冻干机设备性能的测量:两种方法的比较

应用领域:制药工艺,抗体药物,核酸药物,化学药,生物制药/仿制药,其他,疫苗

资料类型:其他资料

方案摘要

The objective of this investigation was to evaluate two methods for measuring the maximum sublimation rate that a freeze-dryer will support—the minimum controllable pressure method and the choke point method. Both methods gave equivalent results, but the minimum controllable pressure method is preferred, since it is easier, faster, and less subjective. The ratio of chamber pressure to condenser pressure corresponding to the onset of chokedflflow was considerably higher in this investigation (up to about 20:1) than in previously published reports. This ratio was not affected by the location of the pressure gauge on the condenser; that is, on the foreline of the vacuum pumpversuson the body of the condenser itself. The total water loss due to sublimation as measured by tunable diode laser absorption spectroscopy was consistently within 5% of gravimetrically determined weight loss, regardless of whether the measurement took place during chokedversusnon-choked process conditions.

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