Production process of water for injection in GMP workshop
Production process of water for injection in GMP pharmaceutical cleanroom
The water for injection in the GMP pharmaceutical cleanroom is distilled water or deionized water obtained by distillation; the single distilled water device has a simple structure and is mainly composed of an evaporation pot, a defoaming device, a waste gas discharger and a condenser. The single-effect distilled water device can remove non-volatile Organic and inorganic impurities, such as suspensions, glue...
Text label: GMP workshop, water injection production process
Production process of water for injection in GMP workshop
The water for injection in the GMP workshop is distilled water or deionized water obtained by distillation; the single distilled water device has a simple structure and is mainly composed of an evaporation pot, a defoaming device, a waste gas discharger and a condenser. The single-effect distilled water device can remove non-volatile Organic and inorganic impurities, such as suspensions, colloids, bacteria, heat sources, etc., are distilled once, and the effluent can only be used as purified water. The output is small and electric heating is suitable for occasions without gas source. The multi-effect distilled water device is composed of multiple single-effect distilled water devices. According to the assembly method, it can be divided into vertical series connection type and horizontal series connection type multi-effect distilled water device.
Vertical series multi-effect distilled water device is a three-effect distilled water device, which is composed of 3 single-effect distilled water devices. The feeding method is three-effect parallel feeding. The liquid foam entrained in the secondary distillation; in the three-effect distillation process, the heat source is fully utilized, and the condensation of water vapor and the preheating of deionized water are organically combined to achieve the purpose of comprehensive utilization of heat, saving energy consumption costs, Economic indicators are good. The horizontal series-connected multi-effect distilled water device is composed of several single-effect mode distilled water devices connected in series. and other components; commonly used in the pharmaceutical industry is a horizontally-connected four-effect distilled water device, which is composed of 4 membrane-type distilled water devices connected in series horizontally. In the distilled water device, the secondary steam is introduced into the next effect to make heating steam Using, a hairpin heat exchanger between the heating chamber tubes is used to heat the feed water. The pneumatic distilled water device is mainly composed of an evaporative condenser and a compressor, as well as auxiliary equipment such as a heat exchanger and a pump; the working principle is to heat the raw water, make it boil and vaporize, generate secondary steam, and compress the secondary steam The pressure and temperature rise at the same time, and then the compressed steam is condensed. The condensate is the prepared distilled water, and the latent heat released by the steam condensation is used as the heat source for heating the raw water. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and sterile workshops.
The production process of water for injection ion exchange resin method in GMP workshop is: tap water→multi-media filter→cation exchange column→anion exchange column→mixed resin column→membrane filtration→multi-effect distilled water device or pressure distilled water device→hot water storage device → water for injection. The production process of reverse osmosis ion exchange resin method is: tap water→multimedia filter→membrane filtration→reverse osmosis→cation exchange column→anion exchange column→mixed resin column→membrane filtration→UV sterilization→water storage→multi-effect distilled water device Or pneumatic distilled water device → hot water storage device → water for injection.
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