Film comprising a contact layer for the wall of a single-use pouch
A film for manufacturing a pouch includes a contact layer including (A) a copolymer of ethylene and α-olefin having a density in the range of 0.870 g/cm 3 to 0.910 g/cm 3 , alone or in mixture with (B) a polyolefin having a density in the range of 0.910 g/cm 3 to 0.940 g/cm 3 , the contact layer including less than 0.10 wt %, preferably less than 0.07 wt %, of additives able to release a degradation compound further to gamma irradiation in the range of 25 kGy-50 kGy that can slow down or delay cellular growth. The process for manufacturing such a film, as well as the single-use pouch manufactured from that film are also described.
1. A film for manufacturing a pouch, said film comprising:
a contact layer comprising (A) a copolymer of ethylene and α-olefin having a density in the range of 0.870 g/cm 3 to 0.905 g/cm 3 , in mixture with (B) a homopolymer of ethylene having a density in the range of 0.910 g/cm 3 to 0.940 g/cm 3 , said contact layer comprising less than 0.10 wt % of additives able to release a degradation compound further to gamma irradiation in the range of 25 kGy-50 kGy, that can slow down or delay cellular growth,
wherein the film is a sterilized film and is configured to be manufactured as the pouch,
wherein an amount of anti-block in the contact layer is less than or equal to 2 wt %,
wherein the contact layer is sealable on itself, and
wherein the contact layer is configured to contact with a biopharmaceutical product without causing degradation of the biopharmaceutical product.
2. The film according to claim 1 , wherein the additives configured to release a degradation compound further to gamma irradiation that can slow down or delay cellular growth are antioxidants.
3. The film according to claim 2 , wherein said antioxidants are phosphite antioxidants.
4. The film according to claim 2 , wherein said antioxidants are tris(2,4-ditert-butylphenyl) phosphites.
5. The film according to claim 1 , wherein the copolymer of ethylene and α-olefin (A) is a plastomer copolymer of ethylene with one or more α-olefins having from 4 carbon atoms to 8 carbon atoms.
6. The film according to claim 1 , wherein the contact layer comprises a mixture of (A) and (B) with a mass ratio (B)/(A) less than or equal to 95/5.
7. The film according to claim 1 , wherein said film is monolayer.
8. The film according to claim 1 , wherein said film is a multilayer film comprising a core layer configured to provide a barrier to the passage of gases such as oxygen or carbon dioxide, and an outer layer,
wherein the contact layer and core layer are made integral with a first tie layer, and the outer layer and the core layer are made integral with a second tie layer in addition to the contact layer.
9. A process for manufacturing the film according to claim 1 , comprising:
extruding the contact layer.
10. A process for manufacturing the multilayer film according to claim 8 , comprising:
coextruding the contact layer, the first tie layer, the core layer, the second tie layer, and the outer layer.
11. A single-use pouch comprising:
a wall comprising the film according to claim 1 .
12. A bioreactor comprising:
the single-use pouch according to claim 11 .
13. The film according to claim 1 , wherein said contact layer comprises less than 0.07 wt % of additives able to release a degradation compound further to gamma irradiation in the range of 25 kGy-50 kGy, that can slow down or delay cellular growth.
14. The film according to claim 5 , wherein the copolymer of ethylene and α-olefin (A) is a linear low density copolymer of ethylene and oct-1-ene made from a process utilizing a metallocene catalyst.
15. The film according to claim 1 , wherein the polyolefin (B) is a low density polymer of ethylene.
16. The film according to claim 1 , wherein said film is a multilayer film comprising one or several layers in addition to the contact layer.
17. The film according to claim 1 , wherein the anti-block in the contact layer is selected from the group consisting silicon dioxide, magnesium silicate, calcium carbonate, calcium stearate, ethylene bisstearamide, stearyl erucamide, stearamide, erucamide, glycerol monostearate, zinc stearate, and silicone.
18. The film according to claim 1 , wherein the contact layer comprises a mixture of (A) and (B) with a mass ratio (B)/(A) in a range of 0.2 to 5.
19. The film according to claim 18 , wherein the range is 0.2 to 2.
20. The film according to claim 8 , wherein the core layer comprises one of: a flex-crack resistant ethylene vinyl alcohol copolymer, and a mixture of an ethylene vinyl alcohol copolymer and an ionomer acid ethylene copolymer.