Thermal stability and chemical durability of PVC-based biomedical devices

Poly(vinyl chloride) (PVC)-based blood circuits for extracorporeal hemodialysis were investigated for the assessment of their thermal stability as well as their chemical durability towards ionizing radiation sterilization and environmental conditions of storage and transportation. Thermal degradation was monitored by measuring the amount of hydrochloric acid (HCl) evolved as a function of different thermal stresses. HCl was extracted from the internal lumen of the blood circuits, and then quantitatively evaluated under the corresponding form of chloride ions by chromatographic technique (HPLC-IC). Behavior of PVC heat stabilizers was evaluated as well, determining also the concentration of calcium and zinc released by the investigated materials, by flame atomic absorption spectroscopy (FAAS) technique. Electron beam irradiation revealed an impact on blood tubing higher than that of environmental storage conditions. Nevertheless, real operative cases of sterilization and storage conditions turned out to be quite safe, and all blood circuits displayed good performances in terms of thermal stability. (c) 2006 Wiley Periodicals, Inc.