Fig 1.
Illustrations of drug preparation and administration device assembly.
(A) Vial access clip with DualGuard needleless connector attached to a drug vial. (B) Vial access device with DualGuard needleless connector attached to a drug vial. (C) Administration set with closed male luer and DualGuard needleless connector attached to an intravenous bag.
Table 1.
Storage durations and conditions of the reconstituted vials and diluted infusion bags before the sampling for potency maintenance and plasticizer migration tests.
Fig 2.
Detection points on administration sets for the tensile test.
The red circles are the detection points.
Table 2.
Results of drug potency maintenance tests for all CSTD components.
Fig 3.
Changes in the appearance of CSTDs during functionality tests.
(A) White matter appeared on the vial access device after 8 h of storage with busulfan (photo shown on the right). New vial access device as control (photo shown on the left). (B) The vial access connector was found to have cracks after being exposed to melphalan for 8 h with vial accessed device (photo shown on the right). New vial access device as control (photo shown on the left). (C) The needleless connector was found to have cracks after being exposed to melphalan for 8 h with administration set (photo shown on the right). The new needleless connectors were used as control (photo shown on the left).