TRANSPORTABLE CLEAN ROOM, METHOD FOR PRODUCING A TRANSPORTABLE CLEAN ROOM, AND METHOD FOR FILLING A MEDICINE CONTAINER IN A TRANSPORTABLE CLEAN ROOM

Abstract

The invention relates to a portable clean room for filling at least one medicine container, located in the clean room with at least one active substance, wherein: the clean room is enclosed in an airtight manner by an at least partially flexible shell, the shell has at least one active substance connection region which can be opened, and a manipulation device and at least one medicine container are located in the clean room. According to the invention, the shell has at least one actuation connection region, wherein the manipulation device has at least one filling device which can be coupled to the active substance connection region for introducing at least one active substance into the at least one medicine container arranged in the clean room, and the manipulation device can be actuated by means of an actuation device via the actuation connection region of the shell, and is designed to displace the filling devicerelative to the at least one medicine containerand/or to actuate the filling device.

Claims

1.-15. (canceled)

16. A clean room for filling at least one medicine container located in the clean room with at least one active substance, the clean room comprising: a shell for airtightly enclosing the clean room, the shell being at least partially flexible and having at least one active substance connection region which is openable and at least one actuation connection region; a manipulation device having at least one filling device coupleable to the at least one active substance connection region for introducing the at least one active substance into the at least one medicine container arranged in the clean room, and the manipulation device; and an actuation device for actuating the manipulation device via the at least one actuating connection region of the shell, the actuation device operable to displace at least one filling device relative to the at least one medicine container, actuate the at least one filling device, or both displace the at least one filling device and actuate the at least one filling device, wherein the clean room is a transportable clean room.

17. The clean room according to claim 16, wherein the manipulation device has at least one closing device for closing the at least one medicine container with at least one closure arranged in the clean room and for moving the at least one closing device relative to the at least one medicine container and/or for actuating the at least one closing device.

18. The clean room according to claim 17, further comprising a provision device arranged in the clean room, the provision device set up around the at least one medicine container for filling the at least one filling device and/or for closing with the at least one closure, and/or to provide the at least one closure for closing with the at least one closing device.

19. The clean room according claim 16, wherein the shell, in a first functional state of the clean room, encloses a first volume in an airtight manner, wherein, in a second functional state of the clean room, the shell encloses a second volume in an airtight manner, the second volume being larger than the first volume to accommodate filling of the at least one medicine container by the at least one filling device within the clean room.

20. The clean room according to claim 16, wherein the shell has at least one air connection region.

21. The clean room according to claim 20, wherein the at least one air connection region is selected from region selected from the group consisting of an openable region, a closable sterile air connection region and a combination thereof.

22. The clean room according to claim 16, wherein the shell is at least partially transparent.

23. The clean room according to claim 16, wherein the shell has at least one manually operable intervention device.

24. The clean room according to claim 23, wherein the at least one manually operable intervention device is an intervention glove.

25. The clean room according to claim 16, further comprising a drive device assigned to a supply device in the clean room, wherein the drive device is connectable with the supply device.

26. The clean room according to claim 25, wherein the drive device is connected to the supply device by a conduit formed on the shell.

27. The clean room according to claim 16, wherein the shell has at least one fastening element on an outside of the clean room and/or at least one clamping element in an interior of the clean room for clamping the shell.

28. A method for producing a transportable clean room comprising: providing at least one flexible shell element; arranging at least one active substance connection region on the at least one flexible shell element; arranging at least one actuation connection region on the at least one flexible shell element; arranging at least one medicine container, a manipulation device having a filling device and at least one closure for the at least one medicine container on the at least one flexible shell element, and airtightly enclosing the at least one medicine container, the manipulation device, the filling device and the closure with the at least one flexible shell element, so that a shell is formed which encloses the at least one medicine container, the manipulation device, the filling device and the closure airtight.

29. The method according to claim 28, further comprising applying a negative pressure to an interior of the shell to collapse the shell.

30. The method according to claim 28, further comprising sterilizing the clean room with superheated steam and/or a protective gas and/or by means of electromagnetic radiation and/or particle radiation.

31. A method for filling a medicine container in the clean room according to claim 16, the method comprising: bringing the shell of the clean room into an expanded position with a gaseous medium introduced into an interior of the clean room; connecting at least one active substance supply to the active substance connection region; connecting an actuating device to the actuating connection region; opening the active substance connection region; introducing an active ingredient into the medicine container by actuating a filling device; opening the clean room by opening the shell; and removing the medicine container.

32. The method according to claim 31, wherein the at least one medicine container is closed with a closure before the shell of the clean room is opened.

