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.

Contact us today to see how Simtra BioPharma Solutions can support you on your next sterile injectable project! 

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