Containers having closed ends, container assemblies and medical devices having such containers
Container assemblies for accommodating pharmaceutical compositions are provided. The container assembly includes a container and a plunger. The container has a hollow cylindrical body with an open end and a closed end, which is closed by a bottom portion. The hollow cylindrical body has a length (L), an outer diameter (DO), and an inner diameter with a length to outer diameter ratio between 3:1 and 15:1. The hollow cylindrical body and the bottom portion are formed integrally and of the same material, which is a glass or polymer material. The container has an inner surface with an average Zn-leachability of 0.00085 μg/cm 2 or less. The plunger is inside the hollow cylindrical body at the open end, is pierceable by a cannula, and is slidable relative to the hollow cylindrical body from the open end towards the closed end.
1. A container assembly for accommodating pharmaceutical compositions, comprising:
a container having a hollow cylindrical body having a constant outer diameter along its length with an open end and a closed end opposite to the open end, the closed end being closed by a bottom portion, the hollow cylindrical body and the bottom portion being formed integrally and of a common material, which is a glass or polymer material, the hollow cylindrical body having a length (L) between 35 mm and 120 mm, an outer diameter (Do) between 8.65 mm and 30 mm, and an inner diameter (Di) between 4.65 mm and 27 mm;
a length to outer diameter ratio between 3:1 and 15:1;
an inner surface of the container having an average Zn-leachability of 0.00135 μg/cm 2 or less; and
a solid plunger having no holes or empty spaces within and having a length, a first surface, a second surface and a perimeter along the length with an outer surface in the open end to sealingly close the inner surface of the open end to define sealed area, wherein the solid plunger is pierceable by a cannula and is slidable on the inner surface from the open end towards the closed end, and wherein the outer surface of the perimeter of the solid plunger completely contacts the inner surface of the hollow cylindrical body.
2. The container assembly of claim 1 , wherein the inner surface of the container has an average Zn-leachability is 0.00085 μg/cm2or less.
3. The container assembly of claim 1 , wherein the inner surface has an average Mg-leachability of 0.04000 μg/cm 2 or less.
4. The container assembly of claim 1 , further comprising a pressure compliance of at least 0.64 N/mm 2 ×(inner diameter) 2 .
5. The container assembly of claim 1 , wherein the common material has a compaction of 200 μm/100 mm or less.
6. The container assembly of claim 1 , wherein the common material is selected from a group consisting of a borosilicate glass, an alumino-silicate glass, a cycloolefin copolymer, and a cycloolefin polymer.
7. A medical device for expelling or injecting pharmaceutical compositions, comprising:
a hollow device body having a cannula;
a container assembly inside the hollow device body, the container assembly comprising:
a container having a hollow cylindrical body having a constant outer diameter along its length with an open end and a closed end opposite to the open end, the closed end being closed by a bottom portion, the hollow cylindrical body and the bottom portion being formed integrally and of a common material, which is a glass or polymer material, the hollow cylindrical body having a length (L) between 35 mm and 120 mm, an outer diameter (Do) between 8.65 mm and 30 mm, and an inner diameter (Di) between 4.65 mm and 27 mm;
a length to outer diameter ratio between 3:1 and 15:1;
an inner surface of the container having an average Zn-leachability of 0.00135 μg/cm 2 or less; and
a solid plunger having no holes or empty spaces within and having a length, a first surface, a second surface and a perimeter along the length with an outer surface in the open end to sealingly close the inner surface of the open end to define a sealed area, wherein the solid plunger is slidable on the inner surface from the open end towards the closed end, and wherein the outer surface of the perimeter of the solid plunger completely contacts the inner surface of the hollow cylindrical body; and
an actuation mechanism that moves the container and the solid plunger relative to each other and relative to the cannula in a substantially axial direction inside the hollow device body, the container assembly being arranged in the hollow device body so that the cannula pierces the solid plunger into the sealed area upon movement by the actuation mechanism and applies pressure to the sealed area.
8. The medical device of claim 7 , further comprising a pharmaceutical composition in the sealed area.
9. The medical device of claim 7 , wherein the common material has a compaction of 200 μm/100 mm or less.
10. The medical device of claim 7 , wherein the common material is selected from a group consisting of a borosilicate glass, an alumino-silicate glass, a cycloolefin copolymer, and a cycloolefin polymer.
11. The medical device of claim 7 , wherein the solid plunger comprises a rubber material having a Zn-leachability of 0.00800 μg/cm 2 or less.
12. The medical device of claim 7 , wherein the container has an inner surface that has an average Zn-leachability is 0.00085 μg/cm 2 or less.
13. The medical device of claim 7 , wherein the container has and inner surface that has an average Zn-leachability is 0.00055 μg/cm 2 or less.
14. The medical device of claim 7 , wherein the inner surface has an average Mg-leachability of 0.04000 μg/cm 2 or less.
15. The medical device of claim 7 , further comprising a pressure compliance of at least 0.64 N/mm 2 ×(inner diameter) 2 .
16. The medical device of claim 7 , wherein the length to outer diameter ratio is between 6:1 and 7:1.1.