#pharmaceutical #purified #water #systems <br>The sanitary wfi heat exchanger (sterile double tube plate heat exchanger) is designed to work under the working conditions with the highest sanitary requirements, and the double tube plate structure design is adopted. The port of the heat exchanger adopts quick installation or flange structure, which effectively avoids the retention of liquid medicine at the connection between the heat exchanger and the pipeline, realizes the real full emptying design, and also makes the equipment disassembly convenient. The unique design of double tube sheet makes it easy to completely empty and keep the heat exchange tube clean, which can ensure the complete separation of the shell side and tube side media, without internal welding points, and effectively eliminate the cross contamination between products and heat exchange media. It is not polluted and can detect leakage, thus avoiding the risk of cross contamination of conventional heat exchanger. <br> <br>Structure Description of Sanitary Heat Exchanger <br>Double tubesheet structure: <br> <br>This series of sanitary shell and tube heat exchanger adopt double tubesheet structure design, so that the tube side and shell side are connected by their own tubesheet respectively, breaking the traditional of tube heat exchangers, where the tube side and shell side share the same connecting tubesheet, so as to minimize the risk of cross contamination, facilitate the timely discovery of potential leakage, and ensure the safe production of users. <br> <br>Full emptying design: <br>the heat exchange tubes are 316L sanitary pipes with smooth surface, straight structure, no dead corners, convenient and thorough cleaning, and the lowest point of the equipment is equipped with an emptying valve, which is conducive to the emptying of materials, cleaning water and condensate after online sterilization. The full emptying design avoids dead corners at the product contact parts, prevents the growth of microorganisms, and is easy to clean and sterilize. <br> <br>Material and surface treatment: <br>this series of heat exchanger is made of 316L stainless steel, or the material required by customers. The roughness coefficient of the inner surface of the pipe in contact with the material is from 0.25 - 0.4 μ m. <br> <br>For more information about pharmaceutical purified water systems, please feel free to contact us! <br> <br> <br> <br>[a]https%3A%2F%2Fwww.biocell-pharma.com%2Fproducts%2Fsanitary-heat-exchanger%2F[/a]

#purified #water #distribution #system <br> <br>[a]https%3A%2F%2Fwww.biocell-pharma.com%2Fproducts%2Fpurified-water-system%2F[/a] <br> <br> <br>Purified Water (PW) System <br>Pharmaceutical purified water systems adopt the latest processes such as reverse osmosis and EDI. Purified water system pharmaceutical designs a complete set of purified water process in a targeted manner. The quality of purified water for pharmaceutical manufacturing meets the requirements of the current USP, EP, JP and ChP for purified water. <br> <br>Pretreatment is mainly used to remove particles that may damage the film and free chlorine. The reverse osmosis process is to separate and remove the soluble solids, organics, colloidal substances and bacteria in the water by using the semipermeable spiral membrane. The raw water is sent to and passes through the reverse osmosis membrane under a certain pressure. The water passes through the tiny pore diameter on the membrane and is collected to obtain pure water. Different impurities are concentrated in the intercepting liquid and discharged. RO can remove more than 96% of dissolved solids, more than 99% of organic matters and colloids, and almost 100% of bacteria from raw water. <br> <br>EDI electromigration removal salt is to use the high voltage of electrodes at both ends of the module to move charged ions in water, and cooperate with ion exchange resin and selective resin membrane to accelerate the removal of ions, so as to achieve the purpose of water purification. During EDI desalination, ions are removed by ion exchange membrane under the action of electric field. At the same time, water molecules generate hydrogen ions and hydroxide ions under the action of electric field, which continuously regenerate the ion exchange resin to keep the ion exchange resin in the best state. <br> <br>Degassing membranes are widely used to remove oxygen and carbon dioxide from water. <br> <br>TYPES OF PURIFIED WATER SYSTEM IN PHARMACEUTICAL INDUSTRY <br>Water Pre-treatment <br>Based on the quality of different raw water, we are committed to providing customers with customized solutions. Modular design is adopted, with reasonable and compact structure, beautiful appearance a... <br> <br>Pharmaceutical Reverse Osmosis System <br>With RO membrane separation technology as the core, it adopts automatic control, integrated design, modular installation, low energy consumption and small floor area. Double pipeline water supply and ... <br> <br>RO Plant With EDI <br>The combination of reverse osmosis and EDI has overcome the deficiency that reverse osmosis effluent cannot be deeply desalted, and further removed trace carbon dioxide, residual salt, silicon dioxide... <br> <br>EDI Water Treatment <br>EDI module is usually placed behind the reverse osmosis system, which not only overcomes the lack of deep desalination of reverse osmosis effluent, but also further removes trace carbon dioxide, resid... <br> <br>FACTORS AFFECTING THE LIFE OF PURIFIED WATER SYSTEM <br>Due to the difference of user&#039;s raw water