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With ISO 13485 certification (medical device quality management), this titanium extrusion line ensures consistent production of titanium alloys for critical medical applications, including:
Implants (orthopedic, dental, spinal)
Surgical instruments
Diagnostic equipment components
Its precision extrusion process delivers exceptional material uniformity, with tensile strength variations below 3% across production batches, ensuring reliable performance in life-critical medical scenarios.
| Parameter | Value |
|---|---|
| Certification | ISO 13485, FDA 21 CFR Part 11, EU MDR 2017/745 |
| Production capacity | 600 kg/h |
| Weight variation | ±1% per hour |
| Tensile strength variation | < 3% across batches |
| Material homogenization | 95% |
| Cleanroom level | ISO Class 7 (with Class 1000 HEPA filtration) |
| Filtration efficiency | 99.97% for particles ≥0.3μm |
| Dimensional tolerance | ±0.01 mm |
| Housing material | 316L stainless steel |
Achieves 600 kg/h production capacity
±1% weight variation per hour
Meets demands of large-scale medical device manufacturing
Maintains precision required for regulatory compliance
Expertly processes:
| Titanium Grade | Description |
|---|---|
| Grade 2 | Commercially pure titanium (dental, surgical instruments) |
| Grade 3 | Higher strength than Grade 2 |
| Grade 4 | Highest strength among commercially pure grades |
| Grade 5 (Ti-6Al-4V ELI) | Most widely used medical titanium alloy |
| Ti-15Mo | Nickel-free, MRI-safe variant |
316L stainless steel housing – corrosion-resistant, easy to clean
Integrated Class 1000 HEPA filtration system
99.97% filtration efficiency for particles ≥0.3μm
Maintains ISO Class 7 cleanliness levels
Critical for preventing particulate contamination in medical components
Counter-rotating twin screws with optimized flight geometry
Achieves 95% material homogenization
Eliminates:
Voids
Inclusions
Defects that could compromise structural integrity of medical implants
Self-cleaning screw elements with 360° wiper flights
Argon gas purging of extrusion chamber – eliminates oxygen exposure
Dedicated material feed systems with HEPA-filtered hoppers
Prevents cross-contamination between batches
| Benefit | Description |
|---|---|
| < 3% tensile strength variation | Consistent mechanical performance across batches |
| 95% material homogenization | No voids, no inclusions |
| ±0.01 mm dimensional tolerance | Precision for delicate medical devices |
| ISO Class 7 cleanroom | Particulate-free production |
| 600 kg/h throughput | Scalable for high-volume production |
| Argon purging | Prevents oxidation during extrusion |
Manufactures precision components for:
| Component | Application |
|---|---|
| Femoral stems | Hip replacement implants |
| Spinal cages | Interbody fusion devices |
| Knee prostheses | Total knee replacement |
| Bone screws | Fracture fixation |
The high strength-to-weight ratio of titanium ensures:
Long-term implant stability
Patient mobility
Reduced implant loosening
Extrudes ultra-thin nitinol-titanium composite tubes for:
| Device | Application |
|---|---|
| Stents | Coronary and peripheral artery disease |
| Guidewires | Navigation through vascular system |
| Catheter shafts | Minimally invasive procedures |
Maintains ±0.01 mm dimensional tolerances – critical for navigating delicate vascular systems.
Produces:
| Component | Application |
|---|---|
| Titanium abutments | Connecting implant to crown |
| Crown frameworks | Support for ceramic crowns |
| Dental implants | Root replacement |
Superior corrosion resistance ensures:
Compatibility with oral environments
Long-term dental restoration performance
Surgical instruments (forceps, retractors, scalpels)
Diagnostic equipment components (MRI-compatible parts)
Trauma fixation devices (plates, screws, nails)
Maxillofacial implants (jaw and facial reconstruction)
| Feature | Medical Titanium Extrusion Line | Conventional Extruder |
|---|---|---|
| Certification | ISO 13485, FDA, EU MDR | General industrial |
| Cleanroom level | ISO Class 7 | None |
| Filtration | Class 1000 HEPA | None or basic |
| Tensile variation | < 3% | 5–10% |
| Homogenization | 95% | 70–80% |
| Contamination prevention | Argon purge + self-cleaning screws | Limited |
| Dimensional tolerance | ±0.01 mm | ±0.05–0.1 mm |
| Housing material | 316L stainless steel | Carbon steel |
| Certification | Scope | Status |
|---|---|---|
| ISO 13485 | Medical device quality management | ✅ Certified |
| FDA 21 CFR Part 11 | Electronic records and signatures | ✅ Compliant |
| EU MDR 2017/745 | Medical device regulation (Europe) | ✅ Compliant |
Ensures compliance with global medical device manufacturing standards and facilitates market access worldwide.
Cleanroom installation: Designed for ISO Class 7 or better environments
Installation time: 4–6 weeks (typical)
Training: Operator and maintenance training included
Documentation: Complete validation package (IQ/OQ/PQ) available
| Task | Frequency |
|---|---|
| HEPA filter check | Monthly |
| Screw element inspection | Quarterly |
| Argon purge system check | Monthly |
| Full validation | Annually (or per regulatory requirement) |
Global service network – spare parts and technical support
Validation support – IQ/OQ/PQ documentation available
Preventive maintenance contracts – available upon request
Q: What certifications does the extrusion line hold?
A: In addition to ISO 13485, it complies with FDA 21 CFR Part 11 (electronic records and signatures) and EU MDR 2017/745 (medical device regulation), ensuring compliance with global medical device manufacturing standards and facilitating market access worldwide.
Q: Can it process composite materials?
A: Yes. The system is specifically configured to process titanium-polymer composites (such as titanium-hydroxyapatite composites) and titanium-ceramic hybrids, enabling the production of lightweight, bioactive implants that promote bone integration.
Q: How is material contamination prevented?
A: The line incorporates a multi-layer contamination prevention system, including:
Self-cleaning screw elements with 360° wiper flights
Argon gas purging of the extrusion chamber to eliminate oxygen exposure
Dedicated material feed systems with HEPA-filtered hoppers to prevent cross-contamination between batches
Q: What titanium alloys can be processed?
A: The line processes Grade 2–5 titanium alloys, including:
Ti-6Al-4V ELI (most widely used medical titanium alloy)
Ti-15Mo (nickel-free, MRI-safe variant)
Commercially pure titanium (Grade 2, 3, 4)
Q: What is the typical dimensional tolerance?
A: The extrusion line maintains ±0.01 mm dimensional tolerances, critical for:
Cardiovascular stents
Guidewires
Catheter shafts
Precision orthopedic components
Q: Is the line suitable for MRI-safe implant production?
A: Yes. The line processes nickel-free titanium alloys (such as Ti-15Mo) specifically developed for MRI-safe medical devices, ensuring compatibility with various patient populations and imaging requirements.
✅ ISO 13485 certified – medical device quality management
✅ FDA 21 CFR Part 11 & EU MDR compliant – global regulatory acceptance
✅ ISO Class 7 cleanroom – particulate-free production
✅ < 3% tensile strength variation – consistent mechanical performance
✅ 95% material homogenization – no voids, no inclusions
✅ ±0.01 mm dimensional tolerance – precision for critical devices
✅ 600 kg/h throughput – scalable for high-volume production
✅ Argon gas purging – prevents oxidation
✅ Processes Grade 2–5 titanium & nickel-free alloys – MRI-safe options
