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Di-(2-ethylhexyl)-phthalate migration from irradiated poly(vinyl chloride) blood bags for graft-vs-host disease prevention

2012; Elsevier BV; Volume: 430; Issue: 1-2 Linguagem: Inglês

10.1016/j.ijpharm.2012.03.039

1873-3476

Ferri Marcella, Emo Chiellini, Pili Giorgio, Grimaldi Luca, Elena Tiziana Florio, Pili Stefania, Cucci Francesco, Latini Giuseppe,

Polymer Science and PVC

Irradiation with 20-25 kGy is a process commonly used for sterilizing poly(vinyl chloride) (PVC) medical devices. Moreover, whole blood and blood components undergo additional irradiation with 25-50 Gy to inhibit the proliferative capacity of lymphocytes and reduce the risk of transfusion-associated graft-vs-host disease (GVHD). Di-(2-ethylhexyl)-phthalate (DEHP) plasticized PVC is extensively used for the production of flexible medical devices including blood bags, but since DEHP is not covalently bound to PVC, it tends to migrate and leach out of the medical device, with harmful consequences for the patients. In this study, the effects of different doses of gamma irradiation on DEHP migration from PVC blood bags was investigated using differential scanning calorimetry (DSC) analysis. Our findings indicate that irradiation with 25-100 Gy reduces the ability of DEHP to migrate from the blood bags, and in the case of a primary container a correlation between the doses of gamma ray irradiation was also observed. In particular, a decrease in DEHP leachability was obtained by increasing the dose of gamma ray irradiation.