Main Applications: Biopharmaceuticals, in vitro diagnostic reagents, medical devices, pharmaceutical industry, oral liquids, cosmetics, food, large-volume parenterals, pharmaceutical preparations, genetic engineering, renal dialysis, etc. water, disinfectants, non-woven industry, medical and health supplies (gauze, masks, wet napkins, protective clothing, medical gloves,引流 tubes, etc.)
※Pure Eco-Friendly Brand 'Design Advantages':
1. Personalized one-on-one service, free on-site site survey, considering placement area and access space, and free original water quality testing.
2. Understand the customer's full-day water demand, peak water usage, water quality requirements, and learn about the customer's production process and industry characteristics.
3. Professional team collaboration with design, coupled with on-site inspections by dedicated service personnel, and one-stop water treatment solution services.
4. Intelligent design with precise control and high degree of automation. Each unit can achieve automatic forward/reverse washing/operation, interlock protection, alarm indication, 4-20mA data open, and can be remotely transmitted to the DCS central control system, truly realizing unattended operation.
5. Segmented testing according to process requirements, capable of measuring conductivity, resistivity, pH, ORP, temperature, flow rate, velocity, and pressure, ensuring that water from each process stage meets quality standards and does not contaminate the finished product water downstream, emphasizing process control.
6. Design products that balance the principles of comprehensive investment and operational costs to suit the client's needs.
※ Pure Environmental Protection Brand 『Production Advantages』:
1. Core components are all imported, and we have established long-term cooperative relationships with numerous international brands such as the US Dow, Hydranet, GE, Siemens, Rhone-Poulenc, Grundfos of Denmark, Rosemount, Nippon Paint of Japan, and Schneider, ensuring reliable product quality.
2. Suppliers conduct product evaluations, eliminating suppliers with poor quality and service, and prioritizing the inclusion of qualified suppliers into the system.
3. Strictly adhere to the quality management system; quality is paramount. Conduct inspections on incoming materials for appearance and performance -- process inspections -- final product quality checks.
4. Production staff produce according to corresponding codes, schedule in groups, responsible for their tasks, establish performance assessment, and ensure traceability.
5. Pre-shipment trial run inspection and electrical point operation 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 post-installation after-sales service mechanism, conduct performance evaluations, set up a customer service department, a complaint hotline, 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 files, conduct monthly phone follow-ups, and promptly provide methods and suggestions for reducing operational costs of equipment.
5. Multiple channels for after-sales feedback, nationwide after-sales maintenance services, quick response, fast processing, 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 comply with 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: Ozone sterilization/Batch sterilization/Hydrogen peroxide sterilization
2. Grade 1 RO+EDI: Product water conductivity ≤ 0.2 us/cm (25°C), all other specifications comply with current pharmacopoeia GMP/FDA purified water standards.
Raw Water → Raw Water Tank → Booster Pump → Sand Filter → Carbon Filter → Softener → Security Filter → High Pressure Pump → First Stage Reverse Osmosis → First Stage Tank → Booster 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. Utilize point-of-loop sterilization methods: Ozone sterilization/Pasteurization/Hydrogen peroxide sterilization
2. This process is suitable for areas with good source water.
3. Grade II RO+EDI: Product water resistivity ≥15 MΩ.CM (25℃), all other specifications comply with 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 → Purified Water Tank → UV Sterilizer → Pure Water Delivery Pump → Fine Filter → Water Usage Point → Return to Purified Water Tank
Note: 1. Utilize point-of-loop sterilization: Ozone sterilization/Batch sterilization/Hydrogen peroxide sterilization
2. Recommend using the process
4. Grade 1 RO + Triple Mixed: Product water resistivity ≥ 5 MΩ.CM (25°C), all other specifications comply with current Pharmacopoeia GMP/FDA purified water standards.
Source Water → Activated Carbon Filter Core → 10um Filter Core → 5um Filter Core → High Pressure Pump → Reverse Osmosis RO System → Primary Polished Mixed Bed → Secondary Polished Mixed Bed → Tertiary Polished Mixed Bed → Fine Filter → Pure Water Storage Tank → UV Sterilizer → Pure Water Delivery Pump → Fine Filter → Water Usage Point → Return to Pure Water Storage Tank
Note:
1. Sterilization with point loop pipelines: Ozone sterilization / Pasteurization / 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: 18550863818; service hotline: 0512-69390898.
We will provide you with detailed plans, drawings, and competitive quotes for your reference and selection!
※ Phone consultation available, enjoy 10% off! Welcome to call!
Section II: 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 conveying to prevent damage from operating without water. The original pump can only restart water supply when the liquid level in the raw water tank recovers to the mid-limit.
