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Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Specifications
Brand Name :
Bright Pack
Model Number :
B010
Certification :
patent for invention、BRC、GRS
Place of Origin :
Guangdong,China
MOQ :
100pcs
Price :
0.02-2usd/pc
Payment Terms :
T/T,Western Union
Supply Ability :
200000pcs/day
Delivery Time :
11-13 work days
Packaging Details :
Export special carton packaging and plate
Sealing Method :
Zipper, Zipper Lock, or Heat Seal
Pattern Customization :
Support
Advantage :
Eco-friendly
Heat Seal :
Yes
Colors :
customized colors
Printing Method :
Digital or Gavure
Pattern Artwork :
Custom
Shape :
Customizable
Artwork :
AI,PDF, PSD etc
Keyword :
Food Packaging bag
Bpa Free :
Yes
Print :
good
Closure Type :
Self-Standing Zipper
Property :
Waterproof
Smell Proof :
Yes
Description
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Product Attributes
Attribute Category Key Features Technical Description
Material & Structure Medical-Grade Foil Laminate 3-layer construction: PET (outer, 12μm) + Aluminum foil (barrier, 7μm) + PE (inner sealant, 66μm). Provides superior moisture/oxygen barrier (MVTR <0.0003 g/100 in²/24hr; OTR negligible).
Sterilization Compatibility EO Gas Validated Compatible with Ethylene Oxide (EO) sterilization (tested per ISO 11140-1). Process indicators change color to confirm sterilization efficacy.
Certification & Compliance ISO 13485 Certified Manufacturing Produced under ISO 13485 quality management system. Complies with ISO 11607-1 (packaging for terminally sterilized devices) and EN 868-5.
Seal Integrity Triple-Seal Design Reinforced chevron seals + corner tack seals prevent curling/delamination. Passes ASTM F88/F2054 seal strength tests (>3.5N/15mm).
Safety Features Internal/External Indicators Dual chemical indicators: External strip confirms exposure to EO; internal strip verifies gas penetration into pouch cavity.
Functional Design Fibre-Free Peel & Clean Opening BOP-treated film ensures residue-free peeling; medical-grade paper minimizes particle shedding during aseptic transfer.
Product Specifications
Parameter Detail Standard/Value
Physical Properties Thickness 85±10 μm (3-layer laminate)
Physical Properties Standard Sizes 90×260mm, 135×255mm (customizable)
Barrier Performance Moisture Vapor Transmission Rate (MVTR) <0.0003 g/100 in²/24hr
Barrier Performance Oxygen Transmission Rate (OTR) <0.05 cc/m²/day
Sterilization Metrics EO Sterilization Cycle Tolerance Validated for 55°C, 60% humidity, 4-6hr exposure
Sterilization Metrics Shelf Life Post-Sterilization 12 months
Mechanical Strength Puncture Resistance 16 lbs
Mechanical Strength Tensile Strength 3,800 psi
Sealing Parameters Heat Sealing Conditions Temperature: 300°F-400°F (149°C-204°C); Time: 0.6-4.5 sec; Pressure: 30-70 PSI
Certifications Regulatory Approvals ISO 13485, ISO 11607-1, EN 868-5, FDA 21 CFR 177
Packaging & Logistics Pack Size 200 pouches/box
Packaging & Logistics MOQ 5,000 pouches
Product Images
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
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Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified

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Product Detail
Brand Name :
Bright Pack
Model Number :
B010
Certification :
patent for invention、BRC、GRS
Place of Origin :
Guangdong,China
MOQ :
100pcs
Price :
0.02-2usd/pc
Contact Supplier
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Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified

Dongguan Bright Packaging Co., Ltd.

Verified Supplier
3 Years
guangdong, dongguan
Since 2015
Business Type :
Manufacturer, Trading Company
Main Products :
Plastic-Free Paper Bag, Green Packing List Envelopes, Pharmacy Dispensing Bags
Total Annual :
$10000000-$70000000
Employee Number :
100~200
Certification Level :
Verified Supplier
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