Lyophilization methods and apparatuses
First Claim
1. A method for lyophilizing a material comprising the step of modifying both a chamber pressure and a shelf temperature according to a designed primary drying cycle during a primary drying step.
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Accused Products
Abstract
A method and apparatus for optimizing the primary drying step of a lyophilization cycle of a biological or pharmaceutical material. In one aspect, the invention is a method for lyophilizing a material comprising the steps of calculating a designed primary drying cycle for the material based on a product temperature profile for the material and modifying both a chamber pressure and a shelf temperature according to a designed primary drying cycle during a primary drying step. In another aspect, the invention is an apparatus for lyophilizing a material according to a designed primary drying cycle comprising a computer-readable medium, a processor in electrical communication with the computer-readable medium, a chamber pressure module in electrical communication with the processor, and a shelf temperature module in electrical communication with the processor.
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Citations
20 Claims
- 1. A method for lyophilizing a material comprising the step of modifying both a chamber pressure and a shelf temperature according to a designed primary drying cycle during a primary drying step.
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20. An apparatus for lyophilizing a material comprising:
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a) a computer-readable medium adapted to record a designed primary drying cycle;
b) a processor in electrical communication with the computer-readable medium and adapted to execute the designed primary drying cycle;
c) a chamber pressure module in electrical communication with the processor and adapted to modify a pressure of a lyophilization chamber in response to an instruction received from the processor; and
d) a shelf temperature module in electrical communication with the processor and adapted to modify a shelf temperature of a lyophilization chamber in response to an instruction received from the processor.
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Specification