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

 
  1. 50 μm Polyethylene
  2. 10 μm Adhesive layer
  3. 20 μm Ethyl Vinyl Alcohol (Gas barrier)
  4. 10 μm Adhesive Layer
  5. 230 μm Ultra low-density polyethylene (Contact Layer)

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.