Characterisation of physical properties is essential not just for optimising quality and performance, but in assessing how your raw materials, intermediaries and final products react to processing conditions and over shelf-life. Physical properties data plays a vital role in stability studies, raw material/drug product release (pharmacopoeial testing) as well as troubleshooting manufacturing and quality issues.

RSSL's teams collaborate to provide the best cross-functional and multidisciplinary scientific service, whatever the requirements of your project - including method development and method validation. Analysis is detailed, wide ranging and will be tailored to your needs, some examples are highlighted below:

  1. Should you be experiencing caking of your powdered product, we can determine hygroscopicity via Dynamic Vapour Sorption (DVS) to define appropriate humidity ranges for storage, processing and amorphous to crystalline structural changes. Combining this technique with microscopy, particle sizing and powder flow analysis can provide further insights into product behaviour to preserve ingredient integrity, inform processing conditions, improve product appearance and performance.

  2. Another example of the application of our technologies, is in the evaluation of medical devices such as pre-filled syringes where we can assist in performance testing through mechanical measurements or detection/identification of manufacturing defects using X-ray Tomography.   

  3. Should you wish to conduct screening of the physical stability of emulsions or suspension-type products, our LUMiSizer (centrifuge combined with NIR Technology) can be applied for rapid pre-stability screening, zeta potential measurements with our Malvern Zetasizer and advanced rheological techniques for the assessment of flow properties over a wide range of shear rates and temperatures.

  4. Active Pharmaceutical Ingredient (API) release optimisation and dissolution issues can be investigated via specific surface area/pore size studies (in conjunction with particle sizing and dissolution testing if required)

Physical Properties & Techniques

Droplets/particle size and size distribution (from nano to millimetre range: Malvern Zetasizer, Malvern Mastersizer 2000/3000 and analytical sieving)

Rheological behaviour - from basic viscosity to complex characterisation

Thermal analysis (via Differential Scanning Calorimetry (DSC) for example melting point, glass transitions, specific heat capacity)

Moisture content (Karl Fischer and TGA)

Water activity/equilibrium relative humidity

Internal structural analysis (X-Ray Tomography)  

Density (solids and semi-solids) 

Predictive physical stability assessments via LUMiSizer and Zeta potential measurements

Particle shape (Microscopy via Light, Confocal and SEM)

Powder flow assessment (for example via tapped/bulk density and shear cell instruments)

Specific surface area (via BET calculations)

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