Description
TEM-50: GMP-Certified Multi-Functional Synthesis & Preparation Unit
TEM-50 Pharmaceutical Synthesis Unit Ointment Production.
Technical Specifications Table:
| Parameter | Specification | GMP Advantage |
|---|---|---|
| Capacity | 50L working volume | Scalable from R&D to production |
| Temperature Range | -20°C to +150°C | Precision ±1°C control |
| Pressure Range | Vacuum to 5 bar | Closed-system processing |
| Mixing System | Dual-shaft: Anchor + Turbine | Homogeneity ≤3% variance |
| Material Contact | SS316L electropolished | EU GMP Annex 1 compliant |
| Automation | PLC with SCADA integration | FDA 21 CFR Part 11 option |
Pharmaceutical Applications
Critical Formulation Capabilities:
🧴 Semi-Solid Production:
• Ointments/Creams (water/oil phases)
• Gels (Carbopol®, HPMC)
• Suppository masses
🧪 Chemical Synthesis:
• Emulsion polymerization
• Hot-melt extrusion
• Nanoparticle dispersion
💊 Specialized Processes:
- Vacuum degassing
- Temperature-controlled crystallization
- High-viscosity mixing (up to 500,000 cP)
GMP Compliance Features:
✅ Cleanability:
- Tri-clamp connections (SMS 1145 standard)
- Automatic CIP/SIP cycles
- Surface finish Ra ≤0.4 μm
✅ Data Integrity:
- Electronic batch records
- Parameter tracking (temp/pressure/rpm)
- Audit trail with user access levels
Competitive Differentiation
Advanced Technical Features:
⚙️ Dual Mixing Technology:
• Anchor impeller: High-viscosity materials
• Turbine impeller: Shear-sensitive emulsions
• Programmable speed profiles (5-120 RPM)
🌡️ Precision Thermal Control:
- Dual-zone heating/cooling jacket
- PT100 sensors (±0.1°C accuracy)
- Explosion-proof options available
🌍 Regional Adaptations:
• Tropical package: Condensation control
• Voltage stabilizer: 220V-380V-480V ±10%
• ATEX certification for hazardous areas
Validation & Documentation
Turnkey Compliance Package:
📜 Included Documentation:
- FAT/SAT protocols (Factory/Site Acceptance Tests)
- IQ/OQ/PQ validation packages
- Material certificates (3.1 mill certs)
📌 Global Certifications:
• CE • UKCA • EAC • ASME BPVC Section VIII
🔧 Technical Services:
- Onsite GMP training
- Process optimization consulting
- 24/7 multilingual support
Technical Comparison
TEM-50 vs. Standard Reactors:
| Feature | TEM-50 | Industry Standard |
|---|---|---|
| Temp Control | ±1°C (dual-zone) | ±3-5°C |
| Mixing Efficiency | Dual-shaft technology | Single impeller |
| CIP Effectiveness | 99.7% residue-free | Manual cleaning required |
| Compliance Docs | Full validation package | Basic manual only |
| Material Finish | Ra 0.4μm electropolished | Ra 1.2-1.8μm |
TEM-50 produce 97% uniform hydrogel: From powder dispersion to deaeration in 45 minutes with full parameter logging.
📜 Schedule virtual airflow visualization test.
💡 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:
🌍 Regional Service Hubs: Dubai (MENA), Hanoi (SEA), Lagos (Africa).
📄 On-Demand Engineering: Product-specific configurations in 1-2 weeks.
📄 On-Demand Engineering: Product-specific configurations in 1-2 weeks.
⚙️ Rapid Customization: Customize equipment for unique products within 1-2 weeks.
🌐 Request Efficiency Audit: Free line analysis with 15% output improvement guarantee.
🛠️ On-Site Calibration: Available within 72hrs in key regions.
📊 Ramp-Up Assurance: On-site commissioning in <72hrs.
🔧 Spare Parts Kits: Region-specific inventory for <24hr delivery.
🔧 Spare Parts Kits: Region-specific inventory for <24hr delivery.
🌡️ For a free product compatibility test using your materials.
⚡Voltage customization available (110V-220V-380V-480V) — trusted by World industrial manufacturers in 16+ countries. Serving manufacturers in 12+ countries across Africa, SE Asia & MENA.
🛡️Support: EN/RU/AR/ES — On-site commissioning available globally.
📥Includes 24/7 remote monitoring and validation support (IQ/OQ/PQ).
✉️Multi-language HMIs, regional certifications included (International calls routed to English-speaking engineers).
Compliance Roadmap:
- CE, EAC, ISO 9001 certifications.
- GMP-ready: 316L SS contact parts, CIP/SIP capabilities.
- ATEX options for chemical solvents.
