Packaging film Imaflexell™ A01

for packagingmultilayerfor pharmaceuticals packaging

Overview
The Imaflexell™ A01 is a three-layer aseptic processing film designed for biopharmaceutical applications. The contact layer is low-density polyethylene (LLDPE) with a permanent antistatic agent. The core is metallocene linear low-density polyethylene (mLLDPE) providing tensile strength and transparency. The outer layer is LLDPE offering flexibility and puncture resistance.

Key features

• Aseptic processing film with antistatic LLDPE contact layer
• Three-layer construction: antistatic LLDPE / mLLDPE core / LLDPE outer layer
• Permanent antistatic property on the contact surface
• High tensile strength, elongation, flexibility and puncture resistance
• Suitable for safe handling and sterile containment in bioprocessing

Applications

• Storage, filling, mixing, waste collection and batch handling in biopharma processing

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 — 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

Physical properties
Appearance: Transparent
Available Width: 1400 mm
Available Thickness: 250 μm
Recommended Sealing Method: Heat Sealing
Recommended Sterilization Method: Gamma, E-Beam
Manufactured Environment: Cleanroom ISO Class 7

Physical test data
Tensile Strength at Break (ASTM D882): 26 / 13 MPa
Elongation at Break (MD/TD) (ASTM D882): 472 / 1103 %
Haze (ASTM D1003): 23 %
Transmittance (ASTM D1003): 90.2 %
Density (ASTM D792): 0.9 gm/cm³
Water Vapour Transmission Rate (23°C, 100% RH) (ASTM F1249): 0.26 g/m²/24h
Oxygen Permeability (23°C, 0% RH) (ASTM D3985): 0.002 cm³/m²/day/bar

Film composition
Outer Layer — LLDPE
Core Layer — mLLDPE (Metallocene LLDPE)
Contact Layer — LLDPE with antistatic agent

Technical specifications

• Product name: Imaflexell™ A01
• Product type: Aseptic Processing Film
• Contact layer: Antistatic LLDPE
• Construction: Three-layer (LLDPE / mLLDPE / LLDPE)
• Width: up to 1400 mm
• Max thickness: 250 μm
• Appearance: Transparent
• Sealing: Heat Sealing
• Sterilization: Gamma, E-Beam
• Manufacturing environment: Cleanroom ISO Class 7
• Key standards: USP <87>, USP <88>, USP <85>, USP <661.1>, ISO 10993-4, ISO 10993-10, ISO 10993-23, FDA 21 CFR 177.1520
• Compliance: ROHS (EU 2015/863), REACH (EC No 1907/2006), Phthalate free, BPA free, ADI free