2. Sand filtration, carbon filtration, and softened water pretreatment, backwashing, and regeneration are all fully automatic. 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, the PLC sends a signal, 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. If the primary high-pressure pump stops due to overloads in 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 and the water supply is restored.
4. The secondary high-pressure pump is controlled by the intermediate water tank level interlock; when the intermediate water tank level reaches or exceeds the middle limit level, the PLC signals and the secondary high-pressure pump automatically starts; when the intermediate water tank level is below the low-low limit level, the PLC signals and the secondary high-pressure pump automatically stops to prevent damage from operating at low pressure; the outlet of the secondary high-pressure pump is designed with a high-pressure protection device, and the pump automatically stops according to the operational program settings when the outlet pressure exceeds the limit, preventing damage to the reverse osmosis membrane from high-pressure operation; 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 instruments that can visually reflect the unit's operating status, including pressure gauges, flowmeters, conductivity, pH, etc., and is set up with a local control panel for on-site operation and control.
6. The first-level 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 gauges to visually reflect the operating status, including pressure gauges, flow meters, and conductivity meters, with local control panels for on-site operation and control. The EDI unit is linked for interlock control with the system operating program:
8. The EDI unit is equipped with a low-water protection device at the inlet, which is designed to prevent damage to the EDI unit from operating without water.
9. Continuous monitoring of the conductivity of EDI units, interlocking control of the EDI water conductivity detection unit and the EDI outlet qualified and unqualified valves; automatically open the EDI outlet unqualified valve and close the qualified valve when the EDI water conductivity exceeds the limit; automatically close the unqualified valve and open the qualified valve when the EDI water conductivity returns to the set standard, to prevent unqualified water from contaminating the finished product water.
10、NaOHThe addition unit is controlled fully automatically, equipped with a metering pump that automatically injects diluted NaOH solution into the pipeline. It offers precise measurement, a lightweight overall design, and 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 with a primary high-pressure pump to strictly control the pH value of the secondary reverse osmosis feed water, ensuring stable water quality of the secondary RO output.
11. During system operation, when the purified water tank is full, the secondary RO and EDI systems continue to run continuously. The EDI product water is recycled to the intermediate water tank, achieving an internal small circulation to reduce the risk of dead water in the system and minimize the risk of microbial growth.
12. The purified water storage tank is monitored and controlled by an internal liquid level gauge, equipped with a static pressure level gauge with a 4-20mA signal output. The purified water storage tank is set up with 4 liquid level points:
13. The purified water transfer pump is controlled by the liquid level linkage of the purified water storage tank; when the liquid level in the purified water storage tank reaches the middle limit, the pump automatically starts according to the system settings; when the liquid level is at the low water mark, the pump stops transferring to prevent damage to the pump when it operates without water; the pump will only start supplying water again when the liquid level in the purified water storage tank returns to or exceeds the middle limit.
14. A return water monitoring system with a 4-20mA signal output is set on the point loop pipeline. The return water flow rate is automatically frequency-controlled by the purified water delivery pump via feedback from the return water flowmeter to adjust the return water flow, ensuring that 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 conductivity of the recycled water in the purified water storage and distribution system. The recycled water conductivity detection device, the recycled water qualified valve, and the recycled water discharge valve are interlocked for control. When the conductivity of the recycled water exceeds the limit, the recycled water qualified valve is automatically closed, and the recycled water discharge valve is simultaneously opened to automatically discharge; when the conductivity of the recycled water returns to the set standard, the recycled water discharge valve is automatically closed, and the recycled water qualified valve is opened.
III. GMP Pharmaceutical Purified Water Validation Documents:
1. Material Reports for Filters, Pipes, and Valves
2. Certificates of conformity, manuals, and accessories for filters, pipes, valves, pumps, instruments, etc.
3. Certificate of Conformity, Instruction Manual
4. Filter Core Integrity Test Report
5. Filter and Pipeline Pressure Test Records and Reports
6. Pipeline Pickling and Passivation Report
7. Automatic Welding Records
8. Offer interior images: 20% for automatic welding points, 99.999% for manual welding points
9. Instrument Calibration Report and Certificate
10. Third-party Water Quality Monitoring Report
11. Provide the necessary DQ, FAT, SAT, IQ, PQ, and OQ verification documents 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 anti-osmosis membranes, were invented by Lob and Sourirtajan at the University of California, USA, in 1960. This advanced membrane separation technology has pores 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. This effectively separates pure water that can pass through from the concentrated water that cannot.
