PEEK Infusion Connector Molding Plastic Custom Injection Mold with Various Cavities

Catheter Connection Plastic Injection Mold: Precision for Medical-Grade Reliability

Product Overview

Core Advantages

1. Medical-Grade Precision & Biocompatibility

• Micron-Level Tolerance: Dimensional accuracy of ±0.002mm for critical sealing surfaces and thread profiles (luer lock compliance with ISO 594-1/2), eliminating leakage risks in fluid transfer.

• Biocompatible Materials: Optimized for medical-grade plastics (PP, PE, PEEK, TPU) and silicone blends—mold surfaces treated with food-safe, non-toxic coatings to prevent material contamination.

• Sterility Compatibility: Smooth, crevice-free cavity design (Ra ≤ 0.01μm) to withstand ethylene oxide (EO) sterilization, gamma radiation, and autoclaving without degradation.

2. Durability for High-Volume Medical Production

• Premium Mold Steels: Core/cavity constructed with medical-grade S136H stainless steel (hardness HRC 56-60) and vacuum heat treatment—resists corrosion from sterilants and maintains precision for 3-5 million cycles.

• Advanced Cooling Systems: Custom spiral cooling channels with temperature control ±0.5℃ to prevent warping of thin-walled connection parts (wall thickness as low as 0.3mm).

• Wear-Resistant Components: Hardened guide pins, ejector pins, and valve gates to handle abrasive medical plastics (e.g., reinforced PEEK) and reduce maintenance downtime.

3. Customization for Medical Catheter Variants

• Standard & Custom Connectors: Luer locks, luer slips, barbed fittings, threaded adapters, and multi-lumen connectors.

• Specialized Features: Anti-kink structures, pressure relief valves, color-coded identification rings, and laser-marked part numbers.

• Mold Compatibility: Compliant with medical injection molding machines (10-50 ton clamping force) and automation systems (robotic part removal, 100% vision inspection integration).

4. Process Optimization for Medical Compliance

• Cleanroom-Friendly Design: Mold structures with sealed hydraulic systems and easy-to-clean surfaces, suitable for Class 8 (ISO 14644-1) cleanroom production.

• Waste Reduction: Hot runner systems with thermal gate control to minimize material scrap (≤2% waste rate) and ensure consistent plastic flow for thin-walled components.

• Traceability: Mold components marked with unique serial numbers for full production traceability, meeting FDA 21 CFR Part 820 requirements.

Manufacturing Process (Medical-Grade Standards)

1. Design Engineering & Validation

• 3D modeling (SolidWorks/ANSYS) with finite element analysis (FEA) for flow simulation and stress testing.

• DFM (Design for Manufacturing) review with medical device engineers to ensure compliance with ISO 10993 biocompatibility standards.

2. Material Selection & Preparation

• Mold core/cavity: S136H stainless steel (medical-grade, corrosion-resistant).

• Mold base: P20 steel with chrome plating (easy sterilization and corrosion protection).

3. Precision Machining & Finishing

• CNC five-axis milling (accuracy ±0.001mm) for complex geometries.

• Wire EDM cutting for micro-features (e.g., barbed fittings, lumen channels).

• Mirror polishing (Ra ≤ 0.01μm) and passivation treatment to meet biocompatibility requirements.

4. Assembly & Medical-Grade Testing

• Cleanroom assembly (Class 7) to prevent particulate contamination.

• Trial injection with medical-grade PP/PE to verify dimensional accuracy (CMM inspection) and leak tightness (pressure testing at 50-100 psi).

• Cycle validation (10,000 shots) to ensure consistency in sterility-compatible production.

Technical Specifications

Application Scope

• Diagnostic Catheters: IV catheters, urinary catheters, and angiographic catheters.

• Therapeutic Catheters: Dialysis catheters, infusion catheters, and neurovascular catheters.

• Surgical Catheters: Laparoscopic instrument connectors, endoscopic adapters, and surgical fluid management systems.

• Veterinary Catheters: Animal-specific luer connectors and fluid transfer adapters.

Quality Assurance & After-Sales Service

• ISO 13485:2016 certified manufacturing facility (medical device quality management system).

• 18-month warranty on all mold components (extended from standard 12 months for medical applications).

• Cleanroom-compatible maintenance kits and sterile replacement parts.

• On-site technical support for cleanroom installation, process validation, and compliance documentation.

• Lifetime technical consultation for mold optimization and regulatory updates.

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