New pharma compliance package for ultrapure water

Veolia Water Technologies UK (VWT UK) has launched its PURELAB®  Pharma Compliance package for those requiring a reliable supply of ultrapure water (UPW) for Quality Control (QC) laboratories. This new package combines purification equipment, intuitive software and all the necessary qualification documentation needed in one easy to use package.

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 can meet the water purity needs of all laboratories - no matter the size or scale - operating under the validation conditions stipulated in either GLP, GMP and GDP. Combined with VWT UK’s intuitive software, the PURELAB®  equipment chosen will be able 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 also provides the water purity evidence needed to meet FDA and EU standards for digital record keeping.

PURELAB® Pharma Compliance’s flexible software is able to deliver different levels of validation, from those needing GLP validation right through to labs that require the latest FDA 21 CFR part 11 compliance.

What’s more, both Installation Qualification (IQ) and Operational Qualification (OQ) documentation are supplied as standard. Plus, the product’s purification and servicing processes support the requirements by USP643 and USP645 - the only accepted method of validation of TOC reading for any system - anywhere.

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