33. The method according to claim 31, further comprising connecting an air supply to an air connection region of the clean room.

34. The method according to claim 33, wherein the air connection region of the clean room is a sterile air connection region of the clean room.

Description

[0053] The invention will be explained in more detail below with reference to the drawing. The single FIGURE shows a schematic cross-sectional view of a transportable clean room according to an embodiment.

[0054] The single FIGURE shows a cross-sectional view of a transportable clean room 1, which is enclosed airtightly by a shell 3. The shell 3 is at least partially flexible. For the most part, the shell 3 is preferably flexible and preferably transparent.

[0055] In addition, the shell 3 has an openable active substance connection region 5 and an air connection region 7. A plurality of medicine containers 9 are arranged in the clean room 1, of which only one is provided with a reference symbol here for the sake of clarity. In addition, a manipulation device 11 is arranged in the clean room 1, which has a filling device 13 and a closing device 15. The filling device 13 is coupled to the active substance connection region 5, in particular connected to it in terms of flow technology by means of a hose 17. In the exemplary embodiment shown here, the filling device 13 also has a filling needle 19, by means of which the active substance can be introduced into the medicine container 9.

[0056] The closing device 15 is designed as a plug setting pin 21. The stopper pin 21 has a sleeve which can be inserted into the medicine container 9 and which is designed to receive an elastically compressible closure, in particular a stopper. The closing device 15 also has a retaining device for the stopper received in the sleeve. After insertion of the sleeve, which has received the stopper, into the medicine container 9, the stopper is held upward in the sleeve by the retaining device. By means of a relative displacement between the sleeve and the retaining device, the stopper can be removed from the sleeve and inserted into the medicine container 9, where it adheres due to its elasticity and closes the medicine container 9. During the relative displacement between the sleeve and the retaining device, the retaining device is preferably held stationary with respect to the medicine container 9 and the sleeve is led out of the medicament container 9, that is to say shifted upward in FIG. 1.

[0057] The shell 3 also has an actuation connection region 23, in particular a robot connection region, here in particular a robot flange. The filling device 13 and the closing device 15 can be actuated by means of an external actuating device 25, here in particular an external robot, which is connected, in particular flanged, to the actuating connection region 23 from the outside such that an active substance flow through the filling device 13 controls, in particular starts and stops, and the medicine container 9 can be closed by means of the closing device 15. In addition, the manipulation device 11 is set up to displace the filling device 13 and the closing device 15. In the exemplary embodiment shown here, the manipulation device 11 is displaced by means of the actuation device 25, the filling device 13 and the closing device 15 here being connected in a stationary manner to the manipulation device 11, and the manipulation device 11 being connected in a stationary manner to the actuation connection region 23. Thus, the filling device 13, the closing device 15, the manipulation device 11 and the actuation connection region 23 can be displaced together by means of the actuation device 25. The shell 3 is particularly flexible in the area around the actuation connection region 23. This ensures at least one displacement of the filling device 13 and the closing device 15 necessary for filling and closing the medicine container 9.

[0058] The clean room 1 also has a supply device 27 which provides the medication containers 9 and a plurality of closures 29 assigned to the medication containers 9, only one of which is provided with a reference number here. The closures 29, here in particular stoppers, are arranged in a closure matrix 31, here in a stopper matrix, preferably prepared. The medicine containers 9 are arranged in a tub 33, an opening 35 of the respective medicament container 9 facing the respectively associated closure 29 and/or the filling device 13 and/or being oriented upwards. The supply device 27 also has a plate system 37. The tub 33 with the medicine containers 9 is arranged on a lower plate 39, and the closure matrix 31 with the closures 29 arranged therein is arranged on an upper plate 41. The upper plate 41 and the lower plate 39 are rotatably mounted independently of one another about a preferably common axis A.

[0059] A drive device 43 is assigned to the supply device 27, the drive device 43 of the exemplary embodiment shown in FIG. 1 being designed as a servo drive. The drive device 43 is operatively connected to the supply device 27, in particular to the plate system 37 of the supply device 27, by means of a hollow shaft 45. Thus, the two plates 39, 41 of the supply device 27, that is to say the lower plate 39 and the upper plate 41, can be rotated about the axis A independently of one another by means of the hollow shaft 45 and a further shaft mounted therein. In addition, the drive device 43 is preferably set up to raise and lower the plates 39, 41 of the plate system 37 independently of one another.

