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    Home > Active Ingredient News > Drugs Articles > Special requirements for the selection of pharmaceutical water equipment systems

    Special requirements for the selection of pharmaceutical water equipment systems

    • Last Update: 2020-11-18
    • Source: Internet
    • Author: User
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    First, the special requirements of pharmaceutical water equipment system The basic characteristics of the equipment selected in the pharmaceutical water system are not much different from the performance of non-pharmaceutical water system equipment.
    , for example, purified water equipment has the same basic function as in other industries.
    pharmaceutical water system only in the control of microorganisms, there are special requirements, and purified water systems used in the water treatment equipment around the requirements of microorganisms in the control system for the corresponding treatment.
    1. Special requirements for pure steam system equipment Pure steam equipment should first be able to produce pure steam with the same water quality index of injection water, pure steam pressure in overcoming the resistance of the pipe system, can meet the pressure and temperature requirements of sterilization equipment or wet heat sterilization of the system pipe.
    pure steam equipment and pipes can be isolated from the atmosphere when not in use and are not contaminated by microorganisms in the air.
    pure steam equipment and distillers, the heat exchanger portion of the distiller should prevent the leakage of cooling water from contaminating pure steam.
    2. Special requirements for injection water system equipment are similar to those for purified water systems and are more stringent.
    water system pays special attention to the control of microbial indicators.
    main equipment in the injection water system are distilled water machines, storage tanks, sanitary-grade conveyor pumps, valves and conveyor pipes.
    for these devices or components, the special requirements of the injection water system are almost as demanding as those of the purified water system. the main principle of
    is to control the quality of distilled water out of water, distilled water machine can sterilise itself, to prevent distilled water and cooling water distilled water and cooling water may produce cross-contamination, water pump health management, system pipe to microorganism retention and breeding, system sterilization with pure steam and so on.
    3. Special requirements for purified water system equipment For purified water systems, microbial control in the water treatment process runs through the entire process.
    For example, if activated carbon filtration device or softener is used in the system, the organic matter intercepted on the upper flow side of the filter will be intercepted because of the adsorption of activated carbon, if there is no corresponding sterilization measures to disinfect the activated carbon filter periodically, reduce the active carbon filter upper flow The biological load on the side, after a period of use, although the function of the activated carbon filter itself (reducing residual chlorine and removing organic matter) has not decreased, but because of its upper-flow side of the organic matter heap, the activated carbon filter after the use of microorganisms in the water indicators exceed the pre-treatment water intake index.
    , for example, purified water storage tanks and distribution lines should be regular microbial disinfection measures.
    , according to the functions and characteristics of water treatment equipment used within the process purified water system, the article should be wrote about controlling and reducing the pollution of microorganisms.
    , the manufacturing materials of the equipment should be selected according to the disinfection method selected.
    e.g., if heat treatment (Pasteurization or steam sterilization) is used, the material used for the manufacture of activated carbon filters or softeners should be temperature-resistant materials, such as stainless steel, and when chemical disinfectants (ozone or hydrogen peroxide) are used, the manufacturing material for the equipment may consider temperature resistance and the corrosion-resistant life of the equipment instead.
    purified water equipment should also have the characteristics of non-flowing dead water section, all equipment should have the ability to empty the residual water inside the system, the water outside the system will not be reflowed back to the system and produce pollution.
    , purified water treatment equipment and system pipes should have the ability to prevent contamination and regular disinfection, reduce biological loads or restore to biological load levels.
    Corey purified water equipment system using today's RO and EDI purified water technology, water quality to meet customer production water requirements, in line with GMP, FDA and other certification requirements.
    system overall user-friendly design, modular installation, small footprint, simple and convenient operation, stable operation, energy efficiency.
    II, injection water and pharmaceutical purified water Purified water and injection water two differences also lies in the water production process, purified water preparation process can have a variety of options, but the national pharmacopeia for injection water preparation process has limited conditions, such as the United States Pharmacopeia clearly stipulates that the preparation process for injection water can only be distillation and reverse osmosis, the Chinese Pharmacopeia provides that the injection water production process must be distillation.
    these are necessary conditions for countries to ensure the quality of water used for injection, in accordance with their own realities.
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