Manufacturing Process & Technical Specifications for TPU Inflatable Lumbar Supports and Air Belts
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I. Core Production Workflow
1. Material Selection
- Air Bladder Main Body:
Thermoplastic polyurethane (TPU) film with pressure resistance, aging resistance, and elasticity (tensile strength ≥40MPa, elongation at break ≥500%).
- Auxiliary Components:
- Inflation valves (medical-grade silicone connectors)
- Sealing gaskets (EPDM rubber)
- Outer fabric layers (breathable mesh, abrasion resistance ≥10,000 Martindale cycles).
2. High-Frequency (HF) Welding Process
- Use 27.12MHz HF equipment to weld TPU film edges with ±0.2mm positional accuracy.
- Valve welding: Specialized 8kW nozzle welding machines ensure leak-proof connections (leakage rate <0.01mL/min at 0.3MPa).
- Puxiong Automated Production Line: Integrates cutting, welding, and laser coding, achieving 300–500 pieces/hour with <0.5% defect rate.
3. Inflation & Pressure Testing
- Post-inflation pressure tests: 0.3MPa hold for 5 minutes, leakage ≤0.5mL/min.
- Functional validation: Operate within 20–30cmH₂O pressure range using pneumatic testers (ISO 4074 compliance).
II. Key Production Equipment
- HF Welding Machines: Multi-station systems with PID-controlled pressure (0.3–0.8MPa).
- Synchronous Melt-Cutting Machines: Laser-guided for burr-free edges (cutting tolerance ±0.1mm).
- Puxiong Automated Line: Combinate UVW motion platforms and machine vision for real-time defect detection.
III. Quality Control & Standards
Testing Items
- Airtightness: 0.3MPa pressure retention, leakage ≤0.5mL/min (ASTM D3078).
- Durability: 200,000 inflation/deflation cycles (ISO 4649 compliant).
- Material Performance:
- Taber abrasion ≤50mg/1,000 cycles
- Peel strength ≥8N/cm (ASTM D1876).
Industry Compliance
- QB/T 5577-2021 (China Light Industry Standard for PVC products, extended to TPU).
- ISO 13485 Certification: Required for medical-grade lumbar supports.
IV. Customization & Innovation
- Smart Adjustment:
Embedded pressure sensors with Bluetooth® connectivity for real-time inflation control (±5% accuracy).
- Multifunctional Designs:
Hybrid modules for thermotherapy (35–45°C) or vibration massage (10–100Hz frequency range).
V. Critical Precautions
- Production Environment:
Maintain 20–25°C ambient temperature and 40–60% RH to prevent TPU hydrolysis or oxidation.
- Safety Protocols:
Comply with pressure vessel standards (GB 150-2011) for inflation systems.
This optimized process ensures medical-grade reliability while supporting high-volume production of ergonomic orthopedic solutions.
