Method Development

Are you always sure that the analytical (standard) method can give you adequate results when ordering individual analysis?Â
The optimisation of a method during the manufacturing process development is frequently needed to fit the systematically chosen Quality-By-Design (QbD).Â
Did you know that Â
- Most standard methods have exceptionsÂ
- Frequently material properties impact the results or even make a method irrelevantÂ
- It saves time and money to adopt standard methods to fit each caseÂ
Particle analytical has +20 years of expertise in method adoption and development!Â
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This is an example of a method development process:Â
- Setting the aim of the methodÂ
- Searching for the optimal analytical parameters to achieve the goalÂ
- Study the properties of the material – we define the package in collaboration with youÂ
- Finding the optimal measurement parameters, i.e. measurement time per step, equilibration conditions, pre-drying time, dispersion media and time etc.Â
- Comparing the method under development with the existing methodsÂ
- Evaluating the critical method variablesÂ
- Evaluation of method robustnessÂ
- Building strategy of risk mitigationÂ
Example of possible Method Development Strategy. The Scheme adopted from Vogt FG, Kord AS (2011). Â