Particle characterization in formulation, pharmaceutical particulate material quality control - presentation
Richard J. Tweedie*
Particulate Sensors Ltd, Newcastle-upon-Tyne, UK
*
www.particulatesensors.com
The twin business imperatives of increasing competitiveness, and reducing risk are common to all manufacturers, if not more so in the pharmaceuticals. This translates into increasing supply chain diversity and product complexity, with a constant pressure on costs, while operating in a highly legislated, regulated environment.
Unit operations involving particulate operations are widespread in the processing of pharmaceuticals, even within the chemical sector; with up to 60% of processes involve particle processing. Therefore maintaining quality control through particle characterization of raw materials and intermediaries is a vital piece of delivering the business objectives.
Despite all the claims and all the hopes, in the last 20 years the capability to characterise particulate systems in-situ has not met with the original expectations. Hence the industry is still dependant on laboratory instrumentation.
As the industry has moved forward so have measurement techniques with improvements to existing methods and an increasing number of new methods aimed at ‘Nano’ material formulations These recent advances in particle characterization allow a much greater degree of understanding both distribution of particle characteristic and the individual properties such particle shape.
The various options available to make these measurements are discussed in relation to the information required.