棚段凍結乾燥機における各バイアル昇華速度の不均等

庫壁温度制御による均等加熱の達成

抄録

Significant inter-vial variance in the sublimation rate has been pointed out by several authors in relation to the placement of the vials on a well controlled shelf. All the previous reports have described the phenomena observed in the experiments or the production processes, and have made some suggestive remarks, but have not clearly proposed a solution to the problem. In the shelf freeze-drying of pharmaceuticals, one of the major ploblems is how to achieve inter-vial uniformity and batch to batch uniformity or consistency. In this study, We have developed a new model of laboratory-scale freeze-dryer which has temperature-controllable chamber walls, and using this new model we have analyzed causes of inter-vial variance in the sublimation rate. The higher sublimation rate for the vials placed on the shelf edge is due to additional heat input from the wall and also due to further additional heat from the shelf surface on which no kissing vial is placed. It is possible to cancel out the additional heat input from the shelf by maintaining an optimum wall temperature, which must be lower than the material temperature. This paper discusses a method for eliminating the inter-vail variance in drying conditions and shortening the drying time by means of chamber wall temperature control.