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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