Precision Medical Tube PVC/Polyurethane Dual-Color Extrusion Line
I. Product Description
This production line is a medical-grade high-precision dual-color catheter extrusion equipment, specializing in the production of precision medical single-color/dual-color catheters (supporting PVC single-color, polyurethane single-color, PVC-polyurethane dual-color co-extrusion), covering clinical scenarios such as infusion catheters, urinary catheters, and interventional catheters. Core Features: - Fully enclosed clean design: Key components use FDA-certified stainless steel to avoid material contamination; - Dual-color layering technology: Achieves a functional structure of "inner layer biocompatible (polyurethane) + outer layer wear-resistant (PVC)", meeting the dual requirements of "safety + performance" for medical catheters; - High-precision control: Outer diameter tolerance ≤ ±0.02mm, wall thickness uniformity ≥ 98%, compliant with **ISO 10993 biocompatibility and USP Class VI pharmaceutical standards; - Customized adaptation: Supports catheter diameter (0.5~12mm), color (transparent/colored), functional modification (antistatic/antibacterial/radiopaque).
II. Equipment Advantages (Core Selling Points)
Core Advantage Specific Description
Turnkey Project Provides a full-process solution including "equipment + medical-specific formulations + standardized processes + lifelong after-sales service". Customers can start production immediately without additional debugging.
Dual-Color Co-extrusion Technology Supports PVC/Polyurethane multi-layer co-extrusion, interlayer bonding strength ≥ 5N/cm, solving the pain point of "single function" in traditional single-color catheters.
Medical-Grade Cleanliness Equipment surface roughness Ra ≤ 0.8μm, dead-angle-free design, compliant with GMP production requirements, avoiding cross-contamination.
Precision Molding Control Multi-zone temperature control (±1°C) + online laser diameter measurement (±0.005mm) + automatic correction, ensuring catheter dimensional consistency.
Full Lifecycle Service Supports OEM customization, compatible design, permanent online video technical support to solve customer's later production issues.
III. Technical Parameter Table
| Parameter Category | Detailed Parameters |
| Applicable Materials | PVC (Polyvinyl Chloride), TPU (Thermoplastic Polyurethane), Medical-grade polymer composite materials |
| Catheter Type | Single-color/Dual-color (PVC+Polyurethane) co-extruded catheter, supports multi-color expansion |
| Catheter Specifications | Diameter: 0.5~12mm; Wall thickness: 0.1~2.0mm (adjustable according to requirements) |
| Production Speed | 5~30m/min (depending on catheter diameter and number of layers) |
| Extrusion System | PVC dedicated single-screw extruder (SJ-65/30) + Polyurethane dedicated twin-screw extruder (JS-50/25) |
| Temperature Control Accuracy | ±1°C (Barrel 3~5 zones + Die head 2~3 zones, independent PID control) |
| Cooling & Sizing | Constant temperature circulating water tank (15~25°C) + Vacuum adsorption sizing (optional) |
| Measurement & Control System | Online laser diameter gauge (accuracy ±0.005mm) + Electromagnetic wall thickness monitor + Automatic correction device |
| Winding System | Active servo winder (I-beam reel/disc type optional), tension fluctuation ≤ ±2% |
| Cleanliness Grade | Equipment interior complies with GMP standards, surface is easy to clean, no dead angles |
IV. Formulation Table (Medical Grade Specific)
| Material Type | Core Components | Functional Characteristics | Compliance Standards |
| PVC Catheter Material | Medical-grade PVC resin + DEHP-free plasticizer + Calcium-zinc stabilizer + Medical lubricant | Good flexibility, high transparency, low toxicity (phthalate-free) | USP Class VI, ISO 10993-5 (Cytotoxicity) |
| Polyurethane Catheter Material | Aliphatic Thermoplastic Polyurethane (TPU) + Antioxidant + Processing aid | High elasticity, wear resistance, biocompatible (cytotoxicity ≤ Grade 1) | USP Class VI, ISO 10993-4 (Hemocompatibility) |
| Functional Additives (Optional) | Antistatic agent (Quaternary ammonium salt), Antibacterial agent (Silver ions), Radiopaque agent (Barium sulfate) | Anti-static adsorption, inhibit bacterial growth, visible under X-ray | Complies with medical additive safety regulations (FDA 21 CFR) |
Note: Formulations can be adjusted according to clinical needs (e.g., reducing hardness for pediatric catheters, improving pushability for interventional catheters).
