1、 Introduction to Pharmacopoeia Purified Water Equipment

The core technology of purified water equipment adopts single-stage or two-stage reverse osmosis, EDI and other processes, and designs a targeted set of high-quality pure water treatment processes to meet the water requirements for the production of purified water or distilled water for pharmaceutical factories, hospitals and laboratory diagnostic reagents. The entire system is composed of SUS304L or SUS316L all stainless steel materials, and ultraviolet and ozone sterilization devices must be equipped before the water point. Pasteurization can also be used.

Biopharmaceutical purified water system: Purified water used in the pharmaceutical industry, also known as deionized water (or desalinated water), usually refers to a type of process water prepared using methods such as reverse osmosis and EDI, and using urban tap water or surface water as raw water without any additives. The national water requirements for the pharmaceutical industry are very strict, so the water produced by purified water equipment used in the pharmaceutical industry must comply with the Chinese Pharmacopoeia (2015 edition). The Excellent Water Treatment Purified Water System is designed and manufactured in accordance with GMP requirements, and the purified water process is designed based on the quality of the source water. At the same time, we provide customers with complete GMP system verification services. The system adopts automatic control mode, which is stable, reliable, exquisite and beautiful, making it the preferred purified water equipment for pharmaceutical production and the pharmaceutical industry. The equipment produced by Excellent Water Treatment has been professionally designed and produced by the manufacturer to provide long-term and stable purified water, which can meet the requirements of pharmaceutical factories, hospitals for purified water production, and infusion production. The excellent water treatment and purification system can be used for water supply in medical devices, pharmaceutical preparations, in vitro diagnostic reagents, pharmaceutical water, blood purification, hemodialysis, biochemical products, medical sterile water, oral liquid water, disinfection rooms, hospital supply rooms, etc.

2、 Excellent Water Treatment Pharmaceutical Purified Water Equipment Service Content:

Including equipment process design, system manufacturing, installation, on-site installation, system trial installation and adjustment, equipment warranty, and after-sales service, etc

3、 Reference standards for excellent purified water equipment design:

1. The relevant technical information, technical specifications, and basic technical requirements provided by the construction party;

2. Current national design specifications, construction and acceptance specifications, and quality assessment standards;

3. The design of reverse osmosis system is based on the United States;

4. ZBG98020-90 "Series Spectrum of Water Treatment Equipment";

5. Code for Design of Relay Protection and Automatic Device of Power Equipment (GB50062-1992);

6. Code for Grounding Design of Industrial and Civil Electrical Installations (GBJ65-1983);

7. Stainless steel thin-walled containers for food industry (QB/T 2681-2004)

8. Steel Welded Atmospheric Pressure Vessels (NB/T 47003.1-2009)

9. Complete sets of low-voltage switchgear and control equipment (IEC439-1)

10. Requirements for "Purified Water" in the 2015 edition of the Chinese Pharmacopoeia

11. European Pharmacopoeia GMP 7.0 edition

12. USP36 "PW" Requirements of the United States Pharmacopeia

4、 Design parameters of excellent water treatment and purification equipment:

1. Raw water requirements: meet the hygiene standards for drinking water (pressure 0.2-0.5MPa); Conductivity ≤ 500 μ s/cm; Total hardness<300PPM

2. Power supply requirements: AC380/220V 50HZ， Three phase five wire, reliably grounded

3. Environmental temperature: 5-40 ℃; Atmospheric pressure: 700Kpa-1060Kpa; Relative humidity: ≤ 80%

4. Desalination rate of reverse osmosis system: ≥ 99%

5. Operating pressure: ≤ 1.5Mpa

6. Equipment production and operation mode: 24-hour production per day;

7. Installation site requirements: The ground should be flat and equipped with a waterproof layer, and there should be a smooth drainage floor drain

8. This system avoids operating in environments with direct sunlight and strong magnetic field interference

9. Other: Users provide equipment site, water source, power supply, and equipment drainage ditch

5、 Excellent purified water equipment process design:

1. The purified water system adopts fully automatic control, with high stability and simple and convenient operation;

2. By using bipolar reverse osmosis technology, the desalination rate is high, the effluent quality is stable, and the performance is reliable, ensuring the stable operation of the system to a large extent.

3. Adopting PLC combined with human-machine interface for fully automatic control, touch screen one click start, simple and convenient operation, clear picture, exquisite and beautiful appearance.

4. Equipped with water quality correction function and water quality warning function, there will never be an emergency situation.

5. Equipped with a purified water delivery and supply system, the water production system is controlled separately from the water supply system. In case of replacement of consumables, there is no need to stop the water supply or production.

