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Classification of pharmaceutical water and water quality indicators
1. Classification of pharmaceutical water
1) Drinking Water: Tap water or deep well water, which is usually provided by the water supply company, or deep water, also called raw water.
2) Purified Water: Water is made 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 preparing common pharmaceutical preparations, but cannot be used for preparation of preparations.
Purified water is prepared by ion exchange, reverse osmosis, ultrafiltration, etc., generally called deionized water. Pharmaceutical purified water equipment is designed with a special distillation method. The distillation process of distilled water is generally called distilled water.
3) Water for Injection: It is water prepared by using purified water as raw water, distilled, condensed and cooled by a specially designed distiller, and then filtered through a membrane.
Water for injection can be used as a solvent for preparing injections.
4) Sterile Water for Injection: water for injection prepared according to the injection production process.
Sterilized water for injection is used as a solvent for sterilizing powder or as a diluent for injection.
2. Water quality standards for pharmaceutical water
1) Drinking water: should meet the sanitary standards of drinking water
2) Purified water: should meet the purified water standard.
In the water production process, online detection of the resistivity value of purified water is usually used to reflect the concentration of various ions in the water. The electrical resistivity of purified water in the pharmaceutical industry should generally be ≥0.5MΩ.CM/25℃, and the electrical resistivity of purified water used for rinsing injections and eye drops containers should be ≥1MΩ.CM/25℃.
Water for injection: It should meet the standards for water for injection.
GMP requirements for pharmaceutical water preparation equipment
1. The structural design should be simple, reliable, and easy to disassemble and assemble.
2. In order to facilitate the disassembly, replacement, and cleaning of parts, the design of the actuator adopts standardized, universal and systematic parts as far as possible.
3. The inner and outer wall surfaces of the equipment should be smooth and flat, free of dead corners, and easy to clean and sterilize. The surface of the parts should be treated with chrome plating to resist corrosion and prevent rust. Avoid using paint on the outside of the equipment to prevent peeling.
4. The equipment for preparing purified water should use low-carbon stainless steel or other materials that have been verified to not pollute water quality. The equipment for preparing purified water should be cleaned regularly and the cleaning effect should be verified.
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