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
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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
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Seal Integrity | Triple-Seal Design | Reinforced chevron seals + corner tack seals prevent curling/delamination. Passes ASTM F88/F2054 seal strength tests (>3.5N/15mm)
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Safety Features | Internal/External Indicators | Dual chemical indicators: External strip confirms exposure to EO; internal strip verifies gas penetration into pouch cavity
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Functional Design | Fibre-Free Peel & Clean Opening | BOP-treated film ensures residue-free peeling; medical-grade paper minimizes particle shedding during aseptic transfer
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