Critical Quality attributes for tablet process parameters—

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 PROCESS PARAMETERS, AND QUALITY ATTRIBUTES FOR TABLETTING UNIT OPERATIONS

Unit operation Process parameter Quality attributes
Mixing 1.    Order of addition

2.    Mixer load level

3.    Impeller speed and  time

4.    Chopper speed and time

5.    Chopper ON/OFF Pattern

6.    Mixing time

Particle size distribution

Bulk/tapped density

Moisture content

Flow properties

Milling 1.    Impact/cutting/screening mills direction.

2.    Speed of mill

3.    Screen size

4.    Feeding rate

Particle size

Particle shape

Flow properties

Polymorphic form

Wet Granulation

(RMG)

1.     Pre-binder addition mix time

2.     Impeller speed and ON time

3.    Chopper speed and ON time

4.    Binder fluid temperature

5.    Binder addition rate and time

6.     Post-granulation mix time

Blend uniformity Flow, Moisture content Particle size and distribution addition Granule size and distribution Granule strength and uniformity Solid form
Spray Granulation

(FBE)

1.    Spray nozzle type and location

2.    Binder addition rate and time

3.    Bowel temperature

4.    Fluid bed granulations Mixing time Spray nozzle (type/quantity/ pattern/configuration)

5.    Binder fluid temperature

6.    Inlet air flow rate, volume, temperature, and dew point

7.    Exhaust air temperature,

8.     Shaking intervals

9.    Product temperature

Blend uniformity Flow Moisture content Particle size and distribution addition Granule size and distribution Granule strength and uniformity Solid form

Moisture content, Residual solvents

Drying (FBD) 1.    Inlet air flow rate, volume, temperature, and dew point

2.    Bowel temperature

3.    Exhaust air temperature,

4.     Shaking intervals

5.    Product temperature

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

(Tray dryer)

1.    Tray Quantity carts and trays per chamber

2.    Quantity of product per tray

3.     Drying time and temperature

4.    Air flow

5.     Inlet air temperature and dew point

6.    Jacket temperature

7.    Condenser temperature

8.     Vacuum strength

Granule size and distribution Granule strength, and uniformity Particle size Flow Bulk/tapped density,  Moisture content Residual solvents.
Roller compaction 1.    Roll speed

2.     Gap setting

3.    Roll pressure

4.     Auger screw rate

5.     Roller type

Appearance Ribbon/particle size and shape Ribbon density, strength, and thickness Solid form
Blending 1.    Blender  type

2.    Blender RPM

3.    Blending time

Blend uniformity

Flow properties

Compression 1.    Compression speed

2.    Force Pre-compression

3.    Force main compression

4.     Force Feed frame type and speed

5.     Hopper design, height,

6.    Depth of fill

7.    Punch penetration depth

Target weight, Weight uniformity Content uniformity,  Hardness Thickness, Tablet porosity Friability
Coating, 1.    Product temperature

2.     Total pre-heating time

3.     Spray nozzle (type/quantity/ pattern/configuration)

4.    Individual gun spray rate

5.     Total spray rate

6.     Pan rotation speed

7.    Atomization air pressure Pattern

8.    Air pressure

9.    Inlet air flow, temperature, dew point

10.    Exhaust air temperature, air flow

11.    Product temperature

12.     Total coating time

Visual attributes,  Moisture content, Weight of core tablets Appearance,  Visual attributes , % Weight gain,  Film thickness, Color uniformity , Hardness Thickness

 

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