Preparation of water for injection in GMP workshop
Preparation of water for injection in GMP pharmaceutical cleanroom
Water for injection is obtained by distillation by using purified water as raw material. The preparation of water for injection is usually obtained by the following three distillation methods: single-effect distillation, multi-effect distillation and hot-pressing distillation; The liquid phase change method and separation method are used to chemically ...
Text label: GMP pharmaceutical cleanroom water injection preparation, purification plant design and installation
Preparation of water for injection in GMP pharmaceutical cleanroom
Water for injection is obtained by distillation by using purified water as raw material. The preparation of water for injection is usually obtained by the following three distillation methods: single-effect distillation, multi-effect distillation and hot-pressing distillation; The process of chemical and microbial purification of raw water by liquid phase transformation and separation methods. In this process, the water is evaporated, the steam produced is separated from the water, and the unevaporated water flows to the back to dissolve the solids and non-evaporated water. Volatile substances and high molecular impurities, in the distillation process, low molecular impurities may be entrained in the steam after water evaporation in the form of water mist or water droplets, so a separation device is required to remove fine water mist and entrained impurities. Impurities, purified steam is condensed into water for injection; in order to meet the verification requirements and reduce the risk of the system, it is recommended that the water for injection preparation equipment should have an automatic control function, so that the parameters required to be controlled during the verification can be monitored and recorded online.
Multi-effect distillation equipment usually consists of two or more evaporative heat exchangers, separation devices, preheaters, two condensers, valves, instruments and control parts, etc. The general system has 3-8 effects, each The effect includes an evaporator and a separation device; in the multi-effect distillation equipment, the purified steam generated by each effect evaporator is used to heat the raw water, and more pure steam is generated in the following effects, After heating and evaporating the raw water, the pure steam undergoes phase change and condensation to become water for injection; in this staged evaporation and condensation process, only the first-effect evaporator needs to be heated by an external heat source, and the pure steam generated by the last effect and the steam generated by each effect. The condensation of water for injection is cooled by an external cooling medium, so the effect of energy saving is very obvious. The more the effect, the better the energy saving effect. The multi-effect distillation equipment adopts the tubular heat exchange flash to generate steam from the raw water, and at the same time condenses the pure steam into water for injection; the industrial steam enters the shell side through the steam inlet of the first-effect evaporator and the raw water entering the evaporator tube side is heated for heating. Exchange, the produced condensate is discharged from the evaporator through the condensate outlet by pressure driving and gravity settling. The inside of the condenser is a multi-lead structure of tubes. The raw material water enters the preheater through the tube side. The pure steam generated by the final effect and the injection water generated earlier enter the shell side and exchange heat with the raw material water passing through the tube side. Water flows through the upper condenser and enters the lower condenser from the water for injection outlet at the bottom, and then flows into the storage tank from the main outlet of water for injection for storage; usually a 0.22μm respirator is installed on the upper part of the condenser to prevent the vacuum from being generated in the equipment after shutdown and can Prevent microorganisms and impurities from entering the condenser to pollute the equipment, and can also discharge non-condensable gases and volatile impurities. Zhongjing Global Purification can provide consulting, planning, design, construction, construction, installation, transformation and other supporting services for GMP workshops and purification plants.
Vapor compression is the evaporation of water in the tube side of the evaporator, and the evaporation tubes are arranged horizontally or vertically. The horizontal design is generally the type of forced circulation through recirculation pumps and nozzles, while the vertical design is a natural circulation type. The main components are evaporator, compressor, heat exchanger, degasser, pump, valve, motor, instrument and control part, etc. In the hot-pressed distilled water machine, the feed water is evaporated on one side of the tube. , the generated steam passes through the separation space and then enters the compressor through the separation device. The pressure and temperature of the compressed steam are increased by the operation of the compressor, and then the high-energy steam is released back to the container of the evaporator and condenser, where The steam condenses and releases potential heat. This process is transferred to the water through the closure of the tubes. The more the water is heated and evaporated, the more steam is produced. Preheating the feed water saves energy, and since the potential heat is reused, there is no need for a separate condenser. The pure steam is sucked by the positive displacement compressor and compressed in the shell side of the main condenser, so that the temperature reaches 125-130 °C. There is a high temperature difference between the compressed steam and the boiling water, so that the steam is completely condensed and the boiling water is evaporated, and the heat of evaporation fully utilized.
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