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As global demand for advanced medical equipment continues to expand, precision, stability, and compliance have become the core requirements for medical-grade plastic components. This project focuses on the design and manufacturing of a high-precision medical device plastic injection mold for a U.S.-based original equipment manufacturer (OEM). The goal is to deliver a molding solution that meets strict medical industry standards while ensuring production efficiency, quality consistency, and long-term reliability.
Project Overview
The U.S. OEM client specializes in Class II and Class III medical devices and requires a mold capable of producing tight-tolerance plastic components used in diagnostic and therapeutic applications. These parts must maintain dimensional stability, biocompatibility, and surface integrity throughout high-volume mass production.
Our engineering team developed a complete injection mold solution that integrates advanced manufacturing techniques, meticulous quality control, and validated materials compliant with medical regulations.
Key Technical Requirements
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Ultra-High Dimensional Precision
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Tolerance requirement: ±0.01–0.02 mm
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Critical fit areas implemented with mirror-polished core and cavity surfaces
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High repeatability ensured through stable mold temperature control
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Medical-Grade Material Compatibility
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Applicable materials: PC, PC+ABS medical grades, PP, PEEK, TPU
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UV-resistant, chemical-resistant, and sterilization-compatible (EtO, gamma, autoclave)
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Mold Design Features
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Multi-cavity layout optimized for cycle time
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Hot runner system to eliminate gates and reduce waste
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Venting optimization to prevent burn marks and ensure surface clarity
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Hardened stainless steel inserts to prevent corrosion from frequent sterilization exposure
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Manufacturing Process Highlights
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CNC high-speed machining with micron-level accuracy
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EDM for complex geometries
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Automated polishing for optical-grade surfaces
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Dimensional validation with CMM and vision measurement systems
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Quality & Compliance Standards
To ensure the mold meets U.S. medical production standards, the entire project is executed under strict quality frameworks, including:
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ISO 13485 Medical Device Quality Management
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ISO 9001 Quality Management
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Full traceability of materials, heat treatment, and process parameters
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Mold qualification stages: T0, T1, T2, FOT, IQ/OQ/PQ support
Project Outcomes
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The final mold achieved 95% dimensional qualification at T1
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Cycle time reduced by 18% through optimized cooling circuits
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Component surface quality reached medical-grade clarity and smoothness
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Mold lifespan validated for 1 million+ shots with minimal maintenance
Client Value Delivered
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Ensured accuracy for critical functional components
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Reduced production waste and increased yield rate
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Enabled stable mass production in the U.S. facility
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Provided long-term cost savings through durable mold structure and optimized runner systems
