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Veolia Water Technologies launches PURELAB® Pharma Compliance
Veolia Water Technologies UK (VWT UK) has launched its PURELAB® Pharma Compliance package for those who require a reliable supply of ultrapure water (UPW) for quality control (QC) laboratories and all the necessary validation and qualification software. This new package provides everything a QC laboratory could need in a tailored, easy to use combination of equipment and services.
The PURELAB® Pharma Compliance package consists of a combination of water purification equipment, software and qualification documentation. As a result, it has the potential to streamline your approach for the delivery of UPW and simplify the subsequent purified water validation guidelines and processes.
Utilising a combination of UV, DI purification and ultrafiltration technology, PURELAB® Pharma Compliance is capable of delivering 18.2 MÙ ultrapure water at a flow rate of up to 2 L/min through a flexible and ergonomically designed dispenser. Developed by ELGA’s industry leading specialist team, the package is designed, manufactured and tested using a quality management system compliant with ISO 9001 and fully approved by Lloyd’s Register Quality Assurance.
As a result, it will provide the required water quality to support the QC tests necessary to validate pharmaceutical purity. Easily scalable, PURELAB® Pharma Compliance can meet the needs of all laboratories – no matter their size or scale – operating under the validation conditions stipulated in either GLP, GMP and GDP.
The newest addition to the PURELAB® range utilises VWT UK’s intuitive software, enabling the equipment to integrate seamlessly into any lab with no disruption to water supply or quality. Once in place, PURELAB® Pharma Compliance’s admin functions, audit trail procedures and security and data integrity capabilities all meet the global regulators best practice for data management following GMP standards. The integrated software package provides all the documentation evidence needed to meet FDA and EU standards for digital record keeping – from labs needing GLP validation right through to those that require the latest FDA 21 CFR part 11 compliance.
Installation Qualification (IQ) documents and Operational Qualification (OQ) documents are also supplied as part of the standard package; in addition to purification and servicing processes support that meets the requirements of USP643 and USP645 – the only accepted method of validation of TOC reading for any system.
Peter Bridge, Head of Scientific Sales at Veolia Water Technologies UK commented:
“Our quality engineering and expertise will allow customers to take advantage of a practical combination of equipment and services that have been optimised with a range of features specifically for QC labs. The PURELAB® Pharma Compliance package gives you an effective and compliant ultrapure water system – with the level of validation support you want.”