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 |
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. |
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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.
