Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging ISO 13485 Certified
Price:
0.03-0.1usd/pc
MOQ:
500kg
Delivery Time:
8-15work days
Brand:
Bright Pack
Product Description
Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging - ISO 13485 Certified
Engineered for critical medical applications, our laser-scored sterile packaging film delivers fail-safe opening performance while maintaining the highest sterility barrier integrity. The precision pre-opened easy-tear feature ensures healthcare professionals can access contents quickly and safely in emergency situations, meeting rigorous medical device packaging standards.
Critical Performance Features
- Controlled Tear Initiation - Laser scoring enables clean, predictable opening
- Sterility Assurance - Validated microbial barrier per ISO 11607-1
- Peel-to-Peel Consistency - Uniform seal strength (1.5-3.5N/15mm)
- Material Versatility - Compatible with Tyvek® alternatives
- Validation Support - DQ/IQ/OQ documentation packages available
Certified Applications
- Surgical instrument sterile barrier systems
- Implantable device packaging
- Diagnostic kit pouches
- Pharmaceutical blister lidding
Product Specifications
| Attribute | Technical Specification |
|---|---|
| Base Material | Medical-grade PET/PE or PET/PP laminates |
| Thickness Range | 75-150μm (validated for sterilization) |
| Laser Score Depth | 30-50% material depth (validated per lot) |
| Tear Propagation Force | 0.8-1.5N (controlled directional tear) |
| Sterilization Methods | Validated for EtO, gamma, and e-beam |
| Seal Strength | 1.5-3.5N/15mm (peelable yet secure) |
| Burst Strength | ≥35kPa (maintains pouch integrity) |
| Air Permeability | <0.5μm pore size (ASTM F1608 compliant) |
| Certifications | ISO 13485, ISO 11607, FDA 21 CFR 177.1520 |
| Release Liners | Optional silicone-coated for adhesive versions |
Sterilization & Validation Support
Performance Guarantees
- Sterility Maintenance: Validated microbial barrier through shelf life
- Aging Compliance: Accelerated aging tests available (ASTM F1980)
- Process Validation: Complete documentation packages for:
- Seal process validation
- Sterilization validation
- Transportation simulation
Available Services
- Shelf-life studies
- Peel strength mapping
- Particulate testing
- Extractables/leachables analysis
Why Choose Our Medical Packaging Film?
- Patient-Safe Design - Eliminates particulate generation during opening
- Regulatory Confidence - Full material master files available
- Process Optimization - Validated for high-speed form-fill-seal machines
- Technical Partnership - Co-development for novel device packaging
Request validation protocols and DMF references!
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Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.
Company
Dongguan Bright Packaging Co., Ltd.
Location
Room 301, Building 5, No.13 Xiyu Road, Hengli Town, Dongguan City, Guangdong Province
Contact Person
Cai