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.