Turnkey WFI and Highly Purified Water System
Baglan Facility Swansea
New validated USP/EP WFI and Highly purified water system
Order placement date: July 2006
Shield Medicare announced their intention to build a new facility in Baglan Swansea resulting from the amalgamation of products from two different sites.
They identified that product water was required to comply with the USP&EP specifications for WFI. In addition, they requested that the feed to the WFI still was also capable of providing a future possible separate supply of highly purified water (EP compliant).
At Baglan, the Puretech Oasys system produces highly purified water on-demand and then maintains the quality and the integrity of the water through internal recirculation. The Oasys provides the feedwater to the vapour compression still. A hot water santisable WFI storage and distribution loop delivers the product water to the various points-of-use on demand.
Scope of Supply – Plant
- Puretech Oasys generation plant (sized to provide 1,000 l/hr 24 hrs/day) complete with pretreatment skid, control panel, on-line chlorine monitoring and control devices. The Oasys utilises RO-CDI-UF to provide Highly Purified Water (endotoxin limit of <0.25eu/ml).
- Vapour compression still capable of delivering 800 litres/hr. The distribution system comprises of a 10m3 stainless steel WFI holding tank with a hot water sanitisable orbitally welded distribution loop with 5 x zero-dead-leg valves at the various points-of-use. Central PLC control system utilising the Siemens PLC within the Oasys. Ethernet capability if requested in the future.
Scope of services
Design, supply, delivery, installation, testing, commissioning, validation and training.
Client witnessed FAT, SAT at Redhill works
Generation and execution of IQ/OQ documentation.
Nigel Perrins, Engineering Manager, T +44 (0) 1639-825651
Denis O’keefe, Validation Manager, T +44 (0) 1639 825 652