| 摘要 |
A method and apparatus for optimizing the primary drying step of a lyophi lization cycle of a biological or pharmaceutical material. In one aspect, th e invention is a method for lyophilizing a material comprising the steps of calculating a designed primary drying cycle for the material based on a prod uct temperature prOfile for the material and modifying both a chamber pressu re and a shelf temperature according to a designed primary drying cycle duri ng a primary drying step. In another aspect, the invention is an apparatus ( 10) for lyophilizing a material according to a designed primary drying cycle comprising a computer-readable medium (12), a processor (14) in electrical communication with the computer-readable medium (12), a chamber pressure mod ule (16) in electrical communication with the processor (14), and a shelf te mperature module (18) in electrical communication with the processor (14).</ SDOAB>
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