ImaflexellTM A02

Aseptic Processing Film with both side (inner/outer) Antistatic LLDPE layers

The Imaflexell™ A02 features a three-layer structure with antistatic properties on both sides. The inner layer is made of linear low-density polyethylene combined with an antistatic agent, ensuring product cleanliness and providing a permanent antistatic eect. The core layer is composed of Metallocene linear low-density polyethylene, oering excellent tensile strength, transparency, and durability. The outer layer also consists of linear low-density polyethylene mixed with a long-lasting antistatic agent.


PHARMACOPOEIA AND BIOCOMPATIBILTY TEST

Ami Polymer Pvt. Ltd. certifies that the product mentioned in this catalogue complies as per below listed testing requirments. Described here in;

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


PHYSICAL PROPERTIES

Technical Data Test Method Unit of Measure Values
Tensile Strength at Break ASTM D882 MPa 24 / 14
Elongation at Break (MD/TD) ASTM D882 % 1368/1278
Haze ASTM D1003 % 29
Transmittance ASTM D1003 % 61.2
Density ASTM D792 gm/cm³ 0.89
Water Vapour Transmission Rate
(23° C, 100% RH)
ASTM F1249 g/m2/24h 0.26*
Oxygen Permeability
(23°C, 0%RH)
ASTM D3985 cm3/m2/day/bar 0.002*