[0060] The upper plate 41 preferably has for each closure matrix 31 one or a total of exactly one empty matrix, as seen in the circumferential direction, from the closure matrix 31, which, for example, can be spaced apart from the closure matrix 31 by 90 or 180 of the circumference of the upper plate 41. The empty matrix is preferably characterized by a number of openings in which no stoppers are arranged and through which the filling needle 19 can reach. The closures 29 and/or the openings of the empty matrix are preferably arranged exactly in a grid which corresponds to the grid in which the medicine containers 9 are arranged in the tub 33. Accordingly, if the closures 29 arranged in this grid are positioned above the medicine container 9, the closures 29 can be easily displaced through the closure device 15 into the medicine containers 9.

[0061] If, on the other hand, the empty matrix with the corresponding grid of openings is arranged above the medicine containers 9, the filling needle 19 can reach through the openings and fill the medicine containers 9 with the active substance.

[0062] Of course, it is also possible that instead of an empty matrix, a large opening, which in particular corresponds approximately to the areal extent of the tub 33, is arranged in the upper plate 41, or that the plate 41 is cut out in a suitable manner for filling the medicine containers 9.

[0063] The shell 3 of the clean room 1 also comprises a manually operable intervention device 47, here in particular an intervention glove. By means of this intervention device 47, it is possible to manually intervene in a filling process and/or to set up the manipulation device 11 and the supply device 27 in preparation for the filling process.

[0064] The shell 3 has on its outside a plurality of fastening elements 49, here in particular six fastening elements 49, for tensioning the shell 3. The fastening elements 49 in the exemplary embodiment shown here are designed as eyelets 51, which cooperate with hooks 55 fastened to a table 53 or to an external support structure (not shown here) in order to open the shell 3. For the sake of clarity, only one fastening element 49, one eyelet 51 and one hook 55 are provided with a reference symbol in FIG. 1.

[0065] Alternatively or additionally, the clean room 1 can also have an inner support structure arranged in the casing 3, by means of which it can be brought into the expanded functional state shown in the FIGURE and kept in this state, this expanded functional state also being referred to as the second functional state.

[0066] The clean room 1 can be evacuated via the air connection region 7, so that the shell 3 has a first, collapsed functional state. Accordingly, the shell 3 encloses a smaller volume than in the second functional state. A gas, in particular sterile air, can also be introduced into the shell 3 via the air connection region in order to bring it from the first functional state into the expanded second functional state. In the second functional state, the shell 3 can be kept under overpressure or under underpressure relative to an exterior.

[0067] The clean room 1 is preferably produced by providing at least one flexible shell element. The at least one active substance connection region 5 is then arranged on the shell element, and the at least one actuation connection region 23, in particular robot connection region, is arranged on the shell element. At least one medicine container, in particular a plurality of medicine containers 9, the manipulation device 11 with the filling device 13 and preferably at least one closure 29 for the at least one medicine container 9 are arranged on the at least one shell element. Then the at least one medicine container 9, the manipulation device 11, the filling device 13 and preferably the closure 29 are enclosed in an airtight manner with the at least one shell element, so that the shell 3 is formed which contains the medicine container 9, the manipulation device 11, the filling device 13, and preferably encloses at least one closure 29 airtightly.

[0068] The clean room 1 is preferably sterilized by means of superheated steam, a protective gas, electromagnetic radiation, and/or particle radiation, in particular electron radiation.

[0069] The medicine container 9 is filled in the clean room 1 by preferably first bringing the shell 3 into its expanded position, at least one active substance supply being connected to the active substance connection region 5, and the actuating device 25, in particular the robot, to the actuation connection region 23, in particular the robot connection region. If the filling device 13 is not already coupled to the active substance connection region 5, it is now coupled to the latter. The active substance connection region is then opened and at least one active substance is introduced into the medicine container 9 by actuating the filling device 13. The medicine container 9 is then preferably closed with a closure 29. If the medicine containers 9 are filled and closed, the clean room 1 is opened by opening the shell 3 and the at least one filled medicine container 9 is removed.

[0070] An air supply, in particular a sterile air supply, is preferably connected to the air connection region 7.

[0071] Overall, it can be seen that with the transportable clean room 1 shown here, at least one, in particular several, medicine containers 9 can be filled with an active ingredient in a particularly effective and cost-effective manner. The storage of such clean rooms 1 is also inexpensive and space-saving, especially if they are in their first functional state. In addition, the risk of contamination of the clean room 1 is reduced. With the clean room 1 proposed here, medicine containers 9 can also be filled in an environment which otherwise has insufficient sterility for filling medication containers 9. The clean room 1 can be used in particular for the production of small doses of active substances, for example for individual medicine, but can also be used for example in crisis regions for the rapid local provision of active substances, for example antidotes or vaccines.