Pharmaceutical Pure Water Equipment

Primary Uses: Biopharmaceuticals, in vitro diagnostic reagents, medical devices, pharmaceutical industry, oral liquids, cosmetics, food, large-volume parenteral nutrition, pharmaceutical preparations, genetic engineering, renal dialysis, water for use, disinfectants, non-woven industry, medical and health supplies (including gauze, masks, wet wipes, protective suits, medical gloves,引流管, etc.)

※Chinese Pure Environmental Protection Brand - 'Design Advantages':

1. Personalized one-on-one service, free on-site site survey, considering placement area and entry space, and free original water quality testing.

2. Understand the customer's full-day water demand, peak water usage, quality requirements, and learn about the customer's production process and industry characteristics.

3. Professional team collaboration in design, coupled with on-site inspections by individual service personnel, and one-stop water treatment solution services.

4. Intelligent design with precise control and high degree of automation. Units can perform automatic forward and reverse washing as well as operation. It features联动 protection, alarm indication, 4-20mA data openness, and can be remotely transmitted to the DCS central 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 in every process stage meets quality standards and does not contaminate the final product water, emphasizing process control.

6. Design products that balance the principles of comprehensive investment and operational costs for customer suitability.

※Pure Eco-Friendly Brand  『Production Advantages』：

1. Core components are all imported, and we have established long-term cooperative relationships with numerous international brands such as the U.S.'s Dow, Hydranet, GE, Siemens, Rhone-Poulenc, Denmark's Grundfos, Rosemount, Japan's Sumitomo, 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 incoming material appearance and performance inspections, production process inspections, and final product quality checks.

4. Production staff produce according to assigned numbers, work in shifts in groups, and are responsible for their designated tasks. Performance evaluation and traceability are strictly established.

5. Pre-shipment trial operation inspection and electrical point operation test to ensure delivery of qualified products to the customer.

※ Pure Environmental Protection Brand - "After-Sales Advantages":

1. Professional installation and after-sales team, providing one-on-one service, enhancing the timeliness of post-installation after-sales support and increasing customer satisfaction.

2. Establish a post-installation after-sales service system, conduct performance evaluations, set up a customer service department, a complaint hotline, 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 to reduce equipment operating costs.

5. Multiple channels for after-sales feedback, offering 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℃), 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 Storage Tank → PH Adjustment → High-Pressure Pump → Secondary Reverse Osmosis → Purified Water Tank → UV Sterilizer → Pure Water Delivery Pump → Fine Filter → Water Use Points → Return to Purified Water Tank

Note: Use point-of-loop sterilization: Ozone sterilization/ Pasteurization/ Peroxide sterilization

2. Grade 1 RO+EDI: Water conductivity ≤0.2 us/cm (25℃), all other specifications meet 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 → First Stage Reverse Osmosis → First Stage Storage Tank → Booster Pump → Fine Filter → EDI Desalination Unit → Purified Water Storage Tank → UV Sterilizer → Pure Water Delivery Pump → Fine Filter → Water Usage Point → Return to Purified Water Storage Tank

Note: 1. Sterilization with point-of-loop pipework: Ozone sterilization/Bacteriostatic pasteurization/Hydrogen peroxide sterilization

2. This process is suitable for areas with good source water.

3. Grade 2 RO+EDI: Water resistivity ≥15 MΩ·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 → Secondary Water Tank → Boost Pump → Fine Filter → EDI Desalination Unit → Purified Water Tank → UV Sterilizer → Pure Water Transfer Pump → Fine Filter → Water Usage Points → Return to Purified 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 + Triple Mixed: Water output resistivity ≥ 5 MΩ.CM (25°C), all other specifications meet the current pharmacopoeia GMP/FDA purified water standards.

Raw Water → Activated Carbon Filter Core → 10um Filter Core → 5um Filter Core → High Pressure Pump → Reverse Osmosis RO System → First Grade Polished Mixed Bed → Second Grade Polished Mixed Bed → Third Grade Polished Mixed Bed → Precision Filter → Purified Water Tank → UV Sterilizer → Pure Water Delivery Pump → Precision Filter → Water Usage Point → Return to Purified Water Tank

Note:

1. Sterilization with point-loop pipelines: 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 the hotline: 24/7 Hotline: 18550863818; Service Hotline: 0512-69390898.

We will provide you with detailed plans, drawings, and competitive quotes for your reference and selection!

