Purified Water System

The 2010 edition of the Pharmacopoeia requires:
The 2010 edition of the Pharmacopoeia has strict requirements for the quality of purified water, and the relevant regulations are as follows:
1) Overall characteristic requirements: This product is a colorless, odorless, and tasteless clear liquid made from drinking water by distillation, ion exchange, reverse osmosis, or other suitable methods, without any additives.
2) Quantifiable indicators: conductivity ≤ 2 μ S/cm (resistivity ≥ 0.5 M Ω) CM)

3) Other inspection indicators:

GMP certification requirements:
1. The structural design should be simple, reliable, and easy to disassemble.
2. For the convenience of disassembly, replacement, and cleaning of parts, the design of the actuator should use standardized, universal, and systematic components as much as possible.
3. The inner and outer wall surfaces of the equipment should be smooth, flat, without dead corners, and easy to clean and sterilize. The surface of the parts should be treated with chrome plating or other surface treatments to resist corrosion and prevent rusting. Avoid using paint on the outside of the equipment to prevent peeling.
4. PreparationPurified water equipmentLow carbon stainless steel or other materials that have been verified to not pollute water quality should be used. The equipment for preparing purified water should be regularly cleaned and the cleaning effect should be verified.
5. The material in contact with injection water must be high-quality low-carbon stainless steel or other materials that have been verified not to pollute the water quality. The equipment for preparing injection water should be regularly cleaned and the cleaning effect should be verified.
6. The storage period of purified water should not exceed 24 hours, and its storage tank should be made of stainless steel material or other materials that have been verified to be non-toxic, corrosion-resistant, and do not leak out pollutant ions. A hydrophobic sterilization filter with non shedding fibers should be installed to protect its ventilation port. The inner wall of the storage tank should be smooth, and there should be no dead corners or sand holes in the connecting pipes and welds. Sensors that do not cause stagnant water pollution and display parameters such as liquid level, temperature, and pressure should be used. Regularly clean, disinfect and sterilize storage tanks, and verify the effectiveness of cleaning and sterilization.
7. Transportation of pharmaceutical water
1) Purified water and pharmaceutical water should be transported using stainless steel pumps that are easy to disassemble, clean, and disinfect. In situations where purified water and injection water require compressed air or nitrogen pressure delivery, the compressed air and nitrogen must be purified.
2) Purified water should be transported through a circulating pipeline. The pipeline design should be concise and avoid blind pipes and dead corners. The pipeline should be made of stainless steel pipes or other pipes that have been verified to be non-toxic, corrosion-resistant, and do not leak pollutants. Valves should be sanitary grade valves without dead corners, and the flow direction of purified water should be indicated.
3) The pipelines and pumps used for transporting purified water and injection water should be regularly cleaned, disinfected, and sterilized before being put into use.
8. The design of pressure vessels must be undertaken by licensed units and qualified personnel, and must be handled in accordance with the relevant provisions of the national standards of the People's Republic of China, "Steel Pressure Vessels" (GB150-80) and "Safety Technical Supervision Regulations for Pressure Vessels".

‍Purified Water Process Flow Chart

Introduction to the functions of the main components:

Multi media filter: removes impurities such as mud, sand, suspended solids, colloids, and algae from water, reducing mechanical damage and pollution to reverse osmosis membrane components;

Reverse osmosis host: removes dissolved salts, colloids, microorganisms, organic matter, etc. from water;

Softener: adsorbs excess calcium and magnesium ions in water, removes scale (calcium carbonate or magnesium carbonate), and softens water quality;

Double tube plate heat exchanger: sterilization cooling;

UV sterilizer: efficient sterilization, purifying water quality;

Additional note: Raw water (compliant with national domestic water standards, conductivity ≤ 500 μ s/cm, turbidity ≤ 5) enters the raw water tank for storage, and then is pressurized by the raw water pump and enters the sand filter and carbon filter. The softener removes suspended solids, colloids, organic matter, and residual chlorine from the raw water, reducing the hardness of the water. The filtered water enters the security filter and is pressurized by the first stage RO high-pressure pump before entering the first stage reverse osmosis system to remove most of the salt in the water and achieve purification. The reverse osmosis effluent is stored in the intermediate water tank; After being pressurized by the secondary high-pressure pump, it enters the secondary reverse osmosis treatment and is stored in the secondary RO water tank. After passing through the ozone sterilization system and ultraviolet sterilizer to stabilize the effluent quality, it is then directed to various water points through pipelines.

The verification document for the purified water equipment system, also known as 4Q verification, includes IQ installation confirmation, OQ operation confirmation, PQ performance confirmation, and DQ design confirmation

IQ installation confirmation
Installation confirmation (IQ) mainly involves confirming that the equipment installation meets the design requirements, with complete documents and attachments, and verifying the existence of the equipment through inspection and documentation after installation. That is to say, by checking files and other items, it is confirmed that the equipment and system have been installed according to the design, meet the requirements and standards of the equipment and system design, and have been installed correctly.

