Selection guide of pharmaceutical water equipment system

1、 The special requirements of pharmaceutical water equipment system the basic characteristics of the equipment selected in pharmaceutical water system are not much different from those of non pharmaceutical water system For example, the basic function of purified water equipment is basically the same as that of other industries The pharmaceutical water system only has its special requirements on the control of microorganisms, and the water treatment equipment used in the purified water system all around the requirements of microorganisms in the control system 1 Special requirements for pure steam system equipment: pure steam equipment shall be able to produce pure steam with the same water quality index as water for injection first The pressure of pure steam can meet the pressure and temperature requirements of sterilization equipment or wet heat sterilization of system pipeline on the basis of overcoming the resistance of pipeline system When the pure steam equipment and pipeline are not used, they can be isolated from the atmosphere and will not be polluted by the microorganism in the air As for pure steam equipment and distilled water machine, the heat exchange part of the distiller shall be able to prevent the pollution of pure steam caused by the leakage of cooling water 2 The special requirements for the equipment of WFI system are similar to those of purified water system, and more stringent Water for injection system pays special attention to the control of microbial indicators The main equipment in the injection water system is distilled water machine, storage tank, sanitary delivery pump, valve and delivery pipeline For these equipment or parts, the special requirements of the WFI system are almost harsh compared with the purified water system The main principle is to control the quality of the distilled water The distilled water machine can sterilize itself to prevent the possible cross contamination between the distilled water and the cooling water of the distilled water machine The sanitary management of the water pump, the detention and breeding of the system pipeline to the microorganism, the pure steam sterilization of the system, etc 3 Special requirements for purified water system equipment for purified water system, microbial control in water treatment process is always throughout the whole treatment process For example, if the activated carbon filter or softener is used in the system, the organics intercepted on the upper flow side of the filter will continue to increase due to the adsorption of the activated carbon If there is no corresponding sterilization measures to periodically disinfect the activated carbon filter and reduce the biological load on the upper flow side of the activated carbon filter, after a period of use, although the activated carbon filter The function of carbon filter itself (reducing residual chlorine and removing organics) does not decrease, but because of the accumulation of organics on the upstream side, the index of microorganism in the water after using the activated carbon filter will exceed the index of influent before treatment For another example, the finished product storage tank and water distribution pipeline of purified water should be provided with measures for microbial disinfection on a regular basis Therefore, according to the functions and characteristics of the water treatment equipment used in the process purified water system, this paper should focus on the control and reduction of microbial pollution In addition, the manufacturing materials of the equipment should be properly selected according to the selected disinfection methods For example, if the method of heat treatment (pasteurization or steam sterilization) is adopted, the materials for manufacturing the activated carbon filter or softener shall be heat-resistant materials, such as stainless steel; when the chemical disinfectant (ozone or hydrogen peroxide) is adopted, the materials for manufacturing the equipment may not consider the problem of temperature resistance, but consider the problem of corrosion-resistant life of the equipment instead The purified water equipment shall also have the characteristics of no stagnant water section, all equipment shall have the ability to vent the residual water inside the system, and the water outside the system will not flow back to the system to generate pollution In a word, purified water treatment equipment and system pipelines shall be able to prevent pollution and regularly disinfect, reduce biological load or restore to the level with biological load Kerui purified water equipment system adopts current advanced RO and EDI purified water process, and the quality of produced water meets the requirements of customers' production water, GMP, FDA and other certification requirements The whole system is humanized design, modular installation, small floor area, simple and convenient operation, stable operation and energy saving 2、 Water for injection and purified water for medicine The difference between purified water and water for injection is also in the water preparation process There are various options for the preparation process of purified water, but there are limited conditions for the preparation process of water for injection in Pharmacopoeia of various countries For example, the United States Pharmacopoeia clearly stipulates that the preparation process of water for injection can only be distillation and reverse osmosis, while the Chinese Pharmacopoeia stipulates that the production process of water for injection must be distillation These are the necessary conditions for each country to ensure the quality of WFI according to its actual situation.