In-vitro diagnostic (IVD) cartridges are critical tools for medical testing, used to detect diseases, monitor health conditions, and analyze biological samples. These cartridges require ultra-clean, particle-free assembly to ensure accurate test results—even tiny debris (≥0.1μm) or contamination can clog microchannels (width 10-100μm), interfere with sample analysis, or lead to false results. Traditional assembly methods such as adhesive bonding or ultrasonic welding often generate particles or introduce contaminants, making them unsuitable for IVD cartridge manufacturing. DaokeDao plastic laser welding produces no debris, dust, or contaminants during the welding process, ensuring the ultra-clean environment required for IVD cartridges. The non-contact process focuses laser energy precisely on the weld joint (positioning accuracy ±0.005mm), minimizing the heat-affected zone (≤0.2mm) and avoiding material degradation. It achieves micron-level precision and hermetic sealing (helium leak rate ≤1×10⁻⁹ mbar·L/s), preventing sample leakage and cross-contamination between microchannels. The process is compatible with medical-grade plastics commonly used in IVD cartridges, including COC, COP, PC, and medical-grade PP, all of which meet biocompatibility standards (ISO 10993). Our laser welding systems are designed to operate in ISO 13485-certified manufacturing environments, with features such as cleanroom-compatible enclosures (ISO 7) and air filtration systems (HEPA H14). They support high-volume production (up to 80 units/hour) with consistent quality, helping IVD manufacturers improve yield to ≥99.5%, reduce test result errors, and meet strict medical regulatory requirements (FDA 21 CFR Part 11).
