Abstract: To explore the applicability of poly (ethylene terephthalate) (PET) barrels for hemodialysis concentrates packaging. Methods To evaluate the applicability of PET barrels for hemodialysis concetrates packaging according to the Polyester Bottles for Oral Liquid Medicine and relevant standards. Results Physical and chemical properties tests and extraction test with hemodialysis concentrates as extraction medium indicated that the physical and chemical properties and extractables of PET barrels well met requirements of the standard. Antimony levels of the extracts using acetic acid solution (pH=2) as extraction medium was 0.093μg/ml, which equals to 47.7μg of antimony in a 5L of A concentrate. When calculated with a dilution by a factor of 35 for concentrate A and for a dialysis duration of five hours, then the amount of concentrate A used for a single hemodialysis treatment is 4.28L, and the maximum antimony in the hemodialysis concentrate for a single hemodialysis course would be 40.8μg, which is far below the Daily Tolerable Intake for adults (60kg) of 360μg calculated with the Daily Tolerable Intake of 6μg/kg specified by WHO. Biological evaluation tests results revealed that, the PET barrel material showed no in vitro cytotoxicity, negative skin sensitization reaction, and no intradermal reaction. The stacking simulation tests showed no deformation, fracture or collapse of the PET barrels which contained hemodilaysis concentrates. Conclusion The results showed that all tests well complied with requirements of appropriate standards or application requirements, and that the PET barrels can be used for hemodialysis concentrates packaging.

Key words: Poly (ethylene terephthalate) (PET), Hemodialysis concentrates, Packaging, Applicability