Abstract
For quality control during dialysis fluid manufacture, it is important to ensure patient protection by monitoring bacterial contamination and taking measures to prevent accidents. When high sensitivity is required to monitor bacterial contamination, the membrane filtration (MF) method is desired. In this study, we evaluated the MF methods (37mm Quality Monitor and MicroFunnelTM SP Filter Unit (Nihon Pall Ltd. Pall Life Science Company, Tokyo, Japan)) with the culture media of R2A/TGE agar or broth. We compared the MF methods with the plate count methods based on bacterial colony numbers from both MF methods about the measurement accuracy of bacteria that exist in dialysis fluid using two standard microorganisms (Pseudomonas fluorescence, Methylobacterium extorquens) and one wild type isolated from the dialysis fluid in our clinic. As a result, all data of the MF methods showed more than 70% bacterial recovery on the basis of each bacterial colony number for Pseudomonas fluorescence (59.3cfu/plate), Methylobacterium extorquens (62.5cfu/plate) and Wild type (38.6cfu/plate) on R2A plate agar. In conclusion, the MF methods that were evaluated in this study may be an effective tool for quality control during the dialysis fluid production process.
