PROBLEM TO BE SOLVED: To provide a method for stabilizing a component in a solution which solves the problem on quality control of the instability of a solute such as the growth of infectious fine particles in the solution, the deterioration of the solute, coagulation, sedimentation and the discoloration of the solution and the problem on the new production step of the clogging of a separation membrane caused by the addition of an additional component for solving the problems.SOLUTION: Fine particles are removed by a membrane separation method where the occurrence of clogging is suppressed. High quality stability is realized by, if necessary, combining gentle component adjustments before and after membrane separation.SELECTED DRAWING: Figure 1COPYRIGHT: (C)2019,JPO&INPIT【課題】溶液中における感染性微粒子の増殖、溶質の変質、凝集、沈殿、溶液の変色といった溶質の不安定性は、品質管理上の課題となる。またこうした課題への対策として追加成分の添加が、膜分離の目詰まりという新たな製造工程上の課題となる。【解決手段】目詰まりの発生を抑制した膜分離法によって微粒子を除去する。また必要に応じて膜分離の前あるいは後にゆるやかな成分調整を組み合わせることで、高い品質安定性を実現する。【選択図】図１
