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YIXUN mold
8480419090
In the healthcare industry, where safety, sterility, and reliability are non-negotiable, medical connectors (e.g., IV tube connectors, diagnostic device ports, surgical instrument junctions) play a critical role in ensuring seamless, contamination-free fluid/gas transfer. Our Healthcare Connector Plastic Mold is engineered exclusively for medical-grade applications—adhering to strict global standards (ISO 13485, FDA, CE) and optimized for biocompatible plastics. As a direct factory with 15+ years of medical mold expertise, we deliver custom solutions that balance ultra-high precision, sterility compatibility, and long-term production stability.
| Connector Type | Typical Use Case | Material Requirement |
| Luer Lock Connectors | IV catheters, syringes, blood transfusion sets | Medical-grade PP, PE, or PPSU (chemical resistance, leak-proof) |
| Barbed Connectors | Respiratory tubes, feeding tubes | Soft medical TPE/TPU (flexibility, biocompatibility) |
| Quick-Disconnect Connectors | Dialysis machines, diagnostic equipment | Medical PC/ABS (high impact resistance, dimensional stability) |
| Valved Connectors | Drug delivery systems, wound care devices | Medical-grade PE or silicone-combined plastics (sterility retention) |
| Specification Category | Details | Compliance & Advantage |
| Mold Material | - Cavity/Core: S136 Stainless Steel (HRC 48-52)- Mold Base: S50C Steel (with anti-rust coating) | - S136: Excellent corrosion resistance (compatible with steam/ethylene oxide sterilization), high polishability (Ra ≤ 0.2μm, preventing bacteria buildup)- Anti-rust coating: Meets FDA 21 CFR Part 175.300 for food/medical contact |
| Target Plastic Materials | Medical-grade PP, PE, PC, PPSU, TPE, TPU | All materials comply with ISO 10993-1 (biological evaluation) and USP Class VI (toxicity testing); supports color customization (e.g., clear for visibility, color-coded for connector identification) |
| Cavity Design | Customizable (1+1, 2+2, 4+4 cavities) | - 1+1 cavity: Ideal for high-precision small connectors (e.g., microfluidic ports)- Multi-cavity (2+2/4+4): Suitable for high-volume production (e.g., standard IV connectors); even pressure distribution ensures ≤ 0.002mm dimensional tolerance |
| Precision Control | - Dimensional tolerance: ±0.001mm- Surface finish: Ra 0.1-0.2μm (mirror polish)- Ejection system: Soft-eject pins (titanium-coated) | - Ultra-tight tolerance: Prevents leaks in fluid/gas transfer- Mirror polish: Eliminates micro-pores where bacteria can accumulate- Soft-eject: Avoids scratches on connector surfaces (critical for sterility) |
| Sterility Compatibility | - Mold components resistant to autoclaving (121°C, 15psi) and ethylene oxide (EO) sterilization- No residual lubricants (uses medical-grade silicone grease) | Ensures mold and finished connectors maintain sterility through multiple sterilization cycles (common in reusable medical devices) |
| Cycle Time | 30-45 Seconds (varies by connector size/material) | Optimized via: - Uniform cooling channels (0.5mm precision drilling)- Heat-resistant mold inserts (for high-temperature plastics like PPSU)- Reduces production time while maintaining part quality |
Material Traceability: All mold steels (S136, S50C) and plastics come with batch certificates (COC) to meet FDA/ISO 13485 audit requirements.
Clean Manufacturing: Our workshop operates in a Class 100,000 cleanroom for mold assembly and trial injection—preventing dust, oil, or particulate contamination.
No Harmful Additives: Mold release agents and lubricants are 100% medical-grade (free of BPA, phthalates, and heavy metals), ensuring connectors are safe for patient contact.
Precision Gate Design: Uses hot runner systems (with medical-grade nozzles) to minimize material waste and ensure uniform filling of small connector features (e.g., Luer lock threads).
Dimensional Inspection: Every mold undergoes 3D coordinate measuring (CMM) testing before delivery; sample connectors are tested for leak tightness (using air pressure or liquid pressure methods).
Wear Resistance: S136 steel cavities support ≥1,000,000 production shots without dimensional degradation—critical for long-term consistency in high-volume medical production.
Complex Geometries: Support for undercuts, thin walls (≥0.2mm), and integrated valves (common in one-way connectors).
Color-Coding: Multi-cavity molds can produce different colored connectors in one cycle (e.g., blue for IV, green for respiratory) to reduce assembly errors.
Material Compatibility: Optimize mold temperature, injection pressure, and cooling for specialized materials (e.g., PPSU for high-temperature sterilization, TPE for soft-seal connectors).
Cost Efficiency: Direct manufacturing (no middlemen) reduces mold costs by 18-25% compared to medical mold distributors.
