JP2004065967A - Apparatus for treating container for pharmaceutical, in particular vial, ampul or the like - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an apparatus having a pneumatically operating sealing device which is improved compared to a conventional type apparatus and can prevent the inside of a casing from contamination when a seal is broken. <P>SOLUTION: Second sealing elements 30, 30a and 30b having annular structures are arranged on the side adjacent to the inside 16 of the casing. When a first sealing element 20 is broken, the second sealing elements 30, 30a and 30b work as a preventive device to prevent the penetration of contaminants into the inside 16 of the casing. <P>COPYRIGHT: (C)2004,JPO

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to an apparatus for treating pharmaceutical containers, in particular vials, ampoules, etc., provided with a casing which is tightly closed to the surroundings except for the area for loading and unloading the containers. An opening is provided in the casing wall, the casing wall is tightly closed by a closing element, in particular a window or a door, which is removably connected to the casing wall; A sealing device which is operated in a matic manner is provided, the sealing device having a first sealing element formed under pressure and having an annular shape, wherein the first sealing element comprises a casing. Of the type arranged between the wall and the closure element.
[0002]
[Prior art]
Such devices are commonly referred to in the pharmaceutical industry as isolators. What is characteristic of such isolators is that such isolators have a closed casing with respect to the surroundings, the casing being open or closed only in the area for loading and unloading pharmaceutical containers. That is, there is no penetrating portion. Inside the isolator, the pharmaceutical container is sterilized, filled and closed. In order to avoid contamination of the interior of the casing with ambient air, especially in the region of the opening, intentional air guidance is provided inside the casing. In order to obtain access to the interior of the casing, in particular in the area of the processing station, the known casing of the isolator furthermore has a number of openings, for example in the form of windows or doors. These openings are detachably or pivotably connected to respective casing walls of the isolator. In order to make the area of the opening in the casing wall airtight, an inflatable seal must generally be provided to seal the gap between the casing wall and the window or door. A disadvantage in this case is that the relatively high internal pressure of the inflatable seal (typically about 0.5 bar to 6 bar) causes unsterilized air and sterile air from the seal upon damage to the seal. It is possible that uncleaned particles can enter the casing interior to be protected. Although the failure of the seal can be detected by the pressure monitor of the inflatable seal, the contamination of the casing interior cannot itself be prevented. This interrupts the aseptic filling or packaging process, which can result in significant financial damage. This is because the filled and packaged product must be discarded in some situations, which can result in a relatively long downtime of the device.
[0003]
[Problems to be solved by the invention]
It is therefore an object of the present invention to provide a device of the type mentioned at the outset with a pneumatically operated sealing device in which the interior of the casing is not contaminated in the event of a seal failure. .
[0004]
[Means for Solving the Problems]
In order to solve this problem, in the configuration of the present invention, a second sealing element formed in an annular shape is disposed on the side closer to the inside of the casing, and the second sealing element is provided with the first sealing element. In the event of a failure, a protection device is provided to prevent intrusion of contaminants into the interior of the casing.
[0005]
【The invention's effect】
The basic principle of the invention is that, in addition to the sealing device which is operated in a pneumatic manner, an additional sealing element is provided, namely an additional sealing element which is arranged on the side closer to the inside of the casing. An element is to provide an additional sealing element which acts as a protection against possible contamination in the event of damage of said pneumatically operated sealing device.
[0006]
Advantageous embodiments of the device according to the invention, in particular for processing pharmaceutical containers such as vials, ampoules and the like, are specified in the dependent claims.
[0007]
In order to protect the first sealing element from outside manual intervention or damage and to enable a predetermined guidance of the first sealing element, in an advantageous embodiment, the first sealing element It is contemplated to form an annular seal frame with a notch.
[0008]
The opening in the casing wall is formed as follows, ie the second sealing element is arranged inside the first sealing element and is brought into direct contact between the casing wall and the closing element If this is the case, a particularly simple installation of the second sealing element without additional components can be obtained.
[0009]
If it is desired to provide as small a thickness as possible or to provide a closing element which closes without protruding as far as possible from the housing wall, another embodiment provides a frame-shaped support on the housing inner wall on the side opposite the sealing frame. It is considered to be arranged in.
[0010]
It is advantageous if a hollow space is formed between the two sealing frames so that the hollow space can be evacuated via a vacuum device. This allows, for one thing, the direct picking up of contaminants which may occur in the event of a sealing device failure, thereby increasing the process reliability or the leakage in the pneumatically operated sealing device. Can be detected, so that a corresponding signal can be generated in the control device of the device.
[0011]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.
[0012]
In the figures, the openings in the casing wall 12 are respectively indicated by the reference numeral 11. Casing wall 12 is a component of casing 13, which is a component of a device (not shown in detail) for processing pharmaceutical containers such as vials, ampoules and the like. Such a device is commonly referred to as an isolator, a feature of which is to remove contamination of the casing interior by ambient air, except for openings in the area where the pharmaceutical container is introduced and discharged. Is that no opening is provided.
