Fusion AE™ Automated Method Development and Validation Software for Galaxie
Key Benefits
- Operator bench-time and cost saving
- Higher sample throughput with error elimination.
- Multiple compounds are handled (up to 10 actives/impurities)
- Multiple study variables can be analyzed simultaneously
- 21 CFR 11 support with Galaxie CDS matched E-signature controls for data exchange
- Automated data Analysis and Reporting that meets FDA and ICH 1 guidelines
Fusion AE™ for Galaxie is an automated Method Development and Method Validation software package that integrates seamlessly with Varian’s Galaxie CDS software. Fusion AE automatically designs and runs experiments that optimize HPLC method parameters based on simultaneously entered multiple-variables such as mobile phase composition, flow rate, column packing functionality, injection volume, temperature, pH etc. Once developed and optimized, users can then automatically validate these methods while operating within the bounds of the FDA’s stringent CFR 21 Part 11 regulatory requirements. Alternatively, if a user is interested strictly in method validation, it is possible to install Fusion AE with this single option active. Fusion AE provides almost complete automation of the method development, optimization and validation process which saves operators time and effort and prevents human error from being introduced into validation results data.
The Fusion AE Method Development module works seamlessly with the Galaxie CDS and can be used, for example, to determine the optimum chromatographic conditions that would be required to separate several peaks with user specified resolutions, tailing factors and minimum run time values. All a user has to do is make a couple of initial runs using a Galaxie method, specify the upper and lower limits for each variable (Resolution, Tailing factor, retention time, etc.) and Fusion AE then:
- automatically determines the number of experimental runs and associated methods that will be required,
- creates these methods, and,
- populates them with the correct flow rate, mobile phase compositions etc. and,
- automatically builds a sequence containing these methods within Galaxie which the user then simply starts.
Once the runs are completed, Fusion AE extracts the results data and analyizes all the variables to determine the set of chromatographic conditions that best satisfies the initial user defined requirements. The optimization process quickly identifies the so-called “variable sweet spots”. and creates an “optimized” Galaxie method. Once parameters have been optimized, the Fusion AE method validation option can be used to completely validate the method.
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HPLC methods can be optimized for parameters such as peak resolution and tailing factors using variables such as buffer % and flow rate.
The Fusion AE Method Validation option works seamlessly with Galaxie CDS and can be used to automatically validate HPLC methods for criteria that include: Linearity, Accuracy, Precision, Range, Ruggedness, Reproducibility, Limit of Detection, Limit of Quantitation. Validations can be in either early or final phase FDA format. Standard system suitability parameters can also be selected and included. The Fusion AE validation template is populated with relevant information, next Fusion AE creates an experimental design that is exported to Galaxie CDS. From there it automatically builds a Galaxie sequence which the user then simply starts. When runs are completed, Fusion AE mines, analyzes and reports validation results data.
Acetophenone - Tailing Factor Response Surface
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