The update reduces the time required for HPLC pump qualification.
Liquid chromatography specialist Testa Analytical has released an updated version of its HPLC pump qualification pack, enabling the tool to be more flexible and audit-ready.
The update includes the introduction of a new pump validation checklist, which guides users through each step of the validation process, reducing the potential for error.
Also included in the update is the ability to adjust accuracy acceptance limits from 0.5% to 5%. This flexibility aligns with the European Directorate for the Quality of Medicines and HealthCare (EDQM) standard.
Adhering to EDQM guidelines, the HPLC pump qualification passing criteria now consider both relative standard deviation and nominal deviation.
The HPLC pump qualification pack includes a Testa Analytical LC flowmeter tablet-computer with pre-installed data validation software. This supports the pack’s ability to automatically perform flow data calculations and HPLC system operational and performance qualification checks.
The pack’s updates reduce the time required for HPLC pump qualification. The emphasis on data traceability and simplification allows companies to optimize their HPLC systems quickly while maintaining compliance.
Last year, Testa Analytical released results of its HPLC Analytical Prep Flowmeter performance experiment, which maintained a focus on accuracy while reducing the time required to conduct a pump validation test for preparative liquid chromatography systems.
