Sterile Water For Injection
What is sterile water for injection?
Sterilized water for injection is indicated as a solvent for sterilized powder for injection or as a diluent for injection solution or as a rinse for endoscopic surgery in various departments. It is a colorless clear liquid; odorless and tasteless.
Sterile water
Sterile water is characterized as water that is free of all microorganisms such as spores, fungi, or bacteria. Sterile water also plays a vital role in medical research. If ordinary water is used in laboratory experiments, it can become contaminated and invalidate the results of laboratory studies. The use of sterile water avoids this risk and its role in medical research is invaluable.
Sterile water is not the same as distilled water, and sterile water should not be confused with distilled water. Distilled water is produced by a process of steam and condensation and does not contain any minerals, such as salt, calcium, or iron. A further distinction should be made between sterile water and saline solutions. Sterile saline contains 0.9% sodium chloride and is used for wound irrigation and cleansing. Saline solution or sodium chloride rinse USP is commonly used for wound irrigation and cleansing due to safety and low toxicity levels.
Water for injection
Water for injection refers to the water that conforms to the provisions of the Chinese Pharmacopoeia under water for injection.
The preparation, storage, and distribution of water for injection should prevent the breeding and contamination of microorganisms. The materials used in the storage tank and transmission pipeline should be non-toxic and corrosion-resistant. The design and installation of pipelines should avoid dead ends and blind pipes. Storage tanks and pipelines should be a specified cleaning and sterilization cycle. The vent of the injection water storage tank should be installed with a hydrophobic sterilization filter that does not shed fibers. The storage of water for injection can be insulated above 80℃, circulated above 70℃, or stored below 4℃.
The pipes used for the pretreatment equipment of water for injection are generally made of ABS engineering plastic, and PVC, PPR, or other suitable materials are also used. However, the distribution system of purified water and water for injection should use piping materials corresponding to chemical disinfection, pasteurization, and thermal sterilization, such as PVDF, ABS, PPR, etc. It is better to use stainless steel, especially since the 316L model is the best. Stainless steel is a general term, strictly speaking, divided into two kinds of stainless steel and acid-resistant steel. Stainless steel is resistant to corrosion of weak media such as atmosphere, steam, and water, but not resistant to acid, alkali, salt, and other chemically aggressive media corrosion of steel, and on the stainless.
Feature of water for injection
To effectively control microbial contamination and at the same time control the level of bacterial endotoxins, two major features have emerged in the design and manufacture of purified water and water for injection systems: first, the increasing use of disinfection/sterilization facilities in the system; and second, the evolution of the piping distribution system from traditional delivery lines to recirculation lines.
In addition, the effect of the flow rate in the tube on microbial growth has to be taken into account. When the Reynolds number Re reached 10,000 forms a stable flow, in order to effectively create adverse environmental conditions for microbial growth. On the contrary, if no attention is paid to the details of the design and manufacture of the water system, resulting in low flow velocities, rough walls or blind pipes, or the selection of valves with unsuitable structures, microorganisms may rely on the objective conditions thus created to build their own hotbeds – biofilms, which bring risks and problems to the operation and daily management of purified water and water for injection systems.
Requirement of water for injection
The injection water system is composed of water treatment equipment, storage equipment, distribution pumps, and pipe networks. There is the possibility of external contamination of the water system by the raw water and the external causes of the water system, and the contamination of the raw water is the most important external source of contamination of the water system. U.S. Pharmacopoeia, European Pharmacopoeia, and Chinese Pharmacopoeia are clearly required to pharmaceutical water at least the raw water to meet the quality standards of drinking water. If not up to drinking water standards, the first pre-purification measures should be taken. As E. coli is water quality suffered obvious signs of contamination, so international drinking water for E. coli is a clear requirement. Other contaminated bacteria are not subdivided, in the standard to “total bacteria”, China’s total bacteria limit of 100 / ml, which indicates that the drinking water standards in line with the original water also have microbial contamination, and the contamination of the water system is mainly Gram-negative bacteria. Others such as the exhaust port of the storage tank without protective measures or the use of poor quality gas filters, water backflow from the contaminated outlet can also lead to external pollution.
