Material Composition & Barrier Structure Multilayer Architecture: Combines PET (polyethylene terephthalate) or BOPP (biaxially oriented polypropylene) as the outer layer for mechanical strength and printability, aluminum foil (Al) or metallized EVOH (ethylene vinyl alcohol) as the core gas barrier layer, and medical-grade CPP (cast polypropylene) or LDPE (low-density polyethylene) as the inner sealant layer. This structure ensures oxygen transmission rate (OTR) ≤0.05 cc/m²/day and water vapor transmission rate (WVTR) ≤0.3 g/m²/day, critical for preventing ClO degradation and moisture ingress Corrosion-Resistant Coatings: Features nano-silica coatings or fluoropolymer treatments to resist oxidation and corrosion from ClO, maintaining film integrity for >12 months Functional Properties Sterilization Compatibility: Withstands ethylene oxide (EO) sterilization, gamma radiation (up to 50 kGy), and autoclaving (121°C, 30 min) without delamination or barrier failure Controlled Gas Release: Engineered micro-perforations or nano-porous layers enable controlled ClO release rates (0.5-5 ppm/h) to maintain antimicrobial efficacy while preventing explosive accumulation Tamper Evidence: Integrates holographic seals or color-changing indicators that activate upon exposure to ClO or tampering, complying with ISO 11607-1 for medical packaging Safety & Compliance Regulatory Certifications: Complies with FDA 21 CFR §177.1520, EU 10/2011, and ISO 13485 for medical device packaging. Heavy metal migration <0.01 ppm and chlorite residue ≤0.5 mg/kg Biological Safety: Passes USP <87> Class VI testing for cytotoxicity, ensuring no leachables affect ClO stability or patient safety Sustainability & Processing Recyclable Mono-Material Options: PP/PE monolithic structures (GRS-certified) with >30% recycled content, reducing carbon footprint to ≤1.2 kg CO/kg High-Speed Convertibility: Compatible with VFFS/HFFS machines at speeds up to 200 bags/minute; supports pre-cut widths (200-1,200 mm ±0.2 mm) for automated lines Product Specifications Physical Parameters Thickness: 60-150 μm (standard: PET/BOPP 15-30 μm + Al/EVOH 6-20 μm + CPP/LDPE 30-70 μm) Roll Dimensions: Core ID 76.2 mm or 152.4 mm; max. roll length 5,000 m; weight ≤100 kg. Barrier Performance OTR (23°C, 0% RH): ≤0.05 cc/m²/day (ASTM D3985) WVTR (38°C, 90% RH): ≤0.3 g/m²/day (ASTM F1249) ClO Retention: ≥95% after 6 months at 25°C (validated via GC-MS headspace analysis) Mechanical & Thermal Properties Puncture Resistance: ≥50 N (ASTM F1306) Tensile Strength: ≥120 MPa (MD), ≥100 MPa (TD) (ASTM D882) Heat Seal Strength: ≥40 N/15mm at 130-160°C (ASTM F88) Temperature Tolerance: -40°C to 121°C. Sterilization & Safety Metrics Gamma Radiation Resistance: No degradation at ≤50 kGy (ISO 11137) Cytotoxicity: Non-cytotoxic (USP <87>) Migration Limits: Heavy metals (Pb, Cd, Hg) <0.01 ppm; chlorite ≤0.5 mg/kg (EU 10/2011) Controlled-Release Parameters ClO Release Rate: 0.5-5 ppm/h (adjustable via film perforation density) Release Duration: 30-60 days (humidity-triggered at RH >60%) Certifications Quality & Safety: ISO 13485 (medical devices), ISO 11607-1 (sterile packaging), BRCGS Packaging Eco-Labels: GRS (recycled content), ISO 14064 (carbon footprint)
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