[0013]
According to FIG. 1, the opening 11 is formed as a square opening with rounded corners, but may have another contour. This opening 11 is closed by a closing element, in the embodiment shown by a window 15, wherein the outer contour of the window 15 completely covers the contour of the opening 11, ie the window 15 completely covers the opening 11. Is covered. In the embodiment shown, the window 15 is arranged on the outer surface of the casing wall 12, so that the casing wall 12 separates the casing interior 16 of the isolator from the circumference indicated by the reference numeral 17.
[0014]
It is conceivable that the window 15 is removably arranged on the housing wall 12, so that after the window 15 has been removed, access to the casing interior 16 is obtained in the area of the window 15. For this purpose, it is further conceivable to couple the window 15 to the casing wall 12 by means of a hinge element (not shown which is not essential to the invention) or the like.
[0015]
In order to form a tight connection between the casing wall 12 and the window 15 so that the ingress of contaminants into the casing interior 16 can be avoided, the area between the casing wall 12 and the window 15 , A first seal 20. According to FIG. 1, this first seal 20 is designed as an inflatable seal, which has a rectangular cross section with a hollow interior space 21. Inflation of the first seal 20 occurs via a connection coupled to a positive pressure source. This connection is not shown for convenience and is not essential to the invention. The seal 20 is formed as an annular seal. That is, the seal 20 has a closed contour. The contour of the seal 20 is adapted to the contour of the opening 11 in the casing wall 12 such that the inner circumference of the seal 20 is larger than the inner circumference of the opening 11. Thus, an annular casing edge 22 is left between the first seal 20 and the opening 11.
[0016]
The first seal 20 is partially surrounded by a seal frame 25. This seal frame 25 is also a component of the window 15. The seal frame 25 has an L-shaped notch 26 on the side facing the first seal 20 to accommodate the first seal 20. The first seal 20 is in contact with the casing wall 12 via a predetermined section 27.
[0017]
In order to avoid the possibility that a medium (air or gas) existing in the internal space 21 of the first seal 20 may enter the casing inner space 16 when the first seal 20 is damaged, the second seal 20 may be used. A seal 30 is provided. This second seal 30 acts as a barrier when the first seal 20 fails. According to the first embodiment shown in FIGS. 1 and 2, the second seal 30 is formed as a flat seal and directly fits into the contour of the opening 11 of the casing wall 12 on the side facing the window 15. It is arranged in a way. The arrangement of the second seal 30 therefore takes place in the region of the casing edge 22. The second seal 30 is formed so as to seal an intermediate space between the casing wall 12 and the window 15. Thus, in the event of a possible failure of the first seal 20, for example, air or gas from the first seal 20 may cause the first seal 20 and the second seal 30 in the region of the casing rim 22 to communicate with each other. It is possible for the air or gas to enter the interior casing 16, although it is possible to enter a space without a seal between them.
[0018]
In the second embodiment of the present invention shown in FIG. 3, a blind hole 31 is formed in a seal frame 25a, and this blind hole 31 is connected to a negative pressure source (not shown) through a lateral hole 32 and an adapter 33. 1 and 2 is different from the first embodiment shown in FIGS. Furthermore, two holes 34, 35 are formed in the casing wall 12a, in which case the first hole 34 is aligned with the blind hole 31 and the second hole 35 is in the section 27, It is arranged between the first seal 20 and the second seal 30. A hollow space 37 is formed by the seals 20 and 30, the casing wall 12 a, and the inner surface 36 of the window 15. The hollow chamber 37 can be evacuated by a negative pressure source (not shown) through a second hole 35, a suction tube 38 connecting the holes 34, 35, and an adapter.
[0019]
The second embodiment of the invention described thus far has the advantage that the outflowing gas or outflow air is sucked out of the cavity 37 during a pressure loss in the first seal 20. Furthermore, damage to the first seal 20 can be detected by a suitable monitoring device of the cavity 37. Thereby, in some cases, the corresponding fault signal may be further transmitted to the control device of the isolator.
[0020]
The third embodiment of the invention shown in FIG. 4 is that a second seal 30a formed as a molded seal is used instead of the second seal 30 formed as a flat seal. 3 is different from the second embodiment shown in FIG. This seal 30a formally engages the housing wall 12a in the area of the opening 11 by means of a U-shaped retaining section 41 and has a sealing lip 42. This sealing lip 42 is in close contact with the inner surface 36 of the window 15. Also in the third embodiment, since the hollow chamber 37a can be evacuated by a negative pressure source (not shown), the negative pressure in the hollow chamber 37a increases the contact of the seal lip 42 with the inner surface 36 of the window 15. Can be Thereby, a reliable seal can be obtained.
