Evaluation of techniques for analysis of plasticants in blood bags

Plastic blood bags are products that present a high risk associated with their use and are part of the Ministry of Health's blood and blood derivatives strategic program. Blood bags are made of plastified PVC with DEHP and should not release any substance above the limits specified in RDC nº 35/2014; however, plasticizers are not chemically bound to PVC and migration to the blood occurs during use of the medical device. In addition, the development of analytical methodologies for migration analysis is of paramount importance to assess patient exposure to plasticizers during the use of blood bags. This work aims to determine the plasticizer content (DEHP and DEHA) by spectrophotometric (pharmacopoeial) and chromatographic methods (CG-FID, HPLC-UV and HPLC-CAD). Plasticizer content determination was performed with three blood bag samples from three different batches and manufacturers. All the methods studied were linear in the studied concentration ranges and allowed the detection of DEHP. All samples were considered satisfactory in relation to the amount of extractable DEHP and the presence of DEHA in the analyzed samples was not detected. In the comparison of the methods by linearity, Mann-Whitney/Wilcoxon test indicated that there were no significant differences between the methods. The use of the HPLC-CAD technique for the determination of DEHP in blood bags is a technological innovation and an alternative for determination of DEHP in blood bags.