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Medical purified water equipment
Name: Medical purified water equipment
Custom processing: Yes Operating pressure: 0.8 (Mpa)
Water resistivity: 18.2
Water output: 15T / H
Dimensions: 650 * 90 * 170 (cm)
Voltage: 380 (V)
Water quality: 600
Power: 200000 (w)
Desalination rate: 98.0 (%)
Stand-alone output: 15T (/ h)
制取规范 Preparation of medical purified water equipment
Classification of pharmaceutical water and water quality indicators 1. Pharmaceutical water (process water: water used in pharmaceutical production process, including drinking water, purified water, water for injection) Classification:
1) Drinking water (Potable-Water): It is usually tap water or deep well water supplied by a water company, also known as raw water, and its quality must meet the national standard GB5749-85 "Sanitary Standard for Drinking Water". According to the 2000 Chinese Pharmacopoeia, drinking water cannot be used directly as a preparation or test water for preparations.
2) Purified Water: It is the pharmaceutical water made from raw water by distillation, ion exchange, reverse osmosis or other suitable methods, without any additives. Purified water can be used as a solvent or test water for the preparation of common pharmaceutical preparations, and should not be used for the preparation of injectables. Purified water prepared by non-heat treatment such as ion exchange method, reverse osmosis method, ultrafiltration method is generally also called deionized water. Purified water prepared by distillation using a specially designed distiller is generally called distilled water. 。 Therefore, purified water equipment is also called deionized water equipment .
3) Water for Injection: Water obtained by purifying water as raw water, distilling it through a specially designed distiller, condensing and cooling, and filtering through a membrane. Water for injection can be used as a solvent for the preparation of injections.
4) Sterile Water for Injection: Water prepared for injection water according to the production process of injection. Sterile water for injection is a solvent or thinner for sterilizing powders.
2. Water quality standards for pharmaceutical water 1) Drinking water: should comply with the national standard of the People's Republic of China "Sanitary Standards for Drinking Water" (GB5749-85)
2) Purified water: It should meet the standards for purified water contained in the 2000 Chinese Pharmacopoeia. In the water production process, the online measurement of the resistivity of purified water is usually used to reflect the concentration of various ions in the water. The resistivity of purified water in the pharmaceutical industry is usually ≥0.5MΩ.CM / 25 ¡ã C. The resistivity of purified water for injection and eye drops container washing should be ≥1MΩ.CM / 25 ¡ã C.
3) Water for injection: It should meet the standards for water for injection contained in the 2000 Chinese Pharmacopoeia.
GMP requirements for water purification equipment for purified water equipment for pharmaceutical use
1. The structural design should be simple, reliable, and easy to disassemble.
2. In order to facilitate disassembly, replacement, and cleaning of parts, the design of the actuator is standardized, generalized and systematic parts as much as possible.
3. The surface of the inner and outer walls of the device must be smooth and flat, without dead corners, and easy to clean and sterilize. The surface of parts should be treated with chrome plating to prevent corrosion and prevent rust. Avoid paint on the outside of the device to prevent it from peeling.
应采用低碳不锈钢或其他经验证不污染水质的材料。 4. Preparation of purified water equipment should use low carbon stainless steel or other materials that have been verified not to pollute water quality. Purified water equipment should be cleaned regularly and the cleaning effect verified.
5. The materials in contact with water for injection must be high-quality low-carbon stainless steel (such as 316L stainless steel) or other materials that have been verified not to cause water pollution. Equipment for the preparation of water for injection should be cleaned regularly and the cleaning effect verified.
6. The storage period of purified water should not be longer than 24 hours, and its storage tank should be made of stainless steel or other materials that have been verified to be non-toxic, corrosion-resistant, and not to leak out pollution ions. A hydrophobic sterilizing filter should be installed to protect the air vent. The inner wall of the storage tank shall be smooth, and there shall be no dead ends or trachoma in the connection and welds. Sensors that display parameters such as liquid level, temperature, and pressure that do not form contaminated water should be used. Storage tanks shall be regularly cleaned, disinfected and sterilized, and the cleaning and sterilization effects shall be verified.
7. Transportation of pharmaceutical water 1) Purified water and pharmaceutical water should be transported by stainless steel pumps that are easy to disassemble, clean and disinfect. Where purified water and water for injection need to be delivered with compressed air or nitrogen pressure, the compressed air and nitrogen must be purified.
2) The purified water should be transported by circulating pipes. The piping design should be simple, and blind pipes and dead ends should be avoided. The piping shall be stainless steel pipe or other pipes that have been verified to be non-toxic, corrosion-resistant, and not to leak out polluted ions. The valve should be a sanitary valve without dead corners. The flow direction of purified water should be indicated.
3) The pipelines and pumps that transport purified water and water for injection should be cleaned, disinfected and sterilized regularly.
8. The design of the pressure vessel must be undertaken by a licensed unit and qualified personnel, and must be handled in accordance with the relevant provisions of the National Standard of the People's Republic of China "Steel Pressure Vessel" (GB150-80) and "Safety Technology Supervision Regulations for Pressure Vessel". .
Medical purified water equipment
Typical purified water preparation system reverse osmosis method:
The technology of preparing pure water by reverse osmosis is a new technology developed in the 1960s. Because of its simple operation process, the salt and heat removal efficiency is high, and it is relatively economical. This method has been included in the 19th edition of the United States Pharmacopeia and is one of the legal methods for preparing water for injection.
Water quality standards for purified water equipment:
Ammonia≤0.3μg / ml
Nitrate ≤0.06μg / ml
Heavy metal ≤0.5μg / ml
Microorganisms 10CFU / 100ml
Endotoxin 0.25EU / ml
Application scope of purified water equipment:
Production engineering water for medical infusions, pharmaceutical preparations, biological preparations, genetic engineering, and renal dialysis.
Medical purified water equipment related: GMP certified purified water equipment of pharmaceutical factory
This equipment is produced by Henan Zhonglan Water Treatment Engineering Co., Ltd., with high stability and moderate price. 、直饮水设备、 超纯水设备 、软化水设备、纯化水设备、矿泉水设备、 污水处理设备及水处理设备配件耗材，欢迎致电或来访参观。 The company's main pure water equipment , direct drinking water equipment, ultra-pure water equipment , demineralized water equipment, purified water equipment, mineral water equipment, sewage treatment equipment and water treatment equipment accessories consumables, please call or visit.