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YIXUN mold
8480419090
Adherence to a closed-loop quality management system, covering mold design validation, raw material qualification, production process control, and post-delivery documentation.
Complete traceability of every component: from mold steel batches to machining parameters and inspection reports, enabling full compliance audits for medical device registrations (e.g., FDA 21 CFR Part 820, EU MDR 2017/745).
Dedicated quality control team certified in medical device manufacturing standards, conducting 100% dimensional inspection and material compatibility testing.
Class 8 Cleanroom Facility: Equipped with HEPA filtration systems, positive pressure environments, and strict personnel gowning protocols to limit particulate counts to ≤352,000 particles (≥0.5μm) per cubic meter.
Cleanroom-compatible machining equipment with oil-free cooling systems, preventing lubricant contamination during mold cavity and core fabrication.
Post-machining cleaning processes: ultrasonic cleaning, high-pressure deionized water rinsing, and vacuum drying to remove residual debris before assembly.
Tolerance Capability: Achieves ±0.005mm dimensional accuracy for critical medical device features (e.g., syringe plunger seals, catheter connectors).
Material Expertise: Utilizes medical-grade mold steels (e.g., 1.2083, S136, H13) with corrosion resistance, high polishability, and compatibility with sterilization processes (autoclaving, ETO, gamma irradiation).
Hot Runner & Cold Runner Options: Customized gating systems to minimize material waste and ensure uniform filling for thin-walled medical parts (e.g., 0.2–0.5mm wall thickness).
Cooling System Optimization: Simulation-driven cooling channel design to reduce cycle time and prevent part warpage, critical for maintaining consistent dimensions in mass production.
Molds are engineered to produce parts that meet USP Class VI and ISO 10993 biocompatibility requirements, ensuring no leachable toxins or harmful substances.
Mold surfaces are polished to Ra ≤0.02μm, reducing bacterial adhesion and enabling efficient sterilization without compromising part integrity.
Verified compatibility with common medical sterilization methods: autoclaving (134°C, 3 bar), ethylene oxide (ETO) sterilization, and gamma irradiation (up to 50 kGy).
Disposable Medical Devices: Syringes, IV catheters, blood collection tubes, diagnostic test cassettes, face masks, and surgical drapes.
Reusable Medical Devices: Surgical instrument handles, endoscope components, dialysis machine parts, and dental equipment housings.
Drug Delivery Systems: Inhaler components, insulin pen cartridges, and transdermal patch applicators.
Implantable Device Components: Non-implantable housings for pacemakers, orthopedic device trays, and prosthetic components.
Design & Validation:
DFM (Design for Manufacturability) analysis for medical parts; mold flow simulation to optimize filling and cooling.
Design review with customers to align with medical device regulatory requirements; production of 2D/3D technical drawings for approval.
Raw Material Procurement & Qualification:
Sourcing certified medical-grade mold steels and components; material certificates (COC/COA) provided for each batch.
Cleanroom Machining & Assembly:
CNC milling, EDM wire cutting, and precision grinding in Class 8 cleanroom; assembly with torque-controlled fasteners to ensure mold alignment.
Cleanroom Inspection & Testing:
Dimensional inspection via CMM (Coordinate Measuring Machine) and optical comparator; surface finish testing via profilometer.
Trial molding with medical-grade resins (e.g., PP, PE, PC, PEEK) to verify part quality; submission of first-article inspection reports (FAIR) for customer approval.
Packaging & Delivery:
Mold packaging in sealed, sterile plastic bags with desiccant; labeled with batch number, inspection status, and handling instructions.
Delivery with complete documentation package: mold design files, material certificates, inspection reports, and cleanroom production records.
Regulatory Expertise: Our team has 10+ years of experience supporting medical device manufacturers in obtaining FDA 510(k), CE marking, and NMPA registrations.
Customization Capability: We offer end-to-end solutions from mold design to mass production support, adapting to your specific medical device requirements.
Long-Term Reliability: Our molds maintain consistent performance for 1–5 million shots (depending on material and application), reducing downtime and maintenance costs.
Global Compliance Support: We provide documentation and technical support to help you meet the regulatory requirements of target markets (US, EU, Asia, etc.).
