Isolator system

Abstract

The invention relates to an isolator system having an isolator (10) with an interior space (22) for processing a substance, which is delimited by a base-side mounting surface (14) for arranging a substance processing unit (20) and an isolator cabin (12) having at least one access opening (24), which is assigned at least one closure device for selectively opening or blocking the access opening, wherein the isolator cabin can be placed or is placed on the base-side mounting surface, and wherein the isolator system has at least one quick-change interface (34) for exchanging the isolator cabin (12) for an additional cabin having a different protection class and / or for exchanging the closure device for an additional closure device having a different protection class.

Description

Technical Field

[0001] The present invention relates to an isolator system having an isolator having an internal space for processing materials, the internal space being defined by a base-side mounting surface for arranging a material processing unit and an isolator compartment having at least one access opening, the access opening being provided with at least one closing device for selectively opening or blocking the access opening. Background Technology

[0002] For example, the type of isolator system described above is known from patent document DE 10 2007 030 789 A1, and is particularly used in the pharmaceutical and food industries for the production, processing and / or packaging of substances.

[0003] In the pharmaceutical and food industries, a variety of different material processing units are typically used to handle very large quantities of substances that vary greatly in their properties, such as toxicity. These substances also differ in their susceptibility to contamination from external sources. The same applies to preventing cross-contamination between different substances.

[0004] In principle, it is conceivable to provide dedicated isolators for specific material processing units and specific materials. However, for such installations, isolators not only occupy a certain floor space, but also require space in their immediate surrounding environment to accommodate peripheral equipment, supply starting materials and remove products, as well as for operation and maintenance personnel to access the isolator and its interior space.

[0005] Similarly, due to the conditions mentioned above, the standard practice is to use a separate isolator for different substances and to thoroughly clean the material handling unit, at least when switching to a different substance. During this period, the isolator cannot be used for production, processing, or packaging purposes. Summary of the Invention

[0006] Based on this premise, the purpose of this invention is to provide an isolator system that allows for improved utilization.

[0007] According to the invention, this objective is achieved in the case of an isolator system of the type mentioned at the beginning, wherein the isolator compartment can be placed or has been placed on a base-side mounting surface, and the isolator system has at least one quick-change interface for replacing the isolator compartment with an additional compartment having a different protection level and / or for replacing the shut-off device with an additional shut-off device having a different protection level.

[0008] The isolator system according to the invention allows for alteration of the isolator system's protection level by replacing the isolator compartment with an additional compartment and / or by replacing the shut-off device with an additional shut-off device. Such protection levels correspond to isolator system classifications, which are specified as levels from 1 (low protection effectiveness) to 6 (high protection effectiveness), specifically designated as OEB values ​​("Occupational Exposure Zone") or OEL values ​​("Occupational Exposure Limits"). The OEB value represents the toxicity of the pure substance to be treated by means of a material handling unit, and the OEL value represents the average concentration load on workers during an eight-hour shift. Therefore, if a certain OEB value and a certain OEL value are predetermined for handling a certain substance, the isolator system must have at least this level of protection.

[0009] To change the protection level, for example, the entire isolator compartment can be replaced with an additional compartment having a different protection level. In this case, the base-side mounting surface remains a fixed component of the isolator system, where the material handling units arranged on the mounting surface can be retained or replaced with the same or different material handling units. The isolator compartment may have a higher protection level than the additional compartment.

[0010] This invention is based on the concept that isolators are typically designed and configured for very specific and unchangeable levels of protection. However, isolators with higher protection levels (e.g., protection level 5) have shut-off devices that make it more difficult to access the interior space of the isolator compartment compared to isolators with lower protection levels (e.g., protection level 3 or 4).

[0011] To change the protection level, the shut-off device can be replaced with an additional shut-off device, especially if other components of the isolator compartment are retained. In this way, for a transition to a lower protection level, access to the internal space of the isolator compartment can be simplified by replacing the shut-off device belonging to the higher protection level with an additional shut-off device belonging to the lower protection level. Conversely, a transition from a lower protection level to a higher protection level is also possible.

