biocellpharma

 The purified water skid  distribution system is usually composed of purified water storage tank, circulating pump, ultraviolet sterilizer, one or more circulating pipes and water using points. The disinfection method is pasteurization or ozone disinfection, so double tube plate heat exchanger or ozone generator is required. The volume of the purified water storage tank shall meet the peak flow of purified water and have a certain balance relationship with the water yield of the purified water preparation system. The flow of circulating pump shall be greater than the sum of peak flow and return flow. Online relevant instruments detect the water quality, and alarm can be given once the water quality exceeds the standard. Unqualified water shall be directly discharged or recycled back to the previous tank. Design Features of PW Tank/Skid ◆The design and manufacturing strictly comply with Chinese GMP, cGMP and FDA requirements. ◆Full drainage design ensures that the entire syste...

 The production capacity of water for injection with full membrane method is 500-30000L/H, which is used in medical, daily chemical and other industries. It uses the end ultrafiltration technology to remove heat source impurities on the basis of traditional purified water, so that the endotoxin index is lower than the standard requirements of the pharmacopoeia, providing a new, stable and reliable choice for the preparation of water for injection system for relevant enterprises. How Does The Cold WFI  Generation Systems Works? The RO system water treatment plant, combined with EDI module and ultrafiltration module, provides a robust production method of water for injection to produce cold WFI that meets the quality standards of the pharmacopoeia: The molecular weight of reverse osmosis membrane element is 100 Dalton, which can remove pyrogen and microorganism. EDI membrane stack can deeply remove ionizable substances that can reduce the conductivity of water through the com...

 RO EDI Plant 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, boron and total organic carbon plasma in RO water, greatly improving the quality of purified water. It is widely used in biotechnology, pharmacy and other industries that must generally comply with USP, EP，JP and ChP regulations. How Does RO EDI Plant  Works？ The reverse osmosis device with EDI (reverse osmosis electrodeionization) is the most preferred purified water preparation technology in the pharmaceutical, food and biotechnology industries. It is basically a combination of reverse osmosis and electrodeionization processes. In reverse osmosis EDI system, single-stage or two-stage reverse osmosis is used to pre desalinate EDI feed water, and then deeply electrodeionize RO production water through EDI to finally produce high-purity water required for applicatio...

 The wfi sanitary heat exchangers  (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. Structure Descri...

 The operation and maintenance of equipment shall be monitored and managed according to the requirements of verification and documents. Ensure that the operating parameters of the pharmaceutical water purification system  are within the range of operating parameters confirmed by the equipment. Types of Pharmaceutical Water Purification Systems 01 Water For Injection (WFI) Generation System Water for injection is distilled from purified water, and its indicators such as bacterial endotoxin meet the requirements of Water for Injection in the Chinese Pharmacopoeia. The water for injection equipment system mainly includes main modules such as water for injection preparation, circulating storage, dynamic distribution and process control. 02 Pure Steam Generation System(PS/CS) The pure steam system consists of a preparation unit and a distribution unit. Pure steam can be prepared by rising film evaporation and falling film evaporation. Pure steam generator usually uses industrial ...

The purified water/water for injection(WFI) combined distribution system is a kind of equipment integration device, which can fully convert and utilize resources and energy, greatly reduce production costs, save equipment floor space, and reduce equipment investment costs. At the same time, wfi skid can integrate the operation control system of the equipment, and the flow picture of the wfi skid  equipment can be freely switched and selected on the same operation interface. Key Criterias for PW distribution & WFI SKID ◆ The wfi skid has no stagnant conditions and areas of low flow rate. ◆ The wfi skid has temperature control. ◆ The wfi skid has proper slope of the pipeline to ensure drainability. ◆ Stainless steel surface finish with appropriate roughness in order to avoid nutrient and biofilm accumulation. ◆ No deadlegs area of the wfi skid. ◆ Periodic sanitisation or sterilisation of the storage tank and loop. ◆ The wfi skid has storage tank protected with 0.2 micron hydroph...