Main description

This system is designed for the purified water project. Design the water source to master the worst water quality, and the production capacity is designed according to requirements. According to the different products, the effluent quality of the system meets the water requirements.

The design water source is based on municipal water.

The system is designed according to the user's raw water quality and the water quality requirements. The system configuration and settings can fully meet the requirements of water inlet conditions, with the principles of automatic, energy saving, simple operation, environmental protection and safety, and ensure the system can run stably for a long time.

The purified water system processes involve pretreatment via softening and microfiltration stage followed by a reverse osmosis stage and a final demineralization via the patented EDI module. This process technology meets current USP and European Pharmacopoeia requirements in a safe and reliable way. Each system is pre-qualified before shipment and undergoes a full functional FAT test at our factory.

Main performance and features

1. TOC＜100ppb
2. Conductivity ＜0.5us/cm
3. Microorganism＜100CFU/ML
4. Endotoxin ＜0.25EU/ml
5. Nitrate＜0.06ppm
6. Heavy metal ＜0.1ppm

1. According to the water quality and customer’s requirements, the two stage RO or RO+EDI configurations are provided.
2. Modular design, compact structure, convenient installation and operation
3. Double-stage softener series operation, no spare equipment dead water risk.
4. Multi-channel diaphragm valves replace multiple individual valves, reduce dead corners, facilitate emptying, reduce the amount of verification documents and reduce the number of welds.
5. The wastewater discharge line is integrated into the frame, with less pipe and less weld, the optimum separation of purified water and waste water.
6. The sampling points at each stage of the system are at their best, easy to maintain and sample.
7. Frequency conversion control, dual pipeline water supply, non-water state low –frequency circulation, no intermediate water tank. Reduce the risk of microbial development.
8. RO unit is developed regularly and the system can be chemically sterilized or pasteurized.
9. Full automatic operation, unattended, remote control
10. The automatic control system meets the requirements of the CFR part 11 and GAMP5 to meet the FDA and EU cGMP requirements.
11. Provide standard and extended documentation according to customer requirements to meet FDA and EU cGMP verification requirements

Technical description

Technical parameters

Distiller 

This machine adopts electrical heating , bidirectional centrifugal separation and internal circulation and heating. It can produce WFI and pure steam simultaneously or individually.

The forerunner technical structure

Head disputation + bidirectional centrifugal separation structure enable internal , external , upper and lower centrifugal separation which produces highly saturated , high quality pure steam.

Distillation is a process for chemical and microbiological purification of raw water by gas-liquid reform and separation. In the process, water is evaporated, in which produced steam breaks away from water, and unevaporated water flowing to behind is dissolved with solids, non-volatile substances and macromolecular impurities. In the distillation process, low-molecular impurities may be entrained and carried in evaporated steam in the form of water mist or droplets, so it needs separation device to remove tiny water mist and entrained impurities, including endotoxin. Purified steam becomes water for injection after condensation. Distilling method can reduce at least 99.99% of endotoxin content.

Main features

1. Multi-effect water distiller adopts unique tertiary separation technology (flash, gravity separation by 180 degrees exhumation and health type spiral separation technology), producing distilled water and pure steam with best quality, as well as safe and reliable.

2. Accelerated speed of spiral separation achieves 17 times of g (g means gravitational acceleration).

3. Unique technology of continuous removal of non-condensable gas.

4. The latest risk prevention design concept: removal of impurities in the early process stage. Seperated impurities (endotoxin, non-condensable gas and other impurities) from each evaporating column (effect) will not be brought into next column (effect), to ensure obtaining WIF with best quality;

--Residual discharge is carried out for each column, to the last column for discharge.

--Continuous exclusion of non-condensable gas is carried out for each column, rather than concentrated to condenser for exclusion.

--Impurities are excluded continuously, not intermittently.

5. All condensers, feedwater pre-heaters and first effect of evaporating column adopts double tube plate design, preventing cross contamination to the greatest degree.

6. Each effect of evaporating column is equipped with special feedwater distribution plate, which can guarantee that supply water can form falling film in the column tube, to ensure the highest evaporation heat exchange efficiency.

Technical parameters