Water quality standards
Purified water production indicators
Chemical indicators: in line with< r>Pharmacopoeia of the People's Republic of China
Requirements for pharmaceutical purified water
Hygiene inspection: microorganisms/
Endotoxin/
Conductivity/ (resistivity*)
Automatic control, simple and convenient operation
Complete set of equipment Made of all stainless steel, the water tank is an all-stainless steel medical water tank
Equipped with a water softener to ensure the stable operation of the R system and the system due to the influence of hardness
It adopts imported Hyde energy ultra-low pressure reverse osmosis, with high desalination rate and long service life. long, stable operation, low energy consumption and reduced %
The reverse osmosis system is controlled in a fully automatic manner, and the main components are imported components, with high stability and simple and convenient operation
The system adopts a constant pressure regulation system to ensure water quality Stable
It adopts authentic and original imported membrane stacks with stable performance and long service life. Through professional technology, it ensures that the water quality remains stable when the system is shut down for a short time or for a long time
The flow meter adopts an imported flow meter, which can prevent Damage to the membrane stack due to blockage of the concentrated water channel or other equipment failures caused by no concentrated water production
The system is equipped with< r> ultraviolet sterilization
and a membrane filter to ensure stable water quality
With various device safety functions such as anhydrous protection and high and low pressure protection
All water tanks use purified water and special water tanks, and are equipped with pressure level gauges, rotating spray cleaning and air breathing devices
Equipped Ozone sterilization ensures quality and quantity, and is designed with optimal configuration.
Requirements for pharmaceutical purified water preparation equipment
The structural design should be simple, reliable and easy to disassemble and assemble.
In order to facilitate disassembly, replacement and cleaning of parts, the design of the actuator uses standardized, universal and systematic parts as much as possible.
The surfaces of the inner and outer walls of the equipment must be smooth and flat without dead corners, making them easy to clean and sterilize. The surface of the parts should be treated with chrome plating to resist corrosion and prevent rust. Avoid using paint on the outside of the equipment to prevent it from peeling.
Purified water preparation equipment should use low-carbon stainless steel or other materials that have been verified not to pollute water quality. Equipment for preparing purified water should be cleaned regularly and the cleaning effect verified.
The materials in contact with water for injection must be high-quality low-carbon stainless steel or other materials that have been verified not to pollute water quality. Equipment for preparing water for injection should be cleaned regularly and the cleaning effect verified.
The purified water storage period should not be longer than an hour, and the storage tank should be made of stainless steel or other materials that have been verified to be non-toxic, corrosion-resistant, and do not leak out polluting ions. To protect the vent, a hydrophobic sterilizing filter that does not shed fibers should be installed. The inner wall of the storage tank should be smooth, and there should be no dead corners and trachoma in the pipes and welds. Sensors that display parameters such as liquid surface temperature and pressure that will not cause stagnant water pollution should be used. Storage tanks must be cleaned, disinfected and sterilized regularly, and the cleaning and sterilization effects must be verified.
Pharmaceutical water transportation
) Purified water and pharmaceutical water should be transported by stainless steel pumps that are easy to disassemble, clean and disinfect. Where purified water and water for injection need to be delivered by compressed air or nitrogen, the compressed air and nitrogen must be purified.
) Purified water should be transported through circulation pipelines. The pipeline design should be simple and blind pipes and dead ends should be avoided. Pipelines should be made of stainless steel pipes or other pipes that have been verified to be non-toxic, corrosion-resistant and non-leaking of polluting ions. The valve should be a sanitary valve without dead ends, and the flow direction should be marked when transporting purified water.
) Pipeline pumps used to transport purified water and water for injection should be regularly cleaned, disinfected and sterilized, and can only be put into use after passing the verification.
The design of pressure vessels must be undertaken by licensed units and qualified personnel, and must be in accordance with the national standards of the People's Republic of China
(B) and pressure vessel safety technical supervision Comply with the relevant provisions of the regulations.
Technical requirements for purified water equipment
The system adopts fully automatic control (manual control can also be used), and the automatic backwash regeneration program can be set during operation
One-level reverse osmosis and< r>Secondary reverse osmosis
It is equipped with a return pipeline, and the reverse osmosis equipment is equipped with a chemical cleaning device and a disinfection device
There is a regulating device between the first-level reverse osmosis and the second-level reverse osmosis to ensure the conductivity of the water produced by the equipment The rate meets the requirements of the Pharmacopoeia
The secondary reverse osmosis membrane uses a positively charged anti-pollution reverse osmosis membrane to ensure the long-term stable operation of the reverse osmosis equipment
The primary reverse osmosis pipeline is made of stainless steel, and the secondary reverse osmosis pipeline is made of stainless steel. The penetration is made of stainless steel
Online conductivity detection instruments are installed in the first-stage reverse osmosis and second-stage reverse osmosis equipment, and the conductivity of the produced water can be viewed at any time
Low-pressure protection is provided before the first-stage reverse osmosis Switch, there are low-pressure protection and high-pressure protection switches before the second-level reverse osmosis
The water recovery rate of the first-level and second-level reverse osmosis can be adjusted, the recovery rate of the first-level reverse osmosis is %%, and the recovery rate of the second-level reverse osmosis is %
The pre-treatment devices all use original imported parts and the pipes between the pre-treatment equipment are made of pipes.
The purified water storage tank is equipped with a breathing filter, and the delivery pipeline is equipped with an ultraviolet sterilizer and a microporous filter to ensure that the pure water meets hygienic requirements.
