In vitro diagnostic extraction reagent tubes are core consumables for nucleic acid and protein detection, requiring ultra-clean, leak-proof and biocompatible sealing, prohibiting particle contamination and chemical leaching, to ensure detection result accuracy. Traditional ultrasonic welding generates micro-particles that contaminate reagents, while adhesive bonding introduces chemical residues, failing to meet medical grade cleanliness requirements. DaokeDao plastic laser welding adopts a non-contact, particle-free process, specially optimized for medical-grade COC, PP and PC materials, fully complying with ISO 10993 biocompatibility and USP Class VI standards, with no chemical additives or solvent residues. The laser achieves ±0.005mm high-precision positioning, forming a continuous and dense hermetic seal, with leakage rate ≤1×10⁻⁹ mbar·L/s, completely avoiding reagent leakage and cross-contamination. The heat-affected zone is controlled within 0.2mm, avoiding material deformation and internal reagent volatilization, ensuring reagent stability and activity. The equipment is suitable for ISO 7 clean room operation, with HEPA filtration system, zero dust emission during welding, single-piece cycle time 5-7 seconds, production capacity 160 pieces per hour, pass rate ≥99.6%. It helps IVD consumable manufacturers reduce detection result errors caused by assembly, meet EU CE and US FDA regulatory requirements, and adapt to high-volume clinical detection consumable supply.
