PROBLEM TO BE SOLVED: To provide a method of manufacturing a preparation-containing vial bottle improved in sterilization properties and productivity.SOLUTION: A method includes: an injection drug sealing process S10 of hermetically enclosing an injection drug solution into a vial bottle together with an internal gas by charging the injection drug solution before freeze-drying into the vial bottle from the mouth of the vial bottle and by fitting a stopper to the mouth from its tip side and a freeze-drying process S20 of freeze-drying the injection drug solution into a freeze dry preparation. The freeze-drying process S20 includes: a cooling and freezing process S21 of cooling and freezing the vial bottle a decompression process S22 of freeze-drying the injection drug solution frozen in a half-capping state that the stopper is fitted to the mouth of the vial bottle while the inside and outside of the vial bottle communicate with each other by sublimation action by reducing the pressure of an atmosphere outside the vial bottle after the cooling processing a substituting process S23 of substituting a nitrogen gas etc., for the inside of a device and a cap-sealing process S24 of sealing the mouth by pressing the stopper in the half-capping state into the vial bottle.COPYRIGHT: (C)2014,JPO&INPIT【課題】滅菌性及び生産性が向上した製剤入りバイアル瓶の製造方法を提供する。【解決手段】バイアル瓶の口部から該バイアル瓶内に凍結乾燥前の注射薬剤溶液を充填して、ストッパーをその先端側から口部に嵌入することで、バイアル瓶内に注射薬剤溶液を内部気体とともに封止する注射薬剤封止工程S10と、注射薬剤溶液を凍結乾燥させて凍結乾燥製剤とする凍結乾燥工程S20とを備え、該凍結乾燥工程S20は、バイアル瓶を冷却凍結する冷却凍結処理S21と、該冷却処理後に、バイアル瓶の外部雰囲気の圧力を減圧させることで、バイアル瓶の口部に対してストッパーをバイアル瓶内外が連通する半打栓状態として凍結された注射器剤溶液を昇華作用によって凍結乾燥させる減圧処理S22と、装置内を窒素ガス等によって置換する置換処理S23と、半打栓状態のストッパーをバイアル瓶内に押し込むことで、口部を密閉する封栓処理S24とを備える。【選択図】図3
