Physical Property* Dimension Value (Before / after gamma sterilization) Procedure
Haze%5 / 5ASTM D-1003
Clarity%98 / 98ASTM D-1003
Transmittance%93 / 93ASTM D-1003
Tensile strength at breakMPa14 / 13ASTM D-882
Elongation at break%280 / 300ASTM D-882
Elastic modulusMPa370 / 350ASTM D-882
Break at cold temperatureºCBelow -45 / below -45ISO 8570
Densityg/cm30.9ASTM D-792
Water vapor transmission rate**g/(m2.day)0.35 / 0.32ASTM F-1249
Oxygen permeability**cm3/(m2.day.atm)< 0.05 / <0.05ASTM D-3985
Carbon dioxide permeability**cm3/(m2.day.atm)<0.2 / <0.2ASTM F-2476
Film thickness0.325 mm  
Gamma sterilization dose 25 kGy except **50 kGy   
Test Specification
Result
Characters
PassPass
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 mgPass
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 VIPass
Buffering capacity
USP <88>
Class VIPass

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.