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WFI equipment
WFI equipment can be obtained by distillation method, reverse osmosis method, ultra-filter method, etc. Various countries have made very clear regulations on the production method of water for injection.
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WFI equipment can be obtained by distillation method, reverse osmosis method, ultra-filter method, etc. Various countries have made very clear regulations on the production method of water for injection, such as:
①The United States Pharmacopoeia (24th Edition) stipulates that "water for injection must be purified by distillation or reverse osmosis from drinking water that meets the legal requirements of the United States Environmental Protection Association or the European Community or Japan."
②The European Pharmacopoeia (1997 edition) stipulates that "Water for injection is obtained by appropriate distillation of drinking water or purified water that meets legal standards.
③The Chinese Pharmacopoeia (2000 edition) stipulates that "this product (water for injection) is water obtained by distillation of purified water".
It can be seen that the purified water for injection water is the preferred method recognized in the world, and the clean steam can be obtained by the same distilled water machine or a separate clean steam generator.
The distillation method has a good effect on the removal of inactive organic and inorganic substances in raw water, including suspended solids, colloids, bacteria, viruses, pyrogens and other impurities. Factors such as the structure, performance, metal material, operation method and raw water quality of the distilled water machine will affect the quality of water for injection. The "multi-effect" of the multi-effect distilled water machine is mainly to save energy, and the heat energy can be used reasonably many times. The key component of the distilled water machine to remove the pyrogen is the steam-water separator.
The requirements for the distilled water machine are:
①Multi-effect distilled water machine or clean steam generator made of 316L pharmaceutical grade stainless steel;
② Electropolishing (240 grains) and passivation treatment;
③ Equipped with instruments for measuring, recording and automatic control of conductivity, and automatically turns to drainage when the conductivity exceeds the set value.
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