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Shanghai Binrun Environmental Protection Technology Co., Ltd
Huainan 3-ton/hour pharmaceutical water equipment
NegotiableUpdate on 05/06
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Overview
In the production system of the pharmaceutical industry, the quality of pharmaceutical water is directly related to the safety and effectiveness of drugs, and is a key element of drug production. The Huainan 3-ton/hour pharmaceutical water equipment strictly follows domestic and foreign standards such as the Chinese Pharmacopoeia, GMP (Good Manufacturing Practice for Drugs), FDA (Food and Drug Administration of the United States), and EU GMP (European Union Good Manufacturing Practice for Drugs), and designs differentiated process routes for different needs of purified water and injection water. Through precise equipment configuration and strict quality control, it provides stable and reliable high-quality water solutions for pharmaceutical enterprises
Product Details
In the production system of the pharmaceutical industry, the quality of pharmaceutical water is directly related to the safety and effectiveness of drugs, and is a key element in drug production3 tons/hour pharmaceutical water equipmentWe strictly follow domestic and international standards such as the Chinese Pharmacopoeia, GMP (Good Manufacturing Practice), FDA (US Food and Drug Administration), and EU GMP (European Union Good Manufacturing Practice). We have designed differentiated process routes for purified water and injection water to meet different needs. Through precise equipment configuration and strict quality control, we provide pharmaceutical companies with stable and reliable high-quality water solutions. The following will elaborate in detail from multiple dimensions such as pharmaceutical water classification and requirements, core process routes, technical parameters, equipment configuration, etc.
1、 Classification and strict requirements for pharmaceutical water use
Pharmaceutical water is mainly divided into purified water and injection water according to its purpose and quality standards, and there are significant differences between the two in terms of production process and quality indicators.
Purified WaterMainly used for ingredient preparation, cleaning of non sterile preparations, and as a water source for preparing injection water. It needs to meet strict quality standards, such as conductivity ≤ 2 μ S/cm at 25 ℃, which directly reflects the content of ion impurities in water. A lower conductivity can avoid adverse effects of ions on drug ingredients; The microbial content should be controlled at ≤ 100 CFU/mL to prevent the growth and reproduction of microorganisms during drug production, which may affect drug quality.
Water for InjectionAs a key raw material for sterile preparations, it is used for the preparation of sterile drugs such as injections, and has stricter requirements for water quality. In addition to requiring a conductivity of ≤ 1 μ S/cm (25 ℃) to ensure higher ion purity, it is also necessary to control the endotoxin content within ≤ 0.25EU/mL, as once endotoxins enter the human body, they may cause serious adverse reactions such as fever and shock; At the same time, sterile standards must be met to ensure that the drug does not pose a risk of infection to patients during use.
2、 Core process route: Differentiated design to meet diverse needs
（1） Purified Water Process (Basic Edition)
The purified water process adopts the process of "raw water pretreatment system reverse osmosis (RO) - electrodeionization (EDI) - ultraviolet sterilization (UV) - sterile water storage tank - terminal filtration (0.22 μ m)", and each link closely cooperates to gradually improve water quality and meet the water demand for non sterile preparation production.
（2） Injection water process (high-end version)
In response to the higher quality requirements for injection water, the process has been upgraded on the basis of purified water, adopting the route of "raw water pretreatment system reverse osmosis (RO) - EDI distillation/ultrafiltration (UF+MF) - sterilization system (such as ozone+UV) - sterile water storage tank". By increasing the depth of treatment and strengthening the sterilization process, the produced water meets the standards of sterility and low endotoxin, which is suitable for the production of sterile preparations.
3、 Detailed process flow and equipment configuration: Precise configuration ensures efficient operation of the process
（1） Pre treatment system: the cornerstone of raw water purification
The pretreatment system is responsible for the important task of removing suspended solids, residual chlorine, organic matter, hardness substances and other impurities from the raw water, providing high-quality influent for the subsequent core treatment unit, effectively protecting the RO membrane and EDI module, and extending the service life of the equipment.
