Pulmatix has state-of-the-art testing facilities at their Glebe headquarters in Sydney. With a comprehensive suit of equipment and expertise we can provide you with critical product data rapidly. Core facilities are outlined on this page

AEROSOL PRODUCTS

  • Malvern SprayTec laser diffraction for analysis of aerosols.
    • Measurement across a wide size range (0.1 – 2000 microns) at 10,000 measurements a second with temporal resolution. Accurate, concentration-independent analysis of wide spray plumes. Accessories for numerous products including nebulisers, pMDI, DPI, nasal sprays and commercial cosmetic and agro sprays.
  • United States Pharmacopeia (USP) testing apparatuses (USP Chapter <601>) for the aerodynamic particle size analysis of medical sprays (dry powder inhalers (DPI), pressurised metered dose inhalers (MDI) and nebulisers)
    • USP Apparatus 1 & 3: Anderson Cascade Impactors (AC) for DPI and MDI
    • USP Apparatus 4: Multistage Liquid Impingers (MSLI) for DPI
    • USP Apparatus 5 & 6: Next Generation Impactors (NGI) for DPI, MDI and nebulisers
  • Fast screening impactor (single cut-off at 5 µm)
  • Dose uniformity analysis (DUSA)
  • Nasal spray testing facility
  • Lung simulator
  • Cell sample deposition apparatus for pre-clinical drug transport and toxicity
  • Aerosol filter deposition apparatus for evaluation of drug dissolution
  • High speed imaging

PHYSICO-CHEMICAL

  • Scanning Electron Microscopy (SEM)
  • Microscopy with chemical analysis (Raman)
  • Atomic force microscopy (AFM)
  • Thermo-gravametic & differential scanning calorimetry (TGA/DSC)
  • Modulated DSC
  • Dynamic Vapour Sorption
  • Particle size analysis (Malvern 3000) for wet and dry samples
  • Karl Fischer water analysis
  • Rheometry
  • Drug dissolution (including Apparatus IV for poorly soluble compounds)
  • Drug, excipient and related substances analysis

STABILITY & ROBUSTNESS

  • Stability
    • Thermal and humidity stability control cabinets
    • Accelerated stability and stress testing
    • Automated actuation apparatus
  • Product robustness
    • Drop testing and orientation studies
    • Visual inspection and analysis
    • Leakage testing
    • Fibre and particulate analysis

 

ANALYTICAL

  • Stand-alone UV/VIS analysis
  • Automated high performance liquid chromatography (HPLC)sSystems with
    • UV/VIS,
    • refractive index
    • photodiode array detectors
  • HPLC- Mass Spectroscopy (HPLC-MS)
  • Gas chromatography
  • Raman chemical analysis
  • Analytical method development
    • Excipients
    • API
    • Related substances and degradation products

PRE-CLINICAL

  • Applied molecular biology
    • Numerous cell models for evaluation formulation components
    • in vitro cell based aerosol apparatus for the evaluation of real products
  • Lung epithelia and nasal epithelia models
    • Toxicity
    • Drug transport studies
    • Metabolises
  • Molecular biology models for the study of inflammation,
  • Molecular biology models for studying epithelia response
  • Microbiological models for the study of infection
  • Biofilm models for chronic infection

MANUFACTURE

  • In-house expertise in formulation and device design
  • Rapid design and implementation
    • 3D prototyping/printing - Fused deposition modeling (FDM)
    • 3D prototyping/printing - Selective Laser Sintering (SLS)
    • CNC machining
  • Particle engineering
    • Bench scale micronisation of powders
    • Water and organic based spray drying
    • Pressurised metered dose inhaler manufacture and filling
    • Rotary evaporator for preparation of liposomal formation
    • High shear liquid mixers 
    • Low Shear and high shear powder mixers
    • Freeze drying

 

The list  not exhaustive. If you have a specific testing requirements please speak to our helpful staff and we can discuss what options and services we can provide.