quality, the required purified water process plans will also be quite different (the system can achieve online pasteurization of pretreatment devices; reverse osmosis membranes and EDI modules can choose normal temperature and resistant pasteurization membranes according to requirements; pre-treatment devices can choose to add scale inhibitors or softeners according to requirements; users have high requirements for TOC indicators, and can choose UF (ultrafiltration) to remove TOC at the water production terminal). Based on years of design and practical experience, Biocell has not only been able to design purified water equipment more in line with users&#039; needs, but also developed a purified water energy conservation and emission reduction process scheme with higher recovery rate for users. <br> <br>Factors Affecting The Life of Purified Water System <br>WHY CHOOSE BIOCELL PW WATER GENGERATION SYSTEM? <br> <br>01 <br>Standardized and systematic parts are convenient for disassembly, maintenance and cleaning of equipment. <br> <br>02 <br>Automatic control is carried out through the terminal control system, and a humanized operation display system is configured to facilitate users to intuitively understand various data and adjust setting parameters. <br> <br>03 <br>The status of flushing, water shortage, full water, maintenance, etc. will be displayed on the purified water operation display system according to the actual situation, and the user will be reminded through the audible and visual alarm system. <br> <br>04 <br>The purified water generator has many unique functions, such as three-level password protection, fault shutdown alarm (manual reset is required), high and low pressure protection, automatic flushing, dual pipe water supply, etc. <br> <br>If you want to know more details of water system pharmaceutical industry, please visit our website.

#purified #water #system <br> <br>[a]https%3A%2F%2Fwww.biocell-pharma.com%2Fproducts%2Fpurified-water-storage-and-distribution-system%2F[/a] <br> <br> <br>PW/WFI Storage &amp; Distribution Systems <br>The purified water distribution system is the core unit of the whole pharmaceutical water system, and its main function is to ensure that the pressure, flow and temperature delivered to the process pipeline meet the process production requirements. The system uses online monitoring instruments such as flow, pressure, temperature, conductivity and TOC to conduct safety performance, real-time monitoring and trend analysis of water quality, and effectively control the load of microorganisms in water through periodic disinfection or sterilization. In addition, sampling valves shall be installed on the water supply starting point, water pipeline and end pipeline of the entire distribution system for water quality sampling. The whole system is mainly composed of inverter, exchanger, sampling valve, diaphragm valve, sanitary pipe fittings, online monitoring instrument and other supporting control systems. <br> <br>PW Tank/Skid <br>The purified water storage tank is manufactured according to the GMP certification requirements, and the tank body is vertical or horizontal. <br> <br>WFI Tank/Skid <br>The storage tank is mainly used for the storage of water for injection. Meet the requirements of GMP for water for injection storage tank. <br> <br>PW/WFI Skid <br>The liquid medicine storage and distribution system includes a storage part and a distribution part. The design of pharmaceutical water distribution system has various forms, and its basic idea is to minimize the operational risk and microbial risk at a reasonable cost. <br> <br>GENERAL PRINCIPLES OF PHARMACEUTICAL WATER STORAGE &amp; DISTRIBUTION SYSTEMS <br>The storage and distribution system of pharmaceutical water includes storage unit, distribution unit and water point pipe network unit. The design of pharmaceutical water distribution system has various forms, and the basic idea is to minimize the operation risk and microbial risk at a reasonable cost. <br> <br>The storage unit is used to store pharmaceutical water meeting the requirements of the pharmacopoeia and meet the maximum peak consumption requirements of the system. The storage system must maintain the quality of water supply, so as to ensure that the quality of the end use of the product is qualified. <br> <br>Circulating design is adopted for the pharmaceutical water supply pipeline.The main function of the distribution system is to deliver pharmaceutical water meeting the requirements of the Pharmacopoeia to the process water point, and ensure that its pressure, flow and temperature meet the requirements of process production or cleaning. <br> <br>The storage and distribution units need to be disinfected regularly to reduce the possibility of microbial breeding. <br> <br>HOW IS WATER SYSTEM DISTRIBUTED? <br> <br>01 <br>PW storage and distribution system <br>Purified water generation and distribution system must be disinfected regularly. Automatic control mode is recommended. The common disinfection methods for purified water storage and distribution system are as follows: 1. Pasteurization; 2. Ozone disinfection <br> <br>02 <br>WFI storage and distribution system <br>WFI storage and distribution systems must be sterilized regularly. Automatic control mode is recommended. Common sterilization methods of wfi storage and distribution system are as follows: 1. Pure steam sterilization; 2. Sterilization with superheated water <br> <br>If you want to know more details of water system in pharmaceutical industry, please visit our website.