Multi media filterThe interior adopts a layered filling structure, with the upper layer filled with quartz sand with a particle size of 0.5-1.2mm. With its small particle gaps, it can effectively intercept tiny particles; Fill the lower layer with smokeless coal with a particle size of 1-2mm to remove larger impurities. When the raw water flows through the filter layer from top to bottom, suspended solids and colloids with a particle size of 5-10 μ m in the water can be removed by the interception, precipitation, and adsorption of the filter material, significantly reducing the turbidity of the raw water and making the effluent clearer, creating favorable conditions for subsequent treatment.
Activated carbon filterHigh quality coconut shell activated carbon is selected, which has a rich microporous structure and a specific surface area of up to 1000-1500m ²/g, endowing it with excellent adsorption performance. On the one hand, activated carbon converts highly oxidizing residual chlorine into harmless chloride ions through catalytic reduction, avoiding oxidative damage to the RO membrane caused by residual chlorine; On the other hand, it can efficiently adsorb organic matter, pigments, and odorous substances in water, reduce the total organic carbon (TOC) content in water, and minimize the interference of organic matter on subsequent processes.
Softener (optional)When the hardness of the raw water is high (usually measured by the concentration of calcium and magnesium ions, if it exceeds a certain threshold, such as calcium and magnesium ion concentration>100ppm), a softener needs to be configured. The softener is filled with sodium type ion exchange resin, which replaces calcium and magnesium ions in water with sodium ions in the resin through ion exchange reaction, effectively reducing the hardness of water, preventing the formation of scale on the surface of the RO membrane, and ensuring the stable operation and efficient desalination performance of the reverse osmosis system.
precision filterUsing a 5 μ m pore size polypropylene (PP) melt blown filter element, it can intercept residual small particles and impurities during the pretreatment process, such as broken filter media, flocs, etc., as the last protective barrier of the RO system, preventing particles from scratching the surface of the RO membrane and ensuring efficient operation of the RO membrane under good conditions.
（2） Reverse osmosis (RO) system: the core unit of deep desalination
The reverse osmosis system is a key link in achieving deep desalination of raw water. Through the selective permeation principle of RO membrane, it removes more than 99% of soluble impurities in water, providing high-quality influent for subsequent EDI treatment.
RO membrane groupDow BW30-400IG DRY membrane element is selected, which has anti pollution performance and high desalination rate. The desalination rate of a single membrane is ≥ 99% (test conditions: 25 ℃, 1500ppm NaCl solution). By reasonably configuring the number and arrangement of membrane components, ensure that the equipment achieves a stable water production of 3 tons/hour. The special structure of RO membrane allows water molecules to pass through under high pressure, effectively intercepting impurities such as salt, organic matter, bacteria, viruses, etc., thus achieving efficient desalination.
high-pressure pumpThe high-pressure pump made of 316L stainless steel material has good corrosion resistance and stability, and can provide a water inlet pressure of 1.0-1.5MPa for RO membrane filtration. The high-pressure pump is equipped with a pressure sensor and an automatic protection device. When the inlet pressure is below the set threshold (such as 0.1MPa) or the system pressure exceeds the safe value (such as 1.8MPa), it will automatically shut down and give an alarm to prevent equipment damage or membrane element rupture caused by abnormal pressure, ensuring the safe and stable operation of the system.
Recovery rate controlThe recovery rate of the RO system can be flexibly adjusted according to the TDS (total dissolved solids) of the raw water, usually controlled between 60-75%. By optimizing the ratio of concentrated water discharge and fresh water collection, while ensuring the quality of water production, we aim to maximize water resource utilization and reduce wastewater discharge. Meanwhile, a reasonable recovery rate setting helps maintain the water flow state on the surface of the RO membrane, prevent concentration polarization, and extend the service life of the RO membrane.
Water quality assurance for effluentAfter first stage reverse osmosis treatment, the effluent quality is significantly improved, the conductivity can be reduced to ≤ 20 μ S/cm (room temperature), and the pollution index SDI<3, providing reliable guarantee for the stable operation of the subsequent EDI system.
（3） Electrodeionization (EDI) system: advanced technology for deep desalination
The EDI system utilizes the synergistic effect of electrodialysis and ion exchange resin to replace traditional mixed bed processes and achieve continuous deep desalination.
working principleUnder the action of a direct current electric field, the ion exchange resin in the EDI module adsorbs cations and anions in water, while the selective permeability of the ion exchange membrane enables directional migration of ions from the fresh water chamber to the concentrated water chamber, achieving deep desalination. This process does not require acid-base chemical regeneration. The hydrogen ions (H ⁺) and hydroxide ions (OH ⁻) generated by water electrolysis continuously regenerate the resin, which not only reduces operating costs and environmental pollution, but also stably produces high-purity purified water with a resistivity of ≥ 15M Ω· cm.
