DOE-based software with a complete library of design types

Fusion Inhaler Testing

Automated Inhaler Testing Software

Works with the following Chromatography Data Software:

Fusion Inhaler Testing (FIT)

Fusion Inhaler Testing (FIT) creates Device Sampling Designs for metered-dose inhalers (MDIs) and dry powder inhalers (DPIs). It supports USP Apparatuses 1–6, Ph.Eur. Apparatuses C, D, and E, and Dose Unit Sampling Apparatuses (DUSAs). FIT also creates coordinated HPLC Testing Designs that are directly exportable to your Chromatography Data Software (CDS) — connectivity includes Agilent ChemStation, Dionex Chromeleon, and Waters Empower 2 and 3.

Key Benefits
  • Automates all QC Testing on HPLC/UHPLC
  • Minimizes Manual Data Transcription Work and Error Checking
  • Supports 21 CFR p11 compliance
  • Saves 2–3 Days per Week per Analyst!
Example Applications
  • Drug Formulations
  • Dosage Delivery Devices
  • Airborne Pollutants

FIT’s Export operation automatically builds the sequence (or sample set) in the CDS, adds the appropriate standards injections, and attaches the LC Assay Method so that the sequence is ready to run on the LC in full walk-away mode.

FIT automatically imports all chromatographic 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 enables users to manage all of their apparatuses and product testing configurations:

FIT was developed in cooperation with several international pharmaceutical and medical device companies to address all USP and Ph.Eur analysis and reporting requirements and be consistent with current cGXP best practices.

Pharma Customer Benchmarking

To benchmark time savings using FIT versus current practice, an international pharmaceutical company repeated a standard set of testing, analysis, and reporting for an inhaled drug product testing protocol. Their estimated time savings using FIT was 40%. In addition, the automated data exchanges with the CDS virtually eliminated the possibility of transcription errors.