Closed vial fill system for aseptic dispensing
First Claim
1. A sterilized kit comprising:
- a final product vial comprising a septum;
a fill cap comprising a spike capable of piercing the septum, wherein the fill cap is capable of being removably coupled to the final product vial;
a tray comprising a vial containment portion sized to receive the final product vial and a cap retention portion sized to receive the fill cap; and
sterile packaging enclosing the final product vial, fill cap, and tray, wherein the spike is capable of piercing the septum when the sterile packaging is unopened.
8 Assignments
0 Petitions
Accused Products
Abstract
A closed path vial fill system includes a bulk product vial, a peristaltic pump operated by a stepper motor, a dispensing manifold assembly to which may be coupled at least one final product vial, an optional quality check station, and an optional waste collection system. A concentration, activity, and volume (CAV) sensor may be incorporated into the system to receive a radiopharmaceutical product directly from a synthesizing unit. A control system may be integrated into the system to provide automated control of various aspects of the radiopharmaceutical dispensing process. The system is used to aseptically dispense finished radiopharmaceuticals into receiving vessels, such as a Quality Control vial, a sterility vial, and/or final product vials, while providing users an efficient means for removing and discarding contaminated disposable components.
-
Citations
20 Claims
-
1. A sterilized kit comprising:
-
a final product vial comprising a septum; a fill cap comprising a spike capable of piercing the septum, wherein the fill cap is capable of being removably coupled to the final product vial; a tray comprising a vial containment portion sized to receive the final product vial and a cap retention portion sized to receive the fill cap; and sterile packaging enclosing the final product vial, fill cap, and tray, wherein the spike is capable of piercing the septum when the sterile packaging is unopened. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
-
-
11. A method of using a sterilized kit, the method comprising:
-
obtaining a sterilized kit in a storage configuration, the sterilized kit comprising; a final product vial comprising a septum; a fill cap comprising a spike; a tray comprising a vial containment portion sized to receive the final product vial and a cap retention portion sized to receive the fill cap; and sterile packaging enclosing the final product vial, fill cap, and tray; wherein the spike is spaced from the septum in the storage configuration; piercing the septum of the final product vial with the spike on the fill cap, thereby creating an opening in the septum; opening the sterile packaging after piercing the septum; adding a product to the final product vial through the spike on the fill cap; and removing the spike from the septum, thereby resealing the opening in the septum. - View Dependent Claims (12, 13, 14, 15, 16)
-
-
17. A sterilized kit comprising:
-
a bulk product vial; a dispensing manifold assembly coupled with the bulk product vial; a final product vial comprising a septum; a fill cap coupled to the dispensing manifold assembly, wherein the fill cap is removably coupleable to the final product vial and comprises a spike capable of piercing the septum of the final product vial; a tray having a vial containment portion sized to receive a final product vial and a cap retention portion sized to receive the fill cap; and sterile packaging enclosing the final product vial, fill cap, and tray, wherein the spike is capable of piercing the septum when the sterile packaging is unopened, and wherein the final product vial and the fill cap are removeable from the tray while coupled to one another. - View Dependent Claims (18, 19, 20)
-
Specification