#pure #steam #generation #system <br> <br>[a]https%3A%2F%2Fwww.biocell-pharma.com%2Fpurified-water-system-for-pharmaceutical-use%2F[/a] <br> <br> <br>Water System for Pharmaceutical Use <br>In the pharmaceutical industry, Biocell provides professional solutions for purified water system in pharma, water for injection system, pure steam system, storage and distribution system in terms of water demand for medical infusion, injection, freeze-dried powder injection, oral liquid, solid preparation and other dosage forms. <br> <br>PURIFIED WATER SYSTEMS IN PHARMACEUTICAL INDUSTRY <br>They are individually customized based on the feed water quality and the production requirements. A variety of optional equipments are available with all units and the instrumentation can be adapted to clients&#039; in-hose standards. The software programs are developed to follow the GAMP guidelines. <br> <br>CASE STUDY OF WATER SYSTEMS IN PHARMACEUTICAL INDUSTRY <br>Oral Liquid Dosage Forms Pharmaceutical Water Systems <br>Oral Liquid Dosage Forms (PW) <br>Oral liquid is a clear liquid preparation for oral use, which uses purified water as the solvent and contains one or more drug components. The drug is dissolved in a suitable solvent. <br> <br>Solid Dosage Forms Pharmaceutical Water Systems <br>Solid Dosage Forms (PW) <br>Purified water is the process water used in the production of solid preparations, usually used for ingredients or cleaning. The quality of purified water is directly related to the quality of drugs produced. <br> <br>Large Volume Parenteral, LVP (WFI System) <br>Large Volume Parenteral, LVP (WFI) <br>Large volume injection is commonly known as large infusion, which usually refers to liquid sterilization preparations with a capacity of 50 ml or more that are directly injected into the body by intravenous drip. Water for injection is the most widely used process raw material in the production of large infusion and participates in the entire production process, including the dissolution of raw and auxiliary materials, volume determination and preparation with finished products, equipment and system cleaning, etc. <br> <br>Powder for injection (WFI Water System) <br>Powder for Injection (WFI) <br>The freeze-dried powder injection is a preparation made by dissolving the medicinal ingredients with water for injection, preparing a solution of a certain concentration, sub packaging it in containers such as ampoules or vials, freezing it under low temperature in a sterile and closed environment, and then sublimating the water for injection in the product by reducing the ambient pressure and slowly increasing the product temperature, leaving a solid form of loose blocky or powder drugs. When using, it is necessary to add water for injection to dissolve the drug into solution and then use it for injection or infusion to treat diseases. <br> <br>water system for pharmaceutical use <br>Sterilization Of Clean Vessels And Piping Systems (PS) <br>Pure steam sterilization can kill all microorganisms and is a very thorough sterilization method. For high-temperature resistant individuals that cannot be effectively killed by conventional disinfection and sterilization methods, such as bacterial spores, fungal spores or dormant bodies, pure steam sterilization can completely kill these organisms. The steam temperature of sterilization increases with the increase of steam pressure. When the steam pressure is increased, the sterilization time can be greatly shortened. At present, for the water system, the pure steam sterilization parameters are usually set to 121 ℃ and 30 min sterilization time. <br> <br>pharmaceutical water systems <br>Humidification Of Air In Clean Rooms (PS) <br>The pure steam used for humidification of HVAC system in key process posts can prevent amine and hydrazine impurities in the steam, which will seriously pollute drugs. <br> <br>PURIFIED WATER METHODS USED IN THE PHARMACEUTICAL INDUSTRY <br>Water is the most widely used raw material in the pharmaceutical industry. <br> <br>Pharmaceutical water mainly includes purified water, water for injection and pure steam. <br> <br>Water for injection and pure steam are used in many areas of the pharmaceutical industry. Pure steam is mainly used to disinfect products in process tanks, filters, piping systems and sterilizers, and also for air humidification in clean room systems. Water for injection is used for the production of drugs and intermediates, as well as the final cleaning of equipment. <br> <br>The purified water system based on reverse osmosis and EDI module adopts the latest technology, such as thermal disinfection. According to the raw water quality and production requirements, the most suitable purified water preparation process and equipment are customized for different working conditions. <br> <br>All devices have a variety of optional components, instruments and meters can be adjusted according to the specific needs of customers, and equipment control software programs are designed and developed according to GAMP validation guidelines.

