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

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Eight Side Sealing Flat Bottom Bag

High Temperature Cooking Bag

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

Brand Name:	Bright Pack
MOQ:	500kg
Price:	$3.2-3.8/kg
Packaging Details:	Export special carton packaging and plate
Payment Terms:	T/T,Western Union

Detail Information

Product Description

Detail Information

Place of Origin:

Guangdong,China

Certification:

patent for invention、BRC、GRS、ISO、FDA、QC

Thickness:

0.01-0.2mm

Custom Order:

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

Supply Ability:

2000kg/day

Highlight:

Medical Sterile Packaging Laser Score Film

Easy-Tear Laser Score Film

Pre-Opened Laser Score Film

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