Requirements for Ultrapure Water Machines - Water Quality Monitoring and Validation

As early as 2005, the "Hemodialysis and Related Water Water Standards" promulgated by the State Food and Drug Administration made mandatory regulations on dialysis water. The standard clearly states that in order to ensure that hemodiafiltration is both safe and effective, a very important aspect is to ensure good water quality. Water quality needs to be controlled and monitored to avoid excess of known or estimated harmful substances. This standard stipulates that the ultrapure water machine needs to ensure excellent water quality when preparing dialysis water, it needs to be able to control and detect the water quality, and it needs to ensure that the water machine can prepare and continuously produce qualified water. Such an ultra-pure water machine is the ultra-pure water equipment that can be used by the matching dialysis machine adopted by the hospital.

Earlier, the "Guidelines for the Preparation and Testing of Reagent Water in Clinical Laboratories - Fourth Edition" issued by the American Clinical and Laboratory Standards Institute (CLSI) clearly pointed out that the ultrapure water used in experimental operations The water needs to be verified and continuously ensured to be of good quality, as well as be able to trend monitor changes in water purity specifications.

Regardless of domestic and foreign standards, a normative standard has been issued for the functions of ultra-pure water machines, that is, the products developed and designed by ultra-pure water equipment manufacturers must be able to verify, validate and automatically monitor the trend of water purity specifications. Changes in ultrapure water machines.

At present, the ultrapure water machines on the market only have basic functions such as automatic water production, automatic shutdown when full of water, water inflow protection alarm, pure water or ultrapure water quality detection and display, and some ultrapure water machines are used in order to reflect the operation. It is more user-friendly, and additional functions such as regular and quantitative water intake, consumable replacement reminder, water quality data recording, and data export through RS232 interface have been added.

However, in order to make up for their own technical deficiencies, some unscrupulous manufacturers have falsified the value displayed on the water quality of the machine when it leaves the factory and directly set the value displayed on the water quality to the national or international standard value.

Therefore, almost none of the ultrapure water machines on the market can meet the national standards and CLSI regulations for ultrapure water equipment. Until 2013, Aquaplore launched a new generation of ultrapure water machine Aquaplore, which integrated the requirements of international standards and actual requirements of users, and fully met the national standards and CLSI regulations for ultrapure water equipment.