1. Virgin Polymer Selection & Compound Stability
Our engineering team selects only high-purity medical-grade PVC and Thermoplastic Elastomers (TPE). Resins are tested for molecular weight distribution, Shore A hardness (typically Shore A 65 to 75 for tubing; Shore A 50 for nasal prongs), and thermal stability. We strictly eliminate heavy metal stabilizers, lead, and recycled industrial plastics.
2. Star-Lumen Extrusion Engineering
Tubing is extruded using precision multi-channel dies that create five continuous internal ribs. This star-lumen configuration ensures that even if external tubing is bent at sharp angles or placed under heavier objects, the internal channels remain open, maintaining continuous oxygen delivery and preventing backpressure on oxygen flowmeters or concentrators.
3. Class 10,000 Cleanroom Assembly
Assembly occurs within validated Class 10,000 (ISO Class 7) controlled cleanrooms. Specialized jigs ensure precise bonding between the nasal prong manifold, extension lines, and adjustment slides. Controlled temperature and humidity prevent micro-cracking and bond degradation during solvent welding.
4. Captive Ethylene Oxide (ETO) Sterilization
Finished devices are sealed in medical-grade Tyvek/Film or Paper/Film peel pouches and sterilized in our in-house ETO gas chambers. Sterilization cycles are validated in accordance with ISO 11135 standards, incorporating physical parameters monitoring, biological indicator (Bacillus atrophaeus) challenge tests, and gas aeration cycles to ensure zero toxic residual ETO or Ethylene Chlorohydrin (ECH).