[0012] For the isolator compartment, preferably, the isolator compartment in the activated state includes peripheral equipment and accessories of a higher protection level, such as protection level 5, for example, a unit for generating a vacuum in the internal space of the isolator compartment and / or a cleaning unit for cleaning the internal space using a cleaning fluid such as hydrogen peroxide. When the isolator compartment is converted to a lower protection level, the peripheral equipment and accessories of the higher protection level will remain, but will not be used during the use phase of the isolator compartment with the lower protection level. This method is based on the concept that a isolator compartment configured for a lower protection level (e.g., protection level 3) can be quickly and easily converted to a higher protection level, even if not practically impossible, as it would be very complex.

[0013] In summary, the isolator system according to the invention enables better and more flexible use of isolators in production environments and simplifies the use of isolators by personnel.

[0014] Preferably, the quick-change interface has a fixed interface section, which in particular interacts with or is releasably connected to the mobile interface section in a form-fitting manner.

[0015] In a particularly simple improvement, the quick-change interface is provided by a seal that acts between the mounting surface and the isolator compartment and is preferably positioned in a fixed location on the mounting surface. In this case, the lower boundary of the isolator compartment rests on the seal, thereby closing the internal space of the isolator. Replacement can be performed by simply lifting the isolator compartment from the seal; subsequently, the isolator compartment can be replaced with an additional compartment having a different level of protection.

[0016] To improve the stability of quick-change interfaces, it is preferable that the interface sections interact with each other in a form-fitting manner. This form-fitting can be achieved, for example, by a manually actuated mechanical element, such as a rotating handle, knurled screw, toggle lever, or quick-release lever.

[0017] In a preferred embodiment, the fixed interface section is specified to be driven by an electric motor or pneumatically. This allows, for example, the use of a central controller with an isolator to automatically produce a shape-fitting interface section.

[0018] To further simplify the replacement of isolator compartments or shut-off devices, it is preferable that the quick-change interface has at least one fixed contact section for electrical contact with the moving contact section. In this way, when the quick-change interface is assembled, an electrical connection can be simultaneously established between the fixed and moving contact sections without requiring a separate installation process for this purpose.

[0019] Accordingly, the quick-change interface may have at least one fixed fluid supply section for supplying fluid to the moving fluid line section. In this way, when the quick-change interface is assembled, a fluid connection can be simultaneously established between the fixed interface section and the moving interface section without requiring a separate installation process for this purpose. The fluid supply may be, for example, a compressed air supply or a negative pressure supply.

[0020] The mounting surface is preferably arranged on a bracket. In this case, the fixed interface section of the quick-change interface is preferably arranged on the mounting surface and / or the bracket, which also simplifies the connection of the fixed interface section driven by the motor.

[0021] Preferably, the mounting surface has a sealing section that closes on the circumferential side and selectively interacts with mating sections of the isolator compartment or the auxiliary compartment that extend in a closed manner on the circumferential side. This allows for a simple seal of the lower boundary of the isolator's internal space, regardless of whether the sealing section also forms a quick-change interface.

[0022] As described above, preferably, the shut-off device has a higher protection level than the auxiliary shut-off device. It should be considered that a shut-off device with a higher protection level may be heavier and occupy more space than an auxiliary shut-off device with a lower protection level. By considering the shut-off device with a higher protection level in relation to the activation state of the isolator compartment, it is thus ensured in a simple way that the isolator compartment can receive shut-off devices with different protection levels.

[0023] Specifically, preferably, the closing device and the additional closing device are each arranged on a support member that forms or has a movable interface section of the quick-change interface. Such a support member can be, for example, a support plate that is already connected to or is connected to the shell of the isolator compartment or the door of the isolator compartment. The support member itself can also form the door of the isolator compartment.

[0024] A preferred shut-off device has fluid-permeable operational protection. For example, it could be a mesh that allows fluid to flow from the surrounding environment into the interior space of the isolator compartment but prevents human intervention within the interior space. Here, the operational protection can be movably (particularly displaceable or pivotable) mounted on a support between a use position that prevents intervention in the interior space and a release position that allows intervention in the interior space.

