The aim of the project is to purchase and implement a purified water production system to ensure the stable production of diagnostic ELISA and PCR kits that meet the requirements of quality, biosafety and international standards of laboratory and biotechnological production. The objectives of the project are to ensure the production of stable quality purified water for the preparation of reagents and buffer solutions; reducing the risk of contamination in the production of diagnostic drugs; ensuring compliance with ISO, GMP/GLP and sanitary standards; improving the quality and reproducibility of manufactured ELISA and PCR test systems; reducing dependence on external suppliers of purified water; creating conditions for the expansion of domestic production of diagnostic reagents for medical and veterinary purposes; improving production efficiency and reliability of technological processes.

As part of the application adjustment, we additionally inform you of the following. The project provides for the introduction of an automated water treatment system to ensure the production of diagnostic ELISA kits with purified pharmaceutical/biotechnological quality water with elements of industrial automation, digital monitoring and integration of engineering infrastructure. Technical characteristics of the system: • the capacity of purified water is at least 50 liters/hour; • storage capacity — 300-500 liters; • Dual–circuit architecture: - purified water production line; – technical line for household and auxiliary purposes; • Reverse osmosis system (preferably two-stage); • UV sterilization of 254 nm; • finishing filtration of 0.22 microns; • automatic membrane flushing; • Online conductivity monitoring; • Automatic alarm system; • possibility of continuous operation; • the possibility of further integration with the ultrapure water system. Automation Parameters: The project provides for: • PLC/HMI control system; • Automatic control of water pressure and conductivity; • Automatic flushing mode switching; • protection of pumps from dry running; • logging of operation parameters; • automatic alarm in case of water quality deviation; • the ability to integrate into the overall production monitoring system of the enterprise; • the ability to connect MES/SCADA as part of further digitalization of production. Measurable KPIs of the project: Expected implementation indicators: • stable production of purified water with a conductivity of less than10-20 µS/cm; • reducing the risk of microbial contamination through UV treatment and finishing filtration; • reduction of production risks related to the human factor by more than 70%; • reducing the likelihood of cross-contamination by separating production and technical lines; • improving the stability of the quality of ELISA reagents; • reduction of production downtime due to automatic flushing and continuous operation; • improving the reproducibility of technological processes. Technological and infrastructural component: The project is focused on the introduction of modern automated engineering infrastructure for biotechnological production, including the integration of water purification systems, sanitation, digital monitoring and production control into a single production environment.