RESOURCE OVERVIEW
Methods for Determining Equipment Capability of Freeze-Dryers
Lyophilization is a drug manufacturing process that involves freezing the formulation, drying the frozen ice under vacuum, and subsequent removal of unfrozen residual water. The pharmaceutical freeze-drying technique is constantly evolving to achieve improvements through a better understanding of the product and process conditions and the efficiency of the equipment. The limiting factor for any freeze-dryer
is a phenomenon called “choked flow”, when the velocity of water vapor in the duct that connects the product chamber with the condenser approaches the speed of light (360m/sec).
This white paper describes two experimental methods of determining “choked flow”, namely the minimum controllable pressure method and choke point method.
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