[0025] A preferred additional closure device has a glove port and / or a fluid-impermeable cover. The glove port allows for fluid-tight intervention within the interior space of the isolator compartment; the fluid-impermeable cover prevents fluid exchange between the interior space of the isolator compartment and its surrounding environment, and selectively also effectively serves as mechanical protection for the glove port.

[0026] Another possibility for adapting to different protection levels is that the isolator compartment and / or the additional compartment have a connection area with a fluid opening that is selectively connected to a suction device for drawing fluid from the interior space or to a fluid barrier to prevent fluid from escaping from the interior space.

[0027] The material processing unit is, in particular, a capsule filling machine or tablet compressor. This type of material processing unit is used to process substances with varying toxicities and sensitivities to external contamination.

[0028] The present invention also relates to a method for providing an isolator using the aforementioned isolator system, providing an isolator having a first protection level, and wherein isolators with different protection levels are provided by replacing and / or removing components of the isolator. Specifically, it is possible to change from protection level 5 to protection level 4 or from protection level 4 to protection level 3. It is also possible to change from a lower protection level to a higher protection level.

[0029] Other features and advantages of the present invention are described below and illustrated with preferred exemplary embodiments. Attached Figure Description

[0030] In the figure

[0031] Figure 1 A perspective view of a first embodiment of the isolator is shown;

[0032] Figure 2 A perspective view of another embodiment of the isolator is shown;

[0033] Figure 3 It shows according to Figure 2 Top view of the mounting plate of the isolator;

[0034] Figure 4 The top perspective shows the... Figure 2 A perspective view showing the details of the isolator;

[0035] Figure 5 The bottom perspective view shows the corresponding Figure 4 The view;

[0036] Figure 6 A front perspective view of one embodiment of an isolator compartment with an additional closing device is shown;

[0037] Figure 7 The diagram shows the corresponding device without an additional shut-off mechanism. Figure 6 The view;

[0038] Figure 8 A diagram showing a corresponding device with a closing mechanism is provided. Figure 7 The view;

[0039] Figure 9 It shows according to Figure 6 Rear perspective view of the isolator compartment with another additional closing device;

[0040] Figure 10 It shows the correspondence without another additional shut-off device. Figure 9 The view;

[0041] Figure 11 A diagram showing a counterpart with another closing device is shown. Figure 10 The view;

[0042] Figure 12 A front perspective view of another embodiment of an isolator compartment with additional closing devices arranged on the door is shown;

[0043] Figure 13 The diagram shows the corresponding device without an additional shut-off mechanism. Figure 12 The view;

[0044] Figure 14 A diagram showing a corresponding device with a closing mechanism is provided. Figure 13 The view;

[0045] Figure 15 It shows according to Figure 12 Rear perspective view of the isolator compartment with an additional closing device arranged on the door;

[0046] Figure 16 It shows the correspondence without another additional shut-off device. Figure 15 The view; and

[0047] Figure 17 A diagram showing a counterpart with another closing device is shown. Figure 16 The view. Detailed Implementation

[0048] One embodiment of the isolator is in Figure 1 The isolator 10 is shown in the figure and is generally indicated by reference numeral 10. The isolator 10 includes an isolator compartment 12 that can be placed or has been placed on a mounting surface 14 on the base side. The mounting surface 14 is connected to a bracket 16, which is fixed in place or movable via casters 18 or a travel drive.

[0049] Mounting surface 14 is used for arranging a material processing unit 20, which is in particular a capsule filling machine or tablet press.

[0050] When the isolator compartment 12 and the base-side mounting surface 14 are connected, the mounting surface 14 and the isolator compartment 12 together define the internal space 22 in which the material processing unit 20 is arranged.

[0051] Mounting surface 14 has a sealing section 26 that extends in a closed manner on the circumferential side to form a fixed interface section 28.

[0052] The lower boundary and demarcation of the isolator compartment 12 have a sealing strip 30, which extends in a closed manner on the circumferential side and forms a movable interface section 32. The interface sections 28 and 32 together form a quick-change interface 34.

