Bio-Cube™ Scalable Bio Solutions

Charter Medical’s BioCube™ single use flexible containers are self supporting to optimize cold storage. Designed for applications in bioprocessing, storage and transport of sterile fluids. Ideal for media fill application in conjunction with cell culture bags.

Available in 2L and 5L sizes.

Ordering Information – Bio-Cube™

Product Number Description Case Qty
CML-BIOCUBE-2L 2L Biocube 20
CML-BIOCUBE5L4P 5L Biocube 20

Clear Pak® Film An Innovative Solution

charter_medical_ClearPakFilm_breakdownCharter Medical’s Clear-Pak® Bio-Containers are designed for applications in processing, handling, storage and transport of sterile fluids. Clear-Pak® is a single web film in a multi-layer, co-extruded format with an Ultra Low Density Polyethylene (ULDPE) contact layer, EVOH gas barrier layer, and Polyethylene (PE) outer layer. The film offers superior clarity, excellent gas barrier properties and is animal derivative component free. Complete validation package available upon request.

Physical Test Data (post gamma irradiation*)

Property Test Protocol Average Value
Tensile Strength ASTM D882 1900 psi
Yield Strength ASTM D882 1200 psi
Elongation at Break ASTM D882 460%
Elastic Modulus ASTM D882 39,000 psi
Tear Resistance ASTM D1004 5.25 lb
Penetration Resistance ASTM F1306 4.94
O2 Transmission Rate ASTM D3985 <0.003mL/100in2·day·atm
CO2 Transmission Rate ASTM F2476 <0.01mL/100in2·day·atm
Moisture Vapor Transmission Rate ASTM F1249 0.021g/100in2·day
Clarity ASTM D1003 97%
Haze ASTM D1003 7%
Transmittance D1003 93%
Operating Range – 80°C to 50°C

Biocompatibility Test Data (post gamma irradiation*)

Property Test Protocol Average Value
USP Class VI USP <88> Pass
Cytotoxicity USP <87> Pass
Bacterial Endotoxin USP <85> Pass
Heavy Metals USP <661> Pass
Buffering Capacity USP <661> < 1 mL
Non-Volatile Residue (NVR) USP <661> < 1 mg
Residue on Ignition USP <661> Pass
Appearance EP <3.1.5> Pass
Acidity and Alkalinity EP <3.1.5> Pass
Absorbance EP <3.1.5> 0.01 Pass
Reducing Substances EP <3.1.5> 0.02 mL Pass
Local Effects After Implantation ISO 10993-6 Pass
Irritation and Delayed-type Sensitivity ISO 10993-10 Pass
Systemic Toxicity ISO 10993-11 Pass
Particulates USP <788> Pass

Gamma Irradiation Level: * Minimum 25 kGy

Charter Medical is a Michelin Company.