Precision Cleanroom Tooling for Healthcare Applications
Manufacturing high-precision healthcare components requires strict compliance, absolute consistency, and zero contamination. Our custom medical plastic injection mold solutions are engineered specifically for Tier-1 medical OEMs and device innovators who cannot afford dimensional variations or production downtime.
From micro-fluidic cartridges to complex surgical handpieces, we build high-cavitation, multi-shot tooling designed to perform seamlessly under Class 8 cleanroom conditions.
Engineered Advantages & Key Features
Micron-Level Accuracy: Machined using high-speed CNC and mirror-EDM to achieve tolerances down to ±0.005mm, ensuring perfect part-to-part repeatability.
Medical-Grade Steel Selection: Built with certified S136, NAK80, or ASSAB steel hardened to HRC 48-52 for optimal corrosion resistance against aggressive resin off-gassing.
Biocompatible Material Compatibility: Optimized runner and gating systems custom-designed for medical-grade PEEK, PC, PP, COP, and TPU resins.
Class 101 Tooling Standards: Built for long-term high-volume manufacturing, capable of exceeding 1,000,000 shots with minimal maintenance requirements.
Key Technical Specifications
|
Parameter |
Specification Standard |
|
Tooling Type |
High-precision medical plastic injection mold (SPI Class 101) |
|
Machining Tolerance |
Up to ±0.005 mm |
|
Cavitation |
Single, Multi-cavity (up to 64 cavities), or Family Molds |
|
Production Environment |
ISO Class 8 (Class 100,000) Cleanroom Compliant |
|
Mold Life Guarantee |
1,000,000+ Cycles |
Frequently Asked Questions
Q: How do you handle mold validation for medical device registration?
A: We provide complete IQ/OQ/PQ validation support, including full steel certification, CMM dimensional inspection reports, and scientific molding process windows to simplify your FDA or CE clearance.
Q: What surface finishes can you achieve for optical or fluidic medical parts?
A: We offer SPI A-1 diamond mirror polishing for high-transparency diagnostic components, as well as specialized laser texturing for enhanced ergonomic grips.
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