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WFI water system
Water for injection refers to water that complies with the provisions of the Pharmacopoeia under water for injection.
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Water for injection refers to water that complies with the provisions of the Pharmacopoeia under water for injection. WFI water system is water obtained by distillation of distilled water or deionized water, so it is also called double WFI water system. In order to effectively control microbial contamination and control the level of bacterial endotoxin at the same time, the design and manufacture of purified water and water for injection systems have two major characteristics: one is the increasing use of disinfection/sterilization facilities in the system; the other is the pipeline The distribution system has evolved from a traditional water supply pipeline to a circulating pipeline.
The preparation, WFI water system should prevent the growth and contamination of microorganisms. The materials used for storage tanks and conveying pipelines should be non-toxic and corrosion-resistant. Design and installation of pipelines should avoid dead ends and blind pipes. Cleaning and sterilization cycles should be specified for storage tanks and pipes. The vent of the water for injection storage tank should be equipped with a hydrophobic sterilizing filter that does not shed fibers. The storage of water for injection can be kept at a temperature above 80 °C, a heat preservation cycle above 70 °C, or stored at a temperature below 4 °C.
The pipes used in the pretreatment equipment of water for injection are generally made of ABS engineering plastics, but also PVC, PPR or other suitable materials. However, the distribution system of purified water and water for injection should use pipeline materials corresponding to chemical disinfection, pasteurization, thermal sterilization, etc., such as PVDF, ABS, PPR, etc., preferably stainless steel, especially 316L model. Stainless steel is a general term, strictly speaking, it is divided into two types: stainless steel and acid-resistant steel. Stainless steel is a steel that is resistant to corrosion by weak media such as atmosphere, steam and water, but is not resistant to corrosion by chemically aggressive media such as acid, alkali, and salt, and has stainless steel.
In addition, the influence of the flow velocity in the tube on the reproduction of microorganisms should also be considered. When the Reynolds number Re reaches 10,000 to form a stable flow, the environmental conditions unfavorable for the growth of microorganisms can be effectively created. On the contrary, if you do not pay attention to the details in the design and manufacture of the water system, resulting in too low flow rate, rough pipe wall or dead pipe in the pipeline, or choosing a valve with an unsuitable structure, it is entirely possible for microorganisms to rely on the objective factors caused by this. Condition, build its own hotbed-biofilm, which brings risks and troubles to the operation and daily management of purified water and water for injection systems.
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