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Pharmaceutical water classification
Publisher: Suzhou Huanke Pharmaceutical Equipment Technology Co., Ltd Time：2023-03-07 15:25:29 Number of clicks：380 Close
Pharmaceutical process books usually refer to drinking water, purified water, water for injection and sterilization water for injection four categories, then the pharmaceutical industry on water equipment and water quality index purification and what requirements?
I. Pharmaceutical water classification and water quality index
1, pharmaceutical water (process water: water, including drinking water, purified water, water injection) classification
1) Drinking water (drinking water) : tap water or deep well water, which is usually provided by the water supply company, or deep water, also known as raw water, whose quality must meet the national standard GB5749-85 "Sanitary Standard for Drinking Water".
2) Water by distillation, ion exchange, reverse osmosis or other suitable methods, without any additives. The purified water can be used as a solvent or test water for the preparation of common pharmaceutical preparations, but not for the preparation of pharmaceutical preparations.
The preparation of purified water by ion exchange, reverse osmosis and ultrafiltration is generally called deionized water. Pharmaceutical water purification equipment is designed with a special distillation process, the distillation process of distilled water is generally called distilled water.
3) Water for Injection: water is prepared by purifying water as raw water, distilled, condensed and cooled by a specially designed still, and then filtered by membrane. Water for injection can be used as a solvent for preparing injections
4) Sterile Water for Injection: Water prepared for injection in accordance with the sterile production process.
Sterilizing water for injection A solvent used to sterilize powder or a diluent for injection.
2, pharmaceutical water quality standards
1) Drinking water: It shall conform to the national standard of the People's Republic of China "Sanitary Standard for Drinking Water" (GB5749-85).
2) Purified water: It shall comply with the purified water standards contained in 2000 Chinese Pharmacopoeia.
In the process of water preparation, the resistivity value of purified water is usually detected online to reflect the concentration of various ions in the water. The electrical resistivity of purified water used in pharmaceutical industry should be ≥0.5 mω.cm /25℃, and that of purified water used for irrigation of injection and eye drop containers should be ≥1 mω.cm /25℃.
3) Water for injection: It shall meet the water for injection standards listed in 2000 Chinese Pharmacopoeia.
2. GMP requirements for pharmaceutical water preparation devices
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.
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Suzhou Huanke Pharmaceutical Equipment Technology Co., Ltd.     
Suzhou Chenglang Cleaning Equipment Co., Ltd. Contact: Zhang Gong Tel：15150275957 Email：285145232@qq.com Company website： http://www.szhuanke.com Add：No. 366, Jinxian Road, Jinjiaba Town, Wujiang District, Suzhou City, Jiangsu Province Su ICP No. 2022043966-1

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