Bardat A, Biguet J, Chatenet E, Courteille F
Centre National de Transfusion Sanguine, Les Ulis, France.
J Parenter Sci Technol. 1993 Nov-Dec;47(6):293-9.
Quality of the final product largely depends on the freeze-drying process. In turn this largely depends on an adequate control of the amount of residual moisture after freeze-drying. Measuring this amount in the chamber of the freeze-dryer to determine the end point of sublimation and the end point of secondary drying provides a reliable control with regard to the methods traditionally used (for example rapid increase in product temperature). The purpose of this study is to evaluate the benefits and disadvantages of the different methods recommended for the monitoring of a freeze-drying cycle. Two systems for the measurement of the moisture in the freeze dryer are evaluated here: the Pirani vacuum gauge, and the moisture sensor. The moisture sensor appears to be the most sensitive and reliable way of determining both the end of sublimation and the end of secondary drying of the full load batch when placed on a freeze-dryer. The immediate benefit for the industry is to allow to scale-up without the risks of under or over estimating the freeze-drying cycle.
最终产品的质量在很大程度上取决于冷冻干燥过程。而这在很大程度上又取决于对冷冻干燥后残余水分量的充分控制。在冷冻干燥机的腔室内测量该水分量以确定升华终点和二次干燥终点，相对于传统使用的方法（例如产品温度的快速升高）而言，提供了一种可靠的控制方式。本研究的目的是评估推荐用于监测冷冻干燥循环的不同方法的优缺点。此处评估了两种用于测量冷冻干燥机内水分的系统：皮拉尼真空计和水分传感器。当放置在冷冻干燥机上时，水分传感器似乎是确定满负荷批次升华终点和二次干燥终点的最灵敏且可靠的方法。该技术对行业的直接好处是能够实现扩大规模，而不存在低估或高估冷冻干燥循环的风险。
