Single-Use Bioprocessing Bag for Growing Cell Media, and Multilayer Film
A multilayer bioreactor bag ( 20 ) made from a multilayer film ( 10 ), the bag having: inner and outer exterior surface layers ( 11, 16 ) on opposing faces of the multilayer film ( 10 ) consisting essentially of a low density polyethylene having a density in a range of 0.91 to 0.94 g/cc to provide a non-tacky exterior surface layers; interior layers disposed between the exterior surface layers comprising a gas barrier layer ( 14 ) and a structural layer ( 12 ) comprising an ethylene alpha-olefin elastomer having a density in a range of 0.87-0.91 to provide a flexible support to the multilayer film.
1 . A multilayer bioreactor bag ( 20 ) made from a multilayer film ( 10 ) comprising:
inner and outer exterior surface layers ( 11 , 16 ) on opposing faces of the multilayer film ( 10 ) consisting essentially of a low density polyethylene having a density in a range of 0.91 to 0.94 g/cc to provide a non-tacky exterior surface layers;
interior layers disposed between the exterior surface layers comprising a gas barrier layer ( 14 ) and a structural layer ( 12 ) comprising an ethylene alpha-olefin elastomer having a density in a range of 0.87-0.91 to provide a flexible support to the multilayer film.
2 . The multilayer bioreactor bag of claim 1 , wherein the multilayer film further comprises one or more tie layers ( 13 , 15 ) to bond the interior layers to one or more of the ethylene alpha-olefin elastomer structural layer ( 12 ) and surface layers ( 11 , 16 ).
3 . The multilayer bioreactor bag of claim 2 , wherein the one or more tie layers ( 13 , 15 ) comprise a mixture of an ethylene alpha-olefin elastomer and a polyolefin copolymer grafted with maleic anhydride.
4 . The multilayer bioreactor bag according to claim 2 , wherein the multilayer film comprises six layers (Layers 1-6) in serial order as listed below:
Layer 1: the inner exterior surface layer ( 11 );
Layer 2: a first ethylene alpha-olefin elastomer structural layer ( 12 );
Layer 3: a first tie layer ( 13 );
Layer 4: the gas barrier layer ( 14 );
Layer 5: a second tie layer ( 15 ); and
Layer 6: the outer exterior surface layer ( 16 ).
5 . The multilayer bioreactor bag of claim 4 , wherein the thickness ranges of the six layers are:
Layer 1 is in a thickness range of 10-100 microns;
Layer 2 is in a thickness range of 100-250 microns;
Layer 3 is in a thickness range of 5-50 microns;
Layer 4 is in a thickness range of 5-50 microns;
Layer 5 is in a thickness range of 5-50 microns; and
Layer 6 is in a thickness range of 10-100 microns.
6 . The multilayer bioreactor bag of claim 5 , wherein the density ranges of the six layers are:
Layer 1 is in a density range of 0.91-0.94 g/cc;
Layer 2 is in a density range of 0.87-0.91 g/cc;
Layer 3 is in a density range of 0.87-0.91 g/cc;
Layer 4 is in a density range of 1.10-1.25 g/cc;
Layer 5 is in a density range of 0.87-0.91 g/cc; and
Layer 6 is in a density range of 0.91-0.94 g/cc.
7 . The multilayer bioreactor bag according to claim 1 , wherein the gas barrier layer ( 14 ) is EVOH.
8 . A multilayer film ( 10 ) comprising:
inner and outer exterior surface layers ( 11 , 16 ) on opposing faces of the multilayer film ( 10 ) consisting essentially of a low density polyethylene having a density in a range of 0.91 to 0.94 g/cc to provide a non-tacky exterior surface layers;
interior layers disposed between the exterior surface layers comprising a gas barrier layer ( 14 ) and a structural layer ( 12 ) comprising an ethylene alpha-olefin elastomer having a density in a range of 0.87-0.91 to provide a flexible support to the multilayer film; and
one or more tie layers ( 13 , 15 ) to bond the interior layers to one or more of the ethylene alpha-olefin elastomer structural layer ( 12 ) and surface layers ( 11 , 16 ).