#exchanger <br> <br>[a]https%3A%2F%2Fwww.biocell-pharma.com%2Fproducts%2Fsanitary-heat-exchanger%2F[/a] <br>SANITARY HEAT EXCHANGER <br>The wfi sanitary heat exchanger (sterile double tube plate heat exchanger) is designed to work under the working conditions with the highest sanitary requirements, and the double tube plate structure design is adopted. The port of the wfi heat exchanger adopts quick installation or flange structure, which effectively avoids the retention of liquid medicine at the connection between the heat exchanger and the pipeline, realizes the real full emptying design, and also makes the equipment disassembly convenient. The unique design of double tube sheet makes it easy to completely empty and keep the wfi heat exchange tube clean, which can ensure the complete separation of the shell side and tube side media, without internal welding points, and effectively eliminate the cross contamination between products and wfi heat exchange media. It is not polluted and can detect leakage, thus avoiding the risk of cross contamination of conventional wfi heat exchanger. <br> <br>Technical Data of Sanitary Heat Exchanger <br>Heat Exchange Area 0.5—15m2 <br>Design Temperature max 165℃ <br>Design Press max 1.6MPa <br>Surface Treatment Ra=0.25—0.5。 <br>Soldering standard EN-288-3,EN287-1 <br>Mounting Type Horizontal or vertical installation. <br> <br>OPERATING PRINCIPLES OF SANITARY HEAT EXCHANGER <br>Operating Principles of Sanitary Heat Exchanger <br>Working Principle <br> <br>The material flows through the inside of the sanitary heat exchange tube, <br> <br>Pharmaceutical Water Systems <br> <br> <br> <br>and the refrigerant or heat medium flows through the outside of the heat exchange tube in the opposite direction. The end of the heat exchange tube is fastened with double tube plates, and serves as a leakage monitoring point to prevent the two-way cross contamination of the material and heat exchange medium. <br> <br>STRUCTURE DESCRIPTION OF SANITARY HEAT EXCHANGER <br>Structure Description of Sanitary Heat Exchanger <br>Double tubesheet structure: <br> <br>This series of heat exchangers adopt double tubesheet structure design, so that the tube side and shell side are connected by their own tubesheet respectively, breaking the traditional of tube heat exchangers, where the tube side and shell side share the same connecting tubesheet, so as to minimize the risk of cross contamination, facilitate the timely discovery of potential leakage, and ensure the safe production of users. <br> <br>Full emptying design: <br> <br>the heat exchange tubes are 316L sanitary pipes with smooth surface, straight structure, no dead corners, convenient and thorough cleaning, and the lowest point of the equipment is equipped with an emptying valve, which is conducive to the emptying of materials, cleaning water and condensate after online sterilization. The full emptying design avoids dead corners at the product contact parts, prevents the growth of microorganisms, and is easy to clean and sterilize. <br> <br>Material and surface treatment: <br> <br>this series of heat exchanger is made of 316L stainless steel, or the material required by customers. The roughness coefficient of the inner surface of the pipe in contact with the material is from 0.25 - 0.4 μ m. <br> <br>OPERATING PRINCIPLES OF SANITARY HEAT EXCHANGER <br>FEATURES OF SANITARY HEAT EXCHANGER <br>1. <br>The heat exchange tube is made of 316L seamless steel pipe. <br> <br>2. <br>Double tube sheet design eliminates cross contamination. <br> <br>3. <br>The tubesheet is forged and the tubesheet thickness exceeds 10mm. <br> <br>4. <br>There is no dead angle at the product contact side and it is completely drained. <br> <br>5. <br>There is no dead space in the heat exchange channel. <br> <br>6. <br>It can be installed vertically or horizontally. <br> <br>7. <br>Product side quick installation interface, shell side flange connection. <br> <br>8. <br>It can be designed and manufactured according to the special technical requirements of customers. <br> <br>9. <br>Design and manufacture according to GMP requirements. <br> <br>10. <br>Provide validation documents for double tube sheet heat exchanger. <br> <br>APPLICATION OF SANITARY HEAT EXCHANGER <br>1. <br>Cooling/heating of water for injection. <br> <br>2. <br>Sterilization of water for injection system by superheated water. <br> <br>3. <br>Temperature rise and cooling of purified water. <br> <br>4. <br>Pasteurization of purified water system. <br> <br>5. <br>Pure steam condensation and cooling. <br> <br>6. <br>Temperature control of highly clean liquid. <br> <br>7. <br>Cooling/heating of liquid medicine. <br> <br>8. <br>Cooling and heating of vaccines and blood products. <br> <br>Biocell offers equipment and engineering system of generation, storage and distribution of purified water, water for injection, pure steam as well as ultra-pure water purification system pharmaceutical industry and also cosmetic and food &amp; beverage industries.

