The purified water distribution system provides optimized purified water and injection water for various equipment water points in pharmaceutical enterprises, ensuring that the water quality of the water points is better than the requirements of the 2015 version of the drug production standards (GMP validation). The system delivers purified water from a pure water storage tank through a circulating pump, distribution pipeline, and sterilization device (pure steam, ozone generator, ultraviolet disinfection device, pipeline sterilization and filtration device selected by the user) to each water consumption point, and monitors and alarms the water quality in the pipeline in real time.
 

2、 Technical requirements and design specifications

● Modular design and assembly of system integration, easy operation, and small space occupation;

System electrical control device: manual, semi-automatic, fully automatic control, color touch screen display, Siemens S200PLC control; Circulating pump frequency conversion speed control has high energy-saving efficiency; The system monitors temperature, pressure, flow rate, conductivity and other parameters online, and is equipped with a standard multi parameter recorder; Real time monitoring of the operating status of the system; One click start, easy and convenient operation.

The water production of the purified water machine system, the volume of the pure water storage tank, and the water used in the purified water distribution system should meet the peak flow rate.

● Flow and pressure: The system ensures that the flow rate and pressure of purified water in the pipeline meet the requirements of the distribution system pipeline and water point equipment. The flow rate of the circulating pump should be greater than the sum of the peak flow rate and reflux flow rate of the distribution system.

The system is designed and manufactured according to hygiene standards (better than GMP validation requirements). The pumps, valves, pipelines, and fittings used in the storage, distribution, and transportation processes of the system should be sanitary, made of SUS316L material, and connected in a card type quick opening manner. The system should not have dead corners or water accumulation areas during installation, and the internal surface roughness Ra of components in contact with purified water should be ≤ 0.4 μ m.

The clean pipeline of the system adopts fully automatic pipe welding equipment to ensure welding quality. Internal mirror photos and inspection reports are provided, and passivation treatment must be carried out after the pipeline is manufactured.

Reasonable setting of online detection points and sampling points in the system can meet the needs of maintenance and verification after the system is put into operation.

Purified water should be recycled, and intermediate storage tanks should not be installed in the circuit to prevent microbial growth. If heating or cooling of purified water is required during use, a double tube plate heat exchanger should be installed near the point of use.

System disinfection and sterilization: Thermal disinfection, ultraviolet disinfection, and chemical disinfection methods are used. In order to prevent the growth of microorganisms on the surface of purified water storage tanks, pipelines, and filter membranes, an ozone generator and ultraviolet disinfection device are designed in the purified water transportation and distribution system to disinfect and monitor the purified water, ensuring that the water quality standards meet GMP requirements during the distribution and transportation process.

Add an air-water mixer in the purified water distribution and transportation system to mix the ozone generated by the ozone generator with the purified water evenly. The mixer circulates in the distribution system, relying on ozone to disinfect the purified water. At the same time, trace amounts of ozone dissolved in the purified water also disinfect the inner walls, valves, pipe fittings, etc. of the pipeline during circulation, effectively preventing the growth of microorganisms inside the system