Description:
Our OEM medical-grade injection-mold tooling for respiratory-mask seal components is engineered to deliver micron-level accuracy and airtight performance. We employ high-precision CNC machining and EDM on premium tool steels—such as hardened H13 and medical-grade stainless steels—followed by meticulous surface finishing to guarantee flawless mold cavities. Paired with ISO 10993-certified liquid silicone rubber (LSR), our process ensures biocompatibility for extended skin contact. From rapid prototyping and mold validation through material selection, post-processing, and full-scale production, our turnkey design-to-delivery service offers fast turnaround, stringent regulatory compliance, and seamless scalability to meet the exacting demands of critical respiratory therapy applications.
Characteristics:
- Raw Materials:ABS, PP, PC, PA66 + 30% glass fiber, PVC, POM, TPE, TPV, ASA, etc.
- Die Steel Grades:P20, P20HH, H13, 420, 2344, 2311
- Runner System:Hot runner or cold runner
- Trademark/Branding:Fully customizable
- Design Software:AutoCAD, UG, Pro/E
- Certifications:TS16949, ISO 9001, ISO 13485
- Packaging:Wooden box or carton box
- Annual Production Capacity:Up to 500 mold sets per year
- Color Options:Customizable
- Minimum Order Quantity:Small orders accepted
- Place of Origin:Xiamen, China
Production Process:
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Material Selection & Compliance
Medical-grade polymers (e.g., silicone, TPE/TPU) are chosen, adhering to FDA, ISO 13485, and USP Class VI biocompatibility standards.
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Precision Mold Design
CAD/CAM-driven tooling design with focus on airtight sealing geometry, draft angles, and surface finish. Moldflow analysis optimizes fill, cooling, and stress distribution.
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Prototype Validation
Pilot runs verify dimensional accuracy (via 3D CMM), seal integrity (pressure/leak testing), and material performance under simulated respiratory conditions.
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High-Tolerance Mold Manufacturing
CNC machining, EDM, and polishing create cavity/core components with micron-level precision. Surface treatments (e.g., nitriding) enhance durability.
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Injection Molding & Post-Processing
Cleanroom production with controlled parameters (temperature, pressure, cycle time). Deburring, ultrasonic cleaning, and laser trimming ensure defect-free edges.
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Quality Assurance & Sterilization
100% leak testing, tensile strength checks, and biocompatibility validation. Post-molding sterilization (EtO, gamma) complies with medical regulatory requirements.
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Traceability & Packaging
Lot tracking, ISO-compliant documentation, and sterile vacuum-sealed packaging for contamination-free delivery.
Quality Control:
Quality control for OEM medical-grade plastic injection mould tooling for respiratory mask seals requires comprehensive process validation, stringent material certification (e.g., USP Class VI biocompatibility), and precision dimensional verification using CMM (Coordinate Measuring Machines) and optical comparators. Suppliers must maintain ISO 13485 certification and FDA-compliant cleanroom manufacturing environments. Critical testing includes airflow leakage validation through custom fixtures, tensile strength analysis via Instron testers, and CT scanning for internal defect detection. Real-time process monitoring with cavity pressure sensors and Scientific Molding documentation ensures repeatability, while final parts undergo 100% visual inspection with automated vision systems and destructive batch testing for seal integrity verification.
Factory Overview:
Our advanced manufacturing campus is outfitted with industry-leading CNC machining centers, mirror EDM, conventional EDM, and high-precision wire-cutting systems—ensuring unparalleled mold accuracy, consistency, and repeatability. On the production floor, 15 rubber compression-molding presses and two high-speed liquid silicone rubber (LSR) injection-molding machines enable us to meet large-volume demands and execute intricate, custom tooling projects with rapid cycle times and tight tolerances.
Quality assurance underpins every stage of our operation. Our ISO 9001 and IATF 16949–certified processes begin with rigorous inspection protocols performed by seasoned QC engineers using 3D optical projectors, sealing-integrity testers, Shore durometers, and elasticity gauges. To maximize efficiency and maintain uniformity, we’ve integrated automated AutoDryers, high-throughput doming stations, and precision die-cutters into our workflow—delivering performance-critical components that consistently exceed the most stringent industry benchmarks.