※ Phone consultation, enjoy 10% off! Welcome to call!

Section II: GMP Pharmaceutical Purified Water Automatic Control Instructions

1. The original pump is controlled in series by the liquid level sensor on the raw water tank. When the raw water tank's level reaches the mid-limit, the pump starts automatically according to the system settings. When the raw water tank is at low water level, the pump stops pumping to prevent damage from operating without water. The pump can only restart供水 once the liquid level in the raw water tank returns to the mid-limit.

2. Sand filtration, carbon filtration, softening—pre-wash, back-wash, and regeneration—are all fully automated. The flushing cycle is determined through actual verification.

3. The primary high-pressure pump is controlled by a cascade of system operation programs; when the system start-up pressure reaches the required value, the PLC sends a signal, and the primary high-pressure pump automatically starts. The pump's inlets and outlets are equipped with high and low-pressure protection pressure 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.

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 sends a signal to automatically start the secondary high-pressure pump; when the intermediate water tank level falls below the low-low limit level, the PLC sends a signal to automatically stop the secondary high-pressure pump to prevent damage from operating under low pressure; the outlet of the secondary high-pressure pump is designed with a high-pressure protection device, which automatically stops the pump according to the operational program settings 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 eliminated.

5. The reverse osmosis unit is equipped with sufficient online instruments that can visually reflect the unit's operating status, including a pressure gauge, flow meter, conductivity, pH, etc. An on-site control panel is set up for local operation and control.

6. The first-level reverse osmosis design features an automatic flush function. The system automatically enters a low-pressure, high-flow flush state according to the operational program after each startup or after running for 4-6 hours, with a flush duration of 15-30 seconds.

7. The EDI unit is equipped with sufficient online gauges that can visually reflect the unit's operating status, including pressure gauges, flowmeters, and conductivity meters. A local control panel is set up for on-site operation and control. The EDI unit is linked to the system operation program for连锁 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 EDI unit's water conductivity, interlocking control between the EDI water conductivity detection unit and the EDI water outlet qualified and unqualified valves; automatically open the 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 finished water.

10、NaOHThe addition device is controlled fully automatically, equipped with a metering pump that automatically injects diluted NaOH solution into the pipeline. The metering is precise, the overall design is lightweight, featuring accurate speed control that is unaffected by heat sources and 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 interlocked with the primary high-pressure pump to strictly control the pH value of the second-stage reverse osmosis feed water, ensuring the stable quality of the second-stage RO product water.

11. During system operation, when the pure water storage tank is full, the second-stage 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 lower the risk of microbial growth.

12. The purified water storage tank is monitored and controlled through an internal liquid level gauge, equipped with a set of static pressure liquid level gauge with a 4-20mA signal output. The purified water storage tank is fitted with 4 liquid level points:

13. The purified water delivery pump is controlled by the liquid level of the purified water storage tank via a连锁 control system; when the liquid level in the storage tank reaches the mid-level, the pump automatically starts based on system settings; when the liquid level is low, the pump stops delivering to prevent damage from operating without water; the pump will only automatically restart and supply water when the liquid level in the storage tank recovers to the mid-level or exceeds it.

14. The recirculation monitoring system on the point-loop pipeline is set up for a 4-20mA signal output. The recirculation water flow is automatically adjusted by the pure water transport pump through signal feedback from the recirculation flowmeter to control the flow rate, ensuring the recirculation water velocity 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 purified water storage and distribution system's return water. Interlock control of the return water conductivity detection device, the return water qualified valve, and the return water discharge valve; when the conductivity of the return water exceeds the limit, the return water qualified valve is automatically closed, and the return water discharge valve is simultaneously opened to automatically discharge; when the conductivity of the return water returns to the set standard, the return water discharge valve is automatically closed, and the return water qualified valve is opened.

