RT Journal Article
SR Electronic
T1 Extraction/leaching of metal containing additives from polyvinyl chloride, ethyl vinyl acetate, and polypropylene bags and infusion sets into infusion solutions
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2018.009019
DO 10.5731/pdajpst.2018.009019
A1 Bohrer, Denise
A1 Mattiazzi, Patricia
A1 Viana, Carine
A1 Nascimento, Paulo
A1 Carvalho, Leandro
A1 Veiga, Marlei
YR 2018
UL http://journal.pda.org/content/early/2018/08/29/pdajpst.2018.009019.abstract
AB Flexible medical devices are primarily made of plasticized polyvinyl chloride (PVC). Lately, PVC is being replaced with ethyl vinyl acetate (EVA) and polypropylene (PP) to avoid undesired migration of the PVC plasticizers. Nevertheless, other additives are necessary to generate useful polymeric materials. Metallic species present in such additives can also leach out into the infusion solutions. The migration of Ba, Cd, Sn, Pb, and Zn from devices made from PVC, EVA, and PP was evaluated. Bags and infusion sets were decomposed, and their metallic contents were analyzed. Glucose, NaCl, and Tween 80 were investigated as extraction media. These solutions were stored in PVC, EVA, and PP bags, heat sterilized, and stored for eight months at room temperature. Aliquots were taken before and after sterilization and then once per month to determine the contents of the metals. Commercial glucose and NaCl infusions were analyzed by taking aliquots of the solutions from the bags and from the administration set after their administration to patients. The three polymers contained the five metals. Ba was found in the highest concentration in all samples, with a mean of 8.0 mg/kg in PVC, 4.2 mg/kg in EVA, and 4.7 mg/kg in PP samples. Despite this, the only element that migrated into the glucose, NaCl, and Tween 80 solutions was Zn. The same result was found for the commercial glucose and NaCl infusions. Moreover, the Zn concentration in the administration sets was on average 52% higher than what was found in the bags.