Views: 0 Author: Site Editor Publish Time: 2025-08-13 Origin: Site
Medical plastic injection molding facilities must adhere to ISO 14644-1 (cleanroom standards) and GMP guidelines. Common classifications include:
| Cleanroom Class | Particle Limit (≥0.5µm/m³) | Typical Applications |
|---|---|---|
| ISO 5 (Class 100) | ≤3,520 | High-risk implants, sterile packaging |
| ISO 7 (Class 10,000) | ≤352,000 | Syringes, catheters, drug containers |
| ISO 8 (Class 100,000) | ≤3,520,000 | Non-sterile medical components |
Key Considerations:
Implantable & sterile products typically require ISO 5-7.
Non-sterile but low-particulate products (e.g., pill bottles) may use ISO 7-8.
HEPA filters (H13 or higher) – Remove ≥99.97% of particles ≥0.3µm.
Unidirectional airflow (laminar flow) – Critical for high-cleanliness zones (e.g., assembly, packaging).
Positive pressure (10-15 Pa) – Prevents contaminants from entering clean areas.
Temperature: 20-24°C (prevents plastic warping & static buildup).
Humidity: 45-65% RH (reduces microbial growth & electrostatic discharge).
Walls/floors: Epoxy resin, stainless steel, or anti-static PVC (easy to clean, no crevices).
Equipment: Injection molding machines must be dust-proof and corrosion-resistant.
Cleanroom garments: Full-body suits, gloves, masks, and shoe covers (ISO 5 requires full coverage).
Air showers: Mandatory 15-30 sec air wash before entry.
Behavior rules: No running, minimal talking to reduce particle generation.
Daily cleaning: Use lint-free wipes & IPA (isopropyl alcohol).
Microbial monitoring: Regular air & surface sampling per ISO 14698.
Medical-grade plastics (FDA/EU-compliant resins like PP, PC, PEEK) must be stored in low-humidity conditions.
Hygroscopic materials (e.g., Nylon, PET) require pre-drying.
Mold cleaning: Prevent cross-contamination between batches.
Real-time monitoring: Particle counters track air quality.
Sterile products: Packaged in ISO 5 (Class 100) environments (e.g., RABS isolators).
Non-sterile products: Use clean, sealed bags.
GMP certification – Required for drug packaging & implants.
ISO 13485 – Quality management for medical devices.
Cleanroom validation – Includes IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification).
| Issue | Possible Cause | Solution |
|---|---|---|
| Particulate contamination | Poor air filtration, dirty molds | Upgrade HEPA filters, enforce mold cleaning SOPs |
| Microbial contamination | High humidity, inadequate disinfection | Improve humidity control, add UV sterilization |
| Static attracting dust | Low humidity, non-ESD materials | Maintain 45-65% |
✔ Match cleanroom class to product risk (ISO 5 for implants, ISO 7-8 for general use).
✔ Invest in HEPA filtration & laminar airflow.
✔ Enforce strict personnel mold protocols (garments, air showers).
✔ Validate compliance with GMP/ISO 13485.
