PP Medical Catheter Extrusion Line — High-Precision Cleanroom Tubing Manufacturing

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Overview

Our PP Medical Catheter Extrusion Line is a turnkey system for producing medical-grade polypropylene tubing and microbore catheters with consistent OD/ID, ultra-smooth surfaces, and repeatable mechanics. Built for cleanroom ISO 7/8 environments, the line integrates PLC/HMI control, closed-loop speed/diameter regulation, and full batch data logging to support GMP manufacturing and device validation.

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Key Features & Benefits

• Tight tolerances: Non-contact laser diameter (and optional wall-thickness) gauges with closed-loop control; typical OD tolerance ±0.02–0.05 mm (application-dependent).
• Cleanroom-ready design: 304/316L wet-contact parts, enclosed water circuit with filtration/UV, low-particle cable management, FDA/USP-compliant elastomers where applicable.
• Stable extrusion: Medical single-screw extruder with optimized L/D, precision die, and melt filtration for gel/black-speck control.
• Radiopaque options: Co-extruded stripe or filler-loaded layer (e.g., barium sulfate/tungsten—grade verification required).
• Traceability & compliance: e-records, audit trail, electronic signatures (21 CFR Part 11 option), recipe/version control, lot/UDI printing.
• Fast changeovers: Quick-change tooling, modular sizing sleeves/mandrels; recipe-driven set-ups cut downtime.
• Low cost per unit: Energy-efficient heaters, VFD/servo drives, closed-loop water; designed for 24/7 operation.

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Typical Applications

• Non-implantable medical tubing (lab sets, suction, drainage, oxygen/air lines)
• Microbore catheter shafts (PP grades permitting)
• Lab & diagnostic tubing, instrument protection sleeves

Note: Final device suitability depends on resin grade, formulation, and regulatory pathway (e.g., ISO 10993 biocompatibility). We can run a feasibility trial with your specified PP.

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Process Flow

Feeding (drying generally not required for PP; optional for blends) → Extrusion & melt filtration → Precision die → Vacuum sizing → Multi-stage DI/RO water cooling → Servo haul-off (closed loop) → In-line laser gauging & SPC → Cut-to-length / servo coiling → Marking (inkjet/laser UDI) → 100% visual inspection → Packaging

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Core Modules

• Medical single-screw extruder (nitrided barrel / wear-resistant screw, multi-zone heating)
• High-precision die & mandrels (single-lumen standard; co-extrusion for stripe/layer optional)
• Vacuum calibration tank with stable vacuum, temp & level control (316L contact surfaces)
• Spray/cascade cooling baths with filtration/UV, optional closed-loop chiller
• Servo haul-off (caterpillar or belt), fully synchronized
• Precision cutter (flying-knife) or dual-station servo coiler for microbore
• Metrology: Laser OD (and optional ultrasonic wall gauge), in-line SPC dashboards & data export
• Marking/inspection: Inkjet/laser coder for UDI/lot; vision system for defects (optional)

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Technical Specifications（typical, customizable）

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Validation, Documentation & Service

• IQ/OQ/PQ support package with calibration certificates
• Material & parts traceability docs; preventive maintenance plan
• On-site installation, operator training, ramp-up support
• Remote diagnostics and rapid spare-parts delivery

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Options

• Co-extruder for radiopaque stripe/layer or color line
• Gravimetric dosing and melt-pump for ultra-stable output
• Vision inspection (scratches, gels, ovality) with auto-reject
• Static eliminators and cleanroom cable trays
• Data connectors: OPC UA/MQTT/CSV export to MES/LIMS

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Customer Case

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Call to Action

Share your target OD/ID & tolerance, line speed or throughput, PP grade & sterilization method (EtO/γ), and regulatory requirements (ISO 13485, 21 CFR Part 11). We’ll return a tailored configuration, layout, lead time, and quote.