GMP Granulators Wet, dry & fluid bed Granulation Systems
Oscillating Granulators: Precision Dry Granulation for Pharma & Nutraceuticals.
Granulators transform powders into uniform granules for optimal tablet compression. LOCUS PHARM delivers GMP-validated systems for:
Wet Granulation: High-shear mixing with binder solutions
Dry Granulation: Roller compaction for moisture-sensitive APIs
Fluid Bed: Single-pot processing (granulation → drying → coating)
For uninterrupted production workflows, LOCUS PHARM recommends oscillating granulators engineered to match your material properties (density, moisture) and volume requirements. These GMP-compliant systems deliver:
Core Technical Specifications:
Mechanism: Dual counter-rotating rollers + oscillating screen
Output: 50-400 kg/h (dry mode)
Uniformity: ±1% particle size distribution
Material Contact: 316L stainless steel (Ra ≤0.4µm EP finish)
Modes: Dry granulation (primary) / limited wet granulation
| Type | Mechanism | Capacity | Uniformity | Ideal For |
|---|---|---|---|---|
| High-Shear | Rotor/chopper | 5-600L | ±1% RSD | Moisture-stable formulations |
| Fluid Bed | Air suspension | 3-500L | ±2% RSD | Heat-sensitive APIs |
| Roller Compactor | Pressure densification | 10-200 kg/h | ±3% RSD | HPAPIs, low-moisture products |
| Oscillating | Rotating screen | 50-400 kg/h | ±2.5% RSD | Granule sizing post-drying |
Core Systems
Key Components:
GMP-Grade Housing: 316L SS with CIP capability
Compression Rollers: Hardened steel (HRC 60-62), adjustable gap
Screens: Interchangeable meshes (0.5-10mm)
Oscillating Mechanism: Eccentric drive with amplitude control
Particle Engineering Benefits:
Bioavailability: Optimized dissolution via uniform density (0.6-0.9 g/cm³)
Dosing Accuracy: ±1% weight variation in tablets/capsules
Stability: Friability <0.5% (exceeds USP <1216>)
Advanced Modules:
In-line NIR moisture analysis
Loss-in-weight binder addition
Containment interfaces (glove ports)
CIP/WIP systems
Critical Success Factors:
Particle Size Distribution: Laser diffraction monitoring
Flowability: Carr Index <25
Compressibility: Kawakita equation optimization
Moisture Control: ±0.1% variance
Our high-shear systems achieve >97% yield with friability <0.6% — exceeding USP <1216> specifications for tablet uniformity.
Tropicalized Designs:
Humidity-controlled HMI cabinets
316L SS with 2.0% Mo content
Voltage stabilization (100-480V)
Potent Compound Handling:
ATEX Zone 1 compliance
Nitrogen purging systems
Continuous emission monitoring
Complete Workflow:
Granulator → Fluid Bed Dryer → Tablet Press → Coater → Blister Machine
LOCUS PHARM Synergies:
Tablet presses (single-punch to rotary)
Capsule fillers
Continuous manufacturing systems
| Requirement | Implementation | Compliance Standard |
|---|---|---|
| Material Traceability | EN 10204 3.1 certificates | EU GMP Annex 15 |
| Cleanability | Dead-leg-free design, CIP integration | ISO 14644-1 Class 7 |
| Surface Finish | Ra ≤0.4µm electropolished | ASME BPE-2022 |
| Documentation | IQ/OQ/PQ validation packages | FDA 21 CFR Part 211 |
Materials: 316L SS (Ra ≤0.4μm EP finish)
Containment: OEB 3-5 options with split valves
Control: Recipe-based PLC with 21 CFR Part 11 compliance
Validation: IQ/OQ/PQ protocols, FAT/SAT support
Key Metrics:
Granule density: 0.5-0.8 g/cm³
Friability: <1% loss
Moisture content: 1.5-2.5%
| Parameter | Dry Granulation (Oscillating) | Wet Granulation |
|---|---|---|
| Moisture | <0.5% (no binders) | 15-20% (binder solution) |
| Throughput | 400 kg/h max | 200 kg/h max (-50%) |
| API Stability | Ideal for moisture-sensitive compounds | Risk of degradation |
| Energy Use | 30 kW avg | 55 kW avg (drying required) |
Pharmaceuticals:
Effervescent tablets
OTC drug granules
HPAPI formulations
Nutraceuticals:
Vitamin blends
Probiotic pellets
Veterinary:
Feed additives
Bolus preparations
| Dosage Form | Granulator Type | Critical Parameters |
|---|---|---|
| Tablets | High-shear | 500-1000μm granule size |
| Capsules | Fluid bed | 15-25% porosity |
| Effervescents | Roller compactor | <0.5% moisture |
| Orally Disintegrating | Single-pot | Fast dissolution profile |
Precision Sizing:
«Proprietary screen oscillation technology achieves ≤5% RSD particle size distribution — outperforming rotary granulators by 3× (per ASTM E2651).»
Material Preservation:
Low-heat compression (<35°C) maintains API stability for thermolabile compounds like probiotics and enzymes.
Throughput Advantage: 400 kg/h output vs. 200 kg/h in wet systems
Compliance Ready: Full validation support (IQ/OQ/PQ)
Material Science: 316L SS with Mo-enhanced corrosion resistance and with Ra ≤0.4μm finish
Global Certification: Meets FDA, EMA, WHO-GMP requirements
Process Precision: ±1% RSD granule uniformity
Containment Expertise: OEB 5 solutions for HPAPIs
Certification Highlights:
ISO 14644-1 Class 7
ASME BPE-2022
ATEX 2014/34/EU
Optimize Your Dry Granulation Process!
✅ GMP Compliance Guarantee
✅ 24/7 Multilingual Support
✅ 24-month performance guarantee
✅ Local technicians in 18 countries
Free line configuration for your products, throughput validation testing!
Contact Specialists for GMP:
Compliance Roadmap:
CE, EAC, ISO 9001 certifications.
GMP-ready: 316L SS contact parts, CIP/SIP capabilities.