6. RO water production and flushing time can be set, and during peak water usage periods, the water production time can be adjusted to ensure stable water usage at the water point.

7. The pre-treatment system, water production system, and water use system in the purified water system are each equipped with a circulating water circuit. Each level of water quality section is set with the function of discharging qualified water and unqualified water to the previous section to ensure stable and safe water quality.

6、 Common process flow of excellent purified water equipment:

(1) Pre treatment+primary reverse osmosis+secondary reverse osmosis+sterilization device+circulation system

(2) Pre treatment+primary reverse osmosis+EDI equipment+sterilization device+circulation system

(3) Preprocessing+primary reverse osmosis+secondary reverse osmosis+EDI equipment+sterilization device+circulation system

7、 Material selection for excellent purified water equipment:

1. Material standard: Strictly follow the 2015 edition pharmacopoeia's regulations for purified water equipment for material selection, and provide various material inspection reports to ensure 100% GMP certification

2. Pipelines and water storage tanks: The water system is a critical system in the pharmaceutical industry and a key equipment for the new GMP risk assessment. In principle, pipelines and water storage tanks must be made of SUS304 material, or L316 material can be selected.

3. Sanitary standard: The components of purified water equipment, including pumps, valves, pipelines, pipe fittings, etc., should be selected as sanitary to avoid contamination caused by corrosion

4. Material Traceable Source: The purified water system material has relevant documentation to provide to customers for archiving and preservation, and all production and manufacturing materials can be traced back to the source

Equipment installation:

1. Design and install modularity, integration, standardization, easy installation, simple operation, and compact structure;

2. The entire purified water system is assembled and debugged in the factory to achieve factory acceptance of the entire system.

3. During the on-site installation of the equipment, the core components will be opened and put into use on site, and customers will be required to record the model on site and participate in the acceptance inspection.

4. During installation, a professional engineer will be appointed to provide on-site explanations on equipment operation, running, and precautions.

Pipeline welding:

1. Purified water is configured with all stainless steel, and welding is preferred for each connecting part. Double sided forming protection welding technology is used, and the inner wall of the pipeline is passivated to prevent the use of threaded connections.

2. Welding is inspected according to SOP, and endoscopic photography is used for testing, ensuring safety and peace of mind;

3. Professional construction welding personnel, all holding welding operation certificates;

4. Both automatic and manual welding are subject to endoscopic photography inspection.

Microbial control:

1. 2D blind spot design (less than 3D, higher design requirements), in special cases, zero blind spot design is adopted;

2. Aseptic water tank; Install rotating spray cleaning and air breathing devices;

3. Flow rate: Ensure turbulence (flow rate greater than 1m/s) in the circuit, maintain positive pressure in the circuit, and prevent microorganisms from staying, adhering, and breeding on the inner wall of the pipeline;

4. Pipeline: The adhesive pads in contact with purified water are all PTPE/EPDM, and the diaphragm valve is installed horizontally at a 45 degree angle. The installation of the circulation pipeline is set at a slope of 0.5%, with the discharge point set as the discharge point;

5. Disinfection and sterilization: equipped with plate heat exchangers, ozone sterilization, UV ultraviolet radiation, and membrane filters to prevent bacteria from affecting water quality.

8、 Purified water equipment distribution system:

1. The storage, distribution, and transportation systems of purified water equipment are designed and constructed in accordance with the standards of sanitary grade products.

2. The pumps, valves, pipelines, and fittings used in the entire storage and transportation system should be of sanitary type, with welding as the preferred connection method, followed by crimping.

3. Eliminate dead corners and water accumulation areas in the purified water system, design without dead corners, and passivate all welding parts in contact with purified water. Take photos of the contact inner surface using an endoscope for inspection, with an average roughness Ra ≤ 0.4 μ m.

4. The pre-treatment system, water production system, and water use system in the purified water system are each equipped with a circulating water circuit. Each level of water quality section is set with the function of discharging qualified water and unqualified water to the previous section to ensure stable and safe water quality.

5. Use plate heat exchangers to heat purified water at the point of use.

6. In order to prevent the growth of microorganisms on the surface of purified water storage tanks, pipelines, and filter membranes, ozone generators and ultraviolet disinfection devices are installed in the transportation and distribution system to disinfect and monitor the purified water, ensuring that it meets GMP standards during the distribution and transportation process.

9、 Technical parameters of purified water equipment

10、 Purified water equipment effluent indicators

Conductivity: (should comply with General Rule 0681), the conductivity value corresponding to the temperature measured in Table 1 is the limit value; If not listed in the table, the limit value should be calculated using linear interpolation, and the measured conductivity value should not exceed the limit value.

Table 1 Limit Table for Temperature and Conductivity