Protective film ImaflexellTM B01

for packagingbarriermultilayer

Short description
The Imaflexell 99 4TM B01 is an aseptic processing film designed for biopharmaceutical single-use systems. It features a five-layer construction with an inner contact layer of Ultra Low-Density Polyethylene (ULDPE) for chemical resistance and mechanical strength, a central EVOH barrier layer for low oxygen transmission, and an outer LDPE layer for abrasion and puncture resistance. The film provides low OTR, high flexibility and reliable sealability for liquid handling and storage applications.

Pharmacopoeia and Biocompatibility Tests
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>
Extractable 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 (Restriction of hazardous substance) : Directive (EU) 2015/863
REACH (SVHC) Complied : (EC) No 1907/2006
TSE/BSE Declaration (ADI - Animal Derived Ingredients free)
Phthalate Content Free
Bisphenol A (BPA) Content Free

Application
The Imaflexell 99 4TM B01 film is intended for biopharma single-use applications such as liquid bags and transfer containers. It is optimized for low oxygen transmission, flexibility and puncture resistance, making it suitable for aseptic transfer, storage and mixing systems. Common applications include:

• Liquid single-use bags and transfer containers
• Mixing and holding systems
• Media storage and distribution
• Bioreactor sampling bags
• Product storage containers

Technical data

• Appearance: Transparent
• Available Width: 1400 mm
• Available Thickness: 320 µm
• Recommended Sealing Method: Heat sealing
• Recommended Sterilization Method: Gamma, E-Beam
• Manufactured Environment: Cleanroom ISO Class 7

Physical properties
Technical Data | Test Method | Unit of Measure | Values
Tensile Strength at Break | ASTM D882 | MPa | 13 / 13
Elongation at Break (MD/TD) | ASTM D882 | % | 509 / 662
Haze | ASTM D1003 | % | 4.3
Transmittance | ASTM D1003 | % | 91.5
Density | ASTM D792 | g/cm3 | 0.91
Water Vapour Transmission Rate (23°C, 100% RH) | ASTM F1249 | g/m2/24h | 0.25
Carbon Dioxide Permeability (23°C, 0% RH) | ASTM F2476 | cm3/m2/day/bar | 0.25
Oxygen Permeability (23°C, 0% RH) | ASTM D3985 | cm3/m2/day/bar | 0.07

Film composition

• LDPE - Outer Layer
• TIE - Bonding Layer
• EVOH - Gas Barrier Layer
• TIE - Bonding Layer
• ULDPE - Contact Layer

Characteristics / technical specifications

• Model: Imaflexell 99 4TM B01
• Brand: Ami Polymer Pvt. Ltd.
• Structure: Five-layer (LDPE / TIE / EVOH / TIE / ULDPE)
• Appearance: Transparent
• Available width: 1400 mm
• Available thickness: 320 µm
• Recommended sealing: Heat sealing
• Sterilization: Gamma, E-Beam
• Manufactured environment: Cleanroom ISO Class 7
• Tensile strength at break: 13 MPa (MD / TD)
• Elongation at break: 509% (MD) / 662% (TD)
• Haze: 4.3%
• Transmittance: 91.5%
• Density: 0.91 g/cm3
• Water vapour transmission rate (23°C, 100% RH): 0.25 g/m2/24h
• CO2 permeability (23°C, 0% RH): 0.25 cm3/m2/day/bar
• Oxygen permeability (23°C, 0% RH): 0.07 cm3/m2/day/bar
• Compliance: USP, ISO, FDA, ROHS, REACH as listed in product tests