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 peristaltic pump coupled with the bulk product vial;
a dispensing manifold assembly coupled with the peristaltic pump; and
at least one final product vial coupled to the dispensing manifold assembly,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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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 peristaltic pump coupled with the bulk product vial; a dispensing manifold assembly coupled with the peristaltic pump; and at least one final product vial coupled to the dispensing manifold assembly, 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)
wherein each of the plurality of valves are configured to divert fluid flowing through the dispensing manifold assembly toward one of the plurality of dispensing ports.
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10. The system of claim 1, further comprising:
an antimicrobial filter disposed upstream of the at least one final product vial.
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11. The system of claim 10, further comprising:
a filter integrity system, the filter integrity system comprising; a pressurized gas line disposed downstream of the antimicrobial filter; and a diverter valve disposed downstream of the antimicrobial filter and coupled with the pressurized gas line, wherein the diverter valve is configured to divert pressurized gas from the pressurized gas line toward the antimicrobial filter.
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12. The system of claim 11, wherein the filter integrity system further comprises a pressure sensor configured to record a pressure on a downstream side of the antimicrobial filter.
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13. The system of claim 11, wherein the filter integrity system further comprises a gas flow detector element disposed on an upstream side of the antimicrobial filter.
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14. The system of claim 1, further comprising:
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at least one vial cap coupled to the at least one final product vial, wherein the at least one vial cap is configured to provide a sealed disconnect between the at least one final product vial and the dispensing manifold assembly.
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15. The system of claim 1, further comprising:
a quality check station disposed on a downstream distal end of the dispensing manifold assembly configured to receive fluid flowing through the dispensing manifold assembly.
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16. The system of claim 1, wherein one of the at least one final product vial contains a growth medium.
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17. The system of claim 16, wherein the final product vial containing the growth medium is in fluid communication with a high performance liquid chromatography (HPLC) load loop.
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18. The system of claim 1, further comprising:
a waste collection system coupled to a downstream distal end of the dispensing manifold assembly.
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19. The system of claim 14,
wherein the at least one final product vial comprises an elastomeric septum and the at least one vial cap comprises a spike; - and
wherein inserting the spike into the elastomeric septum establishes fluid communication between the at least one final product vial and the dispensing manifold assembly.
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20. The system of claim 1, wherein the dispensing manifold assembly comprises a frame configured to support a plurality of rows of the least one final product vial.
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21. The system of claim 20, further comprising a vial bracket attached to the frame and configured to mount the bulk product vial.
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22. The system of claim 21, wherein the vial bracket comprises an orienting feature to seat the bulk vial product at an angle.
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23. The system of claim 21, further comprising:
a precision scale coupled with the vial bracket.
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24. The system of claim 1, further comprising:
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a concentration, activity, and volume (CAV) container; and a CAV sensor configured to detect radionuclide content in the CAV container, wherein the CAV container is in fluid communication with the bulk product vial via the dispensing manifold assembly.
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25. A sterilized kit, comprising:
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one or more sterilized bulk product vials; a plurality of sterilized manifold tubes; and one or more sterilized final product vials, wherein the plurality of manifold tubes are coupleable with a peristaltic pump, wherein the one or more final product vials are coupleable with the manifold tubes, and wherein the manifold tubes are capable of is transferring a predetermined amount of bulk product from the one or more bulk product vials to the one or more final product vials. - 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, 49)
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Specification