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Veolia Water Solutions and Technologies has designed and installed a clean utilities plant at Leo Pharma to produce, store and distribute water for injection and clean steam for the facility.

Both water for injection and clean steam have to comply with the US Pharmacopoeia (USP).

The starting point is a purified water USP production system.

Towns water is softened in duplex Carbosoft softeners, which also remove free chlorine.

The softened water is purified by reverse osmosis and then polished by continuous electrodeionisation to produce 4,000L/h (17 USgpm) of purified water with conductivity typically less than 0.2uS/cm.

The purified water is delivered into a 7,000L tank (1,850 gal) and pumped, via a stainless steel distribution loop, to the water-for-injection still and the clean-steam generator.

Water for injection is produced by distillation using an energy efficient, eight-column, multiple effect still that delivers 2,800L/h (12USgpm) of WFI into a 7,000L tank.

From here it is continuously circulated at 65C (149F) round a 250m (820ft) long distribution loop supplying six points of use.

Four of the points of use deliver hot water, while the other two have point-of-use instantaneous cooling to 20C (68F).

The clean-steam generator is identical in principle to a distillation plant, except that there is only one column and the steam is not condensed.

The generator produces 660 kg/h (1,455lb/h) of clean steam at a pressure of 2 bar/g, which is used for in situ sterilisation of vent filters, purified water and water for injection tanks, feeding the autoclave and for the steaming in place of process equipment.

The complete system is designed to meet all the requirements of cGMP, GAMP and the ISPE Baseline Guide.

Automatic control is by six independent Siemens S7-300 programmable logic controllers linked via a Profibus DP network with a 21 CFR Part 11 compliant operator interface.

The design, construction and start-up phases of the clean utilities plant were managed under GAMP with validation at each stage: Design Qualification, Factory Acceptance Test, Installation Qualification and Operational Qualification.

The clean utilities are a critical part of the expansion project at Leo Pharma.

Veolia Water Solutions & Technologies

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