9 . The multilayer film of claim 8 , wherein the one or more tie layers ( 13 , 15 ) comprise a mixture of an ethylene alpha-olefin elastomer and a polyolefin copolymer grafted with maleic anhydride.
10 . The multilayer film according to claim 8 , wherein the multilayer film comprises six layers (Layers 1-6) in serial order as listed below:
Layer 1: the inner exterior surface layer ( 11 );
Layer 2: a first ethylene alpha-olefin elastomer structural layer ( 12 );
Layer 3: a first tie layer ( 13 );
Layer 4: the gas barrier layer ( 14 );
Layer 5: a second tie layer ( 15 ); and
Layer 6: the outer exterior surface layer ( 16 ).
11 . The multilayer film of claim 10 , wherein the thickness ranges of the six layers are:
Layer 1 is in a thickness range of 10-100 microns;
Layer 2 is in a thickness range of 100-250 microns;
Layer 3 is in a thickness range of 5-50 microns;
Layer 4 is in a thickness range of 5-50 microns;
Layer 5 is in a thickness range of 5-50 microns; and
Layer 6 is in a thickness range of 10-100 microns.
12 . The multilayer film of claim 11 , wherein the density ranges of the six layers are:
Layer 1 is in a density range of 0.91-0.94 g/cc;
Layer 2 is in a density range of 0.87-0.91 g/cc;
Layer 3 is in a density range of 0.87-0.91 g/cc;
Layer 4 is in a density range of 1.10-1.25 g/cc;
Layer 5 is in a density range of 0.87-0.91 g/cc; and
Layer 6 is in a density range of 0.91-0.94 g/cc.
13 . The multilayer film according to claim 8 , wherein the gas barrier layer ( 14 ) is EVOH.
14 . The multilayer film according to claim 8 , wherein the interior layers comprise one or more of anhydride-modified polyethylene, ethylene/unsaturated acid copolymer, ethylene/unsaturated ester copolymer, anhydride-modified polyolefin, polyurethane, and mixtures thereof.
15 . The multilayer bioreactor bag of claim 1 , comprising an inflatable bag ( 20 ) having an enclosed central chamber ( 21 ) for holding a cell or bioreactor liquid media, the inflatable bag ( 20 ) comprising a top sheet ( 22 ) of multilayer polymer material and a bottom sheet ( 24 ) of multilayer polymer material, wherein the multilayer polymer material comprises the multilayer film ( 10 ).
16 . The multilayer bioreactor bag of claim 15 , wherein the top sheet ( 22 ) and the bottom sheet ( 24 ) are heat sealed along perimeter edges to form the central chamber ( 21 ).
17 . The multilayer bioreactor bag of claim 16 , wherein a handle opening ( 25 ) is provided in a top perimeter edge of the bag ( 20 ); and port openings for receiving tubes ( 27 ) are provided in a bottom perimeter edge of the bag ( 20 ).
18 . The multilayer bioreactor bag of claim 1 , wherein the interior layers comprise one or more of anhydride-modified polyethylene, ethylene/unsaturated acid copolymer, ethylene/unsaturated ester copolymer, anhydride-modified polyolefin, polyurethane, and mixtures thereof.
19 . The multilayer bioreactor bag of claim 1 comprising a single use bioprocessing bag for growing cell media wherein:
the ethylene alpha-olefin elastomer is ethylene based octene-1 elastomer; and
the gas barrier layer is ethylene vinyl alcohol copolymer.
20 . The multilayer bioreactor bag of claim 1 , wherein the ratio of layer thickness of each of the exterior surface layers ( 11 , 16 ) to layer thickness of structural layer ( 12 ) is between 1:2.5 and 1:10.