Water for Injection Turnkey Plants for Clean Steam and WFI Generation

A new plant concept is producing water for injection (WFI) and clean steam on a cost-effective and pharmocopoeia-compliant basis. Multi-column distillation and falling film evaporation are the preferred processes.

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Veolia Water Technologies Deutschland GmbH

Veolia Water Solutions & Technologies has recently extended its range of plants and in addition to its high purity water plants now also supplies plants for pharmacopoeia-compliant production of water for injection (WFI) and clean steam. This fills a gap for the company: previously Veolia had to buy in WFI plants for projects, but now they are able to provide complete turnkey solutions for pure and ultrapure media supply, as Tanja Löhe, Head of Pharmaceuticals at Veolia Water Solutions and Technologies, is keen to point out. One key structural detail to note is that the plants are pre-fabricated and pre-certified in modular form on frames, which reduces the cost of integration and standardizes the design.

Small and medium-sized WFI

The company employs two processes which are suitable for different quantities of water. Small and medium-sized WFI quantities are produced using multi-column distillation by means of falling film evaporation (Polaris MED), while thermo-compression (Polaris VCD) scores highly for high flow rates of up to 25,000 liters per hour due to its low operating cost. Depending on requirements, the plant is heated with steam or an electrical heating element or a combination of the two, while a steam compressor supplies the necessary additional energy for the production of distilled water. Softened water is fed into the plant and the WFI temperature is between 25 °C and 90 °C, as required.

Interestingly, regional differences have emerged in the distribution of plant designs: “Users in the USA prefer the MED execution whereas Europe favors the VCD,” explains Löhe. The Polaris CSF Clean Steam Generator produces pure steam at a rate of up to 5,000 kilograms per hour from pre-treated feed water. The heat exchanger’s double tube design prevents the steam from coming into contact with the cleaned water or the ultrapure steam. The mist eliminator ensures the process is free of pyrogens.

Saving tubing

For reliable testing of clean steam quality, the company supplies an EN285-compliant sampling device with a double-tube heat exchanger and conductivity testing for use in the pharmaceutical industry.

The developers at Veolia have designed the entire product range in accordance with international standards and GAMP, cGMP and ISPE guidelines as well as those of the FDA, and the product water quality meets the requirements of international pharmacopoeias, such as USP and Ph Eur. With multi-column distillation, the trick is in the passage of the feed water, which flows through the shell of the still and is used to heat it up, thus reducing the tubing requirement substantially, as Löhe explains. Incidentally, it’s a benefit that clearly impresses customers, as a plant has been supplied to Asia. The mist elimination system uses shear forces and mass differences and separates the water drops off in each column — a critical factor in retaining pyrogens. Accessories in the range include feed water and product storage tanks as well as WFI-compliant pumps.

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