above ambient pressure; decreasing the pressure in the chamber in 40 seconds or less or at a pressure rate drop, Δ
P/Δ
t, greater than about 0.2 psi per second, to uniformly induce nucleation of solidification within the material in the plurality of vials; andcooling of the nucleated material in the plurality of vial or containers to a prescribed final temperature to further solidification. - View Dependent Claims (20)
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21. A method of controlling the condensation process of a gas within a chamber comprising the steps of:
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cooling the gas to a temperature near or below a phase transition temperature in the chamber pressurized above ambient pressure; decreasing the pressure of the pressurized chamber in 40 seconds or less or at a pressure rate drop, Δ
P/Δ
t, greater than about 0.2 psi per second, to induce nucleation of condensation within the gas; andcontinuing cooling of the nucleated gas to a prescribed final temperature to further condensation.
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Specification