Packaging film 9101 Infuflex

barriermultilayerpolyethylene

Product overview
9101 Infuflex Film is a five-layer barrier film formulated for bioprocessing applications that require exceptional oxygen and vapor barrier performance while maintaining clarity and mechanical performance. It is designed for manufacturing single-use 2D and 3D fluid transfer and storage bags.

Film composition

• 0.05 mm LDPE – Outer layer
• 0.01 mm TIE – Bonding layer
• 0.02 mm EVOH – Gas barrier layer
• 0.01 mm TIE – Bonding layer
• 0.23 mm ULDPE – Fluid contact layer

Technical data

• Haze: 7% (ASTM D-1003)
• Clarity: 97% (ASTM D-1003)
• Transmittance: 93% (ASTM D-1003)
• Tensile strength at break: 14/13 MPa (ASTM D-1003)
• Elongation at break MD/TD: 370/350% (ASTM D-882)
• Elastic modulus: 250/270 MPa (ASTM D-882)
• Break at cold temperature: below -45°C (ISO 8570)
• Density: 0.9 g/cm3 (ASTM D-792)
• Water vapour transmission rate: 0.35 / 0.32 g/m²/day (23°C, 100% RH) (ASTM F-1249)
• Oxygen permeability: < 0.05 cm³/m²/day/bar (23°C, 0% RH) (ASTM D-3985)
• CO permeability: < 0.2 cm³/m²/day/bar (23°C, 0% RH) (ASTM F-2476)

Compliance and certification

• ISO 10993-4 Hemolysis
• ISO 10993-5 Cytotoxicity
• ISO 10993-6 Implantation test
• ISO 10993-10 Irritation and Sensitization tests
• ISO 10993-11 Acute Systemic Toxicity test
• USP <85> Bacterial Endotoxins – LAL test
• USP <87> Biological Reactivity Test in vitro
• USP <88> Biological Reactivity Test in vivo, Class VI
• European Pharmacopoeia tests 3.1.5
• USP <661.1> Polyethylene Physicochemical Tests, Extractable Metals, Plastic Additives

Key features

• Total film thickness: 0.325 mm
• Recommended sealing method: Heat sealing
• Recommended sterilization: Gamma or E-Beam
• Multi-layer structure with inert PE fluid contact layer
• Low extractables/leachables and no animal-derived components

Technical specifications

• Product name: 9101 Infuflex Film (five-layer barrier film)
• Layer construction: 0.05 mm LDPE / 0.01 mm TIE / 0.02 mm EVOH / 0.01 mm TIE / 0.23 mm ULDPE
• Primary materials: LDPE, ULDPE, EVOH, tie layers
• Intended use: Manufacture of single-use 2D and 3D bags for bioprocessing
• Barrier performance: O₂ < 0.05 cm³/m²/day/bar; CO < 0.2 cm³/m²/day/bar (23°C, 0% RH)
• WVTR: 0.35 / 0.32 g/m²/day (23°C, 100% RH)
• Optical: Haze 7%, Clarity 97%, Transmittance 93%
• Mechanical: Tensile 14/13 MPa; Elongation MD/TD 370/350%; Elastic modulus 250/270 MPa
• Low temperature resistance: Break below -45°C
• Density: 0.9 g/cm³
• Regulatory: Meets listed ISO and USP tests and European Pharmacopoeia 3.1.5