V. Equipment List
| No. | Equipment Name | Function |
| 1 | Single/Twin-screw Medical Extruder | PVC/TPU melting, plasticizing, extrusion |
| 2 | Co-extrusion Die Head (Optional) | Enables dual-color/multi-color catheter co-extrusion |
| 3 | Vacuum Sizing Tank | Controls outer diameter accuracy, preliminary cooling |
| 4 | Cooling Water Tank / Air Cooling System | Cooling and sizing |
| 5 | Haul-off Unit | Evenly pulls the catheter |
| 6 | Cutter | Cuts to set length |
| 7 | Receiving Rack / Automatic Collection | Neatly collects finished catheters |
| 8 | Control System | Automatic control of temperature, speed, pressure |
VI. Process Flow Chart
Raw Material Pre-treatment: PVC/Polyurethane pellets are dehumidified by vacuum dryer (PVC ≤ 0.02%, Polyurethane ≤ 0.05%)
Melting & Plasticizing: Melted separately through PVC extruder (160~190°C) and Polyurethane extruder (180~220°C)
Dual-Color Co-extrusion: Melted materials enter the precision die head, forming a layered structure of "inner polyurethane + outer PVC"
Cooling & Sizing: Catheter passes through constant temperature circulating water tank (15~25°C) cooled to room temperature, vacuum adsorption fixes shape
Haul-off & Winding: Servo haul-off unit evenly pulls the catheter, after diameter/wall thickness monitoring, wound neatly by the winder
(Optional) Post-processing: UV sterilization, packaging (supports customer customization)
Note: The entire process is equipped with automatic correction and defect detection systems, ensuring product yield ≥ 99.5%.
VII. Application Areas
Infusion Therapy Intravenous infusion catheters, Indwelling needle catheters Inner layer polyurethane (anticoagulant, low adsorption) + Outer layer PVC (flexible, transparent), ensuring drug compatibility
Urology Urinary catheters, Cystostomy tubes Dual-color co-extrusion: Inner smooth polyurethane (reduces mucosal damage) + Outer antibacterial PVC (prevents urinary tract infection)
Interventional Diagnosis & Treatment Angiographic catheters, Guidewire guiding catheters High pushability PVC outer layer + High-pressure resistant polyurethane inner layer, supports X-ray visibility (with barium sulfate additive)
Respiratory Support Endotracheal tubes, Suction catheters Smooth surface PVC (reduces airway irritation) or antibacterial coated dual-color catheters
Specialty Catheters Pediatric fine catheters (0.5~2mm), Drainage tubes, Nasogastric tubes Supports ultra-fine diameters and custom functions (antistatic, radiopaque)
VIII. About APEX
Headquarters Location: Qingdao, Shandong Province, China
Established: 2014 (Over 10 years focusing on medical extrusion equipment)
Market Coverage: Domestic 35% share | North America 9% | South Asia/South America/Eastern Europe/Middle East each 5%~7%
Enterprise Scale: 3 modern branch factories | 2 major medical device industrial parks | 100+ professional technical staff
Core Certifications
ISO 13485 Medical Device Quality System Certification | CE Certification | 100+ Medical Customer Cases
Service Commitment: Quality First | Turnkey Project | Full-process Technical Support | OEM Customization | Permanent Online Video Support
We are committed to providing global medical customers with high-safety, high-precision, and high-reliability medical catheter extrusion solutions!
