水分测量:一种监测冷冻干燥循环的新方法。

A Bardat, J Biguet, E Chatenet, F Courteille
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引用次数: 0

摘要

最终产品的质量在很大程度上取决于冷冻干燥过程。反过来,这在很大程度上取决于对冷冻干燥后残余水分的充分控制。在冷冻干燥机的腔室中测量这个量,以确定升华的终点和二次干燥的终点,这为传统使用的方法(例如产品温度的快速增加)提供了可靠的控制。本研究的目的是评估用于监测冷冻干燥循环的不同方法的优点和缺点。两种系统的测量水分在冷冻干燥机评估在这里:皮拉尼真空计,和水分传感器。当放置在冷冻干燥机上时,湿度传感器似乎是确定升华结束和满载批次二次干燥结束的最敏感和可靠的方法。对行业的直接好处是可以扩大规模,而不会有低估或高估冷冻干燥周期的风险。
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Moisture measurement: a new method for monitoring freeze-drying cycles.

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.

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Evaluating out-of-specification laboratory results. Simplifying and improving process validation. Depyrogenation of pharmaceutical solutions using submicron and ultrafilters. USP perspectives on particle contamination of injectable products. Moisture measurement: a new method for monitoring freeze-drying cycles.
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