Adherence to a closed-loop quality management system, covering mold design validation, raw material qualification, production process control, and post-delivery documentation.
Complete traceability of every component: from mold steel batches to machining parameters and inspection reports, enabling full compliance audits for medical device registrations (e.g., FDA 21 CFR Part 820, EU MDR 2017/745).
Dedicated quality control team certified in medical device manufacturing standards, conducting 100% dimensional inspection and material compatibility testing.
Class 8 Cleanroom Facility: Equipped with HEPA filtration systems, positive pressure environments, and strict personnel gowning protocols to limit particulate counts to ≤352,000 particles (≥0.5μm) per cubic meter.
Cleanroom-compatible machining equipment with oil-free cooling systems, preventing lubricant contamination during mold cavity and core fabrication.
Post-machining cleaning processes: ultrasonic cleaning, high-pressure deionized water rinsing, and vacuum drying to remove residual debris before assembly.
Tolerance Capability: Achieves ±0.005mm dimensional accuracy for critical medical device features (e.g., syringe plunger seals, catheter connectors).
Material Expertise: Utilizes medical-grade mold steels (e.g., 1.2083, S136, H13) with corrosion resistance, high polishability, and compatibility with sterilization processes (autoclaving, ETO, gamma irradiation).
Hot Runner & Cold Runner Options: Customized gating systems to minimize material waste and ensure uniform filling for thin-walled medical parts (e.g., 0.2–0.5mm wall thickness).
Cooling System Optimization: Simulation-driven cooling channel design to reduce cycle time and prevent part warpage, critical for maintaining consistent dimensions in mass production.
Molds are engineered to produce parts that meet USP Class VI and ISO 10993 biocompatibility requirements, ensuring no leachable toxins or harmful substances.
Mold surfaces are polished to Ra ≤0.02μm, reducing bacterial adhesion and enabling efficient sterilization without compromising part integrity.
Verified compatibility with common medical sterilization methods: autoclaving (134°C, 3 bar), ethylene oxide (ETO) sterilization, and gamma irradiation (up to 50 kGy).
Disposable Medical Devices: Syringes, IV catheters, blood collection tubes, diagnostic test cassettes, face masks, and surgical drapes.
Reusable Medical Devices: Surgical instrument handles, endoscope components, dialysis machine parts, and dental equipment housings.
Drug Delivery Systems: Inhaler components, insulin pen cartridges, and transdermal patch applicators.
Implantable Device Components: Non-implantable housings for pacemakers, orthopedic device trays, and prosthetic components.
Design & Validation:
DFM (Design for Manufacturability) analysis for medical parts; mold flow simulation to optimize filling and cooling.
Design review with customers to align with medical device regulatory requirements; production of 2D/3D technical drawings for approval.
Raw Material Procurement & Qualification:
Sourcing certified medical-grade mold steels and components; material certificates (COC/COA) provided for each batch.
Cleanroom Machining & Assembly:
CNC milling, EDM wire cutting, and precision grinding in Class 8 cleanroom; assembly with torque-controlled fasteners to ensure mold alignment.
Cleanroom Inspection & Testing:
Dimensional inspection via CMM (Coordinate Measuring Machine) and optical comparator; surface finish testing via profilometer.
Trial molding with medical-grade resins (e.g., PP, PE, PC, PEEK) to verify part quality; submission of first-article inspection reports (FAIR) for customer approval.
Packaging & Delivery:
Mold packaging in sealed, sterile plastic bags with desiccant; labeled with batch number, inspection status, and handling instructions.
Delivery with complete documentation package: mold design files, material certificates, inspection reports, and cleanroom production records.
Regulatory Expertise: Our team has 10+ years of experience supporting medical device manufacturers in obtaining FDA 510(k), CE marking, and NMPA registrations.
Customization Capability: We offer end-to-end solutions from mold design to mass production support, adapting to your specific medical device requirements.
Long-Term Reliability: Our molds maintain consistent performance for 1–5 million shots (depending on material and application), reducing downtime and maintenance costs.
Global Compliance Support: We provide documentation and technical support to help you meet the regulatory requirements of target markets (US, EU, Asia, etc.).
