The Imaflexell™ C01 features a five-layer structure, with an inner contact layer made from Ethylene-Vinyl Acetate (EVA), providing mechanical strength and high flexibility in low-temperature environments. The outer layer is constructed from Low-Density Polyethylene (LDPE), providing transparency and flexibility. EVA ensures the film maintains its integrity in cryogenic conditions by resisting abrasions, punctures, stretching, and tearing, while staying flexible and not becoming brittle in low temperatures. The film enhance the product's lifespan in demanding cold storage environments.
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 |
| 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 | 16 / 8 |
| Elongation at Break (MD/TD) | ASTM D882 | % | 380/482 |
| Haze | ASTM D1003 | % | 3.57 |
| Transmittance | ASTM D1003 | % | 93.4 |
| Density | ASTM D792 | gm/cm³ | 0.95 |
| Water Vapour Transmission Rate (23° C, 100% RH) |
ASTM F1249 | g/m2/24h | 0.46 |
| Oxygen Permeability (23°C, 0%RH) |
ASTM D3985 | cm3/m2/day/bar | 0.002 |