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GMP WFI system
GMP is the basic rule for the management of pharmaceutical production enterprises in my country. Water for injection as a raw material for large-volume injections and small-volume injections, especially sterile preparations, has high requirements.
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GMP is the basic rule for the management of pharmaceutical production enterprises in my country. Water for injection as a raw material for large-volume injections and small-volume injections, especially sterile preparations, has high requirements.GMP WFI system
In GMP, there are very detailed regulations on the storage and distribution of water for injection: the preparation, storage and distribution of water produced by water for injection equipment should be able to prevent the growth and pollution 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 of 80 or more, a cycle of 65 or more, or less than 4.
In order to ensure the sterility requirements of water produced by water for injection equipment and avoid the breeding ground for bacteria, first of all, certain requirements must be met on the hardware, such as storage tanks and circulation pipes are made of 316L stainless steel, and the inner wall is electropolished and passivated; water A 0.22μm hydrophobic sterilizing filter (respirator) is installed on the tank and can be heated and sterilized; it can withstand 121 high temperature disinfection; the drain valve adopts a guard-grade 316L stainless steel diaphragm valve; the water for injection is stored and circulated according to GMP standards. These requirements are now met by pharmaceutical companies, especially those of liquid preparations.
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