Primary Applications: Biopharmaceuticals, In Vitro Diagnostic Reagents, Medical Devices, Pharmaceutical Industry, Oral Liquids, Cosmetics, Food, Large-Volume Parenterals, Pharmaceutical Preparations, Genetic Engineering, Hemodialysis, etc., plus Water for Use, Disinfectants, Nonwoven Industry, Medical and Health Supplies (gauze, masks, wet wipes, protective clothing, medical gloves,引流 tubes, etc.)
※Green Pure Brand 『Design Advantages』:
1. Personalized one-on-one services, complimentary on-site site survey, considering placement area and access space, and free water quality testing of raw water.
2. Understand the customer's full-day water demand, peak water usage, water quality requirements, and their production process and industry characteristics.
3. Professional team collaboration with design, coupled with on-site inspections by one-on-one service personnel, and one-stop water treatment solution services.
4. Intelligent design with precise control and high degree of automation. Units can achieve automatic forward/backward washing and operation, with interlock protection and alarm indication. Features 4-20mA data openness, allowing remote transmission to the DCS control system, truly achieving unattended operation.
5. Segmented testing according to process requirements, capable of measuring conductivity, resistivity, pH, ORP, temperature, flow rate, velocity, pressure, and other parameters. Ensures that water quality meets standards at every process stage without contaminating the final product water, emphasizing process control.
6. Design products that balance the principles of comprehensive investment and operational costs to meet customer needs.
※Purely Eco-Friendly Brand 『Production Advantages』：
1. Core components are all imported, and we have established long-term cooperative relationships with many international brands such as U.S. Dow, Hydrosphere, GE, Siemens, Rhone-Poulenc, Grundfos of Denmark, Rosemount, Nippon Paint of Japan, and Schneider, ensuring reliable quality of our products.
2. Suppliers conduct product evaluations, eliminating suppliers with poor quality and service, and selecting the best to enter the qualified supplier system.
3. Strictly adhere to the quality management system; quality is paramount. Conduct incoming material appearance and performance inspections, production process inspections, and final product quality checks.
4. Production personnel produce according to corresponding numbers, with group scheduling and responsible division of labor. Performance assessment and traceability are established.
5. Pre-shipment trial operation inspection and electrical point test to ensure delivery of qualified products to the customer.
※ Pure Environmental Protection Brand 『After-Sales Advantage 』:
1. Professional installation and after-sales team, providing one-on-one service, enhancing the timeliness of post-installation after-sales service and boosting customer satisfaction.
2. Establish a service after installation after-sales mechanism, conduct performance evaluations, set up a customer service department, a complaint window, and promptly address customer needs.
3. Full guidance and training throughout the installation and debugging process, including theoretical training, hands-on machine operation training, and general troubleshooting training.
4. Establish customer electronic profiles, conduct monthly phone follow-ups, and promptly provide methods and suggestions for reducing equipment operating costs.
5. Multi-channel after-sales feedback, nationwide after-sales maintenance services, quick response, prompt handling, 24/7 service.
6. We solemnly promise: two-year free warranty for the entire unit, lifetime free technical support.
I. GMP Pharmaceutical Purified Water Production Process:
1. Grade 2 RO: Water conductivity ≤ 2 us/cm (25°C), all other specifications meet the current pharmacopoeia GMP/FDA purified water standards.
Source Water → Source Water Tank → Boost Pump → Sand Filter → Carbon Filter → Softener → Security Filter → High-Pressure Pump → Primary Reverse Osmosis → Primary Water Tank → PH Adjustment → High-Pressure Pump → Secondary Reverse Osmosis → Purified Water Tank → UV Sterilizer → Pure Water Delivery Pump → Fine Filter → Water Usage Point → Return to Purified Water Tank
Note: Use point-of-loop sterilization methods: Ozone sterilization/Batch pasteurization/Hydrogen peroxide sterilization
2. Grade 1 RO+EDI: Product conductivity ≤ 0.2 us/cm (25°C), all other specifications meet the current pharmacopoeia GMP/FDA purified water standards.
