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  • GMP certified purified water equipment for pharmaceutical factory zl-zyc001

    Source: pharmaceutical water purification equipment Author: Bluestar Time: 2015-08-27 Views: Times

    GMP certified purified water equipment for pharmaceutical factory

    Pharmaceutical purified water equipment

    Basic equipment configuration:
    Product name: GMP certified purified water equipment of pharmaceutical factory
    Model: zl-zyc001
    Water inlet diameter 32 (mm)
    t/h Water production 0.5 t / h
    Working pressure   (psi) 1.0Mpa (psi)
    Specification: 1400 * 1650 * 800

       Equipment overview:
    Purified water equipment is used to meet the needs of various industries to produce purified water. It is mostly used in pharmaceutical, biochemical, and hospital industries. The entire system is made of SUS304L or SUS316L stainless steel. Equipped with ultraviolet and ozone sterilization devices (some countries do not allow the use of ozone, so the system uses pasteurization). The core technology of purified water equipment adopts new technologies such as reverse osmosis and EDI. A complete set of high-purity water treatment processes have been specifically designed to meet the water requirements for purified water production and large infusion production in pharmaceutical factories and hospitals.

    Purified aquatic water index
    Chemical index: Comply with the requirements of Pharmacopoeia of the People's Republic of China 2010 for purified pharmaceutical water Hygiene inspection: Microorganisms 10CFU / 100ml
    Endotoxin 0.25EU / ml
    Conductivity ≤ 2μS / cm (Resistivity ≥ 0.5 M Ω * CM)
    (1) Automatic control, simple and convenient operation; (2) The whole set of equipment is made of stainless steel, and the water tank is made of stainless steel medical water tank;
    (3) Equipped with water softener to ensure stable operation of RO system and EDI system due to the influence of hardness;
    (4) Using imported Hydeon ultra-low pressure reverse osmosis, high desalination rate, long service life, stable operation, and low energy consumption reduced by 20%;
    (5) The reverse osmosis system is controlled by a fully automatic method, and the main components are imported components, which has high stability and simple and convenient operation;
    (6) The EDI system uses a constant pressure regulating system to ensure stable water quality;
    (7) Adopting authentic imported membrane stacks, stable performance and long service life, and through professional technology, ensure that the water quality of the EDI system is short-term shutdown or long-term shutdown stability;
    (8) EDI flowmeter adopts imported flowmeter, which can prevent damage to membrane stack caused by non-concentrated water production due to blocked water channels or other equipment failure;
    (9) The EDI system is equipped with ultraviolet sterilization and membrane filters to ensure the stable quality of the water produced by EDI;
    (10) With a variety of device safety functions such as anhydrous protection and high and low pressure protection;
    (11) All water tanks use purified water and special water tanks, and are equipped with pressure level gauges, rotary spray cleaning and air breathing devices;
    (12) Equipped with ozone sterilization, quality and quantity, and designed according to the configuration.

    Pharmaceutical factory certified purified water equipment

    Pharmaceutical purified water equipment

    Process flow:

    Purified water equipment process

    Raw water tank, function: the raw water of the storage system, which regulates the inlet water, and also plays a role in the precipitation of impurities in the water.
    Sand filter, function: preliminary removal of sediment, impurities, suspended solids and other particles in water to reduce water turbidity.
    Carbon filter, function: use the principle of carbon adsorption to absorb the different colors, odors, residual chlorine, etc. in water.
    Security filter, function: prevent large particles of impurities from entering the reverse osmosis membrane, causing damage to the membrane and protecting the reverse osmosis membrane.
    Reverse osmosis host, function: It mainly achieves the purpose of producing purified water through reverse osmosis filtration.
    PH adjustment system, function: By adjusting the pH to about 7, remove CO2 in the water and ensure the quality of the produced water. (Reverse osmosis ensures the quality of the produced water, making the EDI produced water more stable and the life of the nuclear resin longer).
    Purification water tank, function: to store secondary reverse osmosis water to provide water for the terminal purified water point.
    Sterilization and disinfection system, function: used to clean purified water pipeline and purified water tank.
    Ultraviolet sterilizer, function: kill the residual bacteria in the water and ensure the quality of the effluent.
    The function of the micro filter is to remove bacteria and other particles killed by ultraviolet rays.
    Purified water booster pump, function: to deliver pure water at the water point.

    Pipeline system
    1. The connection parts of the purified water equipment system are preferentially welded, followed by snap-in, which eliminates the use of silk-tooth connection.
    2. The whole system adopts one-side welding and two-side forming processes, and automatic welding processes imported from Germany and automatic pipe cutting tools from the United States are used. The water quality is different in grades, which are manual welding and automatic welding processes. Automatic welding is used in contact with purified water. Passivation treatment is performed after welding. An endoscope photo is provided and a test report is attached.
    3. Filters, pressure gauges, conductivity probes, RO membrane shells, and ultraviolet light that come into contact with product water are sanitary clamp connection methods.
    4. The pipelines in contact with the terminal pure water all meet the GMP3D requirements. The rubber pad is PTPE, the diaphragm valve is horizontally installed at 45 degrees, the circulation pipeline installation is set to a slope of 0.5, and the lowest point is the discharge point.
    5. Separate sampling points are set for each system to facilitate the detection of water quality.
    6. The entire system adopts three-dimensional design, production, processing and installation integration, and is equipped with a circulating return water pipe to eliminate backwater pipes.