Principle: Osmosis is a physical phenomenon where water from a solution with lower salt concentration permeates through a semi-permeable membrane into a solution with higher salt concentration until both are equal in concentration. 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, the osmosis can be stopped, and this pressure is called the 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), forcing the water molecules to permeate in the opposite direction to the membrane, resulting in clean water on the other side and effectively removing salt from the water.
Reverse osmosis membranes utilize aromatic polyamide spiral-wound composite membranes. The reverse osmosis system consists of composite membrane elements, high-pressure pumps, fiberglass pressure vessels, chemical cleaning equipment, supports, and an instrument control cabinet. Equipped with a local control panel, which houses various local instruments and control buttons. The reverse osmosis system is controlled by a PLC for fully automatic operation. It is also fitted with flow meters, pressure gauges, conductivity meters, and more.
2. EDI Deionization System
EDI equipment, Continuous Electrical Deionization (EDI), utilizes mixed ion exchange resins to adsorb positive and negative ions in the feed water, while these adsorbed ions are then removed by passing through respective cation and anion exchange membranes under the influence of direct current voltage. The ion exchange resins in this process are electro-continuously regenerated, thus eliminating the need for acids and alkalis for regeneration. This new technology can replace traditional ion exchange (DI) units, producing ultra-pure water with resistivity ≥15MΩ.CM.
Ion exchange membranes and ion exchange resins operate on similar principles, selectively allowing ions to pass through. An anion exchange membrane only permits anions to pass, not cations; conversely, a cation exchange membrane only allows cations to pass, not anions. Filling the space between a pair of anion and cation exchange membranes with mixed ion exchange resins forms an EDI unit. The space occupied by mixed ion exchange resins between the anion and cation exchange membranes 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, the resulting space is known as the concentrate chamber. Under the drive of a given DC voltage, in the freshwater chamber, the anions and cations in the ion exchange resins migrate towards the positive and negative poles, respectively, and pass through the anion and cation exchange membranes into the concentrate chamber, while ions in the feedwater are adsorbed by the ion exchange resins, occupying the voids left by ion electro迁移. 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 concentrate chamber and are removed to become desalinated water. Negatively charged anions (e.g., OH-, Cl-) are attracted to the positive pole (+) and pass through the anion exchange membrane into the adjacent concentrate chamber. Later, these ions, while migrating towards the positive pole, encounter the adjacent cation exchange membrane, which does not allow anions to pass. These ions are thus blocked in the concentrate. Cations in the freshwater flow (e.g., Na+, H+) are similarly blocked in the concentrate chamber. In the concentrate 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 consists 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 itself. There is a high voltage gradient in the EDI component, under which water is electrolyzed to 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 referred to as 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 reserve and dilution transport facilities, safe and reliable use, avoids worker contact with acids and bases
2. Saved on recycled water and wastewater treatment facilities
3. Reduced operational and maintenance costs
4. Compact land area, easy installation, high water yield (up to 90-95%)
5. Continuous operation, stable product water quality, will not shut down due to regeneration
3. Pharmaceutical Water Transportation:
1) Purified 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 to transport purified water or water for injection, the compressed air and nitrogen gas must be purified.
2) Purified water should be transported through a recirculating pipeline. The pipeline design should be simple, avoiding dead ends and blind pipes, and must comply with GMP's 3D standards. 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-leaking of polluting ions. Valves should be of a sanitation-grade design with no blind spots (sanitary diaphragm valves are recommended), and the direction of flow should be indicated during the transportation of purified water.
3) Pipelines and pumps for transporting purified water and injection water should be cleaned and disinfected regularly, and only after verification of compliance can they be put into use.
8. Design of pressure vessels must be carried out 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."
Section 5: Standard for Pharmaceutical Purified Water/Extracorporeal 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
4. Conductivity: ≤1 μS/cm @ 25℃
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 (General Method 1105). The total number of aerobic bacteria in 1 mL 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
Total Organic Carbon: <500 μg/L
5. Other specifications are executed according to the purified water standards.
Six, Selected Classic Customer Cases:
Section 7: Nation-wide Warranty and Service Network
1. Professional installation and after-sales team, providing one-on-one service, enhancing the timeliness of post-installation after-sales service and improving customer satisfaction.
2. Establish a post-installation after-sales service mechanism, conduct performance evaluations, set up a customer service department, a complaint window, and promptly address customer needs.
3. Comprehensive on-site 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 operation costs.
5. Multi-channel after-sales feedback, offering nationwide maintenance and after-sales service, quick response, rapid handling, 24/7 service.
6. We solemnly promise: 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!
※ Phone consultation available with 10% discount, welcome to call!
