Equipment and Facilities

The GMP facility is equipped with modern research laboratories for analytical, preformulation, and formulation research, as well as suites for non-clinical manufacturing research and development and some GMP manufacturing capabilities.

Analytical:

  • GC
  • GC-MS
  • HPLC
  • HPLC-MS
  • UV/Vis Spectrophotometer

Blending Equipment:

  • 5-cubic foot PK V-Blender
  • 8-quart V-Blender
  • 16-quart V-Blender
  • Niro-Fielder GP-1 (high shear granulator)

Capsule Filling Machines:

  • Harro Hofliger-KFM/3 Model
  • Zansi LZ64

Coating:

  • For small clinical lots: ca 1 kg capacity
  • Hi-Coater HT-30
  • Niro-Aeromatic MP-1 Fluid Bed Processor

Density Characterization:

  • Bulk density
  • Tapped density
  • True density

Dissolution System:

  • (1) SR8 Plus Dissolution Test Station (2) with VK8000 Autosampler

Dry Granulation:

  • Particle Size
    • Laser diffraction (dynamic and static)
    • Microscopy
    • SEM
    • Sieve analysis
  • Powder Characterization
  • Suface area
    • Porosity measurement

Mechanical Characterization:

  • InstronFlow Characterization
    • Angle of repose
    • Annular shear cell
    • Carr index
    • Minimum orifice diameter

Milling Equipment:

  • Quadro Comil 197S (development/clinical scale)

Miscellaneous Equipment:

  • Enivironmental chambers for stability, temperature, and humidity
  • Granulation equipment: high shear, low shear, and fluid bed
  • Milling: hammer and fluid energy
  • Vacuum drying

Preformulation:

  • Moisture Content
    • Carl Fisher titration
    • Loss on drying (LOD)
    • Moisture absorption isotherm determination
  • Solubility
    • Osmolarity
    • pH and ion selective techniques
    • Viscosity measurement
  • Thermal Analysis
    • DSC and MDSC

Tableting:

  • Elasticity and other standard tests
  • Heckel analysis
  • Manesty Beta Press
    • High-speed rotary tablet press (16 stations)
  • Stoke's B2 Rotary Tablet Press (16 stations)
    • Instrumented compression and ejection
    • Colton Single Station Tablet
    • Fully instrumented upper and lower force and displacement
  • Tableting Test capabilities

USP and Non-USP Test Capabilities:

  • Foss NIR Spectrophotometer RCA 6500
    • Content variation
    • Tablet disintegration
    • Tablet dissolution for IR and CR
    • Tablet hardness
    • Weight variation