IQ installation confirmation includes
1> Packaging confirmation
2> Equipment List
3> Installation process confirmation
4> Material confirmation (in direct contact with the product)
5> Instrument confirmation
6> Lubricant confirmation (lubricants in contact with the product must be food grade)
7> Confirmation of various technical drawings and operation guidelines
8> Confirmation of Public System

2. DQ design confirmation
Design Qualification (DQ) is the process of inspecting and confirming the design aspects of equipment or facilities. Design confirmation usually refers to the review of the technical specifications adaptability of the equipment to be ordered and the selection of the supplier in the "Guidelines for Drug Production Validation". Meanwhile, in the "Guidelines for the Implementation of Good Manufacturing Practice for Drugs," it is believed that "pre confirmation is the confirmation of equipment design and selection

DQ design confirmation includes
1> Confirmation of equipment performance, material, structure, parts, measuring instruments, and suppliers
2> Confirmation of PID piping and instrumentation diagram
3> CAD engineering drawing confirmation
4> Parts List
5> Circuit diagram

3. OQ operation confirmation
Operational Qualification (OQ) is the process of verifying and testing the operational, control, and performance of pharmaceutical machinery (equipment) through no-load running experiments, by recording and documenting compliance with production process requirements. After installation confirmation, the manufacturer and user of the equipment jointly conduct operational confirmation according to the verification plan to confirm the compliance and coordination of the equipment's operational performance.
OQ operation confirmation includes
1> Calibration of testing instruments
2> Functional testing of various parts of equipment/system
3> Indicator, interlock device, and safety control detection
4> Alarm detection
5> Power outage and repair

4. PQ performance confirmation
Performance Qualification (PQ) is the confirmation of the actual operational performance of the equipment, which should be conducted after the completion of the operational qualification and approval. Industrial load production is carried out under the guidance of the entire pharmaceutical process technology, using simulated production methods to collect and analyze data through observation, recording, sampling and testing to prove the reliability and adaptability of pharmaceutical machinery (equipment) operation to production.
PQ is a simulated production process, in which users carry out actual production operations according to the process requirements of drug production. PQ requires the development of individual confirmation plans for each set of facility equipment and its related process procedures.

1. Water source for preparing injection water

2The water used for the final washing of equipment, utensils, and materials that come into direct contact with non sterile drugs

3Initial cleaning of injection and sterile drug bottles

4. Ingredients for non sterile drugs

5Refined raw materials for non sterile drugs

6Ingredients for injections and sterile flushing agents

7. Aseptic raw material essence

Choose JiefengPurified water equipmentSome customers:

Jiuhui Pharmaceutical Co., Ltd

Hongfutang Group Shenzhen Branch

Shenzhen Botai Biotechnology Co., Ltd

Watsons Group, a subsidiary of Hutchison Whampoa in Hong Kong

Shenzhen Sea Paradise

Shenzhen Changjun Biotechnology Co., Ltd

Shenzhen Hande Tongchuang Biomedical Technology Co., Ltd

Shenzhen Sunshine Road Biomaterials Co., Ltd

Gonglin Industrial (Shenzhen) Co., Ltd

Yunnan Yunyao Group

Kunming Fumin County People's Hospital

Green Biotechnology in Hainan Province

Kangxin Pharmaceutical of Canada

1. The purified water system adopts fully automatic control, with imported components as the main components, high stability, and simple and convenient operation;
2. Using imported Heideneng low-pressure membrane and bipolar reverse osmosis process, the desalination rate is high, the effluent quality is stable, and the performance is reliable Ensure the stable operation of the system to the greatest extent possible.
3. 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, ensuring safety, standardization, cleanliness, and aesthetics.
4. Using the most advanced automatic welding machine imported from Germany, the fully automatic one side welding double-sided forming welding process, and providing welding code records and endoscopic inspection photos for each pipeline, ensuring customer safety and peace of mind.
5. Design, manufacturing, processing, installation, and debugging are integrated, and professional engineers are appointed to explain equipment operation, running, and precautions on site during installation.
6. 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.
7. Set the optimal height position for touch screens, switches, instruments, and meters to facilitate manual operation; The manual and automatic mode conversion is fast and safe, and has a reminder function to prevent erroneous operations from affecting the system.
8. Equipped with a raw water tank, an intermediate water tank, and a level gauge device, it can prevent equipment from being affected by unstable tap water pressure
9. Purified water dedicated sterile purified water tank, equipped with pressure type liquid level gauge, rotary spray cleaning and air breathing device; Establishing multiple safety protection functions such as no water, low pressure, overpressure, etc. at key pressure points;
10. The touch screen is equipped with dynamic animation monitoring screens for water pumps, valves, and water tank levels. When the filter material replacement cycle is up, full water, water shortage, low pressure, and overpressure occur, they will be recorded in the touch screen event log. When there are abnormalities in water quality, pressure, and flow rate, an alarm will be issued.
11. Equipped with pH adjustment and online detection system, and equipped with sampling points, it is convenient to detect water quality at any time;
12. Equipped with UV ultraviolet and ozone sterilizers, the 254nm ultraviolet lamp located after ozone can be used for both disinfection and removal of residual ozone, thoroughly sterilizing and preventing bacteria from affecting water quality; And real-time monitoring of the conductivity of purified water is implemented to maintain a minimum flow rate of 1m/s or above, in order to reduce the possibility of microbial growth in the purified water pipeline network.
13. 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. (If the water quality is restored to qualified within 5 minutes, record it in the record column on the touch screen. If it is not restored after the time, an alarm will be issued.)
14. In order to achieve no dead corners in each section, if there is no fluctuation for 2 to 2 hours after the purified water tank is filled with water, the entire system cycle will be triggered to prevent the pipeline from not flowing for a long time and breeding microorganisms.
15. Equipped with water quality correction function and minimum usage water quality warning function, there will never be an emergency situation.
16. 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.
17. 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.
18. The main electrical components are made of Schneider from France, ensuring quality and quantity, and designed according to the optimal configuration.
19. Install pipelines horizontally and vertically, with a beautiful and elegant appearance, and securely and reliably install cable trays; The wire and cable use the national standard Jinlongyu brand, 6-square-meter copper core national standard wire, which complies with national electrical regulations and ensures the safety and quality of equipment electricity
20. Core components such as reverse osmosis membranes, high-pressure water pumps, and sterile water tanks will require customers to record the model on site and verify its authenticity.