CRITICAL PROCESS PARAMETERS AND CRITICAL QUALITY ATTRIBUTES IN TABLET MANUFACTURING


Stage: Mixing 

CPP
  • Order of addition
  • Mixer load level
  • Impeller speed and time
  • Chopper speed and time
  • Chopper ON/OFF Pattern
  • Mixing time
CQA
  • Particle size distribution,
  • Bulk/tapped density,
  • Moisture content,
  • Flow properties

Stage: Milling

CPP
  • Impact/cutting/screening mills direction.
  • Speed of mill
  • Screen size
  • Feeding rate
CQA
  • Particle size,
  • Particle shape,
  • Flow properties,
  • Polymorphic form
  • Wet Granulation

Stage: Granulation (RMG)

CPP
  • Pre-binder addition mix time
  • Impeller speed and ON time
  • Chopper speed and ON time
  • Binder fluid temperature
  • Binder addition rate and time
  • Post-granulation mix time
CQA
  • Blend uniformity,
  • Flow,
  • Moisture content,
  • Particle size and distribution,
  • Granule size and distribution,
  • Granule strength and uniformity,
  • Solid form

Stage: Spray Granulation (FBE)

CPP
  • Spray nozzle type and location
  • Binder addition rate and time
  • Bowel temperature
  • Fluid bed granulations, Mixing time, Spray nozzle (type/quantity/ pattern/configuration)
  • Binder fluid temperature
  • Inlet air flow rate, volume, temperature, and dew point
  • Exhaust air temperature,
  • Shaking intervals
  • Product temperature
CQA
  • Blend uniformity,
  • Flow,
  • Moisture content,
  • Particle size and distribution, Granule size and distribution,
  • Granule strength and uniformity,
  • Solid form,
  • Moisture content,
  • Residual solvents

Stage: Drying (FBD)

CPP
  • Inlet air flow rate, volume, temperature, and dew point
  • Bowel temperature
  • Exhaust air temperature,
  • Shaking intervals
  • Product temperature

CQA
  • Granule size and distribution,
  • Granule strength, and uniformity,
  • Particle size,
  • Flow,
  • Bulk/tapped density,
  • Moisture content,
  • Residual solvents

Stage: Drying (Tray dryer)

CPP
  • Tray Quantity carts and trays per chamber
  • Quantity of product per tray
  • Drying time and temperature
  • Air flow
  • Inlet air temperature and dew point
  • Jacket temperature
  • Condenser temperature
  • Vacuum strength
CQA
  • Granule size and distribution,
  • Granule strength and uniformity,
  • Particle size,
  • Flow,
  • Bulk/tapped density,
  • Moisture content,
  • Residual solvents.

Stage: Roller compaction

CPP
  • Roll speed
  • Gap setting
  • Roll pressure
  • Auger screw rate
  • Roller type
CQA
  • Appearance,
  • Ribbon/particle size and shape,
  • Ribbon density, strength, and thickness,
  • Solid form

Stage: Blending

CPP
  • Blender type
  • Blender RPM
  • Blending time

CQA
  • Blend uniformity,
  • Flow properties

Stage: Compression

CPP
  • Compression speed
  • Force Pre-compression
  • Force main compression
  • Fedder Speed
  • Filling Depth
  • Punch penetration depth
CQA
  • Target weight,
  • Weight uniformity,
  • Content uniformity,
  • Hardness,
  • Thickness,
  • Tablet porosity,
  • Friability

Stage: Coating

CPP
  • Product temperature
  • Total pre-heating time
  • Spray nozzle (type/ quantity/ pattern/configuration)
  • Individual gun spray rate
  • Total spray rate
  • Pan rotation speed
  • Atomization air pressure Pattern
  • Air pressure
  • Inlet air flow, temperature, dew point
  • Exhaust air temperature, air flow
  • Product temperature
  • Total coating time
CQA
  • Visual attributes,
  • Moisture content,
  • Weight of core tablets
  • Appearance,
  • Visual attributes,
  • % Weight gain,
  • Film thickness,
  • Color uniformity,
  • Hardness,
  • Thickness


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