Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified
Price:
0.02-2usd/pc
MOQ:
100pcs
Delivery Time:
11-13 work days
Brand:
Bright Pack
Product 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 |
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Company
Dongguan Bright Packaging Co., Ltd.
Location
Room 301, Building 5, No.13 Xiyu Road, Hengli Town, Dongguan City, Guangdong Province
Contact Person
Cai