Nexera FV

Nexera FV and LabSolutions™ FV together form a new UHPLC system capable of monitoring flow synthesis and batch synthesis reactions, and automating formulation dissolution testing.
From bulk drug to final product manufacturing, the Food and Drug Administration (FDA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) look for consistency in the manufacturing of pharmaceuticals. There is an increasing need for a Quality by Design (QbD) approach using process analytical technology (PAT), and process monitoring, in which the quality of each product is controlled during each unit operation. In measuring the critical quality attributes (CQA), Nexera FV and LabSolutions FV automate all the steps for PAT, including collection and dispensing of the reaction solution, HPLC analysis, data analysis, and the creation of reports. This achieves substantial labor savings and provides highly reliable data by eliminating human error.
In dissolution testing as well, everything from periodic sample collection from the dissolution vessels to LC analysis is performed automatically, substantially reducing the burden on the analyst.
With its proprietary design, the Nexera FV flow through vial autosampler periodically collects samples that are sent into the flow through vial from the reaction tank or dissolution vessel. Two analytical modes can be selected depending on the sampling time and LC analysis time, to provide optimally timed analytical data collection. Further, the Nexera FV can also be used as a general-purpose UHPLC system, which contributes to increasing the asset's operating rate. Additionally, with just a few simple operations, LabSolutions FV implements settings for online analysis and data analysis for a wide range of applications, including process monitoring and dissolution testing.
Nexera FV and LabSolutions FV expand the possibilities for online LC, providing new solutions for pharmaceutical quality control.