Method for sanitization of a chromatography column
The invention discloses a method for sanitization of a bioprocess chromatography column, comprising the steps of: a) providing a bioprocess chromatography column with a packed bed of separation resin particles and a movable adapter, b) with the adapter in contact with the packed bed, conveying a sanitization fluid through the packed bed to a column outlet; c) raising the adapter to provide a gap between the packed bed and the adapter, d) lowering the adapter to close the gap; and e) conveying an equilibration liquid through the packed bed to a column outlet.
1. A method for sanitization of a bioprocess chromatography column, comprising the steps of:
a) providing a bioprocess chromatography column with a packed bed of separation resin particles and a movable adapter;
b) with the adapter in contact with the packed bed, conveying a sanitization fluid through the packed bed to a column outlet;
b′) closing and opening a column resin valve;
c) raising the adapter to provide a gap between the packed bed and the adapter;
d) lowering the adapter to close the gap;
d′) conveying the sanitization fluid through the packed bed to the column outlet; and
e) conveying an equilibration liquid through the packed bed to a column outlet.
2. The method of claim 1 , wherein steps c) and d) are repeated at least once.
3. The method of claim 1 , wherein before step b′), said column resin valve has been equilibrated with the sanitization fluid.
4. The method of claim 1 , further comprising filling a flush channel between two adapter seals with the sanitization fluid.
5. The method of claim 1 , wherein said sanitization fluid comprises an oxidizing agent.
6. The method of claim 5 , wherein said oxidizing agent comprises a peracid or hydrogen peroxide.
7. The method of claim 5 , wherein said oxidizing agent comprises or is peracetic acid.
8. The method of claim 5 , wherein the concentration of the oxidizing agent in said sanitization fluid is 5-100 mM.
9. The method of claim 1 , wherein said separation resin comprises a crosslinked polysaccharide.
10. The method of claim 1 , wherein proteinaceous affinity ligands are tethered to said separation resin.
11. The method of claim 10 , wherein said proteinaceous affinity ligands comprise Protein A or a variant of Protein A.
12. The method of claim 1 , wherein said packed bed of separation resin is in contact with said sanitization fluid for 10-50 minutes.
13. The method of claim 1 , wherein, before step b), said column with said packed bed of separation resin is used for separation of a biopharmaceutical.
14. The method of claim 1 , wherein, after step e), said column with said packed bed of separation resin is used for separation of a biopharmaceutical.
15. The method of claim 1 , wherein, before step b), said column with said packed bed of separation resin is used for separation of a first biopharmaceutical and, after step e), said column with said packed bed of separation resin is used for separation of a second biopharmaceutical which is different from said first biopharmaceutical.
16. The method of claim 5 , wherein the concentration of the oxidizing agent in said sanitization fluid is 10-30 mM.
17. The method of claim 9 , wherein said separation resin comprises crosslinked agarose.
18. The method of claim 1 , wherein said packed bed of separation resin is in contact with said sanitization fluid for 20-40 minutes.