Audit ready tool for HPLC pump validation

⇤ NEWS | 12th March 2025

TESTA Analytical has released an updated version of its HPLC Pump Qualification Pack designed for regulated labs looking to qualify the operation and performance of their HPLC systems.

Version 1.4 of the popular HPLC Pump Qualification Pack includes a series of updates that make the tool more flexible and audit ready. Improvements include a new Pump Validation Checklist to guide users through the validation process step by step, ensuring a structured workflow thereby reducing the chance of errors. Users can now adjust accuracy acceptance limits from 0.5% to 5% (the European Directorate for the Quality of Medicines and HealthCare (EDQM) standard). This new flexibility allows users to align with various regulatory standards and pump specifications. The HPLC pump qualification passing criteria now consider both relative standard deviation and nominal deviation, in accordance with EDQM guidelines.

The HPLC Pump Qualification Pack includes a TESTA Analytical LC flowmeter, tablet-computer with pre-installed data validation software. The Pack is designed to automatically perform all necessary flow data calculations plus operational and performance qualification checks on your HPLC system. This updated version of the Pack reduces the time required for HPLC pump qualification, while providing traceable audit ready results. By focusing on data traceability and simplifying the qualification process, this audit ready all-in-one pack is an affordable solution for laboratories seeking to maintain compliance and optimize their HPLC systems quickly and effectively.

For further information please visit https://testa-analytical.com/hplc-pump-qualification-pack.html.

Click here to contact Testa Analytical Solutions (+49-30-864-24076).