| 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 |
| 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
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|
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.
