PROBLEM TO BE SOLVED: To provide a method for disinfecting a fine granular preparation by filtration by which the sterility at the secondary side of the disinfection by the filtration can be secured stably and efficiently in an industrial scale without being affected by the unevenness of quality of the product and the filter which is one of the cause of leak of bacteria, and to provide a system for the disinfection by the filtration.SOLUTION: The method for disinfecting the fine granular preparation by the filtration includes a filtering and disinfecting step of the fine granular preparation by using a disinfecting filter. In the filtering and disinfecting step, the limited reduced rate (YMAX) of a flow rate is set, and the control for continuing the filtering and disinfecting step by exchanging the disinfecting filter, or for suspending or finishing the filtering and disinfecting step is carried out before a reduced rate (Y) of the flow rate exceeds the limited reduced rate (YMAX) of the flow rate. The reduced rate (Y) of the flow rate is defined as the percentage of the reduced value of the flow rate based on the initial flow rate (Qinit), and the limited reduced rate (YMAX) of the flow rate is defined as the reduced rate of the flow rate when the bacteria-capturing rate by the disinfecting filter becomes an allowable value or less. The system for disinfecting the fine granular preparation by the filtration uses the method for disinfecting the fine granular preparation by the filtration.COPYRIGHT: (C)2013,JPO&INPIT【課題】菌のリークの原因の一つである製剤やフィルターの品質のバラツキに左右されることなく工業化スケールで安定、且つ、効率的に、ろ過滅菌二次側での無菌性保証をすることができる、微粒子製剤のろ過滅菌方法およびろ過滅菌システムを提供することを課題とする。【解決手段】滅菌フィルターを用いる微粒子製剤のろ過滅菌工程を有し、前記ろ過滅菌工程において、限界流量減少率(YMAX)を設定し、流量減少率(Y)が前記限界流量減少率(YMAX)以上となる前に、滅菌フィルターを交換してろ過滅菌工程を継続、またはろ過滅菌工程を中断もしくは終了する制御を行い、前記流量減少率(Y)は、初期流量(Qinit)に対する、流量減少分の百分率と定義され、前記限界流量減少率(YMAX)は、滅菌フィルターの菌捕捉率が許容値以下となる時の流量減少率と定義される、微粒子製剤のろ過滅菌方法およびそのろ過滅菌方法を使用する微粒子製剤のろ過滅菌システム。【選択図】図1
