EXTRACTION STUDIES ON THE DEVELOPMENT OF PACKAGING MATERIALS FOR DIALYSIS SOLUTIONS: STANDARD PROCEDURE AND SOME RESULTS

摘要

During dialysis treatment of patients with renal failure large volume parenteral solutions in large daily quantities are used for a long time, ranging from a few days or weeks for acute treatment to life-long use in chronic renal failure. Thereby even very low concentrations of contaminants in the solutions could accumulate to toxicologically relevant amounts. Therefore a careful examination in the context of extraction studies is an important aspect of the development of new packaging. The extraction studies at Fresenius Medical Care are carried out primarily on the individual components of the container closure systems (foils, tubes, injection moulding parts, etc.); increasingly also on the used polymer raw materials. The samples are autoclaved with aqueous buffer solutions with defined surface-volume ratios and the extraction solutions are examined by headspace GC, GC-MS, HPLC-UV/DAD, HPLC-MS and ICP, with the main focus on the GC-MS investigations.