Factory Direct Sales! Three-layer And Multi-layer TPU Airbag Inflatable Bags, Made of Soft, Lightweight And Transparent Material.

I. Raw Material Specifications

Medical-grade TPU Film / Pellets (Thermoplastic Polyurethane)

1. Material Grade Requirements

Medical-grade TPU is adopted, categorized into polyester type and polyether type for selection based on device application scenarios:

Polyether TPU: Hydrolysis-resistant, resistant to human sweat/body fluids, low extractables, anti-microbial. Suitable for long-term skin contact and extracorporeal circulation air bladders; excellent low-temperature flexibility for long-term use in bed care and rehabilitation equipment.

Polyester TPU: Superior mechanical strength, air tightness, abrasion resistance and welding strength. Primarily applied to high-pressure intermittent inflatable compression air bladders (gas therapy instruments, limb compression devices).

2. Medical Compliance Standards

Raw materials must hold complete biocompatibility test reports, complying with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (skin irritation/sensitization tests).

Free of phthalate plasticizers, halogens, and heavy metal leaching within specified limits. Able to provide FDA and CE medical material certifications as well as RoHS test reports.

3. Physical Performance Indicators

Air tightness: Extremely low air permeability with sustained pressure retention after inflation; pressure drop ≤5% within 24 hours.

Elongation at break: ≥600%; resistant to cracking and permanent deformation after millions of repeated inflation-deflation cycles.

Softness: Shore A hardness adjustable from 30 to 85. Soft grades (40–60A) for low-pressure care bladders; rigid grades (70–85A) for high-pressure rehabilitation applications.

Bending resistance & anti-aging: Remains flexible without hardening or powdering under ambient or human body temperature for long-term service.

Liquid barrier & disinfection compatibility: Impermeable to liquids; resistant to degradation by alcohol and quaternary ammonium disinfectants during wipe disinfection.

II. Production Process

1. Raw Material Inspection & Warehousing (Incoming Quality Control)

Verify TPU medical qualification documents, biocompatibility reports and batch test certificates.

Laboratory random inspection: film thickness uniformity, tensile strength, air tightness and extractables testing.

Raw materials stored under light-shielded constant temperature, dust-proof and moisture-proof conditions; separate storage zones for medical-grade and industrial-grade materials.

2. TPU Film Slitting & Cutting

Medical-grade TPU rolls are cut to specified dimensions on a clean slitting machine per air bladder drawings via automatic cutting, delivering smooth burr-free edges. For multi-layer air bladders, top sheets, bottom sheets, separators and reinforcing fabrics are cut separately. All operations are performed with dust-free gloves to avoid fingerprint and oil contamination of film surfaces.

3. Accessory Injection Molding (Air Nozzles, Connection Bases)

Medical-grade TPU pellets are high-temperature injection-molded into air nozzles and manifold connectors. Molded parts undergo deburring after cooling, ultrasonic alcohol cleaning and drying for standby use. Air nozzles feature built-in check valves and anti-fallout designs.

4. Thermal Lamination & Reinforcement Fabric Bonding (As Required)

For abrasion-resistant and tear-resistant products, TPU films are laminated with medical elastic nonwovens via low-temperature thermal compounding machines. The process preserves film air tightness with no delamination, cracks or bubbles after lamination.

5. High-Frequency Heat Sealing (Core Forming Process)

High-frequency (HF) thermal compression sealing is the mainstream manufacturing process for medical air bladders, outperforming conventional thermal pressing:

1. Align upper and lower TPU film layers with pre-embedded injection-molded air nozzles along sealing edges.

2. High-precision HF molds compress and fuse the air bladder contours at molecular level, forming a sealed edge width of 3–8 mm.Advantages: Pore-free sealing edges, superior air tightness, waterproof leak resistance; multi-layer composite bladders can be formed in one cycle. For special segmented multi-chamber pressure bags: Multi-station molds form independent air chambers in a single molding step with zero cross-leakage between chambers.

6. Edge Trimming & Preliminary Air Tightness Inspection

Excess sealing edge scrap is removed manually or automatically, followed by edge cleaning. Semi-finished products undergo water immersion inflation testing for visual leak detection at sealing edges; defective products are reworked and sealed.

7. Secondary Precision Pressure Retention Testing (100% Full Inspection)

Automated air tightness testers perform quantitative testing: inflate to standard pressure and hold for 3–5 minutes. The system automatically records pressure drop values; products exceeding the pressure drop threshold are rejected. All air bladders undergo 100% inspection, with test data archived for medical device traceability.

8. Cleaning & Dust-Free Drying

Surface oil and dust are wiped off with alcohol dust-free cloths, followed by clean hot air drying to eliminate residual solvents and prevent skin irritation risks.

9. Sterilization, Dust-Proof Packaging & Warehousing

Separate packaging for Class I and Class II medical devices:

• Standard rehabilitation devices: Individually sealed with medical PE dust-proof bags.

• Invasive and critical care air bladders: Sterilized via Ethylene Oxide (EO) gas. Outer cartons marked with product batch numbers, raw material lot numbers, production traceability codes and expiry dates. Finished goods are stored under constant temperature and dust-proof conditions with a complete material traceability system covering the full supply chain from TPU raw materials to end products.

III. Product Application Scenarios

1. Obstetric & Gynecological Rehabilitation Equipment

• Postpartum Pelvic Floor Repair Air Bladder: Segmented TPU pressure bladders integrated into pelvic correction devices. Cyclic compression and relaxation to rehabilitate pelvic floor muscles and correct pelvic diastasis.

• Postpartum Abdominal Band Compression Bladder: Promotes uterine contraction and eliminates postpartum abdominal edema.

2. Rehabilitation Physiotherapy & Limb Edema Relief Equipment

• Four-Chamber Air Pressure Therapy Instrument Bladders: Segmented bladders for upper limbs, lower limbs and waist-abdomen regions. Indicated for lymphedema, postoperative limb swelling and circulatory disorders in hemiplegic rehabilitation.

• Hand & Ankle Rehabilitation Pressure Bladders: Small single-chamber bladders for swelling physiotherapy after hand fractures and ankle sprains.