Fusion Inhaler Testing (FIT) Software
With customers reporting huge productivity gains, Fusion Inhaler Testing (FIT) is the must have inhaler testing software for today’s inhaler testing laboratory. Support for pharmacopeia methods USP 601, Ph. Eur. 2.9.18, and IP 27427 is assured, but most laboratories performing cascade impaction studies require compliance tools to meet their business rules and regulatory standards.
Fusion Inhaler Testing (FIT) is the only inhaler testing software on the market that provides compliance tools to meet Code of Federal Regulations 21 CFR Part 11 and Good Manufacturing Practice (GMP) standards. FIT provides a compliant platform for the planning of cascade impaction experiments and validated data exchange with your chromatography data system to create sequences and import result data. All calculations and reporting of your Aerodynamic Particle Size Distribution (APSD) and dose uniformity work remain within a compliant platform.
The efficiencies gained by implementation of Fusion Inhaler Testing changed the manner in which our laboratories acquired and processed APSD analysis. We achieved a 88% time saving (from 4 hours to 30 min per batch) by deploying the FIT software. The software enforced 100% right first time sample sets in Empower and eliminated the requirement to transcribe or carry out transcription checks while carrying out APSD analysis. (Louise Tobin – Teva Pharmaceuticals Ireland)
Contact us for more information or to arrange a demonstration.
- No Transcriptions
- Improved Quality
- Saves Time
- Saves Money
- GMP Compliance
Fusion Inhaler Testing (FIT) is the only respiratory data analysis software on the market with validated data exchange tools. Support for Waters Empower (II & III), Thermo Chromeleon and Agilent OpenLab(Chemstation), allow the automatic creation of ready to run samplesets or sequences within the target chromatography data system. Once available, impactor stage mass results can be imported automatically, removing the bottleneck and quality issues associated with data transcription and transcription checking. All data exchange activities are fully audited so that the source of every impactor stage result is known.
Fusion Inhaler Testing (FIT) supports the Next Generation Impactor (NGI), Anderson Cascade Impactor (ACI), Multi-Stage Liquid Impinger (MSLI), and Marple Miller Impactor for the testing of metered dose inhalers, dry powder inhalers, nasal spays, and nebulisers.
Abbreviated Impactor Measurement (AIM) and Efficient Data Analysis (EDA) is also accommodated with support for the Fast Screening Impactor (FSI) and Fast Screening Anderson (FSA) apparatus.
Individual impactors may be defined within the FIT software allowing each impactors mensuration data to be stored. This can then be used as the starting point to calculate each stages effective cut-off diameter, rather than assuming nominal diameters. This improves the accuracy of a given impactor’s result and improves precision when comparing results across different impactors.
Cascade Impactors are often configured differently according to the product under test. For example, expansion chambers, pre-separators or other device components may be added, requiring a sample to be taken from each. FIT allows for product specific testing configurations to be defined that specify where samples are to be generated from. These transfer into the “sampling plan” exported to the CDS for analysis.
Fusion Inhaler Testing (FIT) software fully supports pharmacopeia methods USP 601, Ph. Eur. 2.9.18, and IP 27427.
The calculation wizard offers greater flexibility making it ideal for both QC and R&D activities. Supported respiratory calculations include:
- Material Balance
- Mass Balance,
- Impactor Sized Mass,
- Fine Particle Dose (FPD),
- Fine Particle Fraction (FPF)
- Mass Median Aerodynamic Diameter (MMAD)
- Geometric Standard Deviation (GSD)
- Stage Groups and Size Groups
Where appropriate these can be expressed relative to a dose uniformity result such as Delivered Dose Uniformity (DDU) or Uniformity of Delivered Dose (UDD), Label Claim or Target Delivered Amount, Content Assay, and Recovered or Emitted Dose. Where data is determined from a log-probit plot both interpolation and regression calculation options are available.
This calculation flexibility comes with user controls. The Fusion Administrator application allows user profiles to be defined, templates to be created, and calculation options to be locked down on a product by product basis. This makes Fusion Inhaler Testing (FIT) software perfect for regulated, high throughput QC environments.
In addition to cascade impaction studies and resultant Aerodynamic Particle Size Distribution (APSD) calculations, Fusion Inhaler Testing (FIT) supports a full suite of uniformity testing routines. These include:
- Delivered Dose Uniformity
- Delivered Dose Uniformity Over Entire Contents
- Dose Content Uniformity
- Dose Content Uniformity Through Container Life
- Uniformity of Delivered Dose
Fusion Inhaler Testing (FIT) produces a detailed Aerodynamic Particle Size Distribution (APSD) report for each device at each stage of life tested. A summary report collates results across the batch, reporting the Mean, Variance, Standard Deviation, and %RSD of each key result.
When dose uniformity tests are included the associated reports are generated and pass/fail criteria applied.
Graphical plots are also available as are audit trails. These individual reports may be collated as required to produce a single multi-page report detailing the entire body of work undertaken (e.g. stability pull point).
For those engaged in the early development of an inhaler device or formulation Fusion Product Development provides a platform to do so utilising Quality by Design principles. Study variables and ranges may first be defined to create an Experimental Design. The required cascade impaction tests can then be defined using the Respiratory Toolkit.
The Respiratory Toolkit affords much of the same calculation and CDS data exchange functionality as FIT, only the calculated APSD results are mapped back to the Experimental Design, and empirical models generated to create the Knowledge Space. This can then be used to make predictions and find the set of device or formulation parameters (Critical Process Parameters) that will provide the desired Critical Quality Attributes, for example Fine Particle Dose or MMAD.
For more information on Fusion QbD’s Product Development module and Respiratory Toolkit, click here.
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