[0021]
The fourth embodiment shown in FIG. 5 differs from the second embodiment shown in FIG. 3 in that an additional sealing frame 44 arranged on the inner surface of the casing wall 12b is used. I have. This sealing frame 44 substantially replaces the suction tube 38 and has a blind hole 45 closed for this purpose. In the blind hole 45, a first horizontal hole 46 is opened in the region of the blind hole 31 of the seal frame 25b. A second horizontal hole 47 opening into the hollow chamber 37 b is formed in a section 48 located inside the seal frame 44. This section 48 protrudes into the opening 11 of the casing wall 12b and further supports a second seal 30b in the form of a flat seal.
[0022]
The fifth embodiment shown in FIG. 6 differs from the embodiment shown in FIG. 5 in that an integral seal frame 50 is used instead of the two seal frames 25b and 44 shown in FIG. Are substantially different. The sealing frame 50 is arranged on the outer surface of the casing wall 12b, and the section 51 of the sealing frame 50 protrudes into the opening 11 of the casing wall 12b. Further, the first seal 20 is surrounded by a U-shaped notch 26a. A closed blind hole 52 extends between the housing wall 12b and the first seal 20 and is connected to the cavity 37b on the one hand and to the vacuum source on the other hand via corresponding transverse holes 53, 54. Have been. A second seal 30 b formed as a flat seal is arranged on the inner surface of the window 15 in the region of the section 51.
[Brief description of the drawings]
FIG. 1 is a front view simply showing an opening area of a casing wall of an isolator.
FIG. 2 is a partial cross-sectional view taken along a plane II-II in FIG.
FIG. 3 is a partial cross-sectional view corresponding to FIG. 2 according to a modified embodiment.
FIG. 4 is a partial cross-sectional view corresponding to FIG. 2 according to another modified embodiment.
FIG. 5 is a partial cross-sectional view corresponding to FIG. 2 according to yet another modified embodiment.
FIG. 6 is a partial cross-sectional view corresponding to FIG. 2 according to yet another modified embodiment.
[Explanation of symbols]
Reference Signs List 11 opening, 12 casing wall, 12a casing wall, 12b casing wall, 13 casing, 15 window, 16 casing inner chamber, 17 periphery, 20 seal, 21 internal space, 22 casing edge, 25 seal frame, 25a seal frame, 25b Seal frame, 26 notch, 26a notch, 27 division, 30 seal, 30a seal, 30b seal, 31 blind hole, 32 side hole, 33 adapter, 34 hole, 35 hole, 36 inner surface, 37 hollow chamber, 37a hollow chamber, 37b Hollow chamber, 38 suction tube, 41 holding section, 42 seal lip, 44 seal frame, 45 blind hole, 46 side hole, 47 side hole, 48 section, 50 seal frame, 51 section, 52 blind hole, 53 side hole, 54 Side hole

Claims (9)

A device for treating pharmaceutical containers, in particular vials, ampoules, etc., provided with a casing (13) which is tightly closed to the surroundings, except for the area for loading and unloading the containers. The casing wall (12; 12a; 12b) is provided with an opening (11), the casing wall (12; 12a; 12b) being tightly closed by a closing element (15), in particular a window or door. The closure element (15) is removably connected to the casing wall (12; 12a; 12b) and a pneumatically operated sealing device is provided, said sealing device being operated under positive pressure A first sealing element (20), which is formed in an annular shape, the first sealing element (20) being provided on the casing wall (12; 12a; 12b). A second sealing element (30; 30a; 30b), which is formed in an annular shape, is arranged on the side closer to the inside of the casing (16), in the form arranged between the closing element (15). And the second sealing element (30; 30a; 30b) acts as a protection device in case of failure of the first sealing element (20) to avoid the ingress of contaminants into the casing interior (16). Device for processing pharmaceutical containers, such as in particular vials, ampoules and the like. The closing element (15) has an annular sealing frame (25; 25a; 25b; 50), which seal frame (25; 25a; 25b; 50) replaces the first sealing element (20). 2. The device according to claim 1, wherein the device is at least partially housed in a cutout on the side close to the casing interior. An opening (11) in the casing wall (12; 12a) is arranged at a distance from the first sealing element (20) and a second sealing element (30; 30a) is located in the opening (11). 3. The device according to claim 1, wherein the device is arranged between the housing wall (12; 12 a) and the closing element (15). Device according to claim 1 or 2, wherein the second sealing element (30b) is arranged between the frame-shaped support (44; 51) and the closing element (15). The device according to claim 4, wherein the support (51) is a component of the sealing frame (50). 5. The device according to claim 4, wherein the support (44) is arranged on the casing wall (12b) on the side opposite the sealing frame (25b). A closed cavity (37; 37a; 37b) is formed between the two sealing elements (20, 30; 30a; 30b), and the cavity (37; 37a; 37b) is closed by a negative pressure device. 7. The device according to claim 1, which is evacuable. 8. The device according to claim 7, wherein the cavity (37b) is connected to a negative pressure source via at least one hole (31; 52-54) formed in the sealing frame (25b; 50). . 9. The device according to claim 1, wherein the second sealing element is formed as a flat, shaped or molded seal.

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