RAPID DEPRESSURIZATION CONTROLLED ICE NUCLEATION IN PHARMACEUTICAL FREEZE-DRYING
Abstract:
A lyophilization method for lyophilizing products inside one or more vials within a lyophilization chamber is disclosed which includes humidifying a charge gas to a predetermined relative humidity, cooling shelves in the lyophilization chamber to a predetermined temperature, pressurizing the chamber with the humidified charge gas to a pressurization threshold to thereby achieving a target relative humidity level within the lyophilization chamber, and suddenly releasing pressure within the lyophilization chamber until a depressurization threshold is reached in a short time interval up to about 4 seconds, during the depressurization, product inside one or more vials nucleate.
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