A model for the effect of real leaks on the transport of microorganisms into a vacuum freeze-dryer.

This paper proposes a model for determining the effect that real leaks, whose flow is viscous in nature, could have on the microorganism density in a vacuum freeze-dryer during a drying process. The model considers the entry of microorganisms to result from real leaks stemming from an environment containing a known bioburden. A means for determining the relationship between the rate of pressure rise of the system (ROR) and the density of microorganisms in a system, stemming from an environment of a known bioburden, is examined. The model also considers the change in the bioburden of the dryer with respect to variations in the primary and secondary drying process.