OPTIMIZATION AND CONTROL OF THE FREEZE-DRYING PROCESS OF PHARMACEUTICAL PRODUCTS

摘要

A system for monitoring the lyophilization process of a product in containers (4, 4a, 4b) arranged inside a lyophilization chamber, including a temperature measurement system (6) associated with each container housed inside (10) the lyophilization chamber, capable of surveying local temperature data for each container. The system includes a wireless communication system (8) for the surveyed temperature data and a processing module (16) for said data, located externally to the lyophilization chamber, programmed to determine at least one parameter indicative of the progress of the lyophilization process not measured by the measurement system, through the use of a predetermined representation model of the process, capable of correlating a local temperature value of the container with the parameter.