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

摘要

A system is described for monitoring the lyophilisation process of a product in containers (4, 4a, 4b) arranged inside a lyophilisation chamber, comprising a temperature measurement system (6) associated with each container housed inside (10) said lyophilisation 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 lyophilisation chamber, programmed to determine at least one parameter indicative of the progress of the lyophilisation process not measured by the measurement system, by means of a predetermined representation model of the process, capable of correlating a local temperature value of the container with said parameter.