Device ConfigurationUsing EDI modules from Siemens or IONPURE, combined with a dedicated DC power supply system, the current density can be adjusted according to water quality conditions to optimize desalination efficiency. At the same time, high-precision resistivity online monitoring instruments are equipped to monitor the water resistance rate of the produced water in real time, ensuring stable and compliant water quality.
（4） Post treatment and sterilization system (for injection water only)
Distillation/ultrafiltration (optional)
distillationUsing a multi effect distilled water machine, through the distillation process, the difference in boiling point between water and impurities is utilized to effectively remove pyrogens and microorganisms. The multi effect distilled water machine improves energy utilization efficiency through multi-stage evaporation and condensation, and the distilled water produced can meet the strict requirements of injection water for pyrogen and microorganisms.
Ultrafiltration (UF+MF)The combination of ultrafiltration membrane (with a molecular weight cutoff of usually 1000-10000 Da) and microfiltration membrane (with a pore size of 0.1-0.22 μ m) can effectively intercept endotoxins and microorganisms. Ultrafiltration membranes intercept large molecular substances through screening principles, while microfiltration membranes further filter small particles and microorganisms to ensure water quality meets injection water standards.
Sterilization system
UV sterilizerUsing a low-pressure mercury lamp with a wavelength of 254nm, the lamp power is precisely configured according to the flow rate (10-15 W power is required for processing 1m ³/h of water), ensuring that the ultraviolet radiation dose of the water flow in the equipment is ≥ 40mJ/cm ². Ultraviolet radiation destroys the DNA or RNA structure of microorganisms, causing them to lose their ability to reproduce and survive, with a sterilization rate of over 99.9%, effectively killing residual bacteria, viruses, and other microorganisms in water.
Ozone disinfection (water storage tank)Introduce ozone into the water storage tank and utilize its strong oxidizing properties to assist in sterilization and inhibit microbial growth. Ozone has no residue after decomposition in water, and will not cause secondary pollution to water quality. At the same time, it can effectively maintain a sterile environment in the water storage tank.
Terminal filteringInstall a 0.22 μ m microporous filter membrane to perform final filtration on the treated water, intercepting small particles, impurities, bacteria, and microbial fragments that may remain in the water, ensuring that the final effluent meets sterile standards and meets the strict requirements for injection water.
（5） Storage and Distribution System: Ensuring Safe and Stable Water Use
Aseptic water storage tankMade of 316L stainless steel material, the inner wall is polished to Ra ≤ 0.4 μ m, effectively preventing microbial adhesion and material corrosion. The storage tank has a capacity of ≥ 3 tons and is equipped with nitrogen protection or circulating disinfection system. The nitrogen protection system isolates air and inhibits microbial growth by continuously introducing high-purity nitrogen gas (purity ≥ 99.99%); The circulating disinfection system can regularly perform ozone or high-temperature circulating disinfection on the water tank to ensure stable quality of pharmaceutical water during storage.
allocation systemThe distribution pipeline is made of 316L stainless steel material. For the injection water system, the temperature control of the pipeline is kept above 80 ℃, and the growth of bacteria is suppressed through high temperature circulation. At the same time, the system is equipped with online monitoring devices to monitor key indicators such as conductivity, TOC (total organic carbon), and microorganisms in real time. Once abnormalities are detected, an alarm is immediately triggered and corresponding measures are automatically taken to ensure that the pharmaceutical water delivered to each water point always meets quality standards.
5、 Equipment cost and operating expenses: scientific planning of investment and operation
（1） Initial investment
Purified Water SystemApproximately 300000 to 400000 yuan (including automatic control system), suitable for non sterile formulation production scenarios with relatively basic water quality requirements, such as ingredient preparation and cleaning of ordinary tablets and capsules.
Injection water systemApproximately 500000 to 800000 yuan (including distillation or ultrafiltration+sterilization equipment), suitable for sterile formulation production scenarios that require water quality, such as the preparation of injections and freeze-dried powder injections.
