详情描述

Main Applications: Biopharmaceuticals, in vitro diagnostic reagents, medical devices, pharmaceutical industry, oral liquids, cosmetics, food, large-volume parenterals, pharmaceutical preparations, genetic engineering, renal dialysis, water for various uses, disinfectants, nonwoven industry, medical and health supplies (gauze, masks, wet wipes, protective suits, medical gloves,引流 tubes, etc.)

 

※ Pure Eco-Friendly Brand『Design Advantages』:

1. One-on-one professional 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, water quality requirements, and their production process and industry characteristics.

3. Professional team collaboration with 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 level of automation. Units can perform automatic forward-wash, reverse-wash, and operation. Features include interlock protection, alarm indication, 4-20mA data openness, and remote transmission 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 the water for each 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.

※Purely Eco-Friendly Brand  『Production Advantages』:

1. Core components are all imported, and we have established a solid long-term cooperative relationship with many international brands such as America's DOW, Hydrotreat, GE, Siemens, Rohm and Haas, Denmark's Grundfos, Rosemount, Japan's Siamix, and Schneider, ensuring the reliable quality of our products.

2. Suppliers conduct product assessments, eliminating subpar-quality and poor-service suppliers, and selecting the best to be enrolled in the qualified supplier system.

3. Strictly adhere to quality management systems; quality is paramount. Conduct incoming material inspection for appearance and performance – process inspection – and final product quality inspection.

4. Production staff produce according to assigned numbers, grouped for scheduling, with clear responsibility division. Establish a performance assessment system with strong traceability.

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

※Green 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 support and improving 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 for reducing equipment operation costs.

5. Multi-channel after-sales feedback, nationwide after-sales maintenance services, quick response, fast processing, 24/7 service.

6. We solemnly promise: Two years of free warranty for the entire unit, lifetime free technical support.

Section 1: GMP Pharmaceutical Purified Water Production Process

1. Second-level RO: Conductivity of water ≤ 2 us/cm (at 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 → First Stage Reverse Osmosis → First Stage Storage Tank → PH Adjustment → High-Pressure Pump → Second Stage Reverse Osmosis → Purified Water Storage Tank → UV Sterilizer → Pure Water Delivery Pump → Fine Filter → Water Usage Point → Return to Purified Water Storage Tank

Note: Use point-of-loop sterilization methods: Ozone sterilization/Batch sterilization/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.

Raw Water → Raw 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 Deionization 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: Ozone sterilization/Batch sterilization/Hydrogen peroxide sterilization

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

3. Grade 2 RO+EDI: Water production resistivity ≥ 15 MΩ·cm (25℃), 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 → Secondary Water Tank → Boost Pump → Fine Filter → EDI Deionization Unit → Purified Water Tank → UV Sterilizer → Pure Water Delivery Pump → Fine Filter → Water Usage Point → Return to Purified Water Tank

Note: 1. Use point-of-loop sterilization: Ozone sterilization/ Pasteurization/ Peroxide sterilization

2. Recommend using the process

4. Grade 1 RO + Grade 3 mixed: Product water resistivity ≥ 5 MΩ·cm (25℃), all other specifications meet the 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 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-loop pipeline: Ozone sterilization/Pasteurization/Hydrogen peroxide sterilization

2. Suitable for small pure 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!

※ Call for consultation, enjoy 10% off! Welcome to call!

 

Section II: GMP Pharmaceutical Purified Water Automatic Control Instructions

The raw water 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 raw water pump starts automatically according to the system settings. When the raw water tank is at low water level, the raw water pump stops operation to prevent damage from working without water. The raw water pump can restart supplying water only when the liquid level in the raw water tank returns to the mid-limit.

2. Sand filtration, carbon filtration, softening - all pretreatment, backwashing, and regeneration processes are fully automated. The flushing cycle is determined through actual verification.

3. The primary high-pressure pump is controlled by the system operation program in a连锁 manner; once the system start-up pressure reaches the required value, the PLC signals, 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 will automatically shut down 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 overloads of pressure, temperature, or power, the system will trigger 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 level interlock; when the intermediate tank level reaches or exceeds the mid-level, the PLC sends a signal, and the secondary high-pressure pump automatically starts; when the intermediate tank level falls below the low-low level, the PLC sends a signal, 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, which automatically stops the pump according to the operating program when the outlet pressure exceeds the limit, preventing damage to the reverse osmosis membrane under high pressure; if the secondary high-pressure pump stops due to overloading of pressure, temperature, or power, the system emits an alarm according to the operating 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 on-line instruments that can visually reflect the operational status of the unit, including: pressure gauge, flowmeter, conductivity, pH, etc., with an on-site control panel for local 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/run for 4-6 hours, with a flushing duration of 15-30 seconds.

7. The EDI unit is equipped with sufficient online instruments that can visually reflect the unit's operating status, including pressure gauges, flowmeters, and conductivity meters, with a local control panel for on-site operation and control. The EDI unit is interlocked with the system's operational program for连锁 control.

