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Pharmaceutical water requirements

Publisher: Suzhou Huanke Pharmaceutical Equipment Technology Co., Ltd Time:2023-03-07 15:19:04 Number of clicks:282 Close

1, the structure design should be simple, reliable, easy to disassemble and assemble.

2. In order to facilitate disassembly, replacement and cleaning of parts, the design of actuator adopts standardized, universal and systematic parts as far as possible.


3. The surface of the inner and outer walls of the equipment should be smooth and flat, without dead corners, easy to clean and sterilize. The surface of the parts should be chrome plating and other surface treatment, in order to resist corrosion and prevent rust. Avoid paint on the outside of the equipment to prevent flaking.


4, the preparation of purified water equipment should be used low carbon stainless steel or other certified does not pollute the water quality of the material. The equipment for preparing purified water should be cleaned regularly, and the cleaning effect should be verified.


5. The materials contacted by water for injection must be high-quality low-carbon stainless steel (such as 316L stainless steel) or other materials that have been proven not to pollute the water quality. The equipment preparing water for injection should be cleaned regularly, and the cleaning effect should be verified.

6, purified water storage cycle should not be more than 24 hours, the storage tank should be made of stainless steel materials or other materials that are proven non-toxic, corrosion resistant and do not leak contaminated ions. To protect its vent, a hydrophobic sterilizing filter that does not shed fibers should be installed. The inner wall of the storage tank should be smooth, and there should be no dead Angle and trachoma in the nozzle and weld. Sensors showing liquid level, temperature, pressure and other parameters that do not cause stagnant water pollution should be used. The storage tank should be cleaned, disinfected and sterilized regularly, and the effect of cleaning and sterilizing should be verified.

7. Pharmaceutical water delivery

1) Pharmaceutical purified water equipment should be easy to clean, sterilized stainless steel pump. When compressed air or nitrogen pressure is used, water and water purification water are used in injection, compressed air and nitrogen for purification.
2) Purified water should be transported through circulating pipes. Pipeline design should be concise, should avoid blindness and death. Pipes shall be made of stainless steel pipes or other pipes, non-toxic, corrosion-resistant, corrosion-free and pollution-free. Valve should use no dead Angle of the health valve, the transmission of pure water should be marked flow.
3) The injection pipe that provides purified water and water, and the conveying pump should be cleaned regularly, disinfected and sterilized, and can be put into use after verification.
4) The design of pressure vessels shall be conducted by the unit and licensed qualified personnel in accordance with the relevant provisions of the National Standard for steel pressure vessels of the People's Republic of China (gb150-80) and safety technical supervision regulations for pressure vessels.