Section 3: GMP Pharmaceutical Purified Water Validation Documents

Filter material report, pipeline, valve

2. Certificates of conformity, manuals, and accessories for filters, pipes, valves, pumps, instruments, etc.

3. Complete Machine Certificate of Conformity, Instruction Manual

4. Filter Core Integrity Test Report

5. Filter, pipeline pressure test record report

6. Pipe pickling and passivation report

7. Automatic Welding Records

8. Provide interior images: 20% of automatic welding points, 99.999% of manual welding points

9. Instrument Calibration Report and Certificate

10. Third-party Water Quality Monitoring Report

11. Provide DQ, FAT, SAT, IQ, PQ, OQ verification 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 membranes, also known as RO, are a high-tech membrane separation technology invented by Lob and Sourirtajan from the University of California, USA in 1960. Their pore size is 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, when two bodies of water with different salt concentrations are separated by a semi-permeable membrane, the water on the side with lower salt content will渗透 through the membrane until the concentrations are equalized. However, this process takes a considerable amount of time and is known as natural osmosis. But if a pressure is applied to the side with higher salt content, it can stop the osmosis, and this pressure is called osmotic pressure. Increasing the pressure can make the water渗透 in the opposite direction, 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 forced to the other side of the membrane, resulting in clean water. This process removes salt from the water, hence the principle of reverse osmosis desalination.

The reverse osmosis membrane employs an aromatic polyamide spiral wound composite membrane. The reverse osmosis system 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 system operates with PLC control, fully automatic. It is also fitted with flowmeters, pressure gauges, conductivity meters, and more.

 2. EDI Deionization System

EDI equipment, Continuous Electrodeionization (EDI), utilizes mixed ion exchange resins to adsorb the cations and anions in feedwater. Simultaneously, these adsorbed ions are removed through the anion and cation exchange membranes under the action of direct current voltage. The ion exchange resin in this process is continuously regenerated electrically, thus eliminating the need for acid and alkali 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. A cation exchange membrane only permits cations to pass through, not anions; conversely, an anion exchange membrane only allows anions to pass through, not cations. 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, occupied by the mixed ion exchange resins, is known as the freshwater chamber. Arranging a certain number of EDI units in a row, alternating between anion and cation exchange membranes, and adding special ion exchange resins between them, creates a concentrate chamber. Under the influence of a given direct current 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, filling 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 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. Subsequently, these ions encounter the adjacent cation exchange membrane during their migration towards the positive pole, which does not allow anions to pass, thus blocking these ions in the concentrate. The cations in the freshwater flow (e.g., Na+, H+) are similarly blocked in the concentrate chamber. In the concentrate chamber, the ions passing through the anion and cation membranes maintain electrical neutrality. The electric current and ion migration in the EDI component are proportional. The electric 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. The EDI component has a high voltage gradient, 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 acid/base storage or dilution transportation facilities required, safe and reliable use, avoiding worker exposure to acids and bases

2. Saved regenerative water and regenerative wastewater treatment facilities

3. Reduced operation and maintenance costs

4. Compact footprint, easy installation, and high water yield (up to 90-95%)

5. Continuous operation, stable product and water quality, no downtime due to regeneration

3. Pharmaceutical Water Delivery

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 transportation of purified water or water for injection, both compressed air and nitrogen gas must be purified.

2) Purified water should be conveyed 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-leaching of polluting ions. Valves should be of a sanitary design with no dead corners (recommend using a sanitary diaphragm valve), and the direction of flow should be clearly marked for the conveyance of purified water.

3) Pipes and pumps for transporting purified water and注射用水 shall be regularly cleaned, disinfected, and sterilized. Use shall only commence after verification of compliance.

8. Design of pressure vessels must be undertaken by licensed entities and qualified personnel, in accordance with the relevant provisions of the "National Standard of the People's Republic of China for Steel Pressure Vessels" (GB150-80) and the "Safety Supervision Regulations for Pressure Vessel Technologies."

Section 5: Standard for Pure Water for Pharmaceutical Use/Extracellular Diagnostic Reagents

(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 us/cm@25℃

Total Organic Carbon: ≤0.5 mg/L

6. Non-volatile matter: ≤0.1 mg/L

7. Heavy Metals: ≤0.1mg/L

Microorganisms: ≤50 CFU/ml (Regulatory Standard: Using R2A agar medium, culture at 30~35℃ for not less than 5 days, and test in accordance with the General Methods (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/T 1244-2014

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 6: Selected Classic Customer Cases:

Section 7: Nation-wide Warranty and Service Network

1. Professional installation and after-sales team offering one-on-one service, enhancing the timeliness of post-installation after-sales service and improving customer satisfaction.

2. Establish a post-installation service and after-sales support system, implement performance evaluations, set up a customer service department, and a complaint channel to 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 operation costs.

5. Multiple channels for after-sales feedback, offering 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.

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, enjoy a 10% discount, welcome to call!