Fusion QbD®
Fusion Inhaler Testing
Software for Oral and Nasally Inhaled Drug Product R&D and QC
Links to More Information about Fusion Inhaler Testing!
Product Brochure (PDF | Online) • Part 11 Compliance
S-Matrix – Software Solution Partner of:
Works with the following Chromatography Data Software:
- ChemStation and OpenLab 1.x – Agilent LC Systems
- Chromeleon™ 7.2 (SR5 or later) – Thermo Scientific and Agilent LC Systems
- Empower™ 3 – Waters® and Agilent LC Systems
Click the link below to find out more about the new Inhaler Testing Toolset feature within the Fusion Process Development module for Respiratory Drug Formulation & Device R&D! Fusion Process Development
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 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:
- 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 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 then automatically retrieves and uses the apparatus-specific cutoff diameter values during data analysis.
- Create analysis templates which automatically generate and report results in FDA/USP or EU formats, as well as General, which enables selection of any or all of the possible analysis calculation approaches.
- FIT is also the only inhaler testing software product that provides full support for 21 CFR Part 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 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.