Red blood cell products and the storage of red blood cells in containers free of phthalate plasticizer
Red blood cell products and compositions are disclosed. The product includes a container made from PVC or a non-PVC material that is substantially free of a phthalate plasticizer but otherwise includes one or more non-phthalate plasticizers or extractable agents. The product includes a RBC concentrate which has been combined with an additive solution for storing the RBCs.
1. A container for storing red blood cell compositions comprising:
one or more container walls defining an interior chamber, said container wall(s) comprising a polymeric material that includes polyvinyl chloride and that is (a) at least substantially free of phthalate and (b) comprises up to approximately 45%, by weight, of two extractable non-phthalate ester plasticizers that are effective in suppressing hemolysis in red blood cells, wherein one of said plasticizers is a citrate ester and the other of said ester plasticizers is 1, 2-cyclohexane dicarboxylic acid diisononyl ester.
2. The container of claim 1 wherein said citrate ester is n-butyryl-tri-n-hexyl-citrate.
3. The container of claim 1 wherein said citrate ester is acetyltri-n-butyl citrate.
4. The container of claim 1 further comprising at least a third agent.
5. The container of claim 4 wherein said third agent is effective in suppressing hemolysis in red blood cells.
6. The container of claim 1 wherein said citrate and 1, 2-cyclohexane dicarboxylic acid diisononyl esters together comprise between 20%-45%, by weight, of said polymeric material.
7. The container of claim 1 wherein one of said citrate and 1, 2-cyclohexane dicarboxylic acid diisononyl esters together comprises between approximately 5%-60%, by weight, of the combined weight of said citrate and 1, 2-cyclohexane dicarboxylic acid diisononyl ester and, optionally, additional agents.
8. The container of claim 1 wherein said polyvinyl chloride comprises at least approximately 55%, by weight, of said polymeric material.
9. The container of claim 1 wherein said polymeric material comprises approximately 60%-70% polyvinyl chloride, approximately 15%-30% 1, 2-cyclohexane dicarboxylic acid diisononyl ester and approximately 5%-15% citrate ester.
10. The container of claim 9 further comprising approximately 4%-10% epoxidized oil.
11. The container of claim 10 further comprising approximately 0.5%-3.0% of additional co-stabilizers and lubricants.
12. The container of claim 9 wherein said citrate ester is n-butyryl-tri-n-hexyl-citrate.