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).

Literature

Borman PJ, Chatfield  MJ, Damjanov I, Jackson P (2011) Method ruggedness studies incorporating a risk-based approach: A tutorial, Anal Chim Acta 703(2):101-113.

Vogt FG,  Kord AS (2011) Development of quality-by-design analytical methods. J Pharm Sci 100(3):797-812.

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