Pharma notes
Critical Quality attributes for tab
| 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 |
