Water for injection is distilled water without pyrogen, which is obtained from purified water (deionized water) by distillation and then filtered through 0.22μm~0.10μm sterilizing filter. The preparation of pure water, there are full ion exchange method, electrodialysis - ion exchange method, primary reverse osmosis - ion exchange method, secondary reverse osmosis method and other production processes. Regardless of the process used to prepare pure water, provide distilled water mechanism to prepare distilled water raw water must comply with the Chinese Pharmacopoeia of pure water quality standards.
Theoretically, the distillation method of preparing water for injection removes the fine substances in water (all non-volatile substances larger than 1μm and most of the soluble small molecules of inorganic salts of 0.09~1μm). Pure water after distillation which is not volatile organic, inorganic substances including suspended solids, colloids, bacteria, viruses, pyrogens and other impurities can be removed. However, due to the structure of the distillation machine, performance, metal materials, processing accuracy, operating methods and water quality of the water source and other factors, is bound to affect the quality of distilled water.
Preparation of distilled water, before the 1980s, some factories with boiler steam directly condensed, cooled and made. Technical equipment conditions are better with a single distiller, heavy distillers, heavy distillers in the tower, pavilion type two kinds of water. 1980s along the heavy distillers mostly, and at this time, the domestic has been more common use of steam and water-saving automatic control of multi-effect distillers and pneumatic water distillers such as the amount of distilled water and economic equipment.
Single distiller: by the evaporation pot, baffle (foam) plate, condenser and furnace and other components. The use of water (drinking water) into the condenser return pipe into the funnel, and then injected into the evaporation pot, after heating the pot of water boiling gasification, steam through the block (foam) plate to remove the mist entrained droplets into the condenser and heat exchange is cooled into distilled water. Due to the small amount of water production, the environment is poor, the resulting distilled water quality is poor and other reasons for the production has been eliminated from the game.
Tower distiller: this device is an improvement over the single distiller, first of all, it is a distilled water as a source of water, the secondary distilled water. The second to steam as a heat source to improve the environment. Third, there is a foam barrier device can prevent the steam entrained boiling foam and most of the droplets to make it flow back into the evaporation pot. Fourth, in the collection of primary distilled water set up exhaust (CO2, NH3) discharger, so that the quality of the distilled water produced by a temporary improvement.
In the 1980s, with the introduction of advanced foreign technology, through digestion, absorption, improvement, the Far East, Baoji and other factories have introduced domestic multi-effect distilled water machine and pneumatic distilled water machine, now has been widely used, replacing the first generation of distilled water machine.
Multi-effect distilled water machine: multi-effect distilled water machine performance depends on the pressure of the heating steam and the number of effects. The greater the pressure is the greater the yield of distilled water, the more the number of effects is the higher the utilization rate of heat energy. Multi-effect distilled water machine can be divided into tube and coil type, commonly used tube distilled water machine. Tube type multi-effect distilled water machine for the internal heat transfer tube bundle and tube plate, shell composition of the falling film tube evaporator, generated by the lower part of the steam discharge, and then along the inner liner and the separation of the cylinder between the rotating upward movement of the spiral blade, steam entrained droplets are separated, in the separation of the inner wall of the cylinder to form a layer of water in the hydrophobic ring to the separation of the cylinder and the shell constitutes a hydrophobic channel, the downstream convergence in the bottom of the device, the steam continues to rise to the separation of the cylinder tip, and enter the next tube, the steam is discharged from the steam outlet. Discharge from the steam outlet, into the next effect evaporator. At present, the structure of the multi-effect tube distilled water machine and the inner spiral and the outer spiral points. The principle of the process is: into a double tube plate structure within the top of the evaporator by preheating the raw material water through the film evaporation tube down, the evaporator tube wall of the evaporation device will soon be the raw material water flash vaporization for steam.
At the bottom of the evaporator, the steam forms a 180° turn, and the large water droplets are thrown to the bottom of the column, and the excess raw material water that is not evaporated is also collected at the bottom of the column, and these water pools flow into the top of the next effect, and then repeat the same operation procedure. Steam rises vertically at low speed through the long center section of the evaporator, and gravity continues to remove impurities. At the top of the center section, the steam arrives at the cyclone chamber through an inlet, where the steam forms a high-speed vortex and, due to the fast radial acceleration, the water droplets and impurities are thrown by the strong centrifugal force to the outer edges of the cyclone chamber, and are discharged from the bottom. After the centrifugal process, the steam becomes pure, and the pure steam rises vertically at a low speed and makes a final 180° turn before being discharged through the top outlet of the distillation column. Its final measure is a de-atomizer device in the center tube of the cyclone chamber, which serves as a fourth stage of separation to ensure foolproof quality of water for injection.
Pneumatic distilled water machine: pneumatic, also known as hot pressure, it is the purified water to 2 ~ 3kgf/cm2 pressure, through the water inlet through the heat exchanger and then pumped into the evaporation condenser tube, the water level in the tube by the level regulator adjustment, in the evaporation condenser is equipped with a steam heating coil in the lower part of the heating coil and electric heater for auxiliary heating effect. Evaporation condenser tube of pure water heated into steam into the evaporation chamber temperature of 105 ℃, by the mist eliminator to remove the evaporation rate is too fast and brought into the water droplets, solids, and then into the compressor when the steam is compressed, and its temperature can be as high as 120 ℃, the high-temperature compressed steam into the evaporation condenser between the tubes. At this time, the evaporation condenser tube and tube temperature difference of 15 ℃ or more, high temperature and high pressure steam between the tube to release a large amount of latent heat, the evaporator condenser tube of water heated into steam, the steam into the evaporation room to repeat the previous process. High-temperature compressed steam condensed into distilled water condensed between the tubes were led out, and dissolved in distilled water in the non-condensable gases, from the condensable gas discharger discharged.
The pure distilled water is sent to the heat exchanger by the pump to preheat into the evaporation condenser, and finally flows out at a pressure of 0.1MPa and enters into the heat preservation storage tank through the flow meter. Its characteristics: the use of heat pump evaporation principle, evaporation and condensation *** with a heat exchanger, no cooling water, the use of steam as long as up to 0.1MPa can be, saving more than 90% of the steam, the whole machine can be fully automatic control, the production of distilled water can be in line with the "water for injection" standard.
The daily management of the water system, including operation and maintenance, it is a great relationship between the validation and normal use, so should be established to monitor the pre-maintenance program to ensure that the operation of the water system is always out of a controlled state.
These include:
①Water system operation and maintenance procedures.
②Monitoring programs for key water quality and operating parameters, including calibration of key instruments.
③Periodic disinfection/sterilization plan.
④Preventive maintenance program for water treatment equipment.
5 key water treatment equipment (including major components), piping and distribution systems and operating conditions will be changed management methods.
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