Source Water → Source Water Tank → Boost Pump → Sand Filter → Carbon Filter → Softener → Security Filter → High-Pressure Pump → Primary Reverse Osmosis → Primary Water Tank → Boost Pump → Fine Filter → EDI Desalination Unit → Purified Water Tank → UV Sterilizer → Pure Water Transfer Pump → Fine Filter → Water Usage Point → Return to Purified Water Tank
Note: 1. Use point-of-loop sterilization methods: Ozone sterilization/Batch pasteurization/Hydrogen peroxide sterilization
2. This process is suitable for areas with good source water.
3. Secondary RO+EDI: Product water resistivity ≥15 MΩ·cm (25°C), all other specifications comply with the current pharmacopoeia GMP/FDA purified water standards.
Source Water → Source Water Tank → Booster Pump → Sand Filter → Carbon Filter → Softener → Security Filter → High-Pressure Pump → Primary Reverse Osmosis → Primary Water Tank → PH Adjustment → High-Pressure Pump → Secondary Reverse Osmosis → Secondary Water Tank → Booster Pump → Fine Filter → EDI Desalination Unit → Purification Water Tank → UV Sterilizer → Pure Water Transfer Pump → Fine Filter → Water Usage Point → Return to Purification Water Tank
Note: 1. Use point-of-loop sterilization: Ozone sterilization/Batch pasteurization/Hydrogen peroxide sterilization
2. Recommend using the process
4. Grade 1 RO + Grade 3 Mixed: Water production resistivity ≥ 5 MΩ·cm (25℃), all other specifications comply with the current pharmacopoeia GMP/FDA purified water standards.
Source Water → Activated Carbon Filter → 10um Filter → 5um Filter → High-Pressure Pump → Reverse Osmosis RO System → Primary Polishing Mixed Bed → Secondary Polishing Mixed Bed → Tertiary Polishing Mixed Bed → Fine Filter → Purified Water Tank → UV Sterilizer → Pure Water Delivery Pump → Fine Filter → Water Usage Point → Return to Purified Water Tank
Note:
1. Sterilization via point-of-loop piping: Ozone sterilization/Pasteurization/Hydrogen peroxide sterilization
2. Suitable for small purification water units: Flow range: 50L/H - 200L/H
For more product details, please call our 24-hour hotline at 18550863818 or our service hotline at 0512-69390898.
We will provide you with detailed plans, drawings, and competitive quotes for your reference and selection!
※Phone consultation, enjoy a 10% discount! Welcome to call!
Section 2: GMP Pharmaceutical Purified Water Automatic Control Instructions:
The original pump is controlled in series by the liquid level sensor on the raw water tank. When the liquid level in the raw water tank reaches the mid-limit, the original pump automatically starts according to the system settings. When the raw water tank is at low water level, the original pump stops delivering to prevent damage from operating without water. The original pump can restart supplying water only when the liquid level in the raw water tank recovers to the mid-limit.
2. Sand filtration, activated carbon filtration, and softening with both forward and reverse washing and regeneration are all fully automated. The flushing cycle is determined through actual verification.
3. The primary high-pressure pump is controlled by a series of system operation programs; when the system startup pressure reaches the required value, a PLC signal is issued, and the primary high-pressure pump automatically starts. The pump's inlet and outlet are designed with high and low-pressure protection switches; if the inlet and outlet pressures exceed the limits, the primary high-pressure pump stops automatically according to the operational program settings to prevent damage from working under low pressure or from high pressure damaging the reverse osmosis membrane. When the primary high-pressure pump stops due to overloading of pressure, temperature, or power, the system emits an alarm according to the operational program settings. The primary high-pressure pump can only be restarted by the operator after the fault is resolved.
4. The secondary high-pressure pump is controlled by the intermediate tank's liquid level interlock; when the intermediate tank's liquid level reaches or exceeds the middle limit level, the PLC signals and the secondary high-pressure pump automatically starts; when the intermediate tank's liquid level falls below the low-low limit level, the PLC signals and the secondary high-pressure pump automatically stops to prevent damage from working under low pressure; the secondary high-pressure pump's outlet is designed with a high-pressure protection device, which automatically stops the pump according to the operational program when the outlet pressure exceeds the limit, to prevent damage to the reverse osmosis membrane under high pressure; when the secondary high-pressure pump stops due to overloading of pressure, temperature, or power, the system emits an alarm according to the operational program settings; the secondary high-pressure pump can only be restarted by the operator after the fault is resolved.
