Analytical Labs

  • Dry powder manufacture and characterisation
  • Wet formulation manufacture and characterisation
Analytical Methods and Techniques
  • Aerodynamic Particle Size using NGI (DPI, pMDI, Nebulization)
  • Laser diffraction, Particle Size Measurements
    see Case Studies

    • Time resolved measurements of emptying process
  • Prediction of lung dose (anatomical throats and patient flows)
  • Delivered dose uniformity
  • Device characterization
    • Flows and pressures
  • Electrostatic characterization of
    • Device parts
    • Dry powder formulation
    • Delivered dose
  • Assay and Identification
  • Organic impurities and degradation products
  • Moisture
  • Spray Pattern, see Case Studies
  • Plume Geometry, see Case Studies
Analytical Methods and Techniques
  • XRPD– X-Ray Powder diffraction. Crystallinity, polymorph identification/purity, amorphous content, phase quantification, structural understanding etc.
  • DSC– Differential Scanning Calorimetry. Evaluation of a sample’s thermal behavior, g. melting temperature, glass transition temperature, crystallization temperature etc.
  • TGA– Thermal Gravimetric Analysis. Determination of change in weight as a response to change in temperature, g. quantification of residual solvents.
  • GVS– Gravimetric Vapor Sorption.  Evaluation of hygroscopicity, water sorption behavior at different relative humidity’s, deliquescence and other humidity induced phase changes.
  • TAM– Thermal Activity Monitor (microcalorimetry). Evaluation of any type of biological, chemical and physical process by detection and quantification of the related heat flow (exothermic or endothermic).
  • BET–Determination of specific surface area on powders (using N2 adsorption according to Brunauer – Emmett – Teller – principle). Determination of micro pore volume and meso pore distribution of solid samples.
  • Pycnometry– Helium based instrument used for the determination of absolute density of powders.
Analytical Methods and Techniques
  • LM– Light Microscopy. Optical microscope equipped with crossed polarized filters and camera functionality. Also available in inversed (from bottom) mode.
  • IR– Infrared spectroscopy. Identification of compounds, quantification of content and characterization of interactions in mixtures.
  • Micronisation – Particle size reduction using spiral jet mill
  • Conditioning – Restoration of crystallinity after micronisation with maintained particle size/distribution
  • SEM – High magnification Scanning Electron Microscopy
  • SXRD – Crystal structure determination by single crystal X-ray diffraction
  • Salt & Polymorph screening – Identification of the most optimum form for further development
  • Identification of API crystal modification – down to 0.01% in ordered mixtures
  • Crystallisation – Applying specialised methodologies to crystallise difficult compounds
Device verification Tools
  • Dimensions
  • Force&Torque
  • Malvern Mastersizer