Material Composition Multilayered Hybrid Structure: Combines an oxygen-scavenging layer (e.g., polymer-embedded laccase enzyme or manganese ferrite/ceria nanoparticles)6 a ClO-generating matrix (sodium chlorite or stabilized chlorine dioxide precursors), and a gas-permeable control layer (e.g., microporous polypropylene or ethyl cellulose) for delayed release kinetics. Reactive Components: The oxygen-scavenging system utilizes enzymes (e.g., laccase) or inorganic catalysts (e.g., ceria NPs) to consume ambient oxygen, reducing residual O to ≤0.3% in sealed environments7 This prevents ClO degradation and ensures stable sterilization efficacy. Delayed-Release Mechanism: ClO release is triggered by environmental humidity or enzymatic activation, with kinetics modulated by the gas-permeable layer's porosity and thickness4 Functional Properties Synergistic Sterilization: Combines oxygen scavenging (prevents oxidative degradation of ClO) and controlled ClO release (5-50 ppm sustained concentration over 7-14 days), targeting anaerobic pathogens and biofilms1 Sterilization Compatibility: Validated for ethylene oxide (EtO), gamma irradiation, and hydrogen peroxide plasma sterilization processes without film delamination or functional loss6 Barrier Performance: Achieves oxygen transmission rate (OTR) ≤0.05 cc/m²/day and water vapor transmission rate (WVTR) ≤0.3 g/m²/day to maintain sterility for ≥180 days7 Safety & Compliance Medical-Grade Materials: Complies with ISO 10993 (biocompatibility), FDA 21 CFR §177.1520, and EU MDR 2017/745 for implantable device packaging4 Non-Toxic Byproducts: Oxygen scavenging produces harmless oxides or water, while ClO degrades to chloride ions, posing no residual toxicity Product Specifications Physical Parameters Thickness: 60-200 μm (customizable; oxygen-scavenging layer: 15-30 μm, ClO matrix: 20-50 μm, control layer: 10-40 μm). Width: 100-600 mm (±0.2 mm tolerance; compatible with form-fill-seal machines). Roll Dimensions: Core ID 76 mm/152 mm; max. roll length 2,500 m. Performance Metrics Oxygen Scavenging Capacity: ≤0.3% residual O in 72 hrs at 23°C/100% RH ClO Release Rate: 0.5-2.0 mg/m²/hr (adjustable via control layer porosity; sustained for 7-14 days) Sterilization Efficacy: Log reduction of B. atrophaeus and C. difficile spores within 24 hrs (ISO 11138/11135 validated) Seal Strength: ≥35 N/15mm (ASTM F88; seals to Tyvek® or PET/AL/PP laminates). Sterilization & Stability Temperature Tolerance: -40°C to +121°C (stable during autoclaving at 121°C for 15 mins). Shelf Life: ≥24 months at 15-25°C (60% RH). Regulatory Certifications Standards: ISO 11607-1 (packaging for terminally sterilized devices), ISO 13485 (QMS), REACH SVHC-free Biocompatibility: USP Class VI, ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation)
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