5. The reverse osmosis unit is equipped with sufficient online gauges that provide a direct reflection of the unit's operating status, including a pressure gauge, flow meter, conductivity, pH, etc. A local control panel is set up for on-site operation and control.
6. The first-grade reverse osmosis design features an automatic flushing function. The system automatically enters a low-pressure high-flow flushing state according to the operational program after each startup or after running for 4-6 hours, with a flushing duration of 15-30 seconds.
7. The EDI unit is equipped with sufficient on-line instruments that can visually reflect the operating status of the unit, including pressure gauges, flow meters, conductivity, etc., and is set up with a local control panel for on-site operation and control. The EDI unit is interlocked with the system's operational program for control.
8. The EDI unit is equipped with a low-water protection device at the inlet, designed to prevent damage to the EDI unit from running without water.
9. Continuous monitoring of the conductivity of the EDI unit's effluent, interlocking control between the EDI effluent conductivity detection device and the EDI effluent pass/fail valves; automatically open the EDI effluent fail valve and close the pass valve when the conductivity exceeds the limit; automatically close the fail valve and open the pass valve when the conductivity returns to the set standard, to prevent contaminated water from affecting finished product water.
10、NaOHThe device is controlled fully automatically, equipped with a metering pump that automatically adds diluted NaOH solution to the pipeline. The metering is precise, the overall design is lightweight, and it features accurate speed control, unaffected by heat sources or electromagnetic interference. It can adjust the dosage appropriately based on water volume and flow rate changes through the metering pump, and automatically add chemicals. This metering pump is linked to the primary high-pressure pump, strictly controlling the pH value of the secondary reverse osmosis feed water to ensure stable water quality of the secondary RO output.
11. During system operation, when the pure water storage tank is full, the secondary RO and EDI systems continue to run continuously. The EDI product water is circulated back to the intermediate tank, achieving an internal small circulation to reduce the risk of dead water in the system and minimize microbial growth.
12. The purified water storage tank is equipped with an internal level gauge for monitoring and controlling the liquid level, and comes with a static pressure level gauge that outputs 4-20mA signals. The purified water storage tank has four liquid level points:
13. The purified water transfer pump is controlled by the liquid level连锁 in the purified water storage tank; when the liquid level in the storage tank reaches the mid-limit, the purified water transfer pump automatically starts according to the system settings; when the liquid level in the storage tank is at low water level, the pump stops transferring to prevent damage from operating without water; the pump will only automatically start supplying water when the liquid level in the storage tank recovers to the mid-limit or exceeds it.
14. The return water monitoring system is set up on the point-loop pipeline with a 4-20mA signal output. The return water flow rate is automatically controlled to vary the pure water delivery pump's speed via feedback from the return water flow meter, ensuring the return water flow rate is not less than the set flow rate value (recommended set value: 1.0-2.0 m/s).
15. Continuous monitoring of the online conductivity of the recycled water storage and distribution system. The recycle water conductivity detection device, the recycle water qualified valve, and the recycle water discharge valve are interlocked for control. When the detected conductivity of the recycle water exceeds the limit, the recycle water qualified valve is automatically closed, and the recycle water discharge valve is simultaneously opened to automatically discharge; when the conductivity of the recycle water returns to the set standard, the recycle water discharge valve is automatically closed, and the recycle water qualified valve is opened.