In addition, in the preparation and operation of the water system, there is also internal contamination. Internal pollution and water pollution system design, selection of materials, operation, maintenance, storage, use, and other factors are closely related. A variety of water treatment equipment may become the internal source of microbial contamination, such as raw water microorganisms adsorbed on the surface of activated carbon, deionization resin, membrane, and other equipment, the formation of biofilm, living in the biofilm microorganisms are protected by biofilm, general disinfectants do not work on it. Another source of contamination is found in the distribution system. Microorganisms can generate colonies on pipe surfaces, valves, and other areas and multiply there, forming biofilms that can become persistent sources of contamination. This is why some companies have more stringent standards for the design of their water production systems.
Requirements for pretreatment equipment
a. The pretreatment equipment of purified water can be equipped according to the raw water quality, which is required to reach the drinking water standard first.
b. Multi-media filters and water softeners are required to be able to automatically backflush, regenerate and discharge.
c. Activated carbon filter for the concentration of organic matter, in order to prevent bacteria, and bacterial endotoxin pollution, in addition to the requirement to be able to automatically backflush, but also available steam disinfection.
d. Because the light intensity of UV excitation at 255nm wavelength is inversely proportional to time, it is required to have a meter for recording time and light intensity meter, and its water dipping part is made of 316L stainless steel, and the quartz lampshade should be removable.
e. The purified water after passing through the mixed bed deionizer must be circulated to make the water quality stable. But the mixed bed can only remove the anion and cation in the water and is ineffective in removing the thermogenic.
Requirements for water for injection (clean steam) production equipment
Water for injection can be obtained by distillation, reverse osmosis, ultra-filter method, etc. The growth methods of water for injection in various countries are very clearly defined as follows.
a. The United States Pharmacopoeia (24th edition) stipulates that “water for injection must be obtained by distillation or reverse osmosis purification of drinking water in accordance with the legal requirements of the United States Environmental Protection Association or the European Community or Japan”.
b. European Pharmacopoeia (1997 edition) stipulates that “water for injection is obtained by distillation of drinking water or purified water by appropriate methods in accordance with legal standards.
c. Chinese Pharmacopoeia (2000 edition) stipulates that “this product (water for injection) is obtained by distillation of purified water”.
It can be seen that water for injection is obtained by distillation of purified water, which is the preferred method recognized worldwide, while clean steam can be obtained from the same distillation machine or a separate clean steam generator.
The distillation method does not play a sexual organic, inorganic substances in raw water, including suspended matter, colloid, bacteria, viruses, thermogenic and other impurities have a very good removal effect. The structure, performance, metal material, operation method, and raw water quality of the water distillation machine will affect the quality of water for injection. The “multi-effect” multi-effect water distillation machine is mainly energy saving, and the heat can be used reasonably many times. The key component of a water distillation machine to remove thermogenesis is the steam-water separator.
Requirement for water storage containers (storage tanks)
The overall requirements of the water storage container are to prevent the formation of biofilm, reduce corrosion and facilitate the disinfection of the tank with chemicals; the tank should be sealed, and the internal surface should be smooth, which helps thermal and chemical disinfection and can prevent the formation of biofilm.
Storage tank to compensate for changes in water level, there are usually two methods: one is the use of respirators; another method is the use of a nitrogen-filled self-control system, in the peak of water consumption, the amount of nitrogen sent by the sterile filter automatically increase to ensure that the storage tank can maintain positive pressure, the amount of water sent automatically reduce, but still maintain a small positive pressure outside the storage tank, the advantage of this is to prevent the rise of oxygen content in the water, to prevent Carbon dioxide into the storage tank and can prevent microbial contamination.
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