（2） Operating costs
Cost of consumables replacement
RO membraneThe service life is 3-5 years, and the replacement cost is about 50000 to 80000 yuan per set. The average annual consumable cost is about 10000 to 27000 yuan.
EDI moduleThe service life is 5-8 years, and the replacement cost is about 100000-150000 yuan/time. The average annual consumable cost is about 12500-30000 yuan.
UV tube/ozone generatorIt needs to be replaced once a year, with a cost of about 0.1-0.2 yuan/ton. Calculated based on a water production rate of 3 tons/hour and 8 hours of operation per day, the annual related cost is about 730-1460 yuan.
energy consumption costThe comprehensive energy consumption of the equipment is about 2-3 yuan/ton, mainly including the power consumption of high-pressure pumps, low-pressure pumps, EDI modules, ultraviolet sterilizers and other equipment. The annual operating cost (calculated based on 8 hours of operation per day and 300 days per year) is about 14400-21600 yuan.
Total cost estimationTaking into account factors such as consumable replacement, energy consumption, and equipment depreciation, the total cost of producing purified water is about 3-5 yuan/ton, and the total cost of producing injection water is about 4-6 yuan/ton. The specific cost can be adjusted according to actual operating conditions and raw water quality.
6、 Application scenarios and selection suggestions: Accurately adapting to pharmaceutical needs
Application scenarios of purified waterSuitable for ingredient preparation, cleaning of non sterile preparations such as ordinary tablets, capsules, oral liquids, as well as laboratory use of ordinary experimental water. It is recommended to use the process combination of RO+EDI+UV+nitrogen to protect the water storage tank. High cost-effective brands such as Shanghai Binrun and Hubei Binrun that support customized services can be selected to adjust equipment parameters according to the actual needs of the enterprise and meet production water requirements.
Application scenarios of injection waterMainly used for the preparation of sterile preparations such as injections and freeze-dried powder injections, as well as sterile cleaning of medical devices. It is recommended to adopt the process scheme of RO+EDI+distillation/ultrafiltration+sterilization system, and prioritize brands with mature technology and reliable product quality, such as Shanghai Binrun, Hubei Binrun, etc., to ensure that the produced injection water meets high standard requirements and guarantees drug production safety.
7、 Key points of maintenance and compliance: Ensure stable and compliant operation of equipment
（1） Daily maintenance management
consumable replacementRegularly replace the pre-treatment filter cartridge every 3-6 months, and perform regular chemical cleaning (using acid/alkali washing) on the RO membrane based on water quality and operating time to remove pollutants from the membrane surface and restore the membrane's desalination performance and water production; Regularly check the operating parameters such as current and voltage of the EDI module to prevent resin scaling or channel blockage.
data recordingDetailed recording of key parameters such as RO conductivity, EDI current, UV irradiation intensity, and water storage tank temperature. Through data analysis, potential problems in equipment operation can be identified in a timely manner and corresponding adjustment measures can be taken.
（2） Disinfection management
Disinfection of water storage tankFor the purified water system, disinfect the sterile water storage tank with ozone or high-temperature circulation every week; For injection water systems, daily ozone or high-temperature circulation disinfection is carried out to effectively kill microorganisms that may grow in the water tank, ensuring the quality and safety of stored pharmaceutical water.
pipe flushingThe purified water system pipeline is thoroughly flushed every month, and the injection water system pipeline is flushed every week to prevent microbial adhesion and impurity deposition on the inner wall of the pipeline, ensure smooth water flow channels, and avoid secondary pollution.
（3） Verify file support
The manufacturer provides a complete validation document package, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) reports. These verification documents provide detailed information on the entire process of equipment design, installation, operation, and performance testing, providing strong support for pharmaceutical companies to establish quality management systems and respond to regulatory audits, ensuring compliance and reliability throughout the entire lifecycle of the equipment.
Huainan 3-ton/hour pharmaceutical water equipmentWe provide a complete water solution for the pharmaceutical industry through scientific and rigorous process design, high-quality and reliable equipment configuration, strict and standardized quality control, and an after-sales service system. Whether it is the demand for purified water in the production of non sterile preparations or the strict requirements for injection water in the production of sterile preparations, this equipment can meet the diverse production needs of pharmaceutical companies with its stable performance and quality, helping the pharmaceutical industry to ensure drug quality and promote high-quality development of the industry.
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