WATER FOR INJECTION GENERATION AND STORAGE SYSTEM
WEMAC LDS series Multi effect water distiller is a kind of water for injection generation equipment using purified water as raw water, and heated by industrial steam.
The water for injection produced by LDS series Multi effect water distiller meets the requirements of WFI in Chinese Pharmacopoeia (CP2020), United States Pharmacopoeia (USP43) and European Pharmacopoeia (EP10).
Qualified raw water is pressurized by a multi-stage pump and then enters the condenser, and then enters each effect preheater in turn (the raw water is heated by secondary steam and distilled water in the condenser, and after entering each effect preheater is heated by condensed water of secondary steam, which will be heated by industrial steam condensed water in the first-effect preheater). Then it enters the first-effect evaporator and sprayed on the inner wall of the heating tube through the material water distributor, so that the material water flows in a film status on the tube wall, and is heated and vaporized by the industrial steam. The generated secondary steam with water droplets enters the steam-water separator from the lower end of the evaporation chamber, the separated pure steam enters the next effect as heating steam, and the unevaporated raw water enters the next effect, and the above process is repeated. The pure steam generated by the final effect enters the condenser and is cooled by condensing water from each effect except the first effect. After removing the non-condensable gas (depending on the model, the evaporator may also be equipped with such a continuous discharge device of non-condensable gas). Condensed gas becomes water for injection. The outlet generally undergoes online conductivity testing, qualified distilled water is output as water for injection, and unqualified distilled water will be discharged.
1. Structure: The external preheater, condenser and first-effect evaporator are all designed with double tube sheets, and the inner tube sheet is expanded and welded externally to avoid cross contamination.
2. Separation device: three-stage separation with falling film evaporation, gravity separation and spiral flow.
3. Material: all parts in contact with raw water, water for injection and secondary pure steam are made of SS316L.
4. Thermal preservation and insulation: the evaporator, preheater, and condenser all use aluminum silicate needle punched blanket, which has good extensibility, light weight, excellent heat insulation and strong stability.
5. Surface treatment: The internal and external surfaces are electrochemically polished to effectively ensure the smoothness of the stainless steel surface. The external surface can also be sandblasted.
6. Energy saving and consumption reduction: Since the secondary steam is used step by step in each effect, the multi-effect water distiller has a high utilization rate of industrial steam and has obvious energy saving effects. With the increase in the number of evaporators, this energy saving effect becomes more obvious. At the same time, the amount of cooling water is also greatly reduced as the effect number increases. The five-effect distiller produced by our company uses a small amount of cooling water, and the six-effect distiller does not require cooling water.
7. Use stainless steel pipes as far as possible to directly stretch the elbow to avoid welding. Welding parts of pipelines and accessories should be automatically welded with argon protection (single-side welding and double-side forming process) to ensure welding quality, and electrochemical polishing after welding.
8. Provide verification materials such as endoscopic inspection photos, solder joint diagrams, pressure test and pickling passivation reports, and system design documents.
9. The control system adopts HMI+PLC fully automatic control, and the operation interface is simple. Various communication modes are available. Control system authority levels: at least three levels of authority can be set.
10. Online monitoring of parameters such as conductivity, temperature and flow. The recorder can choose a paperless recorder or a paper recorder to record and print key parameters.
11. The control system can be equipped with electronic signatures and electronic records to make the system control with audit trail function, and meet the requirements of GAMP 5 and 21 CFR PART 11.