Table 4 The requirement as validation processes for the dialysis fluid purification procedure

• Intended of quality of purification of dialysis fluid

• Validity of equipment, preparation processes, products, and plan of the preparation method (system design of apparatuses)

• Confirmation of the designs of the equipment, processes and preparation methods, and their completion as designed (installation qualification)

• Confirmation of the utility of the equipment, processes, and methods, in order to achieve the intended objective (operational qualification)

• Testing of the system under the conditions of actual preparation and confirmation of the operation of the system as designed (performance qualification) (periodic evaluation of the quality of supply water, RO water, and dialysis fluid)

• Guarantee the disinfection of the interior of the system during non-use periods