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 EDI unit's water conductivity online, interlocking control of the EDI water conductivity detection unit and the EDI outlet qualified and unqualified valves; automatically open the EDI unqualified outlet 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 device is controlled fully automatically, equipped with a metering pump that automatically injects diluted NaOH solution into the pipeline. The metering is precise, with a lightweight overall design and accurate speed control, unaffected by heat sources or electromagnetic interference. It can adjust the dosing appropriately based on changes in water volume and flow rate through the metering pump, and automatically add reagents. This metering pump is interlocked with the 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 pure water storage tank is full, the secondary RO and EDI systems continue to run continuously. The EDI water is recycled to the intermediate water tank, achieving an internal small circulation to reduce the risk of dead water in the system and the potential for microbial growth.

12. The purified water storage tank is monitored and controlled by an internal liquid level gauge, equipped with a set of static pressure level gauges 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连锁 in the purified water storage tank; when the liquid level in the storage tank reaches the mid-limit, the pump automatically starts according to the system settings; when the liquid level is low, the pump stops transferring to prevent damage from operating without water; the pump will only restart to supply water when the liquid level in the storage tank recovers to the mid-limit or exceeds it.

14. Employ a return flow monitoring system with 4-20mA signal output on the point-loop pipeline. The return flow velocity is automatically frequency-controlled by the signal feedback from the return flow meter to adjust the purified water delivery pump, ensuring the return flow velocity is not less than the set velocity value (recommended set value: 1.0-2.0 m/s).

15. Continuous monitoring of the return water conductivity in the purified water storage and distribution system. The return water conductivity detection device, the return water qualified valve, and the return water discharge valve are interlocked for control. When the detected return water conductivity 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 return water conductivity returns to the set standard, the return water discharge valve is automatically closed, and the return water qualified valve is opened.

III. GMP Pharmaceutical Purified Water Validation Documents:

Filter, Pipe, Valve Material Report

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

3. Certificate of Conformity, Instruction Manual

4. Filter Core Integrity Test Report

5. Filter and Pipe Pressure Test Record Report

6. Pipe Pickling and Passivation Report

7. Automatic Welding Records

8. Offer 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 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 hyper-filtration, were invented by Lob and Sourirtajan of the University of California, Los Angeles in 1960. These advanced membrane separation technologies have 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, and viruses in the source water cannot, effectively separating 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 concentrations are equal. This process, known as natural osmosis, takes a considerable amount of time. However, 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 (like raw water), forcing the water molecules to permeate to the other side of the membrane, resulting in clean water. This process removes salt from the water, thus achieving desalination.

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, brackets, 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 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 the positive and negative ions in the feedwater. Simultaneously, these adsorbed ions are separated under the effect of direct current voltage, passing through anion and cation exchange membranes respectively for removal. The ion exchange resins in this process are electrically continuously regenerated, 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 resistivity ≥15MΩ.CM.

Ion exchange membranes and ion exchange resins operate on similar principles, selectively allowing ions to pass through. The anion exchange membrane only permits anions to pass through, not cations; conversely, the cation exchange membrane only allows cations to pass through, 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 the mixed ion exchange resins between the anion and cation exchange membranes is known as the freshwater chamber. Arranging a certain number of EDI units in series, with alternating anion and cation exchange membranes, and adding special ion exchange resins between the membranes, the space formed is called the concentrate chamber. Under the push 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, 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. Later, these ions encounter the adjacent cation exchange membrane during their continued migration towards the positive pole, but the cation exchange membrane does not allow anions to pass, so these ions are blocked in the concentrate. Positive ions (e.g., Na+, H+) in the freshwater are blocked in the concentrate chamber in a similar manner. In the concentrate chamber, the 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 undergoes electrolysis 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 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 like weak electrolytes.

Features of EDI

1. No need for acid/base regeneration, no acid/base storage or dilution transportation facilities, safe and reliable to use, avoiding worker exposure to acids and bases

2. Saves on recycled water and treatment facilities for recycled wastewater

3. Reduced operating and maintenance costs

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

5. Continuous operation, stable product water quality, no downtime 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 transportation of purified water or water for injections, the compressed air and nitrogen gas must be purified.

2) Pure water should be transported through a recirculating pipeline. The pipeline design should be simple and avoid blind pipes and dead ends, meeting the 3D standards required by GMP. Threaded connections are not permitted. The pipeline should be made of stainless steel pipe or other materials that are verified to be non-toxic, corrosion-resistant, and non-leaching of pollutants. Valves should be sanitized grade valves with no blind spots (suggested: sanitized diaphragm valves), and the flow direction of the purified water should be marked.

3) Piping for purified water and injection water, as well as transfer pumps, should be cleaned and disinfected regularly. They must be verified and deemed合格 before they can 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 "National Standard of the People's Republic of China for Steel Pressure Vessels" (GB150-80) and the "Safety Supervision Regulations for Pressure Vessel Technology."

V. Standard for Medicinal Purified Water/Extracorporeal Diagnostic Reagents Water

(1) Current edition of the Chinese Pharmacopoeia GMP purified water requirements

Appearance: Colorless clear liquid, odorless, tasteless

2. PH：5.0~7.0

Ammonia: ≤0.3 mg/L

4. Conductivity: ≤1 us/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: Cultured on R2A agar medium at 30~35℃ for at least 5 days, legally tested (General Method 1105) the total 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 μS/cm @ 25℃

Microorganisms: 50 cfu/ml

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: National 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 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 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 operation costs.

5. Multiple channels for after-sales feedback, providing nationwide maintenance and after-sales service, with quick response and fast handling, 24/7 availability.

6. Solemn Promise: Two-year free warranty on 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!