Lyophilization methods and apparatuses

F - Mech Eng,Light,Heat,Weapons – 26 – B

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F26B 5/06 (2006.01)

Patent

CA 2665902

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).

La présente invention concerne un procédé et un appareil pour optimiser la première étape de séchage d'un cycle de lyophilisation d'un matériau biologique ou pharmaceutique. Selon un aspect, l'invention concerne un procédé pour lyophiliser un matériau comprenant les étapes de calcul d'un premier cycle de séchage destiné au matériau basé sur un profil de température de produit pour le matériau et de modification à la fois d'une pression de chambre et d'une température de plateau selon un premier cycle de séchage conçu pendant une première étape de séchage. Selon un autre aspect, l'invention concerne un appareil pour lyophiliser un matériau selon un premier cycle de séchage conçu comprenant un support lisible par ordinateur, un processeur en communication électrique avec le support lisible par ordinateur, un module de pression de chambre en communication électrique avec le processeur, et un module de température de plateau en communication électrique avec le processeur.

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