When it comes to Certified Reference Materials (CRMs), who ensures that the materials themselves are compliant?
Altus Science provides CRMs for a variety of industries focusing on calibration standards for Total Organic Carbon (TOC) and Conductivity analysers. Established in 2012, the privately owned company is accredited by UKAS, and audited to both ISO 17025 and ISO Guide 34. Their Runcorn facility is home to a range of analytical instruments used for verification purposes but, fundamental to the company’s business is the quality of the ultrapure water used in the production of the CRMs.
Calibration, Validation and Consumables for all TOC analysers
By 2017, Altus Science had grown to such an extent that their laboratory water purification system was unable to cope with production. “Our quality management system required us to take daily samples to monitor water quality,” says Altus Science Managing Director Graham Roscoe, “It became obvious that we had to upgrade.” Graham consulted Wellingborough based ADEPT Pure Water. “I felt that we could work together with ADEPT as partners,” says Graham, “Both companies had the knowledge and ADEPT would allow us input to develop a system which would be right for our application.“
How the bespoke ultrapure water system performs
ADEPT’s engineers designed a bespoke system for Altus Science. Mains water is softened and then deionised by a twin pass ECO RO reverse osmosis system to provide make-up to a polishing ring main. The deionised water is delivered to a PVDF storage tank and is continuously recirculated, at 1,000L/h, via a 20mm PVDF ring main to three points of use in the Quality & R&D laboratory and a further two in the production laboratory. The ring main includes a 185nm UV irradiation lamp, which oxidises trace organic matter to carbon dioxide and water, and this is followed by a cylinder containing Purolite UltraClean UCW9966 mixed bed ion exchange resin. The resin provides ultra low TOC leakage and the highest quality water achievable with TOC less than 1μg/L and conductivity <0.1µS/cm. This more than meets the 100µg/l TOC and 1.1µS/cm conductivity compendial water quality requirement for Altus Sciences’ pharmaceutical customers. The resin is not regenerated, since this would reduce performance, but is replaced annually. The new water purification system, was installed in April 2017 and commissioned in July, is provided with online monitoring of resistivity and TOC, significantly reducing the need for sampling and analysis.