Preparation of process water in GMP clean workshop
Preparation of process water in GMP clean workshop
The purified water of GMP clean pharmaceutical cleanroom is water prepared by ion exchange method, reverse osmosis method, distillation method or other suitable methods, and does not contain any additives. The source of purified water is drinking water. Treatment, such as flocculation, filtration, adsorption, etc., to ensure purification...
Text label: GMP clean workshop, GMP purification workshop, water preparation for clean pharmaceutical cleanroom
GMP clean workshop process water preparation
The purified water of GMP clean pharmaceutical cleanroom is water prepared by ion exchange method, reverse osmosis method, distillation method or other suitable methods, and does not contain any additives. The source of purified water is drinking water. Treatment, such as flocculation, filtration, adsorption, etc., to ensure the normal operation of purified water equipment. There are two processes for the preparation of water for injection, one is prepared by distillation from purified water as raw material, and the other is prepared from drinking water as raw material through reverse osmosis, filtration, sterilization and other processes.
When the water production of the particle exchange column is below 5m3/h, it is usually made of plexiglass. The ratio of the column height to the column diameter is 5-10. When the water production volume is large, the material is mostly steel-lined rubber or composite glass fiber reinforced plastic. Plexiglass, its height-diameter ratio is 2-5; the height of the resin layer accounts for about 60% of the height of the cylinder, the upper sewage outlet is used to discharge air during the working period, and is used for sewage during regeneration and backwashing, and the lower sewage outlet is used before work. It is used to introduce compressed air to loosen the resin, and it is used for sewage discharge during positive washing; the operation of the ion exchange column can be divided into 4 steps, water production, backwashing, regeneration, and positive washing. When the resin is exchanged and balanced, it will lose Replacement capacity, the production needs to be stopped at this time, and the resin is activated and regenerated. The cationic resin needs to be regenerated with 5% hydrochloric acid solution, and the anion resin needs to be regenerated with 5% sodium hydroxide.
The electrodialyzer is composed of anion and cation exchange membrane, separator, polar plate, pressing device and other components. Under the action of an external DC electric field, the selective permeability of the ion exchange membrane to the ions in the solution is used, and the anion in the chamber solution , cations undergo ion migration, and pass through the anion and cation exchange membranes to achieve desalination or concentration; both ends of the electrodialyzer are electrodes, and the electrode chamber, concentration chamber and thin chamber are all made of 2mm thick separators. Membrane; the assembly method of electrodialyzer is represented by 'stage' and 'sectionThe combination with the number of stages is determined by the amount of water produced and the water quality. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean workshops and purification workshops.
Reverse osmosis is actually to remove impurities through a semi-permeable membrane to obtain pure water. Usually osmosis is the natural infiltration of a concentrated solution to a dilute solution, but here it relies on the external pressure to make the raw water in the raw water. Water permeates through the membrane, and impurities are blocked by the membrane, and the concentration of impurities in the raw water will become higher and higher, so it is called reverse osmosis; the structure of reverse osmosis device is exactly the same as that of general microporous membrane filtration device, but it requires higher pressure. Therefore, the structural strength requirements are high and the water permeability is low, so the membrane area per unit volume in the reverse osmosis device is generally larger; compared with the roll type module, the hollow fiber reverse osmosis membrane module has a large inner membrane area per unit volume and a compact structure. , low working pressure, small size of equipment, long life, no pollution, etc., but the price of components is high, it is difficult to decontaminate the membrane when the membrane is blocked, the water pretreatment requirements are strict, and the membrane cannot be replaced and repaired once it is damaged; During osmotic operation, the permeability coefficients of water and salt increase with the increase of temperature. If the temperature is too high, it will cause the compaction of the membrane or cause the hydrolysis of the membrane. Therefore, it is advisable to operate at 20-30 °C; It increases with the increase of pressure. The operating pressure should be determined according to the content of salts, the water permeability of the membrane and the recovery rate of water, which is generally 2.5-7MPa; Concentration polarization, resistance increases, water permeability decreases, and even causes salt to precipitate on the membrane surface. For this reason, it is necessary to increase the influent flow rate to maintain a turbulent state.
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