Method Development

Are you always sure that the analytical (standard) method can give you adequate results when ordering individual analysis? 

The optimisation of a method during the manufacturing process development is frequently needed to fit the systematically chosen Quality-By-Design (QbD). 

Did you know that  

• Most standard methods have exceptions 
• Frequently material properties impact the results  or even make a method irrelevant 
• It saves time and money to adopt standard methods to fit each case 

Particle analytical has +20 years of expertise in method adoption and development! 

More Information 

This is an example of a method development process: 

• Setting the aim of the method 
• Searching for the optimal analytical parameters to achieve the goal 
• Study the properties of the material – we define the package in collaboration with you 

• Finding the optimal measurement parameters, i.e. measurement time per step, equilibration conditions, pre-drying time, dispersion media and time etc. 
• Comparing the method under development with the existing methods 
• Evaluating the critical method variables 
• Evaluation of method robustness 
• Building strategy of risk mitigation 

Example of possible Method Development Strategy. The Scheme adopted from Vogt FG, Kord AS (2011).