Closed vial fill system for aseptic dispensing
First Claim
1. A closed path vial fill system, comprising:
- a bulk product vial containing a bulk product;
a first tube element inserted into a peristaltic pump, wherein the first tube element is coupled with the bulk product vial;
a dispensing manifold assembly coupled with the first tube element;
at least one final product vial coupled to the dispensing manifold assembly;
a valve disposed between the peristaltic pump and the dispensing manifold assembly, the valve having a first position and a second position; and
a dilution container having a dilution solution, wherein the dilution container is coupled to the valve,wherein in the first position, the valve allows fluid to flow from the dilution container to the bulk product vial,wherein in the second position, the valve allows fluid to flow from the bulk product vial to the dispensing manifold assembly, andwherein the peristaltic pump is configured to transfer a predetermined amount of bulk product from the bulk product vial to the at least one final product vial via the dispensing manifold assembly.
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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.
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Citations
49 Claims
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1. A closed path vial fill system, comprising:
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a bulk product vial containing a bulk product; a first tube element inserted into a peristaltic pump, wherein the first tube element is coupled with the bulk product vial; a dispensing manifold assembly coupled with the first tube element; at least one final product vial coupled to the dispensing manifold assembly; a valve disposed between the peristaltic pump and the dispensing manifold assembly, the valve having a first position and a second position; and a dilution container having a dilution solution, wherein the dilution container is coupled to the valve, wherein in the first position, the valve allows fluid to flow from the dilution container to the bulk product vial, wherein in the second position, the valve allows fluid to flow from the bulk product vial to the dispensing manifold assembly, and wherein the peristaltic pump is configured to transfer a predetermined amount of bulk product from the bulk product vial to the at least one final product vial via the dispensing manifold assembly. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. A sterilized kit, comprising:
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one or more sterilized bulk product vials; a sterilized dispensing manifold assembly; a plurality of sterilized final product vials configured to receive a predetermined amount of bulk product from one of the one or more sterilized bulk product vials, wherein the plurality of sterilized final product vials are coupleable to the sterilized dispensing manifold assembly; a sterilized tube element that couples the one or more sterilized bulk product vials to the sterilized dispensing manifold assembly, wherein the sterilized tube element is coupleable with a peristaltic pump; and a sterilized dilution container comprising a dilution solution, wherein the dilution solution is capable of being transferred from the sterilized dilution container to the one or more sterilized bulk product vials through the sterilized tube element. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48)
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49. A closed path vial fill system, comprising:
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a bulk product vial containing a bulk product; a first tube element inserted into a peristaltic pump, wherein the first tube element is coupled with the bulk product vial; a dispensing manifold assembly coupled with the first tube element; at least one final product vial coupled to the dispensing manifold assembly; a valve disposed between the peristaltic pump and the dispensing manifold assembly, the valve having a first position and a second position; and a dilution container having a dilution solution, wherein the dilution container is coupled to the valve, wherein in the first position, the valve is closed to the dispensing manifold assembly and allows fluid to flow from the dilution container to the bulk product vial, wherein in the second position, the valve is closed to the dilution container and allows fluid to flow from the bulk product vial to the dispensing manifold assembly, and wherein the peristaltic pump is configured to transfer a predetermined amount of bulk product from the bulk product vial to the at least one final product vial via the dispensing manifold assembly.
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Specification