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With ISO 13485 certification (medical device quality management), this extrusion line ensures consistent production of titanium alloys for critical medical applications, including implants, surgical instruments, and 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.
High Throughput: Achieves a production capacity of 600 kg/h with ±1% weight variation per hour, meeting the demands of large-scale medical device manufacturing while maintaining the precision required for regulatory compliance.
Titanium Compatibility: Expertly processes Grade 2–5 titanium alloys (including Ti-6Al-4V ELI, the most widely used medical titanium alloy) as well as nickel-free variants (such as Ti-15Mo) specifically developed for MRI-safe medical devices, ensuring compatibility with various patient populations.
Cleanroom Compliance: Constructed with a 316L stainless steel housing and integrated Class 1000 HEPA filtration system (providing 99.97% filtration efficiency for particles ≥0.3μm), the line maintains ISO Class 7 cleanliness levels, critical for preventing particulate contamination in medical components.
Advanced Mixing: Features counter-rotating twin screws with optimized flight geometry that achieve 95% material homogenization, eliminating voids and inclusions in extruded parts—defects that could compromise the structural integrity of medical implants.
Orthopedics: Manufactures precision components for orthopedic implants including femoral stems, spinal cages, knee prostheses, and bone screws, where the high strength-to-weight ratio of titanium ensures long-term implant stability and patient mobility.
Cardiology: Extrudes ultra-thin nitinol-titanium composite tubes for cardiovascular devices such as stents, guidewires, and catheter shafts, maintaining precise dimensional tolerances (±0.01mm) critical for navigating delicate vascular systems.
Dental: Produces titanium abutments, crown frameworks, and dental implants with superior corrosion resistance, ensuring compatibility with oral environments and long-term dental restoration performance.
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, and dedicated material feed systems with HEPA-filtered hoppers to prevent cross-contamination between batches.
With ISO 13485 certification (medical device quality management), this extrusion line ensures consistent production of titanium alloys for critical medical applications, including implants, surgical instruments, and 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.
High Throughput: Achieves a production capacity of 600 kg/h with ±1% weight variation per hour, meeting the demands of large-scale medical device manufacturing while maintaining the precision required for regulatory compliance.
Titanium Compatibility: Expertly processes Grade 2–5 titanium alloys (including Ti-6Al-4V ELI, the most widely used medical titanium alloy) as well as nickel-free variants (such as Ti-15Mo) specifically developed for MRI-safe medical devices, ensuring compatibility with various patient populations.
Cleanroom Compliance: Constructed with a 316L stainless steel housing and integrated Class 1000 HEPA filtration system (providing 99.97% filtration efficiency for particles ≥0.3μm), the line maintains ISO Class 7 cleanliness levels, critical for preventing particulate contamination in medical components.
Advanced Mixing: Features counter-rotating twin screws with optimized flight geometry that achieve 95% material homogenization, eliminating voids and inclusions in extruded parts—defects that could compromise the structural integrity of medical implants.
Orthopedics: Manufactures precision components for orthopedic implants including femoral stems, spinal cages, knee prostheses, and bone screws, where the high strength-to-weight ratio of titanium ensures long-term implant stability and patient mobility.
Cardiology: Extrudes ultra-thin nitinol-titanium composite tubes for cardiovascular devices such as stents, guidewires, and catheter shafts, maintaining precise dimensional tolerances (±0.01mm) critical for navigating delicate vascular systems.
Dental: Produces titanium abutments, crown frameworks, and dental implants with superior corrosion resistance, ensuring compatibility with oral environments and long-term dental restoration performance.
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, and dedicated material feed systems with HEPA-filtered hoppers to prevent cross-contamination between batches.
