Imaflexell™ L01 features a three-layer all-ULDPE structure designed for high-performance aseptic liner applications. The use of Ultra Low-Density Polyethylene (ULDPE) across all layers provides a low melting temperature, ensuring excellent sealing characteristics. The film delivers outstanding flexibility and softness, enabling superior handling and adaptability. Its optimized structure oers enhanced toughness, puncture resistance, and resistance to abrasions and tears, eectively preventing leaks. The homogeneous ULDPE design ensures consistent performance, improved durability, and reliable sealing integrity for critical applications.
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 | |
| Technical Data | Test Method | Unit of Measure | Values |
|---|---|---|---|
| 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 | gm/cm³ | 0.89 |