Gibco® PE Film Data
| Physical Property* | Dimension | Value (Before / after gamma sterilization) | Procedure |
|---|---|---|---|
| Haze | % | 5 / 5 | ASTM D-1003 |
| Clarity | % | 98 / 98 | ASTM D-1003 |
| Transmittance | % | 93 / 93 | ASTM D-1003 |
| Tensile strength at break | MPa | 14 / 13 | ASTM D-882 |
| Elongation at break | % | 280 / 300 | ASTM D-882 |
| Elastic modulus | MPa | 370 / 350 | ASTM D-882 |
| Break at cold temperature | ºC | Below -45 / below -45 | ISO 8570 |
| Density | g/cm3 | 0.9 | ASTM D-792 |
| Water vapor transmission rate** | g/(m2.day) | 0.35 / 0.32 | ASTM F-1249 |
| Oxygen permeability** | cm3/(m2.day.atm) | < 0.05 / <0.05 | ASTM D-3985 |
| Carbon dioxide permeability** | cm3/(m2.day.atm) | <0.2 / <0.2 | ASTM F-2476 |
| Film thickness | 0.325 mm | ||
| Gamma sterilization dose 25 kGy except **50 kGy |
| Test | Specification | Result |
|---|---|---|
| Characters | Pass | Pass |
| Identificaion (A-IR spectrophotometry) | Pass | Pass |
| Identification (B-titanium-dioxide) | Pass (≤4%) | Pass |
| C-titanium-dioxide | Pass | Pass |
| Appearance of solution S1 | Pass | Pass |
| Acidity or alkalinity | ≤ 1.5 mL 0.01 N NaOH ≤ 1.0 mL 0.01 N HCl | Pass (0.60 mL) Pass (0.40 mL) |
| UV absorbance (220-340 nm) | ≤ 0.20 | Pass (0.01) |
| Reducing substances | ≤ 0.5 mL | Pass (0.20 mL) |
| Extractable aluminum | ≤ 1 ppm | Pass |
| Extractable zinconium | 0.0 | ≤ 0.1 ppm |
| Extractable chromium | ≤ 0.05 ppm | Pass |
| Extractable heavy metals | ≤ 2.5 ppm | Pass |
| Extractable titanium | ≤ 1 ppm | Pass |
| Extractable vanadium | ≤ 0.1 ppm | Pass |
| Extractable zinc | ≤ 1 ppm | Pass |
| Extractable zirconium | ≤ 0.1 ppm | Pass |
| Sulphated ash | ≤ 1% | Pass (0.02%) |
| Substances soluble in hexane | NA | Impracticable |
| Antioxidants (max. 3) | Pass | Pass |
| Antioxidants | < 0.3% | Pass |
| Amides and stearates | Pass | Pass |
| Test | Method | Specification | Result |
|---|---|---|---|
| Nonvolatile residue | USP <661> | ≤ 15 mg | Pass |
| Residue on ignition | USP <661> | ≤ 5 mg | Pass |
| Heavy metals | USP <661> | < 2 ppm | Pass |
| Buffering capacity | USP <661> | ≤ 10 mL | Pass |
| Test | Method | Specification | Result |
|---|---|---|---|
| Elution test | USP <87> | Pass | Pass |
| Systemic injection test | USP <88> | Class VI | Pass |
| Intracutaneous test | USP <88> | Class VI | Pass |
| Buffering capacity | USP <88> | Class VI | Pass |
Gas Transmission Rates
| Lower is Better The Gibco® PE film demonstrates significantly lower gas transmission rates in comparison to other bags on the market. |
 |
Gibco® PE film construction
 |
|
Gibco® PE film pH stability
Shelf life stability study over a 19 month period for CD-CHO, DMEM, and FreeStyle™ 293. Media packaged in the Gibco® PE film remains within pH specification limits.
