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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

Name: PreOpened EasyTear Laser Score Film For Medical Sterile Packaging ISO 13485 Certified
Brand: Bright Pack
Price: 3.2 USD

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

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

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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

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!

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