ELGA, part of Veolia Water Technologies UK (VWT UK) has launched its PURELAB Pharma Compliance package for those requiring a reliable supply of ultrapure water for Quality Control (QC) laboratories.
This new package combines purification equipment, intuitive software and all the necessary qualification documentation needed, which can be tailored to the exact needs of any QC laboratory.
Capable of delivering 18.2 MW-cm ultrapure water at a flowrate of up to 2 l/min, the PURELAB Pharma Compliance can provide the correct volumes of water to support the QC tests necessary for pharmaceutical raw material and product testing. It can also 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.
The newest addition to the PURELAB range, the Pharma Compliance’s admin functions, security and data integrity capabilities, password accessibility, audit trail procedures and permissions all meet the global regulators best practice for data management following Good Manufacturing Practice (GMP) standards. The system also provides the evidence of water purity, which is necessary to meet FDA and EU standards for digital record keeping.
Installation Qualification (IQ) documents and Operational Qualification (OQ) documents are supplied as part of the standard package. Plus, Pharma Compliance also supports purification and servicing processes required by US pharmacopeia 643 and 645 – the only accepted method of validation of TOC reading for any system.
Peter Bridge, Head of Scientific Sales at VWT UK commented:
“We know that for many, ensuring a reliable supply of ultrapure water for QC laboratory processes, while maintaining confidence in your validation can be challenging. This is why we have added Pharma Compliance to our PURELAB range. Combining our industry leading technology with compliant digital record keeping, we offer the ideal solution, whatever the compliance needs.”
To find out more about PURELAB Pharma Compliance visit www.veoliawatertechnologies.co.uk/products/purelab-pharma-compliance