Rapid Turnaround: Lead time of 35-45 days (from design confirmation to mold trial)—faster than industry averages (50-60 days)—to accelerate your medical device launch.
End-to-End Support: Our engineering team provides DFM (Design for Manufacturability) analysis for your connector 3D model, suggesting optimizations to improve moldability and reduce production defects.
Design Validation: Simulate mold performance via CAD/CAE software (e.g., Moldflow) to predict filling, cooling, and warpage—adjusting designs before production.
In-Process Testing: Every mold component (cavities, ejector pins, cooling channels) is inspected for dimensional accuracy and surface finish.
Trial Injection: Produce 100-200 sample connectors using medical-grade plastic; test samples for:
Biocompatibility (ISO 10993-5 cytotoxicity)
Dimensional stability (after sterilization cycles)
Leak tightness (per ISO 80369 standards for medical connectors)
Certification Delivery: Provide a comprehensive quality package including:
ISO 13485 mold manufacturing certificate
Material COC (Certificate of Conformance)
CMM inspection report
Sample test data (leakage, biocompatibility)
Warranty: 2-year free warranty (covers defects in mold materials/workmanship; includes free replacement of worn S136 components for the first year).
Maintenance: Provide a sterile maintenance kit (medical-grade cleaning agents, silicone grease) and a detailed manual for mold care in cleanroom environments.
Regulatory Support: Assist with documentation for your medical device certification (e.g., FDA 510(k), CE MDR) by providing mold manufacturing records.
Inquiry: Share your connector 3D model (STEP/IGES), material specs, production volume, and compliance requirements (e.g., FDA, CE).
DFM Analysis: Our engineers review your design, provide feedback on moldability, and suggest optimizations (e.g., wall thickness, gate location).
Quotation: Submit a detailed quote (mold cost, lead time, payment terms) within 48 hours, including compliance guarantees.
Design Confirmation: Share mold 2D/3D drawings for your approval; revise until all requirements are met.
Mold Production: Start manufacturing after receiving a 40% deposit (compliant with medical industry payment standards).
Trial & Acceptance: Conduct trial injection in our cleanroom; send samples for your testing. Balance payment (50%) due after sample approval.
Delivery & Training: Deliver the mold (packaged in sterile, anti-static crates) and provide on-site training for your team on mold operation/cleaning. Final payment (10%) due after 3 months of stable production.
In the healthcare industry, where safety, sterility, and reliability are non-negotiable, medical connectors (e.g., IV tube connectors, diagnostic device ports, surgical instrument junctions) play a critical role in ensuring seamless, contamination-free fluid/gas transfer. Our Healthcare Connector Plastic Mold is engineered exclusively for medical-grade applications—adhering to strict global standards (ISO 13485, FDA, CE) and optimized for biocompatible plastics. As a direct factory with 15+ years of medical mold expertise, we deliver custom solutions that balance ultra-high precision, sterility compatibility, and long-term production stability.
| Connector Type | Typical Use Case | Material Requirement |
| Luer Lock Connectors | IV catheters, syringes, blood transfusion sets | Medical-grade PP, PE, or PPSU (chemical resistance, leak-proof) |
| Barbed Connectors | Respiratory tubes, feeding tubes | Soft medical TPE/TPU (flexibility, biocompatibility) |
| Quick-Disconnect Connectors | Dialysis machines, diagnostic equipment | Medical PC/ABS (high impact resistance, dimensional stability) |
| Valved Connectors | Drug delivery systems, wound care devices | Medical-grade PE or silicone-combined plastics (sterility retention) |
| Specification Category | Details | Compliance & Advantage |
| Mold Material | - Cavity/Core: S136 Stainless Steel (HRC 48-52)- Mold Base: S50C Steel (with anti-rust coating) | - S136: Excellent corrosion resistance (compatible with steam/ethylene oxide sterilization), high polishability (Ra ≤ 0.2μm, preventing bacteria buildup)- Anti-rust coating: Meets FDA 21 CFR Part 175.300 for food/medical contact |
| Target Plastic Materials | Medical-grade PP, PE, PC, PPSU, TPE, TPU | All materials comply with ISO 10993-1 (biological evaluation) and USP Class VI (toxicity testing); supports color customization (e.g., clear for visibility, color-coded for connector identification) |
| Cavity Design | Customizable (1+1, 2+2, 4+4 cavities) | - 1+1 cavity: Ideal for high-precision small connectors (e.g., microfluidic ports)- Multi-cavity (2+2/4+4): Suitable for high-volume production (e.g., standard IV connectors); even pressure distribution ensures ≤ 0.002mm dimensional tolerance |
| Precision Control | - Dimensional tolerance: ±0.001mm- Surface finish: Ra 0.1-0.2μm (mirror polish)- Ejection system: Soft-eject pins (titanium-coated) | - Ultra-tight tolerance: Prevents leaks in fluid/gas transfer- Mirror polish: Eliminates micro-pores where bacteria can accumulate- Soft-eject: Avoids scratches on connector surfaces (critical for sterility) |
| Sterility Compatibility | - Mold components resistant to autoclaving (121°C, 15psi) and ethylene oxide (EO) sterilization- No residual lubricants (uses medical-grade silicone grease) | Ensures mold and finished connectors maintain sterility through multiple sterilization cycles (common in reusable medical devices) |
| Cycle Time | 30-45 Seconds (varies by connector size/material) | Optimized via: - Uniform cooling channels (0.5mm precision drilling)- Heat-resistant mold inserts (for high-temperature plastics like PPSU)- Reduces production time while maintaining part quality |
Material Traceability: All mold steels (S136, S50C) and plastics come with batch certificates (COC) to meet FDA/ISO 13485 audit requirements.
