EXTRACTABLE AND LEACHABLE STUDIES OF TWIST-OFF PORTS (T.O.P.) USED FOR BLOOD PACK CONTAINERS

摘要

Current peel tabs on the Blood-Pack? containers and transfer pack units will be replaced with the T.O.P. parts, which are made of PVC containing DINCH and epoxidized soybean oil (ESBO) plasticizers. ICP/OES reported zinc as both an extractable and teachable. GC/MS analyses showed many extractables. Leachable compounds were much fewer in number and lower in concentration, compared to the extractables. Extractables and ieachables included 2-hexanone, hexanal, cyclopentanone, cyclohexanone, 2,5-hexanedione, hexanoic acid, and degradants of DINCH. UPLC/UV/MS analyses showed that most of the i extractables/leachables were impurities/degradation products of ESBO, and small amounts of DINCH and its fragments. Significant amounts of formate and acetate were detected as extractables but were not observed as Ieachables.