| Customization: | Available |
|---|---|
| Application: | Household, Promotion, Food |
| Material: | Laminated Material |
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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
| 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 |
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
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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