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• Solid dispersions or inclusion complexes (e.g., cyclodextrins).
Quality Control Documentation:
Every test recorded in batch manufacturing records (BMR) and batch packing records (BPR).
All deviations and out-of-specification results investigated.
Tablet Manufacturing Equipment – Overview:
1. Mixers and Blenders:
o Purpose: achieve uniform distribution of ingredients.
o Types:
▪ Double cone blender.
▪ V-blender.
▪ Ribbon mixer.
▪ Planetary mixer (for wet massing).
o Mixing time optimized to prevent segregation.
2. Granulators:
o Used to convert powder into granules.
o Types:
▪ High-shear mixer granulator.
▪ Fluid-bed granulator.
▪ Oscillating granulator.
▪ Sigma blade mixer.
3. Dryers:
o Purpose: reduce moisture to safe limits.
o Types:
▪ Tray dryer.
▪ Fluid-bed dryer (FBD).
▪ Vacuum dryer.
o Optimum drying avoids overhard granules.
4. Milling and Sieving Equipment:
o Multimill, Comminuting mill, Vibrosifter.
o Sieves of defined aperture used (as per BP standards).
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