Why FDA Certification is the Gateway for Medical Packaging?
In U.S. healthcare logistics, packaging materials directly impact the safety and efficacy of medical devices. According to FDA 21 CFR Part 210, medical-grade stretch film must meet triple standards: microbial barrier, material compatibility, and transportation stability. Professional medical stretch film reduces 87% of transportation contamination risks, becoming the core guarantee for safe medical cargo transport.
Medical Grade Stretch Film Technical Standards
| Parameter | Industrial Grade | Medical Grade | Sterilization Grade | Test Standard |
|---|---|---|---|---|
| Material Certification | None | FDA CFR 21 | ISO 11607-1 | USP Class VI |
| Microbial Limit | Not required | ≤100 CFU/㎡ | ≤50 CFU/㎡ | ISO 11737 |
| Water Vapor Transmission | Uncontrolled | ≤100 g/㎡/24h | ≤50 g/㎡/24h | ASTM D3985 |
| Tear Resistance | ≥30 N/mm | ≥45 N/mm | ≥60 N/mm | ASTM D1004 |
| Heavy Metals | Not required | ≤10 ppm | ≤5 ppm | USP 232 |
Four Golden Rules of Medical Packaging
- Cleanliness Classification
- Class 1000: General medical devices
- Class 100: Implantable devices
- Class 10: High-risk invasive devices
- Barrier Performance Matrix
- Microbial barrier: ≤0.3μm pore composite structure
- Chemical barrier: Resistance to disinfectants/EO gas
- Physical barrier: ≥40N puncture resistance
- Traceability Requirements
Each roll must provide unique identification including material lot number, production date, and sterilization validity - Compatibility Testing
New packaging systems require accelerated aging validation (ASTM F1980) and real-time aging verification
Siliangdi remains committed to innovation, quality, and service. We will continue developing and producing more eco-friendly, high-performance packaging materials, striving to provide exceptional packaging solutions for more enterprises. Together, we enhance brand value and market competitiveness.
Contact Us for Custom Sizes & Private Label Options
Email：packing@siliangdi.com
Email：SLD@siliangdi.com