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Continuous Validation of HPLC Performance in a Regulated Lab Environment

A computer screen next to 3 HPLC machines.
Credit: TESTA Analytical.
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TESTA Analytical reports on how its flowmeter software driver for chromatography data systems (CDS) has successfully passed extensive testing in a regulated pharmaceutical laboratory environment.


Thorough testing of new software packages and drivers are nowadays an integral part of any new product release. This testing gains even higher importance when the software to be released is designed to operate flawlessly with chromatography software packages from different HPLC and GPC/SEC manufacturers.

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Jeanette Ziemba, technical manager at TESTA Analytical commented “In addition to undergoing a full cycle of in-house testing, our new flowmeter software driver has been extensively evaluated by a leading European pharmaceutical lab. Managing its diverse range of different HPLC instruments with different chromatography data systems in a tightly regulated client-server environment – the lab was delighted how the software driver enabled easy acquisition and traceable logging of flow data from all its liquid chromatographs. The ability to support multiple Flowmeters connected to different HPLC systems in both analytical and semi-prep applications, also simplifies the task considerably.”


She added “Being able to save real-time flow rate data with each chromatogram is a valuable aid to enabling total quality assessment of any HPLC, UHPLC, LC/MS or GPC/SEC system. The software driver, based on rc.NET technology, has been proven to provide cross-platform connectivity of all TESTA Analytical flowmeters to Chromatography Data System software packages including OpenLab (Agilent Corp), Clarity Chromatography Software (DataApex), Empower (Waters Corp), LabSolutions (Shimadzu Corp) and WinGPC Software (Agilent).”


Ms. Ziemba concluded “The ability to collect and store real-time flow rate data along with chromatography detector signals not only enhances quality assessment but also provides continuous validation of compliance to the planned chromatographic separation method. Overall, this affordable flowmeter software driver compliments and extends the capabilities of any modern liquid chromatography software package.”