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Purified water plant in pharmaceutical industry
The materials used in the pipes of the Purified water plant in pharmaceutical industry should be non-toxic and corrosion-resistant. Commonly used materials are 304 stainless steel and 316L.
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There are many preparation methods for purified water, distillation, ion exchange, reverse osmosis, etc. are all applicable. Although the Pharmacopoeia does not clearly specify the specific preparation method, it is necessary to monitor each production link, control microorganisms, and ensure the water quality at the point of use. . In the pharmaceutical industry, purified water systems must undergo validation, including design validation, installation validation, operational validation, and performance validation, to demonstrate that the system can consistently and consistently produce water, and store and distribute purified water that meets pharmacopeia quality requirements.
purified water plant in pharmaceutical industry includes multiple units such as pretreatment, reverse osmosis, EDI, control, and disinfection, and each component needs to undergo strict process control.
The materials used in the pipes of the Purified water plant in pharmaceutical industry should be non-toxic and corrosion-resistant. Commonly used materials are 304 stainless steel and 316L.
The connection of each part of the system is preferably welded or clamped, followed by flange connection, and threaded connection is avoided. In particular, the parts in direct contact with purified water are automatically welded. Welding requires samples and records. After welding, pickling and passivation are performed to form a passivation film, and endoscopy is carried out according to the standard. The pipes should be sealed to prevent foreign matter from entering the inside of the pipes.
All pipelines in contact with purified water must meet the requirements of GMP 3D, and use PTPE rubber pads. The angle installation of the diaphragm valve is related to the size of the diaphragm valve. The installation slope of the circulation pipeline is 0.5%-5%, and the lowest point is set as the discharge point. . In addition, in order to facilitate the detection of effluent quality, sampling points should be set up in each pressure section.
In terms of valve selection, the parts in contact with purified water should use diaphragm valves instead of ball valves, and special valve groups should be strictly used according to the requirements of dead ends.
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