Main application

The purified water is mainly used for high demand water standard such as electronics, medicine, health products, food and so on.The raw water needs to meet the drinking water standard. After filtration, reverse osmosis (RO), sterilization and other processes, the purified water is pumped to the water point through external transportation to complete the whole preparation process: the system is made of stainless steel and can be effectively rust-proof. It is equipped with advanced technology of reverse osmosis system and equipped with sterilizing devices before water point to improve water safety in order to meet the needs of hospitals, pharmaceutical enterprises, health products , food and IV solution production, and can meet the 2015 edition of the Chinese Pharmacopoeia and the national GMP standards. The disinfection methods of pharmaceutical purified water equipment system include pasteurization, ozone disinfection and chemical disinfection according to actual needs;

Multi-effect distilled water machine adopts a process of chemical and microbial purification of raw water by gas-liquid phase method and separation method. In this process, the water is evaporated, the steam is removed from the water, and the unevaporated water that flows back dissolves solids, non-volatile substances, and polymer impurities. In the process of evaporation, low molecular impurities may be carried in the form of water mist or water droplets in the steam evaporated by water, so a separation device is needed to remove fine water mist and entrained impurities. This includes endotoxin. The purified steam is condensed into water for injection, and the content of endotoxin can be reduced by distillation at least 99.99%;

Pure steam is usually steam prepared from purified water by pure steam generator or the first effect evaporator of multi-effect distilled water machine. Both deionized water and purified water can be used as raw water of pure steam generator. After evaporation, separation (removal of pollutants such as particulate and bacterial endotoxin), they can be transported to the point of use under certain pressure;

The water distribution system is designed according to the actual needs of customers and disinfection requirements, based on GMP、ISPE engineering guidelines and FDA specifications, it’s with frame structure, space saving, plug and play, easy installation, pre-installation and operation confirmation in manufacturing plant, and all pipes are 316 stainless steel, no dead angle, sanitary chuck connection all products contact surface, roughness (Ra) less than 0.6 pm, and can achieve temperature control, avoid bacteria breeding and meet FDA requirements;

Performance

1. Characteristics of Purified Water Equipment:

▶ The water quality meets the requirements of the Chinese pharmacopoeia standards and FDA: fully automatic operation of the equipment and fully automatic processing procedures with conditions (e.g. backwash, regeneration, pickling, disinfection procedures); monomer and piping equipment meet the GMP requirements (e.g. back-end treatment equipment sterilizer, membrane filter, terminal water tank, pipeline all using 316 L materials, pretreatment equipment pipeline using SUS304 materials).

▶ Purified water quality standard: conductivity ≤0.5μs/cm;TOC≤200 ppb; microbial ≤10 cfu/ml;

▶ In order to facilitate disassembly, replacement and cleaning of parts, the design of the actuator should be standardized, universal and systematic;

▶ The surface of the inner and outer wall of the purified water machine is smooth and flat without dead angle or blind angle, which is easy to clean and avoid the breeding of bacteria and microorganisms;

▶ Adopt module design and quick connection design, easy to install and maintain;

▶ The surface of the parts is treated with chrome plating, rust-proof and corrosion-resistant;

▶ Mainly made of stainless steel and other non-polluting water quality materials;

▶ The storage period of purified water in storage tank should not exceed 24 hours to avoid the long residence time of purified water affecting water quality;

▶ The operating display system can display different states, such as flushing, water shortage, full water, overhaul and so on, at the same time through the acousto-optic alarm system for alaming;

▶ The system can automatically adjust the production capacity of the system during water production and circulation, and reduce the energy consumption of the equipment;

▶ Purified water system can be configured with multi-channel valve design to meet the process zero dead angle requirements;

▶ Purified water system can be equipped with self-inspection, power failure automatic reset, high and low pressure protection, water shortage protection and other functions;

▶ Purified water systems can be configured RO systems or EDI systems;

▶ The purified water system can be equipped with partial concentrated water recovery device, and the overall recovery rate of the system is more than 80%;

▶ Through the programming controller for automatic control, the use of humanized operation display system, convenient for users to intuitively understand the relevant information and convenient to complete the operation;

▶ Can be customized according to the actual needs of customers;

2. Performance of multi-effect distilled water equipment:

▶ All equipment is made of 316 L stainless steel, the working surface is pickled and passivated;

▶ Capacity: 120-5000 L/h

▶ Water for injection standard: conductivity ≤0.5μs/cm;TOC≤200 ppb; microbial ≤ within 10 cfu/100ml; toxicity 0.25 EU/ml;

▶ Reliable operation of equipment, stable water quality;

▶ With special atomizing nozzle , the raw water is atomized and evenly distributed, and it is continuously and efficiently removed before the falling film evaporates;

▶ The specially designed distillation column adopts the new expansion connection technology, guarantees the stainless steel composition, fully guarantees the equipment to run stably for a long time;

▶ Multi-stage separation method to obtain high-quality injection water;

▶ Automatic track welding of 316 L stainless steel tube with mirror polishing, clean flange and pharmaceutical grade gasket;

▶ With the rock wool for thermal insulation , covered with 304 stainless steel subgloss protective layer, and stainless steel frame ;

▶ Multi-effect distilled water equipment self-disinfection, self-sterilization concept, fully meet the GMP requirements;

▶ Can be customized according to the actual needs of customers;

3.Performance of pure steam equipment:

▶ Pure steam needs a rapid response, from standby to full load output <30 s, greatly shorten sterilization cycle;

▶ Accurate pure steam output pressure, temperature control, fluctuation ± less than 5%;

▶ Can be unattended, suitable for multiple different needs of sterilization point parallel use;

▶ Capacity: 100-5000Lt/h;

▶ Typical waste disposal ratio :2-8 %

▶ Capacity adjusted through PID proportional ;

▶ Gas pressure output range of pure steam Bar:2-5

▶ The quality of pure steam meets the requirements of non-condensable gas content, dryness and superheat as defined in the HTM2010(EN 285) standard;

▶ Can be customized according to the actual needs of customers;

4. Performance for Water distribution system

▶ PW/WFI modular design, compact structure, easy operation and maintenance;

▶ Can be customized multi-cycle, circulating pump frequency conversion operation, system process design and operation in accordance with the GMP and ISPE guidelines;

▶ Distribution pump chamber discharge valve without dead angle;

▶ Automatic control storage distribution system on-line cleaning and disinfection;

▶ Hot water / ozone disinfection for purified water distribution

▶ Super hot water / pure steam disinfection for injection water distribution

▶ Design and construction of integrated solutions such as purified water, injection water, pure steam, compressed air and nitrogen , meet the needs of pharmaceutical enterprises;

▶ The control system can be equipped with automatic production of electronic reports and electronic records, with audit tracking, intelligent maintenance, remote troubleshooting and other functions;