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.
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.
KUROSAKI YASUO
| JP2002361012A | 2002-12-17 | |||
| JPH10235120A | 1998-09-08 | |||
| JP2008080193A | 2008-04-10 | |||
| JP2008524284A | 2008-07-10 | |||
| JP2002361012A | 2002-12-17 | |||
| JPH10235120A | 1998-09-08 | |||
| JP2008080193A | 2008-04-10 | |||
| JP2008524284A | 2008-07-10 |
Haruko Sanwa
Hideaki Ito