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NEW - Automated Inhaler Testing Software

Works with Varian® GalaxieTM and Waters® EmpowerTM (Versions 1 and 2) Chromatography Data Systems

Fusion Inhaler TestingTM (FIT) - creates Device Sampling Designs for metered-dose inhalers (MDIs), dry powder inhalers (DPIs), single stage impingers (SSLIs), and multistage impingers (MSLIs).

FIT also creates coordinated HPLC Testing Designs that are directly exportable to the Chromatography Data System (CDS). The Export operation will automatically build the sequence (or sample set) in the CDS and attach the HPLC Assay Method so that the assay is ready to run on the HPLC once the mobile phase reservoirs are filled and the autosampler tray contains all required sample vials.

FIT automatically imports all chromatogram results from the CDS and generates all results and graphs typically required for inhaler testing. Key features include regulatory-compliant reporting, output formats such as *.PDF and *.DOC, a full 21 CFR 11 compliance toolset, and a workflow management system.

FIT was developed in cooperation with major international pharmaceutical and medical device companies to be consistent with USP <601> and current cGLP best practices.



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