Bags are assemblies that, besides the film, also include components such as ports, tubing, connectors, filters, sensors and impellers, which all are listed as separate test items in the BioPhorum protocolThus, it is preferred to test the film and the other bag components separately. Impellers may be difficult to scale down and it is thus recommended to test the individual impeller materials separately in the format of coupons.
Vent filters are not considered to be in fluid contact and do not need to be tested.
Time points for film used in storage bags are T1, T21 and T70 days.
Time points for film used in bioreactor and mixing bags are T1 and T21 days.