Preparation of purified water in GMP pharmaceutical cleanroom
The raw water pretreatment device in GMP workshop is generally composed of raw water pump, multi-media filter, activated carbon filter, precision filter and water softener; the multi-media filter is mostly filled with quartz sand, etc., mainly through mechanical filtration and adsorption. , to remove solid impurities such as suspended solids in water...
Text label: GMP workshop design, GMP workshop engineering company, purified water preparation
Preparation of purified water in GMP workshop
The raw water pretreatment device in GMP pharmaceutical cleanroom is generally composed of raw water pump, multi-media filter, activated carbon filter, precision filter and water softener; the multi-media filter is mostly filled with quartz sand, etc., mainly through mechanical filtration and adsorption. , remove suspended solids and other solid impurities in the water, reduce the turbidity of the water, and the bacteria and organic matter in the water can also be removed in large quantities with the reduction of the turbidity; the activated carbon filter has a strong physical adsorption capacity, which can effectively adsorb water. The impurities, especially organics and microorganisms, also have a good adsorption effect on the residual chlorine in the water; the function of the precision filter is to intercept all substances with a particle size larger than 5 μm to meet the influent requirements of electrodialysis, reverse osmosis and particle exchange. ; Ion exchange is one of the basic methods of raw water treatment. The ion exchange resin is used to remove the yin and yang particles in the dissolved salts, minerals and dissolved gases in the water. The advantage of ion exchange treatment of raw water is that all water has high chemical purity, The equipment is simple, the fuel and cooling water are saved, and the cost is low, but the microorganisms and personnel are not easy to remove, and the ion exchange resin needs to be regenerated or replaced regularly.
Reverse osmosis is a membrane separation operation that uses pressure difference as the driving force to remove dissolved salts in water by using a semi-permeable membrane; the semi-permeable membranes commonly used in reverse osmosis include cellulose acetate membrane and polyamide membrane, generally a The first-stage reverse osmosis device can remove 90%-95% of monovalent ions, 98%-99% of divalent ions, and can also remove microorganisms; the structure of reverse osmosis device is the same as that of general microporous membrane The pressure is generally 2.5-7MPa, so the structural requirements are high; due to the low rate of water permeation through the membrane, the membrane area per unit volume in the reverse osmosis device is generally larger, so the reverse osmosis devices used in the industry are mostly spiral. Coiled and hollow fiber structures. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and sterile workshops.
Distillation is the most classic and reliable method for preparing water for injection. Distillation removes various volatile and non-volatile substances by repeating the evaporation and condensation process, including heat pumps, inorganic salts, organic salts, soluble polymer materials, etc.; The quality of the obtained water for injection is closely related to the water source, the treatment of the raw water, the material structure of the distiller and the storage of the water. A part of the first distilled water is properly discarded, and it can be formally collected after the inspection is passed. When collecting, care should be taken to prevent dust and other dirt from falling into it. It is best to use a collection system with a sterile filter device, and seal it at above 80 °C or after sterilization. save.
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