LYOPHILIZATION METHODS AND APPARATUSES

摘要

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 (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 module (16) in electrical communication with the processor (14), and a shelf temperature module (18) in electrical communication with the processor (14).