Comprehensive process monitoring is necessary in the development and subsequent production of high-value products, particularly in the biotech and pharmaceutical sectors, for internal quality assurance and regulatory compliance documentation.
Process analytical technologies, which include everything from product temperature sensors to online mass spectrometers, provide insight into complex processes and enable stable drying processes.
Industrial-scale freeze-drying requires robust processes that are initially developed on pilot systems and then scaled up. The objective is to develop drying recipes (profiles of
vacuum and shelf temperature versus time) that allow the best possible quality to be achieved in the shortest possible time.
Pilot systems must therefore have the same technology and geometry as the subsequent production freeze-dryer, such as rectangular product chambers and shelves, cooled and heated by
liquid media.
The following table lists the parameters used by Christ for process control and monitoring. When used together with basic recipes stored in the freeze dryer control system for various products, an automatic, self-optimising process can be achieved.