Anesthesia and Intensive Care Medical Grade PVC Tube with Custom Solution Factory

Description:

Our factory focus on manufacturing medical-grade PVC tubing for use in anesthesia delivery, respiratory systems, and intensive care applications. Crafted from high-quality, phthalate-free PVC compounds, our tubing is enhanced with non-toxic stabilizers and plasticizers, ensuring biocompatibility, superior flexibility, and resistance to kinking or cracking. Produced through precision extrusion and sterilized using gamma irradiation or ETO methods, our products comply with ISO 13485 and FDA standards for medical device safety.

We offer comprehensive OEM customization options, including variations in size, color, and hardness, along with a seamless one-stop service that covers everything from material selection and prototyping to bulk production and global logistics. With our extensive expertise, we provide reliable, compliant tubing solutions tailored for critical healthcare applications. Trust us to streamline your supply chain and deliver high-quality products that meet the highest standards of safety and performance.

Basic Information:

• Material: Phthalate-free PVC with calcium-zinc stabilizers and non-toxic plasticizers
• Production Process: Precision extrusion, gamma/ETO sterilization, 100% pressure testing
• Inner Diameter (ID): 2mm–20mm (customizable)
• Wall Thickness: 0.5mm–3mm (±0.1mm tolerance)
• Hardness: 50A–90A Shore (adjustable)
• Color Options: Transparent, opaque, or custom colors (FDA-compliant)
• Certifications: ISO 9001, ISO 13485, FDA, RoHS
• Sterilization: Gamma irradiation, ETO (validated for medical use)
• Custom Markings: Laser etching, graduations, OEM logos
• Sample Availability: Free samples (3–5 days lead time)
• Production Capacity: 1,000,000+ pieces/month
• Packaging: Sterile pouches, bulk coils, or custom packaging (anti-static/sealed)
• Delivery Time: Samples: 3–5 days; Bulk orders: 2–4 weeks
• Design Support: CAD prototyping, material testing, application-specific engineering

Quality Assurance:

Our quality assurance program is designed to ensure full compliance with ISO 13485, FDA 21 CFR, and CE-MDR regulations, with a primary focus on biocompatibility and patient safety. We conduct comprehensive material testing, including FTIR spectroscopy for polymer purity and GC-MS analysis to confirm phthalate-free compliance.

Our production process utilizes automated extrusion technology, coupled with inline laser measurement systems, ensuring precise dimensional control (ID ±0.1mm, wall thickness ±5%). We perform critical performance tests, including burst pressure testing (up to 5 times the rated pressure), tensile strength evaluation (ASTM D638), and cytotoxicity testing (ISO 10993-5).

Sterilization processes are rigorously validated through gamma irradiation or ETO, with residual testing to confirm effectiveness. Each batch undergoes a 100% visual inspection, supported by AQL sampling to maintain consistency. We also provide third-party certifications, such as RoHS and USP Class VI, along with traceable lot documentation, ensuring reliable, safe products for use in anesthesia and intensive care applications.

production process of Anesthesia and Intensive Care Medical Grade PVC Tube with Custom Solution

Production Process:

1. Material Formulation and Compounding

Medical-grade PVC resin is blended with non-phthalate plasticizers, stabilizers, and additives to achieve flexibility, biocompatibility, and chemical resistance. Raw materials undergo USP Class VI or ISO 10993 biocompatibility pre-qualification.

2. High-Shear Mixing and Homogenization

Components are homogenized under controlled temperature in industrial mixers (e.g., Banbury mixers) to ensure uniform dispersion of additives and eliminate particulate contamination.

3. Twin-Screw Extrusion

The compounded PVC is fed into a medical-grade extruder with precision temperature zones. A rotating mandrel die forms the tubing’s lumen geometry, while real-time laser micrometers monitor wall thickness and outer diameter consistency.

4. Post-Extrusion Annealing

Tubing passes through calibrated water baths or air-cooling systems to relieve residual stresses and stabilize dimensional tolerances (<±5% variation per ASTM D876 standards).

5. Surface Modification (Optional)

Hydrophilic coatings or antimicrobial layers (e.g., silver-ion impregnation) may be applied via dip-coating or plasma treatment for specialized applications.

6. In-Line Quality Control

Automated vision systems conduct 100% inspection for defects, while samples undergo burst pressure testing (per ASTM D1598) and elongation verification (ASTM D882).

7. Sterilization Validation

Terminal sterilization using gamma irradiation (25–50 kGy) or ethylene oxide (EtO) is performed in validated chambers, followed by residual gas analysis and sterility testing per ISO 11135/11137 protocols.

8. Final Packaging and Traceability

Tubing is coiled or cut to length in ISO Class 7 cleanrooms, packaged in validated Tyvek® pouches, and labeled with UDI-compliant codes for full lot traceability.

9. Regulatory Compliance Documentation

Batch records, material certifications, and sterilization validations are archived per 21 CFR Part 820 (QSR) and EU MDR requirements.

Factory Show:

Our advanced manufacturing facility is equipped with state-of-the-art technology to ensure exceptional production quality and precision. Our capabilities include 25 high-tonnage punch presses ranging from 25 to 300 tons, high-accuracy wire EDM systems, precision grinding and polishing equipment, dedicated welding stations, and ultrasonic cleaning technology for superior surface treatment.

We offer a full suite of metal plating solutions, including electroplating, zinc plating, nickel plating, chrome plating, and anodizing. By utilizing cutting-edge plating techniques, we achieve uniform, high-performance finishes that enhance corrosion resistance and durability while maintaining strict adherence to industry specifications.

With fully automated production systems, rigorous quality control protocols, and a steadfast commitment to manufacturing excellence, we ensure that every metal stamping component meets the most stringent industry standards. Our operations are certified to ISO 9001 and IATF 16949, reinforcing our dedication to quality, precision, and reliability across all production stages.