The Imaflexell™ B01 features a five-layer structure with an inner contact layer of Ultra Low-Density Polyethylene (ULDPE) resists a wide range of chemicals, while enhancing mechanical strength and an outer layer of Low-Density Polyethylene (LDPE) that provides durability by resisting abrasions, punctures and tearing to prevent leaks. The core layer made of EVOH is barrier against oxygen, which helps in preserving the integrity and shelf life of sensitive products.
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 | 13 / 13 |
| Elongation at Break (MD/TD) | ASTM D882 | % | 509 / 662 |
| Haze | ASTM D1003 | % | 4.3 |
| Transmittance | ASTM D1003 | % | 91.5 |
| Density | ASTM D792 | gm/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 |