Stage 01
API Synthesis
The active pharmaceutical ingredient (API) is synthesised via chemical reactions in stainless steel reactors under controlled temperature, pressure and pH. Intermediate products are purified at each step.
Reactor: SS 316L
Temp: 20–80 °C
Purity: ≥99.5%
Stage 02
Weighing & Dispensing
API and excipients (binders, fillers, disintegrants, lubricants) are precisely weighed in a contained dispensing booth under negative pressure to prevent cross-contamination and protect operators.
Accuracy: ±0.1%
Containment: OEB 4
HEPA filtered
Stage 03
Wet Granulation
Dry API and excipient powders are blended, then a granulating liquid (binder solution) is added in a high-shear mixer. The wet mass is processed into uniform granules that improve flow and compressibility.
High-shear mixer
Binder: PVP/HPMC
LOD: 2–5%
Stage 04
Drying & Milling
Wet granules are dried in a fluid bed dryer where hot air flows upward through the bed, removing moisture uniformly. Dry granules are then milled to the target particle size distribution.
Fluid bed: 50–70 °C
LOD target: <2%
Mill mesh: 1–2 mm
Stage 05
Blending & Lubrication
Dried granules are blended with lubricants (magnesium stearate), glidants (colloidal silica), and disintegrants in a tumble blender to achieve content uniformity before compression.
Tumble blender
MgSt: 0.5–1%
RSD: <2%
Stage 06
Tablet Compression
The lubricated blend is fed into a rotary tablet press where upper and lower punches compress the granules into tablets at precise weight, hardness, and thickness. Output: 200,000–1M tablets/hour.
Rotary press: 36–61 stations
Hardness: 5–20 kP
Weight CV: <1%
Stage 07
Film Coating
Tablets tumble in a perforated pan while coating solution is sprayed and warm air dries it. The polymer film masks taste, protects API from moisture/light, aids swallowing, and enables enteric or sustained release.
Coating: HPMC/EC
Weight gain: 2–5%
Inlet air: 55–65 °C
Stage 08
QC, Packaging & Release
Coated tablets pass through metal detectors, vision systems (colour, size, print), and dissolution testing. Accepted tablets are blistered or bottled, then held in quarantine pending QA batch release.
Vision: 99.9% accuracy
Blister: Alu-Alu / PVC
Quarantine: 2–5 days