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本文根据冻干过程干燥室内的露点值和物料的水分含量有关提出一种新的方法——露点法来监控冻干过程物料的水分迁移情况。以浓度为2%(W/V)的甘露醇(冻干保护剂)为研究对象,分别取80个,160个,20个小瓶,通过不同的过充小瓶数(1个,2个),不同的溶液高度(溶液高度6.5mm,0.32mm)来检验露点法在监测整批样品冻干过程的灵敏性。与称重法对照,称重法即在冻干过程不同的时刻取出样品测量整批样品质量。实验结果表明露点法即使当过充小瓶率为0.625%,或者溶液高度为0.32mm时仍有足够的灵敏度,露点法得到的一次升华结束点与称重法结果一致。这说明非接触法露点法是一种可靠,便利的监测一次升华结束点的方法,将其应用于控制成批冻干样品大有可为。
In this paper, a new method, the dew point method, is proposed to monitor the moisture transfer in the freeze-drying process based on the dew point of the drying chamber and the moisture content of the material. Taking 2% (W / V) mannitol (lyoprotectant) as the research object, we took 80, 160 and 20 vials respectively and passed different number of overcharged vials (1, 2) Different solution heights (solution height 6.5 mm, 0.32 mm) were used to test the sensitivity of the dewpoint method in monitoring the freeze-drying of bulk samples. Compared with the weighing method, weighing method that is different at the time of freeze-drying process to remove the sample to measure the quality of the entire batch of samples. The experimental results show that the dew point method has sufficient sensitivity even when the overfilled vial rate is 0.625% or the solution height is 0.32 mm. The end point of a sublimation obtained by the dew point method is consistent with the result of the weighing method. This shows that the non-contact method of dew point method is a reliable and convenient method to monitor the end of a sublimation method, its application to control lot of lyophilized samples promising.