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 (Attributes Table)

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!