Purified water equipment process flow
Raw water raw water pressure pump multi-media filter activated carbon filter water softener (or anti-scaling dosing device) precision filter first-stage reverse osmosis adjustment intermediate water tank (Optional) Second-stage reverse osmosis (reverse osmosis membrane surface is positively charged) purified water tank pure water pump ultraviolet sterilizer microporous filter water point
Purified water equipment
< r>Multi-media filter< br/>
Multi-media filter tanks are mostly filled with filter materials such as quartz sand, anthracite and manganese sand. Its main function is to reduce water turbidity and remove a large number of bacteria, viruses and organic matter in the water. This creates favorable conditions for the subsequent disinfection process. Manganese sand has a significant effect on removing iron and manganese.
Purified water equipment
< r>Activated carbon filter
Activated carbon has a large number of micropores and a huge specific surface area, and has extremely strong physical adsorption capacity. It can very effectively absorb impurities in water, especially organic matter and microorganisms. The oxygen-containing catalytic oxidation and chemical adsorption functions formed on the surface of activated carbon can remove part of the metal ions in the water. Activated carbon has a strong adsorption effect on residual chlorine remaining in the water to protect downstream stainless steel equipment and pipeline surfaces and meet the water inlet requirements of subsequent water treatment units.
Purified water equipment
< r>Automatic backflush regeneration softening tank
The softening tank is filled with sodium-type cation exchange resin. Through the ion exchange reaction of the resin, it reduces the hardness of water and prevents calcium and magnesium ions from combining with carbonate and sulfate ions to cause scaling in subsequent water treatment equipment or pipelines.
Purified water equipment
< r>Precision filter
Precision filter is also called security filter, and its filtration accuracy is generally . Its function is to intercept all substances larger than the particle size to meet the water entry requirements of reverse osmosis.
Purified water equipment
< r>Reverse osmosis
The key to the application of reverse osmosis technology lies in the performance of the reverse osmosis membrane that removes salt. A reverse osmosis membrane is a semi-permeable membrane that only allows water molecules to pass through but does not allow solutes to pass through. In addition to applying the principles of reverse osmosis and reverse osmosis, reverse osmosis technology also utilizes the selective adsorption of membranes and the screening mechanism for organic matter. Most reverse osmosis membranes have pore sizes of less than or equal to 100%, and their separation objects are organic matter in the solution that is in the ionic range and has a molecular weight of several hundred. It can filter out various bacteria, such as Pseudomonas aeruginosa (), one of the smallest bacteria, and can also filter out various viruses, such as influenza virus (), meningitis virus (), and pyrogens (~). This is an issue of great concern for pharmaceutical water.
Due to the simple operation process of reverse osmosis and its high desalination efficiency, it also has high pyrogen removal ability when used in pharmaceutical process water. It is also relatively economical and has become the preferred water treatment unit in pharmaceutical water process. Reverse osmosis technology is not only used in the preparation process of purified water, but also can produce water with the quality of water for injection. The United States Pharmacopoeia has included this method as one of the legal methods for preparing water for injection since the 19th edition. 1
Purified water equipment
< r> Sterilization system
Oxygen and ultraviolet light are combined in an orderly manner for disinfection/sterilization. Ozone is a strong oxidant, and its oxidizing ability ranks second among natural elements after fluorine. Ozone can oxidize and decompose the glucose oxidase necessary for oxidizing glucose within bacteria. It can also directly interact with bacterial viruses, destroy cell ribonucleic acid, decompose macromolecule polymers such as R proteins, lipids and polysaccharides, and enable bacterial material metabolism and growth. and the reproductive process is disrupted. In water treatment, it has significant effects on deodorizing, decolorizing, sterilizing, removing ferromanganese phenol cyanide and reducing B, etc. Ultraviolet light can reduce the formation rate of new colonies in the pretreatment system of the water system. The ultraviolet lamp located after the ozone can be used for disinfection and removal of ozone residues at the same time.
B Circulation backflow to prevent bacterial growth. In the purified water system, the pretreatment system, water production system and water use system are respectively equipped with circulating water channels. During holidays or when no water is used at night, when the purified water tank is full and the conductivity of the outlet water exceeds the standard, the water in each system maintains a certain degree of Cycle, supplemented by UV or ozone/UV sterilization if necessary to prevent bacterial growth.
Purified water equipment
Application fields
Purified water equipment is mainly used for production water for medical large-scale infusion, pharmaceutical preparations, biological preparations, etc., genetic engineering dialysis and other water use.
After-sales service
The company implements one-year warranty and lifetime warranty for each set of equipment provided. It has a complete parts library, provides all spare parts, and provides users with relevant Suppliers/manufacturers of equipment and consumable materials
Within one year from the date of acceptance of the equipment, unless there are force majeure factors such as man-made or natural disasters, if the water output fails due to quality problems of the equipment itself, Our company will be responsible for free repair or replacement. Maintenance services after the free maintenance service period will only be charged a reasonable cost.
Before the equipment is debugged and delivered for use, complete operation and maintenance procedures will be provided to customers, free operation and maintenance training will be provided, and a service engineer will be stationed on site to follow and operate the service day after day
During the annual warranty period, service engineers are dispatched every month to check the operating status of the equipment on site, and make irregular phone calls to visit the operating status of the equipment. Outside the warranty period, after-sales service engineers and technicians make regular visits to equipment users, regularly check operation records, and collect feedback information and guidance. Assist users to solve related problems.
Provide users with relevant technical consultation and rational suggestions for reducing operating costs
According to the equipment condition, if our company receives a repair notification, it can be solved by phone, and it needs to be on site within hours. solve.