Packaging film ImaflexellTM L01

multilayerfor pharmaceuticals packagingliner

Product Overview
Imaflexell4 L01 is a three-layer homogeneous ULDPE film developed for aseptic liner applications in biopharma. The all-ULDPE construction provides a low melting temperature for reliable heat sealing, combined with excellent flexibility and softness to facilitate handling and conformation to containers. The optimized structure delivers enhanced toughness, puncture resistance and abrasion resistance to reduce risk of leaks and maintain sealing integrity in critical processes.

Pharmacopoeia and Biocompatibility Test
Biological Reactivity, in vitro (Cytotoxicity Test): USP <87>
Biological Reactivity, in vivo (Acute Systemic Toxicity, Intracutaneous and Implantation Test): USP <88>
Bacterial Endotoxins - LAL Test: USP <85>
Extractables Study as per BPOG Guidelines: 24 hours, 21 days, *70 days
Physicochemical Test: USP <661.1>
Hemocompatibility Test: ISO 10993-4
Skin Sensitization Test: *ISO 10993-10
Skin Irritation Test: ISO 10993-23
Food grade test: FDA 21 CFR 177.1520
ROHS Complied (Directive (EU) 2015/863)
REACH (SVHC) Complied: (EC) No 1907/2006
TSE/BSE Declaration: Animal Derived Ingredients (ADI) free
Phthalate Content: Free
Bisphenol A (BPA) Content: Free

Application
Designed for safe handling and sterile containment, Imaflexell4 L01 is suitable for storage, filling, mixing, waste collection and batch handling in biopharmaceutical processing where aseptic liners are required. Its combination of flexibility and puncture resistance supports reliable use in single-use systems and liner containment.

Technical Data

• Appearance: Transparent
• Available width: 1400 mm
• Available thickness: 250 µm
• Recommended sealing method: Heat sealing
• Recommended sterilization method: Gamma irradiation, E-beam
• Manufactured environment: Cleanroom ISO Class 7

Physical Properties
Tensile strength at break | ASTM D882 | MPa | 19/21
Elongation at break (MD/TD) | ASTM D882 | % | 815/1010
Haze | ASTM D1003 | % | 5.9
Transmittance | ASTM D1003 | % | 91.7
Density | ASTM D792 | g/cm3 | 0.89

Film Composition
Outer layer: ULDPE
Core layer: ULDPE
Contact layer: ULDPE

Features / Technical specifications

• Three-layer homogeneous ULDPE construction (Outer / Core / Contact all ULDPE)
• Transparent appearance
• Available width up to 1400 mm
• Available thickness: 250 µm
• Tensile strength at break: 19/21 MPa (ASTM D882)
• Elongation at break (MD/TD): 815% / 1010% (ASTM D882)
• Haze: 5.9% (ASTM D1003)
• Transmittance: 91.7% (ASTM D1003)
• Density: 0.89 g/cm3 (ASTM D792)
• Recommended sealing: Heat sealing
• Recommended sterilization: Gamma irradiation or E-beam
• Manufactured in Cleanroom ISO Class 7
• Certified/tested for USP <87>, USP <88>, USP <85>, USP <661.1>
• Extractables study per BPOG: 24 hours, 21 days, 70 days
• Hemocompatibility (ISO 10993-4), Skin Sensitization (ISO 10993-10), Skin Irritation (ISO 10993-23)
• Food grade compliance: FDA 21 CFR 177.1520
• ROHS and REACH (SVHC) compliant
• TSE/BSE declaration: Animal Derived Ingredients free
• Phthalate free and BPA free
• High flexibility, softness, puncture and abrasion resistance for aseptic liner and biopharma applications