PROBLEM TO BE SOLVED: To provide a sterile refining apparatus for active pharmaceutical ingredients, the apparatus being able to further reduce the content of impurities.SOLUTION: The sterile refining apparatus for active pharmaceutical ingredients is used for performing a first step in which after a solution of pharmaceutical crude ingredients is prepared by dissolving pharmaceutical crude ingredients in a first solution, the prepared solution is sterilized, a second step in which the pharmaceutical ingredients is crystallized by adding an aseptically filtered second solvent to the sterile prepared solution, and a third step in which the crystallized pharmaceutical ingredients is filtered, dried, and pulverized, and the thus obtained powder of pharmaceutical ingredients is filled into a container. In the sterile refining apparatus, the steps are connected by pipes from a pharmaceutical crude ingredients input part to a container filling device 39 in order to carry out the steps under inert gas atmosphere by use of a series of inline systems. The pharmaceutical ingredients are filtered and dried in the third step is conveyed out from a conveyance port by inert gas flowing downstream from a filtering dryer, is conveyed to a powder transport hopper 31, located below the filtering dryer, by a vibration feeder 29, and is conveyed to a pulverizing device 36 by a screw conveyer.COPYRIGHT: (C)2013,JPO&INPIT【課題】不純物の含有量をより低下させることができる医薬品原薬の無菌化精製装置を提供する。【解決手段】医薬品粗原薬を第1の溶媒に溶解して粗原薬溶液を調製した後、無菌化する第1工程、無菌濾過された第2の溶媒を添加し、医薬品原薬を晶析させる第2工程、濾過及び乾燥後、粉砕し、得られた粉末状の医薬品原薬を容器内に充填する第3工程を行うための医薬品原薬の無菌化精製装置において、各工程は一連のインラインシステムにより不活性化ガス雰囲気下で行うために粗原薬投入部から容器充填装置39まで配管で連結され、第3工程において濾過及び乾燥された医薬品原薬は、濾過乾燥機から下流方向への不活性ガス気流により搬出口より搬出され、振動フィーダ29により、濾過乾燥機の下方に位置する粉体移送用ホッパ31へ搬送され、スクリュコンベアにより粉砕機36へ搬送される。【選択図】図2
