IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
US-0597456
(2005-08-30)
|
등록번호 |
US-7504646
(2009-03-17)
|
국제출원번호 |
PCT/US05/030796
(2005-08-30)
|
§371/§102 date |
20070117
(20070117)
|
국제공개번호 |
WO06/026603
(2006-03-09)
|
발명자
/ 주소 |
- Balestracci,Ernest
- Melchore, Jr.,James A.
- Monteferrante,Jo Anna
- Ropiak,Irene Kucharewicz
- Schramm,Ernst
- Zodda,Julius P.
- Quirico,Charles
|
출원인 / 주소 |
|
대리인 / 주소 |
Fredrickson & Byron, P.A.
|
인용정보 |
피인용 횟수 :
26 인용 특허 :
32 |
초록
▼
The invention is directed to improved containers for pharmaceuticals and any tubing and tubing connectors associated therewith, particularly containers for pharmaceuticals which are irradiated, heated or otherwise subjected to increased pressure. In a preferred embodiment, the invention is directed
The invention is directed to improved containers for pharmaceuticals and any tubing and tubing connectors associated therewith, particularly containers for pharmaceuticals which are irradiated, heated or otherwise subjected to increased pressure. In a preferred embodiment, the invention is directed to an improved container for use in a radioisotope generator, such as a rubidium-82 generator.
대표청구항
▼
What is claimed is: 1. An improved pharmaceutical container for containing a pharmaceutical agent which is heated, subjected to increased pressure or radioactive, comprising: a. an inlet arm, b. an inlet arm support, c. a hollow column, d. an outlet arm, and e. an outlet arm support, wherein the o
What is claimed is: 1. An improved pharmaceutical container for containing a pharmaceutical agent which is heated, subjected to increased pressure or radioactive, comprising: a. an inlet arm, b. an inlet arm support, c. a hollow column, d. an outlet arm, and e. an outlet arm support, wherein the outlet arm does not protrude into the hollow portion of the column and a notch is provided in the hollow column at the point where the outlet arm intersects the hollow column. 2. The improved pharmaceutical container of claim 1, wherein the container is constructed of a material which is resistant to radiation. 3. The improved pharmaceutical container of claim 1 or 2, wherein the container is constructed of a radiation resistant polypropylene. 4. The improved pharmaceutical container of claim 1 or 2, wherein the container is constructed of PP 13R9A polypropylene. 5. The improved pharmaceutical container of claim 1 or 2, further comprising a basket receptacle area inside the column for receiving a basket where the inlet arm intersects the column, said basket receptacle area further comprising one or more notches, said notches configured to cooperate with one or more protrusions on a basket to be inserted into the basket receptacle area in such a way so as to insure that the basket is properly seated in the basket receptacle area. 6. The improved pharmaceutical container of claim 1 or 2, further comprising two stoppers which form tight seals with and prevent leakage from an open top end and an open bottom end of the column, wherein said stoppers are made of a material which is resistant to radiation, optionally further comprising a packing material which optionally contains a pharmaceutical agent. 7. The improved pharmaceutical container of claim 1, further comprising two stoppers which form tight seals with and prevent leakage from an open top end and an open bottom end of the column, the stoppers being made of a material which is resistant to radiation; and, optionally further comprising a packing material which optionally contains a pharmaceutical agent; wherein the bottom stopper takes up substantially all of the space at the open bottom end of the column, without blocking the outlet arm, so as to reduce the amount of the dead volume at the bottom of the column. 8. The improved pharmaceutical container of claim 1, 2 or 7, further comprising two stoppers which form tight seals with and prevent leakage from an open top end and an open bottom end of the column, the stoppers being made of a material which is resistant to radiation; and, optionally further comprising a packing material which optionally contains a pharmaceutical agent; wherein said stoppers are made of a material selected from the group consisting of isoprene/chlorobutyl, bromobutyl and FM 140/0. 9. The improved pharmaceutical container of claim 2 or 7, further comprising two stoppers which form tight seals with and prevent leakage from an open top end and an open bottom end of the column, the stoppers being made of a material which is resistant to radiation; and, optionally further comprising a packing material which optionally contains a pharmaceutical agent; wherein said stoppers are made of isoprene/chlorobutyl. 