Clean Manufacturing: Our workshop operates in a Class 100,000 cleanroom for mold assembly and trial injection—preventing dust, oil, or particulate contamination.
No Harmful Additives: Mold release agents and lubricants are 100% medical-grade (free of BPA, phthalates, and heavy metals), ensuring connectors are safe for patient contact.
Precision Gate Design: Uses hot runner systems (with medical-grade nozzles) to minimize material waste and ensure uniform filling of small connector features (e.g., Luer lock threads).
Dimensional Inspection: Every mold undergoes 3D coordinate measuring (CMM) testing before delivery; sample connectors are tested for leak tightness (using air pressure or liquid pressure methods).
Wear Resistance: S136 steel cavities support ≥1,000,000 production shots without dimensional degradation—critical for long-term consistency in high-volume medical production.
Complex Geometries: Support for undercuts, thin walls (≥0.2mm), and integrated valves (common in one-way connectors).
Color-Coding: Multi-cavity molds can produce different colored connectors in one cycle (e.g., blue for IV, green for respiratory) to reduce assembly errors.
Material Compatibility: Optimize mold temperature, injection pressure, and cooling for specialized materials (e.g., PPSU for high-temperature sterilization, TPE for soft-seal connectors).
Cost Efficiency: Direct manufacturing (no middlemen) reduces mold costs by 18-25% compared to medical mold distributors.
Rapid Turnaround: Lead time of 35-45 days (from design confirmation to mold trial)—faster than industry averages (50-60 days)—to accelerate your medical device launch.
End-to-End Support: Our engineering team provides DFM (Design for Manufacturability) analysis for your connector 3D model, suggesting optimizations to improve moldability and reduce production defects.
Design Validation: Simulate mold performance via CAD/CAE software (e.g., Moldflow) to predict filling, cooling, and warpage—adjusting designs before production.
In-Process Testing: Every mold component (cavities, ejector pins, cooling channels) is inspected for dimensional accuracy and surface finish.
Trial Injection: Produce 100-200 sample connectors using medical-grade plastic; test samples for:
Biocompatibility (ISO 10993-5 cytotoxicity)
Dimensional stability (after sterilization cycles)
Leak tightness (per ISO 80369 standards for medical connectors)
Certification Delivery: Provide a comprehensive quality package including:
ISO 13485 mold manufacturing certificate
Material COC (Certificate of Conformance)
CMM inspection report
Sample test data (leakage, biocompatibility)
Warranty: 2-year free warranty (covers defects in mold materials/workmanship; includes free replacement of worn S136 components for the first year).
Maintenance: Provide a sterile maintenance kit (medical-grade cleaning agents, silicone grease) and a detailed manual for mold care in cleanroom environments.
Regulatory Support: Assist with documentation for your medical device certification (e.g., FDA 510(k), CE MDR) by providing mold manufacturing records.
Inquiry: Share your connector 3D model (STEP/IGES), material specs, production volume, and compliance requirements (e.g., FDA, CE).
DFM Analysis: Our engineers review your design, provide feedback on moldability, and suggest optimizations (e.g., wall thickness, gate location).
Quotation: Submit a detailed quote (mold cost, lead time, payment terms) within 48 hours, including compliance guarantees.
Design Confirmation: Share mold 2D/3D drawings for your approval; revise until all requirements are met.
Mold Production: Start manufacturing after receiving a 40% deposit (compliant with medical industry payment standards).
Trial & Acceptance: Conduct trial injection in our cleanroom; send samples for your testing. Balance payment (50%) due after sample approval.
Delivery & Training: Deliver the mold (packaged in sterile, anti-static crates) and provide on-site training for your team on mold operation/cleaning. Final payment (10%) due after 3 months of stable production.
