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Purified Water for Medical Purposes

Country/Region china
Company Beijing Safer De-Tech Environmental Protection Technology Co., Ltd.
Categories RO Water Purifier Plant
Telephone 86-10-51386806
ICP License Issued by the Chinese Ministry
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    Purified Water for Medical Purposes

    1. The standard the pure water treatment plant in medicals is abided by: GMP Standards in the Pharmacopeia (the 2000 Version) of People's Republic of China
    2. The plant runs either completely automatically or automatically on a specific condition. (For example, backwashing, regenerating, acid cleaning and sterilization.)
    3. Plant components and pipes all meet te demand of GMP.
    4. The Standard of Pure Water Quality:
    --Electric Resistivity0.5M
    --Electrical Conductivity2S
    --Ammonia0.3g/ml
    --Nitrate0.06g/ml
    --Heavy Metal0.5g/ml
    RO (Reverse Osmosis) is a new technology that was developed in the 1960s. Due to its simple operation and high salt/heat source removal efficiency and economicalness, the American Pharmacopeia recorded the method from its 19th edition, confirming it as another method of preparing water for injection.
    5. The GMP Requirement on Medical Water Preparing Devices:
    a) Simple structure, reliable and convenient installation and disinstallation
    b) The structure should use standardized, generallized and systematic parts and fittings.
    c) Both the interior and exterior wall surface should be smooth, flat, even and easy for cleaning and sterilization. The surface should be treated with chromeplate to make it anti-corrosion and rust proof. The exterior surface of the plant should avoid oil paint coating.
    d) The raw material of the device should use good low-carbon stainless steel or other materials that will not pollute the water. The device should be cleaned regularly, and the cleaning effect should be examined.
    e) The container of the water for injection shoulde use good low-carbon stainless steel (such as 316L stainless steel) or other materials that will not pollute the water. The device should be cleaned regularly, and the cleaning effect should be examined.
    f) The pure water storage period should not exceed 24 hours. The storage tank should use stainless steel or other non-polluting, anti-corrosion materials as the raw material. Protect its pumping hole with fiber filter in a hydrophobic nature. The interior wall of the storage tank should be smooth. A regular cleaning and sterilization is a must, with their effects carefully examined.
    g) The Supply of Water for Injection
    --A sterilized stainless steel pump with easy installation and disinstallation should be used to supply the water for injection. If it's in a situation that needs the help of compressed air or nitrogen, the gases should be pretreated with sterilization.
    --Circulation lines should be used. Its structure shoulde be simple it has to use innocuous and anti-corrosion pipe as raw materials. The valve should be of hygiene standard, and the flow direction should be clearly marked.
    --The said pipes and pumps for the transmission of pure water and water for injection should be cleaned and sterilized regularly, and they can only be used after the process passes examination.
    8. Pressure vessel design should be carried out by those with certification and the design should reach the standard of "GB150-80 Steel Pressure Vessels " and the "The Technical Supervision Regulations for the Safety of Pressure Vessels".

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