Custom Medical Extruder Manufacturer & Production Systems

Precision-engineered medical tubing extrusion lines delivering class-leading dimensional tolerance, advanced multi-lumen configuration, and ISO 13485-ready compliance frameworks for global OEMs.

About Us

Jiangsu Baodie Automation Equipment Co., Ltd.

BAOD EXTRUSION (Jiangsu Baodie Automation Equipment Co., Ltd.) founded in 2002, dedicated to designing, manufacturing and sales of plastic extrusion equipment. Based on 18 years experience of designing and fabricating high quality machines in Taiwan, the original parent company (KINGSWEL GROUP) invested in establishing extrusion machines manufacturing base in Shanghai in 1999.

With our long-term focus on research and development, we specialize in high-efficiency engineering solutions designed for global medical compliance standards.

  • Precision extrusion technology with sub-micron control
  • High efficiency extrusion technology optimized for energy savings
  • Highly automated extrusion process featuring smart PLC interfaces
  • Comprehensive safety protection of extrusion equipment

25

Years Manufacturing Experience

16000㎡

Factory Area

100+

Dedicated Professionals

Precision Medical Extrusion Engineering Whitepaper

A comprehensive review of technical parameters, cleanroom compliance, global supply chain structures, and validation protocols in medical grade catheter and tubing extrusion.

1. Advanced Physics of Precision Medical Extrusion

Medical tubing extrusion requires a deep understanding of polymer rheology, thermodynamics, and fluid dynamics. Unlike standard industrial profile extrusion, medical tube manufacturing deals with complex polymers such as TPU (thermoplastic polyurethane), Pebax, FEP, PEEK, and medical-grade PVC. Each material exhibits distinct melt viscosity curves, shear sensitivity, and thermal degradation profiles. To achieve dimensional stabilities where Outer Diameter (OD) tolerances are held strictly within ±0.01 mm, precision control of the screw speed, barrel temperature zones, and melt pressure is critical.

The core of BAOD's extrusion systems lies in optimized screw geometry. Using a barrier screw configuration with L/D ratios varying between 25:1 to 30:1, our systems prevent premature shear-heating of shear-sensitive polymers while ensuring complete melt homogenization. This high degree of thermal stability is what enables the consistent production of micro-bore catheters and multi-lumen tubing.

Precision Melt Pump

Provides volumetric metering of the polymer melt to smooth out pressure fluctuations from the extruder screw.

Closed-Loop Control

Utilizes laser micrometer data to automatically adjust puller speeds and maintain exact tubing dimensions.

Vacuum Sizing Tech

Employs high-precision vacuum calibration tanks with micro-adjustable water temperatures and flow rates.

2. Regulatory Compliance & Localized Validation Supports

Medical manufacturing is highly regulated under strict regulatory frameworks. Extrusion equipment must be capable of operating within Class 10,000 (ISO Class 7) or Class 100,000 (ISO Class 8) cleanrooms. At BAOD Extrusion, our lines are engineered with smooth stainless steel surfaces, enclosed drive motors, vacuum water systems designed to avoid misting, and integrated exhaust filtration setups to prevent airborne particulates.

Furthermore, local validation support is essential. We assist global buyers by supplying detailed IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) documentation. Key parameters such as melt temperature uniformity, calibration tank vacuum consistency, and haul-off pulling pull stability are documented to conform directly with FDA 21 CFR Part 11 and GAMP 5 validation principles, making local regulatory audits straightforward.

3. Leveraging China's Vertically Integrated Supply Chain

Manufacturing precision medical equipment in China presents distinct competitive advantages. The proximity of machining shops, raw material suppliers, and specialized component manufacturers in the Jiangsu and Shanghai regions enables BAOD to optimize production costs while speeding up engineering cycles. This vertical integration allows us to build customized extrusion tooling—including co-extrusion crossheads, complex multi-lumen dies, and automatic downstream cutting systems—in a fraction of the time required by Western competitors.

While maintaining a highly competitive cost structure, we source key mechanical and electrical control components globally. Siemens PLC control packages, Omron temperature controls, Dynisco melt pressure transducers, and servo-driven pullers ensure the machinery meets international safety standards while outperforming expectations in long-term reliability.

4. Localized Application Scenarios & Global Demands

Medical extruders operate in diverse environments. In regions with high ambient humidity, custom dehumidifying material dryers must be paired with the extruder to prevent hydrolytic degradation of hygroscopic polymers like Pebax or polyurethane. In localized micro-extrusion projects, such as neural-intervention micro-catheters, systems must incorporate micro-scale crossheads and high-frequency pullers with minimal mechanical vibration.

Global procurement teams prioritize OEE (Overall Equipment Effectiveness), ease of tool changeovers, and remote diagnostics. BAOD meets these demands by providing cloud-enabled connectivity interfaces where engineers in Europe or the Americas can access real-time system performance charts, download process logs, and perform diagnostic checks alongside our local support teams.

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Expert Q&A on Medical Extrusion Engineering

How do you guarantee OD/ID concentricity in multi-lumen medical extrusion?
We use specialized high-precision co-extrusion crossheads equipped with micro-adjustable die centering bolts. The tooling features independent air lumen channels controlled by high-speed, micro-pressure electronic regulators. Coupled with a dual-axis laser micrometer gauge and a closed-loop PLC feedback loop, we automatically adjust haul-off speed and air injection levels to maintain a concentricity of over 95% for multi-lumen profiles.
What steps are taken to make BAOD extrusion lines suitable for cleanroom environments?
Our medical extrusion machinery is manufactured with cleanroom compatibility as a design priority. We utilize SUS304/316 medical-grade stainless steel for all contact components. Motors are fully enclosed to prevent wear particles from entering the environment, and hydraulic or oil lubrication loops are replaced with non-contaminating linear magnetic mechanisms or sealed bearings. The vacuum calibration system is fully closed-loop to prevent humidity/mist leakage.
How does BAOD support the IQ/OQ/PQ validation process for overseas buyers?
We offer comprehensive documentation support following GAMP 5 principles. This includes providing detailed equipment manuals, electrical drawings, structural designs, and calibration certificates for all sensors. Before shipping, we conduct Factory Acceptance Testing (FAT) with video validation. Our team or local engineering partners can then support Site Acceptance Testing (SAT) and guide your compliance team through IQ/OQ/PQ steps.
Why choose a China-based custom extruder manufacturer over European brands?
Working with BAOD in China allows you to experience the fast iteration cycles made possible by our regional supply chain, coupled with professional design engineering. We offer rapid custom engineering options and use the same high-end global parts (like Siemens and Omron) as European manufacturers, but at a more competitive cost structure. This enables you to build customized R&D lines or expand production capacity with a lower total cost of ownership.