Precision Plastic Mould Solutions

Precision Medical Infusion Needle Manufacturing Specifications

Component Overview

• Part Name: Medical Infusion Needle (Class II Medical Device)

• Primary Material: PP 9074MED (USP Class VI Certified)

• Wall Thickness: 0.7mm ±0.03mm (Critical Flow Path Sections)

• Surface Finish: SPI-A2 (Ra ≤ 0.025μm for Fluid Contact Surfaces)

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Advanced Tooling Configuration

• Mold System: 16-Cavity High-Precision Stack Mold

• Core/Cavity Material: Uddeholm M300 Tool Steel

• Hardened to 52-54 HRC

• Mirror Polished with EDM Texturing

• PVD Coated for Corrosion Resistance

• Mold Base: NAK80 Pre-Hardened Steel (40-42 HRC)

• Integrated Temperature Control Channels

• Guided Ejector System with Sleeved Leaders

Hot Runner Technology

• System: Moldmaster 8-Point Hot Nozzle System

• Individual Zone Temperature Control (±0.5°C)

• Balanced Melt Flow Distribution

• Quick-Change Nozzle Tips for Different Gate Styles

• Gate Type: 0.35mm Hemispherical Hot Tip Gate

• Automatic Gate Cutting System

• Zero Drool Shut-Off Mechanism

Injection Molding Process

• Machine: Toshiba EC-SX 180 All-Electric Press

• Clamping Force: 1800 kN

• Injection Accuracy: ±0.15% Shot Weight

• Repeatability: ±0.002mm Positioning

• Process Parameters:

• Melt Temp: 220-230°C (Precision Controlled)

• Mold Temp: 60-65°C (Water-Oil Hybrid System)

• Injection Speed: 120mm/s (3-Stage Profile)

• Packing Pressure: 80MPa (Decay Curve Controlled)

Quality Assurance Protocols

1. Dimensional Verification:

• Optical Comparator Inspection (0.001mm Resolution)

• CMM Sampling Every 4 Hours (Full GD&T Report)

2. Functional Testing:

• Flow Rate Testing at 23°C ±1°C

• Burst Pressure Verification (Minimum 300kPa)

3. Material Compliance:

• FTIR Material Conformity Testing

• USP <88> Biological Reactivity Testing

Production Validation

• Process Capability: CpK ≥ 1.67 (Critical Dimensions)

• Annual Capacity: 18 Million Units (3-Shift Operation)

• Cleanroom Standards: ISO Class 7 Molding Environment

• Validation Documentation: Full IQ/OQ/PQ Package Available

Regulatory Support

• FDA 21 CFR Part 820 Compliance

• ISO 13485:2016 Certified Process

• REACH & RoHS Material Certification

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