METHOD OF MANUFACTURING FREEZE DRY PREPARATION CONTAINED IN VIAL BOTTLE, AND STOPPER

摘要

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.