The starting point was a new purified water USP production system. The town’s water is softened in duplex CarboSoft softeners, which also remove free chlorine. It is then purified by reverse osmosis and polished by continuous electrodeionisation (CEDI) to produce 4,000litres/h of purified water with conductivity typically less than 0.2µS/cm.
The purified water is delivered into a 7,000litre tank and pumped, via a stainless steel distribution loop, to the water for injection (WFI) still and clean steam generator. WFI is produced by distillation using an energy-efficient eight-column multiple effect still that delivers 2,800litres/h of WFI into a 7,000litre tank. From here it is continuously circulated at 65°C round a 250m distribution loop supplying six points of use.
The clean steam generator is identical in principle to a distillation plant except there is only one column and the steam is not condensed. The generator produces 660kg/h of clean steam at a pressure of 2barg.
The complete system is designed to meet all the requirements of cGMP, GAMP and the ISPE Baseline Guide.