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要旨:
The lyophilization is one of the most important technological manufacturing processes in the pharmaceutical industry and is used to stabilize a high number of biological active products. In order to realize this, the aqueous preparations are frozen and subsequently the water is removed under reduced pressure by sublimation (Pikal, 1994). Because the lyophilization shows numerous disadvantages, for example high invest and operating costs and the use of a low-temperature technology, in run of a capacity expansion at Roche Diagnostics GmbH possible alternative drying technologies should be identified. These technologies, which have been evaluated as suitable, will be investigated in a feasibility study.
By experts and an extensive literature survey and patent research seven substitution technologies could be identified in addition to possible optimization of the typical method. By pair-wise comparison and a subsequent benefit-analysis the most promising methods, which were placed behind the typical method and their optimizations, were selected for a feasibility study. These were the spray drying, the dynamic freeze drying of Meridion and the vacuum drying under rotation.
The feasibility has been proven in the dynamic freeze drying of Meridion and in spray drying. Here, the required residual moisture and a consistent product quality have been demonstrated, so storage stability can be guaranteed. However, in the dynamic freeze drying much higher cost than conventional freeze drying was observed, whereas the spray drying can feature benefits in terms of cost. By using the rotary vacuum dryer it was not possible to ensure residual moisture of the lyophilisates of maximal 5 % with the used test equipment. However, there was no damage of the product during the drying, which could be detected by positive HPLC-results and enzyme activity tests.