Section 3: GMP Pharmaceutical Purified Water Validation Documents
Filter, Pipe, Valve Material Report
2. Certificates of conformity, manuals, and accessories for filters, pipes, valves, pumps, instruments, etc.
3. Certificate of Compliance, Instruction Manual
4. Filter Core Integrity Test Report
5. Filter, Pipeline Pressure Test Record Report
6. Pipeline Pickling and Passivation Report
7. Automatic Welding Records
8. Provide endoscopic images: 20% of the automatic welding points, 99.999% of the manual welding points
9. Instrument Calibration Report and Certificate
10. Third-party Water Quality Monitoring Report
11. Provide DQ, FAT, SAT, IQ, PQ, OQ validation documents required for the user's equipment.
IV. Introduction to Core Components of GMP Pharmaceutical Purified Water System
1. Reverse Osmosis (RO) System
Reverse osmosis (RO) membranes, also known as hyperfiltration, are a high-tech membrane separation technology invented by Loeb and Sourirtajan of the University of California, Los Angeles in 1960. Their pore sizes are as small as nanometers (1 nanometer = 10^-9 meters). Under certain pressure, H2O molecules can pass through the RO membrane, while inorganic salts, heavy metal ions, organic matter, colloids, bacteria, viruses, and other impurities in the source water cannot pass through the RO membrane, thus strictly separating the pure water that can pass through from the concentrated water that cannot.
Principle: Osmosis is a physical phenomenon where water from two bodies of water with different salt concentrations, separated by a semi-permeable membrane, will pass through the membrane until the salt concentrations are equalized. However, this process takes a long time and is known as natural osmosis. If a pressure is applied to the side with higher salt concentration, it can stop the osmosis, and this pressure is called osmotic pressure. Increasing the pressure can reverse the osmosis, leaving the salt behind. Therefore, the principle of reverse osmosis desalination is to apply a pressure greater than the natural osmotic pressure to saltwater (such as raw water), causing the water molecules to be pushed to the other side of the membrane, resulting in clean water. This process removes salt from the water, thus achieving desalination.
The reverse osmosis membrane employs an aromatic polyamide spiral wound composite membrane. The reverse osmosis unit consists of composite membrane elements, high-pressure pumps, fiberglass pressure vessels, chemical cleaning units, supports, and instrument control cabinets. Equipped with a local control panel, which houses various local instruments and control buttons. The reverse osmosis unit is controlled by a PLC and operates automatically. It is also equipped with flowmeters, pressure gauges, conductivity meters, and more.
2. EDI Deionization System
EDI equipment, Continuous Electrical Deionization (EDI), utilizes mixed ion exchange resins to adsorb both positive and negative ions from the feed water, while these adsorbed ions are then removed by passing through anion and cation exchange membranes under the effect of direct current voltage. In this process, the ion exchange resins are electrically continuously regenerated, thus eliminating the need for acids and bases for regeneration. This new technology can replace traditional ion exchange (DI) units to produce ultra-pure water with a resistivity of ≥15MΩ.CM.
Ion exchange membranes and ion exchange resins operate on similar principles, selectively allowing ions to pass through. An anion exchange membrane permits only anions to pass through, blocking cations; conversely, a cation exchange membrane allows only cations to pass, blocking anions. Filling the space between a pair of anion and cation exchange membranes with mixed ion exchange resins forms an EDI unit. The space between the anion and cation exchange membranes filled with mixed ion exchange resins is called the freshwater chamber. Arranging a certain number of EDI units in a row, alternating anion and cation exchange membranes, and adding special ion exchange resins between the membranes, creates a brine chamber. Under the push of a given DC voltage, in the freshwater chamber, anions and cations in the ion exchange resins migrate to the positive and negative poles, respectively, and pass through the anion and cation exchange membranes into the brine chamber, while ions in the feedwater are adsorbed by the ion exchange resins, occupying the voids left by ion electro migration. In fact, ion migration and adsorption occur simultaneously and continuously. Through this process, ions in the feedwater pass through the ion exchange membranes into the brine chamber and are removed to become demineralized water. Negatively charged anions (e.g., OH-, Cl-) are attracted to the positive pole (+) and pass through the anion exchange membrane into the adjacent brine chamber. Subsequently, these ions encounter the nearby cation exchange membrane while migrating towards the positive pole, which does not allow anions to pass, so these ions are blocked in the brine. Positively charged cations (e.g., Na+, H+) in the freshwater are similarly blocked in the brine chamber. In the brine chamber, ions passing through the anion and cation membranes maintain electrical neutrality. The electrical current and ion migration in the EDI component are proportional. The electrical current is composed of two parts: one from the migration of the removed ions, and the other from the migration of H+ and OH- ions produced by the electrical ionization of water. There is a high voltage gradient in the EDI component, which causes water to electrolyze and produce a large amount of H+ and OH-. These locally produced H+ and OH- continuously regenerate the ion exchange resins. The ion exchange resins in the EDI component can be divided into two parts: the working resin and the polishing resin, with the boundary between them being the working front. The working resin is responsible for removing most of the ions, while the polishing resin is responsible for removing difficult-to-remove ions, such as weak electrolytes.
