Shenzhen Alu Rapid Prototype Precision Co., Ltd.

1.Process:

Micro Injection Molding: Molten medical-grade plastic is injected into a highly precise mold, often made using advanced techniques like micro-machining or EDM (Electrical Discharge Machining). The process involves high-pressure injection, precise temperature control, and rapid cooling to form tiny, complex parts.

Mold Design: Molds are engineered with micro-scale cavities, often requiring advanced tooling (e.g., 5-axis CNC or laser machining) to achieve fine details.

Cleanroom Manufacturing: Performed in controlled environments (e.g., ISO Class 7 or 8 cleanrooms) to ensure sterility and prevent contamination.

2.Applications in the Medical Field:

Microfluidic Devices: Channels and components for lab-on-chip systems, drug delivery, and diagnostic testing (e.g., blood analysis chips).

Implants: Tiny components like stents, cochlear implant parts, or intraocular lens haptics.

Surgical Tools: Micro-scale connectors, fasteners, or end effectors for minimally invasive surgery devices.

Wearable Devices: Small housings or sensors for insulin pumps, heart monitors, or drug delivery systems.

Dental Devices: Precision components for orthodontic aligners or dental implants.

3.Materials:

Biocompatible plastics such as PEEK, polycarbonate, LCP (Liquid Crystal Polymer), polypropylene, and medical-grade silicone.

Bioresorbable materials like PLA or PGA for temporary implants.

Materials must comply with ISO 10993 for biocompatibility and FDA or CE regulations.

4.Advantages:

High Precision: Produces complex geometries with micron-level accuracy, critical for micro-scale medical applications.

Scalability: Suitable for high-volume production with consistent quality, reducing costs for mass-produced disposables.

Customization: Enables patient-specific or device-specific components with intricate designs.

Efficiency: Fast cycle times (seconds) for high-throughput manufacturing.

5.Challenges:

Tooling Complexity: Micro molds require advanced fabrication and maintenance, increasing initial costs.

Material Flow: Precise control is needed to ensure molten plastic fills tiny mold cavities without defects.

Regulatory Compliance: Parts must meet strict standards (e.g., ISO 13485, FDA), requiring rigorous quality control and documentation.

Defect Sensitivity: Small defects (e.g., flash, voids) can significantly impact performance, necessitating advanced inspection (e.g., microscopy, CT scanning).

6.Quality Control:

Dimensional inspection using tools like optical comparators or coordinate measuring machines (CMM).

Testing for biocompatibility, sterility, and mechanical properties.

Traceability for regulatory compliance, ensuring every part meets medical standards.