10. The improved pharmaceutical container of claim 1, 2 or 7, further comprising two stoppers which form tight seals with and prevent leakage from an open top end and an open bottom end of the column, the stoppers being made of a material which is resistant to radiation; and, optionally further comprising a packing material which optionally contains a pharmaceutical agent; wherein each of said stoppers comprises a top cylindrical portion and a bottom cylindrical portion, said bottom cylindrical portion having a diameter sufficient to insure a tight seal between the stopper and the cylinder interface, and said top cylindrical portion having a diameter greater than the bottom cylindrical portion. 11. The improved pharmaceutical container of claim 10, wherein the bottom cylindrical portion contains a U-shaped channel at its base. 12. The improved pharmaceutical container of claim 11, wherein the top cylindrical portion has indicia disposed on its surface, said indicia disposed so that it indicates the direction of the open end of the U-shaped channel. 13. The improved pharmaceutical container of claim 6, further comprising a centrally located indentation at a top end of each of the stoppers. 14. The improved pharmaceutical container of claim 6, wherein the stoppers are held in place by crimping a crimp seal around the stoppers to affix them to the container. 15. The improved pharmaceutical container of claim 14, wherein the crimping is performed with an automatic or semi-automatic crimper. 16. The improved pharmaceutical container of claim 15, wherein the automatic crimper is a pneumatic crimper. 17. The improved pharmaceutical container of claim 14, wherein the crimp seal is crimped at a pressure of about 60-140 psi. 18. The improved pharmaceutical container of claim 14, wherein the crimp seal is constructed of a material which is resistant to radiation. 19. The improved pharmaceutical container of claim 14, wherein the crimp seal is constructed of a material selected from the group consisting of aluminum, steel and tin. 20. The improved pharmaceutical container of claim 14, wherein the crimped stopper is able to withstand a pressure of between 90 psi and 200 psi inside the sealed container. 21. The improved pharmaceutical container of claim 14, wherein the crimp seal is made of aluminum and comprises a top crimp member and a bottom washer. 22. The improved pharmaceutical container of claim 14, wherein the crimp seal is made of steel and comprises a single crimp seal member. 23. The improved pharmaceutical container of claim 21, wherein the top crimp member comprises a generally circular surface with a central hole and a skirt, and the bottom washer comprises a generally circular surface with a central hole. 24. The improved pharmaceutical container of claim 22, wherein the crimp seal member comprises a generally circular surface with a central hole and a skirt. 25. The improved pharmaceutical container of claim 23, wherein the top crimp member further comprises an insert, said insert being seated in or under the central hole, and further wherein said insert contains a central hole whose diameter is less than the diameter of the central hole in the top crimp member. 26. The improved pharmaceutical container of claim 14, wherein said crimp seal comprises a single crimp seal member made of steel with a generally circular surface having a diameter of about 20.75 mm��0.25 mm and a skirt with a height of about 7.00 mm��0.25 mm, and wherein said generally circular surface has a central hole with a diameter of about 5.00 mm��0.25 mm. 27. The improved pharmaceutical container of claim 24, further comprising a removable cover which covers the central hole in the top crimp member. 28. The improved pharmaceutical container of claim 1, for generating rubidium-82. 29. The improved pharmaceutical container of claim 1, further comprising a first connector tube which attaches to the inlet arm via a Luer lock, and a second connector tube which attaches to the outlet arm via a Luer lock, wherein a portion of each Luer lock is affixed to each of the connector tubes and another portion of the Luer locks is affixed to each of the inlet arm and outlet arm. 30. The improved pharmaceutical container of claim 29, wherein the connector tubes and the Luer lock portions attached to the connector tubes are made of materials which are resistant to radiation. 31. The improved pharmaceutical container of claim 29 or 30, wherein the connector tubes are made of a flexible, radiation resistant polyvinyl chloride and the Luer lock portions attached to the connector tubes are made of a rigid, radiation resistant polyvinyl chloride. 32. The improved pharmaceutical container of claim 29 or 30, wherein the connector tubes are made of PVC 2232 A/R-78S clear 030X and the Luer lock portions attached to the connector tubes are made of PVC 2212 RHT/1-118 clear 080X. 33. The improved pharmaceutical container of claim 1, which is shipped or packed in with an absorbent material. 34. The improved pharmaceutical container of claim 33, wherein the absorbent material is GP-100.
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