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Pharmaceutical Water generation systems
In the inspection of drug GMP, Pharmaceutical water generation systems is often a focus of quality inspection.
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Pharmaceutical Water generation systems
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In the inspection of drug GMP, Pharmaceutical water generation systems is often a focus of quality inspection. GMP stipulates that the preparation, storage and distribution of purified water shall prevent the growth of microorganisms. Pharmacopoeia requires that the microbial limit of purified water is not higher than 100/ml. There are many ways to control the number of microorganisms in purified water within the qualified limit, and pasteurization is a commonly used disinfection method.
Because pathogens are not heat-resistant, pasteurization mainly uses this property to heat the liquid to a specific temperature and maintain it for a period of time, thereby killing the pathogen. The core equipment of the pasteurization system is a heat exchanger, which uses steam or electric heating as the heat source. The disinfection medium can be purified water, or the purified water in the storage tank can be heated by a jacket as a sterilizer. Usually, the water temperature is controlled. above 80°C. This disinfection method is more environmentally friendly, low cost, safe and effective, and has excellent verifiability and disinfection effect, so it is often used in the disinfection of purified water systems.
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