    RO membrane shell, precision filter technical requirements
    1. The whole structure is made of seamless 304 stainless steel pipe.
    2. Any active interface of purified water is sanitary clamp connection. (Eg membrane shell, pressure gauge)
    3. RO membrane has a unique full drainage design, which can completely drain the internal concentrated water.
    4. Purified water section pipeline is an automatic welding process, which is implemented by German welding machine and GF special pipe cutting tool.
    5. The precision filter is detachable, and the inside is a clean structure.

    Functional description
    1. It adopts Japanese Mitsubishi PLC + touch screen automatic control method, and the control lines are all 24V safety voltage.
    2. The touch screen has a process flow screen, and a dynamic animation monitoring screen is provided for the pump, valve, and water tank level.
    3.Humanized alarm recording and prompt function; when the filter replacement cycle is reached, full water, water shortage, low pressure, overpressure will be recorded in the touch screen event record column, and it will be issued when it encounters abnormal water quality, pressure and flow. Call the police.
    4. The water quality section at all levels sets the function of passing qualified water and unqualified discharge to the previous paragraph to ensure the water quality is stable and safe. (If the recovery water quality is qualified within 5 minutes, record in the record bar on the touch screen, and no alarm will be issued after the time is exceeded). In addition, it also has a water quality correction function, with a minimum use of water quality warning function, and no emergency state will ever occur.
    5. PLC + touch screen automatic control method is adopted, which is stable, reliable, exquisite and beautiful. The automatic mode is one-button startup, and the operation is simple and convenient.
    6. The manual mode has built-in management rights, which are three levels of management: administrator, engineer, and operator.
    7. It is convenient to switch between manual and automatic modes, and has a special reminder function to prevent non-operators from operating this equipment by mistake.
    8. In order to achieve no dead ends in each section, if the secondary reverse osmosis and purified water tank are full of water, the terminal will not use water within 2 hours, and the terminal water tank liquid level will not change. It will automatically circulate to the tap water tank to trigger the whole system to re-water, preventing The pipeline is not flowing for a long time to breed bacteria. At the same time, the conductivity of purified water is monitored in real time to maintain a minimum flow rate of more than 1m / s. In order to reduce the possibility of microbial growth in purified water pipe network.
    9. Signal point of the liquid level switch system of each water tank, and RO flushing. (Power on, cycle time can be modified on the touch screen, set up permission management)
    10. Humanized 3D design conforms to ergonomics; touch screens, switches, instruments, and meters are set at height positions, which are in line with the average height of Chinese people and convenient for manual operation.
    11. The RO water production and flushing time can be set. When the water is peak, the water production time can be adjusted and the water point can be used to stabilize the water.
    12. The water production system is controlled separately from the water supply system. If consumables are replaced, it is not necessary to stop the water supply or water production.
    13. Using three-dimensional design animation installation, reasonable place according to site conditions, and set up convenient maintenance channels.
    14. The installation pipeline should be horizontal and vertical, beautiful and elegant, and the cable bridge should be firm and reliable. 15. The wires and cables should conform to the national electrical code.
    16. Pipes are installed on-site by manual welding, and the pipes are firm and reliable. Each pipe bracket is installed at a standard interval, and the pipe has a certain slope of 5/1000.
    17. Weld daily samples, records, and prints, and keep it clean and tidy after construction every day. Pipes should be sealed to prevent foreign objects from entering the pipe.
    18. Provide axonometric drawings of each pipeline, welding code records, pickling passivation, pressure test report, and endoscope inspection photos.

    Main configuration
    1. In line with China's GMP certification requirements, tailored specifically for pharmaceutical companies, Kerui not only provides a set of stable and reliable equipment, but also provides certification system information and comprehensive solutions.
    2. The system adopts all stainless steel configuration, stable operation, delicate and beautiful, simple and convenient operation.
    3. Equipped with raw water tank, intermediate water tank, and liquid level device to prevent the equipment from being affected by unstable tap water pressure.
    4. Equipped with special sterile water tank for purified water, equipped with pressure level gauge, rotary spray cleaning and air breathing device.
    5. Equipped with water tank water inlet solenoid valve, the performance is more stable than conventional floating ball water inlet valve.
    6. Adopt dual-stage reverse osmosis system configuration to ensure the system's stable operation to a large extent.
    7. Equipped with pH adjustment and online detection system, Milton roy metering pump in the United States, adjust the pH value to prevent the impact of CO2 on the quality of produced water.
    8.Using imported Hydeen ultra-low pressure reverse osmosis, high desalination rate, long service life, stable operation, and 20% energy consumption reduction
    9. Reverse osmosis scientific configuration through membrane design software and field operation experience.
    10. Equipped with special concentrated water diaphragm regulating valve, easy to operate.
    11. Equipped with ozone sterilization; more thorough cleaning.
    12. Equipped with UV rays and membrane filters to prevent bacteria from affecting the water quality.
    13. Have multiple protection and safety functions such as anhydrous, low pressure, overpressure, etc. at key points of pressure.
    14. The main electrical components are made of Schneider from France, with guaranteed quality and quantity, and designed according to the configuration.

    Purified water equipment can be used for medical equipment, pharmaceutical water, blood purification, large infusion, biochemical water, medical sterile water, oral liquid water, etc. (for pharmaceutical preparations, injection preparations and other preparation industries, please see the pharmaceutical water production equipment system on this site), The produced water can be further processed into sterile distilled water.

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