#pharmaceuticals <br> <br>[a]https%3A%2F%2Fwww.biocell-pharma.com%2Fproducts%2Fpurified-water-system%2F[/a] <br> <br>Purified water system for pharmaceuticals adopts the latest processes such as reverse osmosis and EDI. Purified water generation and distribution system designs a complete set of purified water process in a targeted manner. The quality of water system in pharma company meets the requirements of the current USP, EP, JP and ChP for purified water. <br> <br>Pretreatment is mainly used to remove particles that may damage the film and free chlorine. The reverse osmosis process is to separate and remove the soluble solids, organics, colloidal substances and bacteria in the water by using the semipermeable spiral membrane. The raw water is sent to and passes through the reverse osmosis membrane under a certain pressure. The water passes through the tiny pore diameter on the membrane and is collected to obtain pure water. Different impurities are concentrated in the intercepting liquid and discharged. RO can remove more than 96% of dissolved solids, more than 99% of organic matters and colloids, and almost 100% of bacteria from raw water. <br> <br>EDI electromigration removal salt is to use the high voltage of electrodes at both ends of the module to move charged ions in water, and cooperate with ion exchange resin and selective resin membrane to accelerate the removal of ions, so as to achieve the purpose of water purification. During EDI desalination, ions are removed by ion exchange membrane under the action of electric field. At the same time, water molecules generate hydrogen ions and hydroxide ions under the action of electric field, which continuously regenerate the ion exchange resin to keep the ion exchange resin in the best state. <br> <br>Degassing membranes are widely used to remove oxygen and carbon dioxide from water. <br> <br>TYPES OF PURIFIED WATER SYSTEM IN PHARMACEUTICAL INDUSTRY <br>EDI PLANT WATER TREATMENT <br>Water Pre-treatment <br>Based on the quality of different raw water, we are committed to providing customers with customized solutions. Modular design is adopted, with reasonable and compact structure, beautiful appearance a... <br> <br>Pharmaceutical Reverse Osmosis System <br>With RO membrane separation technology as the core, it adopts automatic control, integrated design, modular installation, low energy consumption and small floor area. Double pipeline water supply and ... <br> <br>RO Plant With EDI <br>The combination of reverse osmosis and EDI has overcome the deficiency that reverse osmosis effluent cannot be deeply desalted, and further removed trace carbon dioxide, residual salt, silicon dioxide... <br> <br>EDI PLANT WATER TREATMENT <br>EDI module is usually placed behind the reverse osmosis system, which not only overcomes the lack of deep desalination of reverse osmosis effluent, but also further removes trace carbon dioxide, resid... <br> <br>FACTORS AFFECTING THE LIFE OF PURIFIED WATER SYSTEM <br>Due to the difference of user&#039;s raw water quality, the required purified water process plans will also be quite different (the system can achieve online pasteurization of pretreatment devices; reverse osmosis membranes and EDI modules can choose normal temperature and resistant pasteurization membranes according to requirements; pre-treatment devices can choose to add scale inhibitors or softeners according to requirements; users have high requirements for TOC indicators, and can choose UF (ultrafiltration) to remove TOC at the water production terminal). Based on years of design and practical experience, Biocell has not only been able to design purified water equipment more in line with users&#039; needs, but also developed a purified water energy conservation and emission reduction process scheme with higher recovery rate for users. <br> <br>Factors Affecting The Life of Purified Water System <br>Why Choose BIOCELL Purified Water Generation System in Pharmaceutical Industry? <br> <br>01 <br>Standardized and systematic parts are convenient for disassembly, maintenance and cleaning of equipment. <br> <br>02 <br>Automatic control is carried out through the terminal control system, and a humanized operation display system is configured to facilitate users to intuitively understand various data and adjust setting parameters. <br> <br>03 <br>The status of flushing, water shortage, full water, maintenance, etc. will be displayed on the purified water operation display system according to the actual situation, and the user will be reminded through the audible and visual alarm system. <br> <br>04 <br>The purified water generator has many unique functions, such as three-level password protection, fault shutdown alarm (manual reset is required), high and low pressure protection, automatic flushing, dual pipe water supply, etc. <br> <br>If you want to know more details of water system pharmaceutical industry, please visit our website.