Innovative particle size distribution and thermal analysis techniques are key to solving powder characterisation challenges

Mathieu Van Schel, Group Leader, Eurofins BioPharma Product Testing, Les Ulis, France, mathieuvanschel@eurofins.com; Terry Schuck, Senior Manager of Biologics Raw Materials, Eurofins BioPharma Product Testing, Lancaster, PA, TerrySchuck@eurofinsUS.com

Powder characterisation is a key challenge for the pharmaceutical industry at every step of the product lifecycle: from R&D formulation, production, as well as quality control for testing raw materials, API, or even final products. Particle size of a pharmaceutical material can affect the flow characteristics of a powder. This can impact manufacturing processes, such as blending, tableting, dissolution, and bioavailability of the active ingredient. Thermal characterisation of pharmaceuticals can help identify polymorphism and purity. These characteristics provide information for drug development, pre-formulation, and quality control. Moreover, the regulation chapters around the powder characterisation are becoming more restrictive as authorities expect the use of more state-of-the-art and innovative techniques and data to support pharmaceutical products.

To achieve these powder characterisation techniques, the Wet Chemistry / Particle Size Distribution (PSD) teams at Eurofins EPQC (les Ulis) and Eurofins BioPharma Product Testing (Lancaster, Pa) use a broad range of equipment to perform PSD analysis at macro and nano scales and thermal analysis.

• For PSD analysis, the teams are capable of analysing powder at the macro scale level using various types of sieves (air jet or regular sieves), visible microscopes, as well as analysing powder at the nano and macro scale using laser diffraction equipment (Beckman Coulter LS 13 320, Malvern Mastersizer 3000, equipped with a couple of analysis modules – e.g.: aero S).

• For thermal characterisation, the teams have the ability to quantify melting temperature (Tm), crystallisation temperature (Tc), glass transition temperature (Tg) and purity testing using Differential Scanning Calorimetry (DSC) or a broad range of thermometers.

Today, numerous powder matrices are analysed every year at Eurofins EPQC and Eurofins BioPharma Product Testing sites according to Ph. Eur., USP regulations, and customerbased methods.

In addition, if clients are more interested in Particle Size Distribution characterisation of liquid or micelles, Eurofins is also able to perform such activities (using either our Malvern Mastersizer 3000 or our Malvern Zetasizer). Contact us for further information or visit: www.eurofins.com/ebpt