Varian launches improved throughput software

The new Fusion AE software​ companion plug-in application for its Galaxie Chromatography Data System (CDS) lets scientists run checks to determine whether the method can be validated while in the development phase. Once optimised, the scientists then can run required method validation experiments automatically.

The software's phased approach to method validation results in bench-time savings as well as higher sample throughput. Fusion AE meets the FDA's stringent 21 CFR Part 11 regulatory requirements, and all method validation experiment designs, analysis, and reporting conforms to FDA and ICH guidances.

For pharmaceutical, biotechnology, and other industrial labs required to meet the requirements of regulatory authorities, such as the Federal Drug Administration (FDA) or Environmental Protection Agency (EPA), Fusion AE simplifies the process, speeding up sample throughput by providing rapid optimisation and validation of methods on a continuous basis.

In pharmaceutical research and development (R&D) laboratories, scientists can use Fusion AE's method development/optimisation option to optimise methods based on simultaneously entered multiple variables, such as mobile phase composition, flow rate, column packing functionality, injection volume, temperature, and pH, among others. Current software packages are capable of studying only one or two variables simultaneously.

Quality control (QC) labs can use Fusion AE's automated method validation component to revalidate analytical methods transferred from R&D, saving time and eliminating errors. Fusion AE has demonstrated a 60 per cent to 85 per cent reduction in cycle time (including data analysis and report generation) compared to current manual execution of validation standard operating procedures (SOPs).