Specifications
Brand Name :
Bright Pack
Certification :
patent for invention、BRC、GRS、ISO、FDA、QC
Place of Origin :
Guangdong,China
MOQ :
500kg
Price :
$3.2-3.8/kg
Payment Terms :
T/T,Western Union
Supply Ability :
2000kg/day
Delivery Time :
8-15work days
Packaging Details :
Export special carton packaging and plate
Thickness :
0.01-0.2mm
Custom Order :
Accept
Zipper :
on top
Project :
Roll film for food packaging
Uv Protection :
Yes
Feature :
Moisture-proof
Design :
As Your Request
Port :
ShenZhen Port
Oem :
Accept OEM Bag 9 Color Offset Printing
Heat Seal :
Yes
Web :
www.verticalpackagingmachinery.com
Size :
Customized
Smell Proof :
Yes
Corner :
Round or straight corners
Sealing Method :
Heat Seal
Description
  • 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)

    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!

    • Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

      Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified
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Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging ISO 13485 Certified

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Brand Name :
Bright Pack
Certification :
patent for invention、BRC、GRS、ISO、FDA、QC
Place of Origin :
Guangdong,China
MOQ :
500kg
Price :
$3.2-3.8/kg
Payment Terms :
T/T,Western Union
Contact Supplier
video
Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified
Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified
Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified
Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified
Pre-Opened Easy-Tear Laser Score Film For Medical Sterile Packaging  ISO 13485 Certified

Dongguan Bright Packaging Co., Ltd.

Verified Supplier
2 Years
guangdong, dongguan
Since 2015
Business Type :
Manufacturer
Total Annual :
5000000-7000000
Employee Number :
100~200
Certification Level :
Verified Supplier

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