Cellbag™
Truly Custom Bioreactors
Add a filter, quick connect fitting or 10 feet of tubing - you decide! Disposable bioreactors available in standard formats or easily customized to suit your specific cell culture process needs for research, development or cGMP manufacturing operations. Our Product Specialists will work with you to create your ideal cell culture bag for use with the WAVE Bioreactor System.
The cell contact surface is a USP Class VI ethylene vinyl acetate (EVA) / low density polyethylene copolymer of the type routinely used for blood collection and handling of biological fluids. Outer layers are made of proprietary composites that provide exceptional strength and extremely low gas permeability.
Features:
- Easy to use.
- Save time.
- Get consistent results.
- Multi-featured products to meet your needs.
Cellbag™ Technology
Technology:
Bioreactor Bags
Cellbag bioreactor chambers are intended for single-use, and are suitable for cGMP production of human therapeutics. Cellbag components are similar to those used for biological storage bags and meet USP Class VI specifications for plastics. Validation data and Cellbag DMF are available to demonstrate biocompatibility, however the user is advised to validate suitability for specific applications. Cellbags can be supplied with advanced single use, optical sensing technologies such as dissolved oxygen and pH probes. Many fittings such as ReadyMate aseptic connectors, dip tubes, screw cap ports, temperature ports, perfusion filters, and special tubing ports are available.
Film
Cellbags are manufactured from multi-layer laminated clear plastic films designed to provide high mechanical strength and bioinert fluid contact. The cell contact surface is a USP Class VI ethylene vinyl acetate / low density polyethylene copolymer. of the type routinely used for blood collection and handling of biological fluids. Outer layers are made of composites that provide exceptional strength and extremely low gas permeability. Mechanical strength: Film seal strength >67 N/cm. Each chamber is tested for leaks by pressure-hold test prior to sterilization.
STERILITY AND ENDOTOXIN
Sterilized by gamma radiation at 25-40 kGy. Individual radiation indicators are affixed to each Cellbag. Lot radiation information provided. Each lot is tested for bacterial endotoxin. Lot release requires endotoxin below 0.125 EU/ml.
CUSTOMIZATION
Cellbags can be readily customized for user-specified connectors, tube sets, and special components.
Connectors (Typical)
| Air inlet |
0.2 micron gas filter |
| Air outlet |
0.2 micron gas filter with check valve |
| Sampling |
Needleless self-sealing syringe port No laminar hood required |
| Fill/Harvest |
C-Flex™ tubing suitable for sterile fusing terminated with luer or MPC coupling |
| Multiuse |
Luer port with cap |
| Oxywell2™ |
Silicone sheath for DO probe |
BIOCOMPATIBILITY
Testing is performed on irradiated film (50 kGy):
USP XXII plastic class VI and ISO 10993:
| ISO 10993-4 |
Hemolysis study in vivo, extraction method |
| ISO 10993-5 |
Cytotoxicity study using ISO elution method |
| ISO 10993-6 |
Muscle implantation study in rabbit |
| ISO 10993-10 |
Acute intracutaneous reactivity study in rabbit |
| ISO 10993-11 |
Acute systemic toxicity in mouse |
TEMPERATURE & PRESSURE RATING
Cellbags may be used from 0°C to 50°C.
Maximum operating pressure is 1.5 psig (0.1 bar).
