Description
M-50 Mobile Homogenizer System for Pharmaceutical and Cosmetic Substances
M-50 mobile tank moving between lab stations.
Rotor-stator head creating nanoemulsion (CFD flow visualization).
21 CFR Part 11 compliant HMI interface.
Critical Innovations
-
Mobile Containment: Tank-on-wheels with triple-jacketed cooling (-20°C to 150°C) – transport mixtures between labs/pilot plants.
-
High Shear Homogenization: Rotor-stator generator (10-25μm gap) achieves 25,000 s⁻¹ shear – creates nanoemulsions ≤200nm.
-
Sanitary Design: Electropolished AISI 316L (Ra ≤0.4μm) with zero dead legs (ASME BPE-2022).
-
Data Integrity: 21 CFR Part 11-compliant HMI with electronic batch records and audit trails.
Technical Specifications
| Parameter | Value |
|---|---|
| Tank Capacity | 50L (GMP mobile vessel) |
| Shear Rate | Up to 25,000 s⁻¹ |
| Viscosity Range | 1-500,000 cP |
| Temperature Control | -20°C to 150°C (±0.5°C) |
| Power | 4 kW (220V/380V) |
| Surface Finish | Ra ≤0.4μm (internal), Rz ≤1.6μm (external) |
| Certifications | FDA 21 CFR 211, EU GMP Annex 1 |
Industry-Specific Applications
-
Pharma: Vaccine adjuvant emulsification (CIP/SIP at 121°C/15psi) .
-
Biotech: Cell lysate homogenization with cryogenic cooling option .
-
Cosmetics: Nanoemulsions for serums (droplet size ≤200nm) .
-
Nutraceuticals: Lipid nanoparticle (LNP) encapsulation .
Workflow Advantages
| Feature | Benefit |
|---|---|
| Wheeled Tank | Move batches between R&D → QC → filling (GMP traceability) |
| Quick-Change Heads | Swap rotor-stator → anchor → dissolver in <10 mins |
| Explosion Safety | ATEX Zone 1 option for solvent-based formulations |
| Scale-Up Ready | Identical shear profiles to production units (CFD-verified) |
Regional Adaptation
-
Tropical Climates: Condensation-proof electronics; 40°C/95% RH operation .
-
Voltage Flexibility: 220V/380V/480V with local certifications (GOST-R, INMETRO, CCC) .
-
Regulatory Support: Localized validation packages (IQ/OQ/PQ) for ANVISA, MOH, CDSCO .
Compliance & Certifications
-
Pharma: EU GMP Annex 1, FDA 21 CFR 211.
-
Materials: USP Class VI, FDA 21 CFR 177.2600.
-
Safety: CE, ISO 13849 PLd.
-
Data Integrity: 21 CFR Part 11, EU Annex 11.
Technical Support
-
Validation Kits: Country-specific IQ/OQ documentation (Brazil, India, ASEAN).
-
Shear Mapping: Free CFD reports for particle size optimization.
-
Emergency Service: 24h response for critical batch failures.
💡 Mention your: Target market (EU/US/Global South), Active ingredient, Required throughput.
🔬 Schedule virtual factory acceptance test with our engineers.
🏷️ Request Compliance Audit: Free gap analysis with throughput simulation.
Ready to Eliminate Production Bottlenecks?
Need Industrial Production Automation?
✅ GMP Compliance Guarantee
✅ 24/7 Multilingual Support
✅ 24-month performance guarantee
✅ Local technicians in 18 countries
Start small, get a free production layout designed for your growth trajectory. Scale smarter with engineering support!
📥Free line configuration for your products, throughput validation testing!
🎓Contact Specialists for Packaging Equipment:
📄 On-Demand Engineering: Product-specific configurations in 1-2 weeks.
🔧 Spare Parts Kits: Region-specific inventory for <24hr delivery.
🌡️ For a free product compatibility test using your materials.
Compliance Roadmap:
- CE, EAC, ISO 9001 certifications.
- GMP-ready: 316L SS contact parts, CIP/SIP capabilities.
- ATEX options for chemical solvents.
