PURELAB PHARMA COMPLIANCE – BRINGING ELGA’S ULTRAPURE WATER PURIFICATION TO GXP QUALITY CONTROL LABORATORIES

The ELGA Veolia Purelab Pharma Compliance delivers a lab water solution focused on building the perfect relationship between discovery, production, and traceability, resulting in an intuitive, efficient, and compliant purification system.

Purelab Pharma Compliance is packed with innovative features optimised for QC laboratories. It offers all the necessary purification, software capabilities, qualification documentation, and online support services necessary for the validation required to meet Good Manufacturing Practice (GMP). This includes secure software providing the evidence to meet FDA and EU standards for digital record keeping. Qualification documents provided enable the unit to support labs subject to validation under GxP.

The highly competitive total cost of ownership, robust traceability, and great ergonomics combine to create a simply compliant, simply effective, and simply transparent solution by:

Secure software offers a range of admin, security and data features providing evidence to meet FDA and EU standards for digital record keeping.
Purification processes fulfill United States Pharmacopeia standards 643 and 645.
Supported by a global network of service teams with significant experience of supporting laboratory equipment subject to validation under GMP.
Space-saving to enhance QC output, designed to be modular and stackable to save space, whether wall-mounted or under the bench.
Cost-effective design delivering water to support QC tests necessary to validate drug purity in pharma manufacturing. Consumables are designed to minimise cost and environmental waste. ELGA delivers a lower total cost of ownership that can be easily integrated into any laboratory.

“Control of the quality of water, in particular the microbiological quality, is a major concern, and the pharmaceutical industry devotes considerable resources to the development and maintenance of water purification systems.”

Challenges to maintaining the correct level of water purity at different stages of drug manufacture, keeping the level of water contaminants down, and ensuring there is sufficient water of the correct purity level are discussed in this whitepaper you can download for free below.

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Case Study

LS Scientific & ELGA deliver UltraPure water to the NAFDAC Laboratory – Lagos. The aim is to eliminate counterfeit pharmaceuticals, foods and beverage products not manufactured in Nigeria. In this project it was critical for their applications that the water purification unit could provide treated water of < 0.1 µS/cm, up to 8 l/hr, <0.1 CFU/ml bacterial level.

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Infographic – Blast your problems out of the water

Let us show you how to seek and destroy water impurities in your cell culture, molecular biology and liquid chromatography experiments.

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Ensuring Water in Pharma QC Labs is Compliant (Whitepaper)

At what stage of the drug production and QC process does the water used need to meet regulatory compliance standards, or is it enough that it simply
meets GxP requirements? How is water used when things go wrong in production, to get to the bottom of QC issues? How can we be sure that any
QC issues arising do not come from the water itself? These are just a few of the questions we need to answer when considering suitable water purification
systems for QC labs

Get the details here

Want to know more about your lab water quality?

Request info or a FREE water quality test here.

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