Features of EDI
1. No need for acid/base regeneration, no need for acid/base storage and dilution transportation facilities; safe and reliable to use, avoiding worker contact with acids and bases.
2. Saved regenerative water and regenerative wastewater treatment facilities
3. Reduced operation and maintenance costs
4. Compact footprint, easy installation, high water yield (up to 90-95%)
5. Continuous operation, stable product water quality, no shutdown due to regeneration
3. Pharmaceutical Water Supply
1) Purified water and pharmaceutical water should be transported by stainless steel pumps that are easy to dismantle for cleaning and disinfection. In cases where compressed air or nitrogen gas is required for the supply of purified water or water for injection, the compressed air and nitrogen gas must be purified.
2) Purified water should be transported through a closed-loop piping system. The pipeline design should be simple and free of dead ends and blind pipes, adhering to the 3D standards required by GMP. Threaded connections are not permitted. The pipeline should be made of stainless steel or other materials that are verified to be non-toxic, corrosion-resistant, and non-leaching of pollutants. Valves should be sanitized, angle-free models (suggested: diaphragm valves), and the direction of water flow should be clearly marked during transportation.
3) Piping for purified water and injection water, as well as delivery pumps, should be cleaned and disinfected regularly. Sterilization is required before they can be put into use, and they must pass verification.
8. Design of pressure vessels must be undertaken by licensed entities and qualified personnel, in accordance with the relevant provisions of the People's Republic of China's National Standard for Steel Pressure Vessels (GB150-80) and the "Safety Supervision Regulations for Pressure Vessel Technology."
V. Standard for Pharmaceutical Purified Water / Ex Vivo Diagnostic Reagents Water
(1) Current edition of the Chinese Pharmacopoeia GMP requirements for purified water
Appearance: Colorless clear liquid, odorless, tasteless
2. PH：5.0~7.0
Ammonia: ≤0.3 mg/L
Conductivity: ≤1 μS/cm @ 25℃
5. Total Organic Carbon: ≤0.5 mg/L
6. Non-volatile matter: ≤0.1 mg/L
7. Heavy Metals: ≤0.1 mg/L
Microorganisms: ≤50 CFU/ml (Regulatory Standard: Using R2A agar medium, incubate at 30~35℃ for not less than 5 days, and test in accordance with the General Rules 1105. The total number of aerobic bacteria in 1mL of the test sample shall not exceed 100 CFU.)
(II) Standard for Water Used in In Vitro Diagnostic Reagents YY/T1244-2014
1. This product should be colorless and transparent liquid.
Conductivity: ≤1 us/cm@25℃
3. Microorganisms: 50 cfu/ml
4. Total Organic Carbon: ＜500 μg/L
5. Other indicators are executed according to the purified water standard.
Section VI: Selected Classic Customer Cases:
Section 7: Nation-wide Warranty and Service Network
1. A professional installation and after-sales team provides one-on-one service, enhancing the timeliness of post-installation after-sales support and boosting customer satisfaction.
2. Establish a post-installation after-sales service mechanism, conduct performance evaluations, set up a customer service department, a complaint channel, and promptly address customer concerns.
3. Full guidance and training throughout the installation and debugging process, including theoretical training, hands-on machine operation training, and general troubleshooting training.
4. Establish customer electronic profiles, conduct monthly phone follow-ups, and promptly provide methods and suggestions for reducing equipment operating costs.
5. Multiple channels for after-sales feedback, providing nationwide maintenance and after-sales service, with quick response and fast handling, 24/7 service.
6. Strictly Commitment: Two-year free warranty for the entire unit, lifetime free technical support.
For more product details, please call our 24-hour hotline at 18550863818 or our service hotline at 0512-69390898.
We will provide you with detailed plans, drawings, and competitive quotes for your reference and selection!
※ Call for consultation, enjoy 10% off! Welcome to call!
