Fusion Inhaler Testing (FIT) – creates Device Sampling Designs for metered-dose inhalers (MDIs) and dry powder inhalers (DPIs). Supports USP Apparatuses 1–6, Ph.Eur. Apparatuses C, D, and E.
FIT also creates coordinated HPLC Testing Designs that are directly exportable to Chromatography Data Systems (CDS). The 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 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 enables users to manage all your apparatuses and product testing configurations:
- Input apparatus-specific mensuration data and associated expiration dates. The program can automatically calculate and store the effective cutoff diameter data for an apparatus from the mensuration data, and automatically communicate these data to each product testing project.
- Create product-specific Product Testing Configurations to which multiple apparatuses can be assigned.
- Easily map individual testing apparatuses to their associated test data. The program will then automatically retrieve and use the apparatus-specific cutoff diameter data in data analysis.
- Create analysis templates which automatically generate and report results in FDA/USP or EU formats, as well as General, which enables you to select any or all of the possible analysis calculation approaches.
- Remember, FIT is the only software product that provides full support for 21 CFR 11 Compliance!
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 cGLP best practices.
