METHOD OF FILLING PHARMACEUTICAL CONTAINERS

Abstract

There is described a method of aseptically filling a plurality of nested containers with a pharmaceutical product and applying closures to filled containers in an aseptic environment, said method comprising: removing any coverings from the nested containers and nested closures; locating the uncovered containers laterally adjacent to the closures on a shuttle; moving the uncovered containers and uncovered closures to an aseptic filling zone; transferring the uncovered containers and closures to a multi-nest holder; locating the uncovered containers laterally adjacent to a plurality of closures in the multi-nest holder; filling the containers with a pharmaceutical product; removing a closure from the nest of closures into a closure transfer device; moving the nest of filled containers beneath the closure transfer device; and removing a closure from the closure transfer device into the filled container thereby scaling the filled container.

Claims

1-36. (canceled)

37. A pharmaceutical product filling apparatus wherein the filling apparatus comprises: a transfer chamber for housing a plurality of nested containers and nested closures; a covering removal zone; and an aseptically controlled filling zone; and wherein a rotatable wall separates the transfer chamber and the covering removal zone.

38. A pharmaceutical product filling apparatus according to claim 37, wherein the plurality of nested containers and nested closures are mounted on the movable wall to transfer the plurality of nested containers and nested closures from the covering removal zone to the aseptically controlled filling zone.

39. A pharmaceutical product filling apparatus according to claim 38, comprising tubs for carrying the plurality of nested containers and nested closures, wherein the moveable wall is provided with a means for supporting the tubs.

40. A pharmaceutical product filling apparatus according to claim 39, wherein the means for supporting the tubs are shelving rods.

41. A pharmaceutical product filling apparatus according to claim 39, wherein the moveable wall is provided with a means for supporting tubs on both sides of the wall.

42. A pharmaceutical product filling apparatus according to claim 37, wherein the covering removal zone is generally aseptic.

43. A pharmaceutical product filling apparatus according to claim 39, wherein the covering removal zone is remotely operated or robotically operated.

44. A pharmaceutical product filling apparatus according to claim 42, comprising an aseptic covering removal zone manipulator operable to: pick up a tub of covered nested containers from the wall; and to move the tub to a covering removal apparatus.

45. A pharmaceutical product filling apparatus according to claim 44, wherein the aseptic covering removal zone manipulator is remotely operated or robotically operated.

46. A pharmaceutical product filling apparatus according to claim 37, comprising a pharmaceutical product dispensing system in the aseptically controlled filling zone.

47. A pharmaceutical product filling apparatus according to claim 46, comprising a multi-nest holder for receiving the containers from the tub for filling.

48. A method of aseptically filling a plurality of nested containers comprising the steps of: providing a transfer chamber; moving a plurality of nested containers and nested closures from the transfer chamber into an aseptic covering removal zone by rotating a rotatable wall between the transfer chamber and the aseptic covering removal zone; moving the plurality of nested containers to an aseptically controlled filling zone; and, filling the plurality of nested containers.

49. A method according to claim 48, wherein the plurality of nested containers and nested closures are moved from the transfer chamber into the aseptic covering removal zone by loading the plurality of nested containers and nested closures on the movable wall, such that the movable wall can move the plurality of nested containers from a loading area to a covering removal zone.

50. A method according to claim 49, comprising the step of loading the plurality of nested containers and nested closures onto a tub, and wherein means for supporting the tub is integral to the moveable wall.

51. A method according to claim 50, wherein the moveable wall is provided with means for supporting tubs.

52. A method according to claim 51, wherein the moveable wall is provided with means for supporting tubs on both sides of the wall.

53. A method according to claim 48, wherein the covering removal zone is remotely operated or robotically operated.

54. A method according to claim 53, wherein the aseptic covering removal zone manipulator is operated to: pick up the tub of covered nested containers from the wall; and to move the tub to a covering removal apparatus.

55. A method according to claim 54, wherein the manipulator apparatus is robotically operated.

56. A method of aseptically filling a plurality of nested containers with a pharmaceutical product and applying closures to filled pharmaceutical containers in an aseptically controlled environment, said method comprising: optionally decontaminating the plurality of nested containers and nested closures in a transfer chamber; moving the decontaminated plurality of nested containers and nested closures from the transfer chamber into an aseptic covering removal zone; removing any coverings from the plurality of nested containers and nested closures to provide a plurality of uncovered nested containers and uncovered nested closures; locating the uncovered nested containers laterally adjacent to a plurality of nested closures on a shuttle by use of a manipulator; moving the uncovered nested containers and uncovered nested closures to an aseptically controlled filling zone; transferring the uncovered nested containers and closures to a multi-nest holder attached to a manipulator; locating the uncovered nested containers laterally adjacent to a plurality of nested closures in the multi-nest holder; filling the uncovered nested containers with a pharmaceutical product to provide a nest of filled containers; removing a closure from the nest of closures into a closure transfer device; moving the nest of filled containers beneath the closure transfer device; and removing a closure from the closure transfer device into the filled container thereby sealing the filled container.

