Heya Precision: High-Resolution Electroformed Molds For Microfluidic Diagnostic Chips

Why Heya’s High-Resolution Electroformed Molds Stand Out

• Tolerance Gaps Ruin Detection Accuracy: Generic molds with ≥0.005mm tolerance create inconsistent micro-channel dimensions, leading to uneven fluid flow (e.g., delayed sample mixing in PCR chips) and false positive/negative results;
• Substrate Incompatibility Causes Chip Scrap: Poorly optimized molds struggle with PDMS (sticky, high-shrinkage) or glass (brittle, tight bonding requirements), resulting in 15–20% chip 报废率 (scrap rate) during demolding or bonding;
• Low Resolution Loses Functional Details: Diagnostic chips rely on tiny structures (e.g., 50μm-wide reagent reservoirs, 20μm-thin valve gaps) that standard molds can’t replicate, rendering chips non-functional.

Core Customization Capabilities for Diagnostic Chip Molds

Technical Specs: Built for Accurate, Scalable Diagnostic Chip Production

Quality & Compliance for Clinical Diagnostics

• Medical-Grade Certifications: Molds meet ISO 13485 (Medical Device Quality Management System) standards—critical for IVD products requiring regulatory approval (FDA 510(k), CE IVDR).
• Biocompatibility Assurance: Electroforming materials (99.95% pure nickel, nickel-copper alloy) pass ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation) tests—no leachable contaminants to compromise biological samples (blood, saliva, cells).
• Cleanroom Manufacturing: Molds are produced in a Class 1000 cleanroom (ISO 14644-1) to avoid dust/particle contamination—essential for diagnostic chips where even 1μm particles can block micro-channels or interfere with assays.
• Traceability: Full batch records (material certificates, dimensional inspection reports, cleanroom monitoring data) are provided—supporting regulatory audits (e.g., FDA inspections) for IVD products.

Who Benefits from Our Diagnostic Chip Molds

• IVD Manufacturers: For high-volume production of rapid diagnostic chips (e.g., COVID-19, flu, malaria tests) where ±0.002mm tolerance ensures consistent assay performance.
• POC Device Developers: For compact diagnostic chips (e.g., handheld blood glucose monitors, on-site pathogen detectors) requiring small, precise micro-structures and PDMS/glass compatibility.
• Clinical Research Labs: For custom diagnostic chips (e.g., personalized cancer biomarker tests) with unique microfluidic layouts—our DFM support accelerates prototype iteration.

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Heya Precision: Factory Overview & Production Excellence

Factory Basics: Location & Scale

• Strategic Location: Based in Dongguan, China’s core precision manufacturing hub—enabling efficient access to raw material suppliers, logistics networks, and global shipping ports (Shenzhen/Hong Kong), ensuring timely delivery for international clients.
• Optimized Space: Over 1000㎡ of dedicated production area, divided into functional zones (precision machining, electroforming, plastic molding, surface treatment, and quality inspection) to streamline workflows and minimize cross-contamination risks.
• Compliant Environment: Adheres to industrial safety and environmental standards, with well-ventilated workspaces, anti-static flooring in precision zones, and organized storage for mold components—reflecting our commitment to orderly, professional production.

Production Capabilities: Equipment & Processes

• Precision Machining Zone: Hosts high-speed CNC engraving machines (for intricate mold details) and multi-axis CNC machining centers—capable of handling complex mold geometries with dimensional tolerance as tight as ±0.005mm, critical for electroformed mold cores.
• Surface Treatment Zone: Features in-house mold texturing (pattern etching) and brushing finish equipment—eliminating reliance on third-party vendors to reduce lead times. We also offer outsourced texturing/brushing services for external mold manufacturers, showcasing our flexible capabilities.
• Plastic Molding Zone: Includes injection molding machines tailored for small-to-medium volume plastic parts, compatible with diverse resins (PC, PMMA, ABS) commonly used in automotive, electronics, and consumer goods industries.

Team & Quality Control

• Skilled Workforce: A 30+ team of experienced professionals, including 5+ senior mold engineers (with 10+ years in precision machining), 12+ certified technicians, and dedicated quality inspectors—ensuring every stage (from raw material intake to final mold testing) meets Heya Precision’s standards.
• End-to-End Quality Checks: Embeds strict inspection checkpoints:
  • Raw material verification (mold steel, resins) with supplier certificates;
  • In-process testing (CMM measurements for machining accuracy, surface roughness tests for texturing);
  • Final validation (mold trial runs, dimensional sampling) before shipment.

Support for OEM/ODM

• Flexible Production Lines: Accommodate small-batch prototype orders (e.g., 1–10 mold cores) and medium-volume production (100–5,000 plastic parts) without compromising precision.
• Collaborative Workflow: Dedicates project managers to OEM/ODM clients, ensuring clear communication between your team and our factory—from design confirmation (DFM analysis) to production scheduling and post-delivery support.