[0053] To mount the isolator compartment 12 onto the mounting surface 14, a lifting unit 36 ​​is provided that lowers the isolator compartment 12 from a state of being raised from the mounting surface toward the mounting surface 14 until the sealing strip 30 impacts the sealing section 26 and is pressed into the sealing section due to the weight of the isolator compartment 12, thereby creating a fluid-tight connection between the mounting surface 14 and the isolator compartment 12.

[0054] Isolator compartment 12 includes components arranged on access opening 24 but not in... Figure 1 The closing device is shown below. (Refer to the following...) Figures 6 to 17 Describe this closing device.

[0055] Figure 1 The isolator 10 shown is part of an isolator system that includes, in addition to the isolator compartment 12 shown in the figure, another auxiliary compartment (not shown). The isolator compartment 12 and the auxiliary compartment are respectively equipped with shut-off devices and additional shut-off devices belonging to different protection levels in the areas of their respective access openings 24. In this way, an isolator 10 with a changed protection level can be provided by easily replacing the isolator compartment 12 with the auxiliary compartment.

[0056] Figures 2 to 5 Another embodiment of the isolator 10 is shown, the isolator 10 having, according to Figure 1 The isolator 10 is similar in design to the one used in the quick-change interface 34 configuration. Figure 1 The implementation methods differ. According to... Figures 2 to 5 In the embodiments, the quick-change interface 34 is provided at least individually, preferably twice, see [reference]. Figure 2 and Figure 3At least one fixed interface section 28 is arranged in the edge region or side of the mounting surface 14. The at least one fixed interface section 28 has a receiving element 36 for form-fittingly receiving and locking the form-fitting element 38 of the movable interface section 32 of the isolator compartment 12 by an electric motor.

[0057] In addition, the fixed interface section 28 also has a fixed contact section 40 for electrical contact with the movable contact section 42 of the movable interface section 32, see [link to documentation]. Figure 4 and Figure 5 .

[0058] according to Figures 2 to 5 The isolator 10 is also part of the isolator system, which includes an additional compartment (not shown) in addition to the isolator compartment 12 shown. The corresponding entry openings 24 of the isolator compartment 12 and the additional compartment are respectively provided with closing devices and additional closing devices of different protection levels.

[0059] Figures 6 to 11 An embodiment of the isolator compartment 12 of the isolator 10 is shown. Figures 6 to 8 A front perspective view is shown. Figures 9 to 11 A rear perspective view is shown.

[0060] The isolator compartment 12 has a front wall 44 and a rear wall 46. A door 48 is pivotally mounted on the front wall 44, for example by means of a hinge 49. The door 48 has a door opening 50 integrated into the door, see [link to relevant documentation]. Figure 7 The door opening 50 can be selectively closed via support 52 or support 56, and a first-level protection closing device 54 is arranged on and specifically secured to support 52. See [link to relevant documentation]. Figure 6 An additional closing device 56, with a protection level different from the first protection level, is arranged on the support 56 and is specifically fastened to the support 56. See [link to relevant documentation]. Figure 8 .

[0061] Support members 52 and 56 can each be connected to the isolator compartment 12 via quick-change interface 34. The quick-change interface 34 is designed as a releasable connection unit, such as a screw connection. For this purpose, door 48 has at least one fixed interface section 60 in the form of a screw socket (see...). Figure 7 Support members 52 and 56 have a movable interface section 62 in the form of at least one screw channel area for each screw (not shown) to pass through, see [link to relevant documentation]. Figure 6 and Figure 8 The movable interface sections 62 of the different supports 52 and 56 can be selectively and interchangeably connected or connected to the fixed interface section 60.

[0062] When one of the support members 52 and 56 is omitted, an isolator compartment 12 with a relatively low protection level is provided, see [reference]. Figure 7 It has an open door opening 50 with door 48.

[0063] Optionally, the boundary of the door opening 50 of the door 48 forms a fixed interface section 60, which interacts with the movable interface section 62 of the support 52 or 56 in various situations (e.g., having an undercut swivel hook in the engaged position).

