1. Application conditions

♦ The system can alternately produce pure steam or injected water, and the two working states can realize disturbance-free switching;
♦ The pyrogen-free saturated pure steam can be used for sterilization in sterilization cabinets, bioreactors, liquid distribution tanks and pipeline systems that directly or indirectly contact the final product, and can also be used as humidity in high-cleanliness areas control;
♦ Injection water can be used for the dissolution configuration of sterile products and the cleaning of systems that directly or indirectly contact sterile products.

2. Performance characteristics
(1) High-quality selection
♦ The electric single-effect pure steam distilled water integrated machine (DPSG-E series) is designed, constructed and verified according to the latest FDA and GMP requirements. It can provide with the quality of water for injection, pure steam and pure steam that meet the Chinese, American and European Pharmacopoeias, while also meeting the SIP sterilization requirements of HTM2010 (EN285);
♦ Factory acceptance test (FAT) combined with DQ, IQ, OQ can provide customers with performance and quality assurance;
♦ The metal parts of the contact product are made of SS316L and Incoy800 stainless steel, and the finish requirements are Ra<0.6um;
♦ Use materials that meet FDA or USP VI for non-metallic parts that contact the product;
♦ Strictly control the critical quality monitoring points of the system, such as dead angle, slope, and drainage capacity;
♦ The injection water make-up pipe can realize automatic steam purging and sterilization, and there is no baffle on the water production side to clean and sterilize dead corners;
♦ The conductivity, temperature and pressure of produced water (steam) are continuously monitored and recorded by a recorder.
(2) Simple design, stable operation
♦ The evaporator adopts a high-quality electric heater with a fully diffuse operation design, no stress concentration, no dry burning phenomenon, and not easy to scale;
♦ There are no parts in the separator that need to be maintained and cleaned or are prone to contamination;
♦ The water and heat convection circulation inside the evaporator and the separator is easy to discharge endotoxin;
♦ The condenser is designed with double tube plate, with pure steam on the tube side, high heat exchange efficiency and no stress concentration;
♦ Thermally remove insoluble gases in purified water to ensure the quality of pure steam and improve the stability of system operation;
♦ Purified water inlet, injection aquatic product water, injection water cooling, preheating electric heater and evaporating electric heater are all controlled by PLC through PID continuous control, and the system has high stability.
(3) Easy to install and maintain
♦ All electric heaters are easy to disassemble and maintain;
♦ Modular design, highly integrated, only need to connect purified water, tap water, compressed air and electricity to be put into use on site, without steam and chilled water;
♦ Pressure condenser, the overall height of the equipment is low, and the installation space requirement of the plant is low.
(4) Control system
♦ The control system that complies with GAMP5 and 21CFR Part11 can provide operators with a safe and humanized operation interface. The system runs fully automatically and performs real-time monitoring and recording.

3. Capacity parameters: