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.
Film
Cellbags are manufactured from multi-layer laminated clear plastic films designed to provide high mechanical strength and bioinert fluid contact. Typically, the fluid contact layer is a medical grade low density polyethylene. The second or outer layer provides mechanical strength and a gas-impermeable barrier. This non-contact layer is typically made of low density polyethylene, EVA or Nylon/EVOH copolymers. Other films for specialty
applications are available.
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. MECHANICAL STRENGTH Film seal strength >67 N/cm. Each chamber is tested for leaks by pressure-hold test prior to sterilization.
| 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 | |
Many optional fittings such as pH probes, dip tubes, screw cap ports, temperature ports, perfusion filters, and special tubing ports are available.
| BIOCOMPATIBILITY Testing is performed on irradiated film (50 kGy): USP XXII plastic class VI and ISO 10993: |
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| ISO 10993-5 | 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).
