Jennings T A
T. A. Jennings Associates, Inc., Bala Cynwyd, Pennsylvania.
J Parenter Sci Technol. 1990 Jan-Feb;44(1):22-5.
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.
本文提出了一个模型，用于确定实际泄漏（其流动本质上是粘性的）在干燥过程中对真空冷冻干燥机内微生物密度可能产生的影响。该模型认为微生物的进入是由于来自含有已知生物负载的环境的实际泄漏所致。研究了一种确定系统压力上升速率（ROR）与源于已知生物负载环境的系统中微生物密度之间关系的方法。该模型还考虑了干燥机生物负载随一次干燥和二次干燥过程变化的情况。