Description

[0086] The invention will now be illustrated by way of example only and with reference to the accompanying figures in which:

[0087] FIGS. 1(a) and 1(b) are perspective views of the filling apparatus;

[0088] FIG. 2 is a plan view of the filling apparatus;

[0089] FIGS. 3(a) and 3(b) are perspective views of the filling apparatus with the moveable wall in a partially rotated position;

[0090] FIG. 4 is a plan view of the filling apparatus with the moveable wall in a partially rotated position;

[0091] FIGS. 5(a) and 5(b) are perspective views of the filling apparatus in an aseptic housing;

[0092] FIGS. 6(a) to 6(n) are perspective views of the apparatus in the filling zone, illustrating the stepwise filling process, wherein the nested containers are positioned below the nested closures; and

[0093] FIGS. 7(a) to 7(n) are perspective views of the apparatus in the filling zone, illustrating the stepwise filling process, wherein the nested containers are positioned alongside the nested closures.

[0094] In the figures herein the following numbering has been used: [0095] 1 a filling apparatus [0096] 2 loading zone [0097] 3 covering removal zone [0098] 4 filling zone [0099] 5 wall [0100] 6 shelving rods [0101] 7 tub [0102] 7a uncovered tub [0103] 8 first manipulator [0104] 9 covering removal apparatus [0105] 10 nest of containers [0106] 11 nest of closures [0107] 12 shuttle [0108] 13 spindle [0109] 14 housing [0110] 15 inspection doors

[0111] Referring to FIGS. 1(a), 1(b) and 2; a filling apparatus (1) comprises a loading zone (2), a covering removal zone (3) and a filling zone (4).

[0112] The loading zone (2) includes a rotatably mounted wall (5), wherein the wall (5) is provided with a plurality of shelving rods (6), wherein each pair of shelving rods (6) is capable of supporting a tub (7).

[0113] Each tub (7) will be filled with containers (for filling) or closures (not shown).

[0114] A first manipulator (8), e.g. an articulated robotic arm, collects the tubs (7), moving each tub (7) from the loading zone (2) to the covering removal zone (3).

[0115] In the covering removal zone (3) the first manipulator (8) operates to remove the tub (7) and transfers the tub (7) to a covering removal apparatus (9). The covering removal zone (3) may include means (not shown) for heating the tub (7). In the covering removal zone (3), covering removal apparatus (9) removes any covering from the tub (7), including any liner (not shown) to expose a nest of containers (10) or a nest of closures (11).

[0116] Once uncovered, the first manipulator (8) transfers an uncovered tub (7a) holding a nest of containers (10) or a nest of closures (11) to a shuttle (12), which transfers the uncovered tub (7a) into the filling zone (4).

[0117] Operations in the filling zone (4) are described in more detail below, with reference to FIGS. 6(a) to 6(1).

[0118] Referring to FIGS. 3(a), 3(b) and 4; a filling apparatus (1) comprises a loading zone (2), a covering removal zone (3) and a filling zone (4). A rotatably mounted wall (5) is located around a vertically mounted spindle (13). The rotatable wall (5) is capable of delivering sealed tubs (7) from the loading zone (2) to the covering removal zone (3), such that the filling process may be more of a continuous process rather than a batch process.

[0119] Referring to FIGS. 5(a) and 5(b); a filling apparatus (1) may be located in a housing (14), which includes inspection doors (15a, b and c).

[0120] Referring to FIGS. 6(a) to 6(n) are perspective views of the apparatus in the filling zone, illustrating the stepwise filling process, wherein the nested containers are positioned beneath the nested closures.

[0121] Referring to FIGS. 6(a) to 6(n): [0122] FIG. 6(a) illustrates Step 1: Align caps with cap pushers #1 and #6 (row 1, position 1 and row 1, position 6); [0123] FIG. 6(b) illustrates Step 2: Push caps #1 and #6 into cradle; [0124] FIG. 6(c) illustrates Step 3: Lift cap pushers leaving caps in cradle [0125] FIG. 6(d) illustrates Step 4: Align caps above containers #1 and #6 ( . . . that were filled last cycle); [0126] FIG. 6(e) illustrates Step 5: Simultaneously push caps onto containers, with force reaction support from below, and lift vials being filled out of the nest on weigh cells; [0127] FIG. 6(f) illustrates Step 6: Lift cap pushers and filling needles lower cap supports and weigh cells; [0128] FIG. 6(g) illustrates Step 7: Align cap pushers above caps #2 and #7; [0129] FIG. 6(h) illustrates Step 8: Push caps #2 and #7 into cradle; [0130] FIG. 6(i) illustrates Step 9: Lift cap pushers leaving caps in cradle; [0131] FIG. 6(j) illustrates Step 10: Align caps above vials #2 and #7 ( . . . that were filled last cycle); [0132] FIG. 6(k) illustrates Step 11: Simultaneously push caps onto containers, with force reaction support from below, and lift containers being filled out of the tray on weigh cells; [0133] FIG. 6(l) illustrates Step 12: Lift cap pushers and filling needles lower cap supports and weigh cells; [0134] FIG. 6(m) illustrates Step 13: Align cap pushers above caps #3 and #8; [0135] FIG. 6(n) illustrates a close up view of the nested containers and nested closures.

[0136] Referring to FIGS. 7(a) to 7(n) are perspective views of the apparatus in the filling zone, illustrating the stepwise filling process, analogous to the steps of FIGS. 6(a) to 6(n), wherein the nested containers are positioned alongside the nested closures.