Introduction

As high-precision, personalized medical devices evolve, medical-grade PEEK (polyetheretherketone) has become critical for 

high-end components (e.g., interbody fusion cages, surgical anchors). It meets ISO 10993 biocompatibility standards, 

withstands 260°C long-term use, and offers strong mechanical stability. However, its semi-crystalline nature (30%-35% crystallinity) 

and strict medical rules create technical challenges for molding. This article simplifies the core conditions, paired with new-era 

smart manufacturing.

1. Material Properties & Preprocessing

1.1 Key PEEK Performance

Melting point: 335-345°C (minor grade fluctuations)

Mechanical strength: Yield tensile ≥92MPa; flexural modulus ≥3.8GPa (23°C)

Melt flow rate: 6-12g/10min (unfilled); 3-5g/10min (30% carbon fiber-reinforced)

Biocompatibility: Pass 12 tests (cytotoxicity, sensitization, etc.)

1.2 Preprocessing Steps

PEEK’s 0.5% water absorption (23°C/50% RH) causes defects—fix with:

Drying: 155-165°C hot air for 2.5-3h (residual moisture ≤0.02%).

Cleaning: Use dedicated cleaners (e.g., CLEANER PEEK-800); avoid PVC/PA66 or copper contamination.

2. Mold Design & Manufacturing

2.1 Structural Design

Gating: 1.2mm (unfilled) / ≥2mm (reinforced) diameter; fan gates for thick parts, submarine gates for thin parts (sink marks ≤0.1mm).

Ejection: Draft angle 1.8°-3° (inner) / 1.2°-2° (outer); TiN-coated ejectors (friction ≤0.18), spacing ≤80mm.

2.2 Materials & Surface Treatment

Steel: 316L/17-4PH (cavities); S136H (templates, HRC 45-48).

Finishing: Mirror polish (Ra ≤0.2μm); DLC coating (2-3μm, FDA-approved) for implants.

2.3 Temperature Control

Mold temp: 180-200°C (higher for reinforced PEEK).

Uniformity: Cavity surface temp deviation ≤±2°C.

3. Molding Process Control

3.1 Injection Machine Needs

Setup: Staged temp control (feed: 280-300°C; compression: 340-360°C; metering: 380-400°C); medical-grade machines (injection 

pressure accuracy ±0.1MPa).

Safety: 99.99% nitrogen protection when barrel temp >350°C.

3.2 Key Parameters

Injection: Melt temp 380-400°C; pressure 120-150MPa; holding pressure 70%-80% of injection pressure (8-15s).

Cooling: 2-3x holding time; demolding temp ≤220°C (deformation ≤0.1%).

4. Quality & Compliance

4.1 Validation & SPC

Mold checks: Pass DQ/IQ/OQ (500 shots, key dimension deviation ≤±0.03mm); PQ pass rate ≥99.5%.

SPC: Monitor temp/pressure/time; CPK ≥1.67.

4.2 Testing

Precision: CMM (±0.005mm); microscope (black spots ≤0.05mm, scratches ≤0.2mm).

Performance: Tensile deviation ≤±5%; cell viability ≥90% (cytotoxicity test).

4.3 Compliance

Certifications: ISO 13485 (molds); FDA 21 CFR Part 177.2600 (materials); CE (MDR for EU).

Traceability: Batch records kept ≥5 years.

5. New-Era Technologies

Smart Manufacturing: CAE (Moldflow) cuts trial runs by 30%; IoT+AI keeps yield ≥98.5%.

3D Printing & Materials: 3D-printed molds (SLM) boost cooling efficiency by 40%; PEEK-HA (10%-15% HA) improves osseointegration by 30%.

6. Typical Cases

6.1 Cervical Fusion Cage Mold

Material: AKSOPEEK? CF30 (30% carbon fiber)

Process: Mold temp 190°C, melt temp 395°C, cycle 45s

Result: Dimension deviation ±0.02mm; flexural strength ≥200MPa (ISO 10993-19).

6.2 Radiopaque Anchor Mold

Material: Victrex? PEEK 450G +25% tungsten

Process: Mold temp 185°C, injection speed 90mm/s

Result: X-ray detectable; yield 99.8%.

Conclusion

Molding medical-grade PEEK requires balancing materials, design, processes, quality control, and new tech. In the new era, 

compliance (ISO 13485, FDA) and smart tools (CAE, IoT, 3D printing) are non-negotiable. Future focus: PEEK-metal hybrids and 

ultra-thin wall (≤0.5mm) molding to advance local high-end medical devices.