Water for injection system
Release date: November 27, 2019 11:54:03
1、 Brief introduction of water for injection system
Water for injection refers to water conforming to the provisions of water for injection in Chinese Pharmacopoeia. Water for injection is distilled water or deionized distilled water, so distilled water is weighed. In order to effectively control microbial contamination and control the level of bacterial endotoxin at the same time, there are two characteristics in the design and manufacture of purified water and water for injection systems: one is that more and more disinfection / sterilization facilities are used in the system; the other is that disinfection / sterilization facilities are used more and more in the system piping The distribution system has evolved from the traditional water supply pipeline to the circulating pipeline.
The preparation, storage and distribution of water for injection should prevent microbial growth and contamination. The materials used in storage tanks and pipelines shall be non-toxic and corrosion-resistant. Dead angle and blind pipe shall be avoided in design and installation of pipeline. The cleaning and sterilization cycle of storage tank and pipeline shall be specified. The air vent of water for injection tank shall be equipped with hydrophobic sterilization filter without fiber shedding. The water for injection can be stored above 80 ℃, 70 ℃ or below 4 ℃.
2、 Water for injection system distribution
The pipeline used for pretreatment equipment of water for injection system is generally used ABS engineering plastics PVC, PPR or other suitable materials are also used. However, the distribution system of purified water and water for injection should adopt Chemical disinfection 、 pasteurization 、 Heat sterilization Stainless steel is the best choice for piping materials such as PVDF, ABS and PPR, especially 316L. Stainless steel is the general term, strictly speaking, it is divided into stainless steel and acid resistant steel. Stainless steel is resistant to atmospheric, steam and water corrosion of weak medium, but not acid, alkali, salt and other chemical corrosive medium corrosion steel, and has rust resistance. In accordance with the "Chinese Pharmacopoeia" and the strict distribution of water for injection system in 2010, water for injection must be distributed according to the scientific method.
3、 Characteristics of water for injection system:
According to the requirements of 2010 edition of Chinese pharmacopoeia for injection water preparation system, as well as the water quality situation of China Pharmaceutical Industry and all parts of the country, our company independently developed and produced "Huiyuan" series of water for injection preparation system with stable effluent quality and high cost performance, and can customize the water for injection preparation system according to customer requirements to meet the GMP certification requirements.
Structure of water for injection system : falling film evaporation, spiral separation, built-in preheating, double tubesheet structure, to minimize dead water
Water for injection system materials All heat exchange tubes are seamless tubes without forged parts
Water for injection system processing : automatic argon arc welding, whole distillation tower pickling and passivation
Water for injection system testing : air tightness test
Water for injection system control Based on years of experience, our company has developed the automatic control system of water for injection preparation system, which adopts fully automatic control equipment for automatic operation, cleaning, online detection, etc., and the core components are of famous brands at home and abroad
4、 The water for injection system includes the following equipment:
1. Plate heat exchanger Plate type heat exchanger is a new type of high efficiency heat exchanger composed of a series of corrugated metal sheets.
2. Pure steam generator Pure steam generator uses deionized water (distilled water) as raw material. The heat source is boiler steam or electric heating to produce pure steam without pyrogen, which is used to disinfect pipelines, storage tanks and various sterilization equipment.
3. Electric multi effect distilled water machine Electric multi effect distilled water machine is a special equipment for producing distilled water with electric energy. The distilled water produced meets the requirements of "water for injection" in Pharmacopoeia of the people's Republic of China (2005 Edition), and can also lead out pure steam for sterilization and disinfection. It is the most ideal distilled water and pure steam production equipment for pharmaceutical factories, hospitals and biochemical research departments without steam boilers.
Note: Pharmacopoeia of the people's Republic of China, hereinafter referred to as "Chinese Pharmacopoeia". The National Pharmacopoeia Committee (formerly known as the Pharmacopoeia Committee of the Ministry of health, founded in 1950) is responsible for the compilation of the Pharmacopoeia of the people's Republic of China and the formulation and revision of the national drug standards according to the provisions of the drug administration law of the people's Republic of China. Pharmacopoeia of the people's Republic of China was published on July 5, 2012 by the Ministry of Health (No. 12, 2012), which specifies that the first supplement of the 2010 edition of the Pharmacopoeia of the people's Republic of China shall be implemented from October 1, 2012. At present, the first supplement of Pharmacopoeia of the people's Republic of China (2010 Edition) (hereinafter referred to as the "supplement") has been compiled by the State Pharmacopoeia Committee and published exclusively by China Pharmaceutical Science and Technology Press.