[0064] In the region of the rear wall 46, the isolator compartment 12 has a frame 64 that frames the frame opening 66, see [reference needed]. Figure 10 The frame 64 can be fixedly attached to the rear wall 46, or it can be designed as a pivotable door, for example, corresponding to a door 48 on the front side 44 of the isolator compartment 12. The frame opening 66 can be closed via a quick-change interface 34, as shown in the reference above. Figures 6 to 8 The type described. For example, a support 52 with a closing device 54 can be used, see [link to relevant documentation]. Figure 9 Alternatively, a support member 56 with a suction area 68 may also be used, see [link to relevant documentation]. Figure 11 .

[0065] The suction area 68 communicates with the interior space 22 of the isolator chamber 12 and supplies air from the interior space 22 of the isolator chamber 12 to a fluid opening 70 that can be selectively connected to or connected to a suction device (not shown) via the suction area 68.

[0066] Compare Figure 6 and Figure 9 Both closing devices 54 have fluid-impermeable covers 72. The closing devices 54 may have glove ports that can be covered by the covers 72.

[0067] according to Figure 6 and Figure 9 The configuration of isolator compartment 12 is classified as first protection level, specifically protection level 5. According to... Figure 8 and Figure 11 The isolation chamber 12 is configured to be classified as a relatively low protection level, such as protection level 3 (fluid opening 70 is open) or protection level 4 (fluid opening 70 is connected to an external suction device).

[0068] The following is for reference. Figures 12 to 17 One embodiment of the described isolator compartment 12 has the same characteristics as according to... Figures 6 to 11 The isolator compartment 12 is of a fairly high design. According to... Figures 12 to 17 In one embodiment, a door 48 is arranged on the front wall 44, the door being openable and closed by means of a hinge 49, and forming a closing device 54 (see...). Figure 12 ), for open access opening 24 (see Figure 13 ) or for use with an additional closing device 58 (see Figure 14 ) support components.

[0069] The quick-change interface 34 is designed as a releasable connection unit, such as a screw connection. For this purpose, the door 48 has at least one fixed interface section 60 in the form of a screw socket (see...). Figure 13 Closing device 54 (see) Figure 12 ) and additional closing device 58 (see Figure 14 Each has at least one screw-type moving interface segment 62, see Figure 12 and 14 The movable interface sections 62 of the two closing devices 54 and 58 are selectively and interchangeably connected or can be connected to the fixed interface section 60.

[0070] When the arrangement of shut-off devices 54 and 58 is omitted, an isolator compartment 12 with a relatively low protection level is provided, see [reference]. Figure 13 It has an open entry opening 24 with door 48.

[0071] according to Figures 12 to 17 The isolator compartment 12 has a panel 74 on its rear wall 46 that partially closes the rear wall, and on said panel 74, a closing device 54 (or glove port) is selectively arranged, and an additional panel 76 is selectively arranged (see...). Figure 15 ) or an additional closing device 58 in the form of a suction area 68 and an additional door 78 (see Figure 17 The additional door 78 can be attached via hinge 82 and held, for example, magnetically in the closed door position.

[0072] Panel 74 may be without other components and, for example, have an open access opening 24 and a selectively open additional opening 80, see [reference needed]. Figure 16 .

[0073] Panel 74 forms a support fixedly connected to the rear wall 46, or alternatively, is designed as a pivotable door, for example, corresponding to a door 48 on the front side 44 of the isolator compartment 12.

[0074] The quick-change interface 34 is designed as a releasable connection unit, for example, in the form of a screw connection. For this purpose, panel 74 (or door 48) has at least one fixed interface section 60 in the form of a screw socket (see...). Figure 16 Closing device 54 and additional panel 76 (see) Figure 15 ) as well as suction area 68 and additional door 78 (see Figure 17 Each has at least one screw-type moving interface segment 62, see Figure 15 and 17 These mobile interface segments 62 are selectively and interchangeably connected to or can be connected to fixed interface segments 60.

[0075] When the arrangement of shut-off devices 54 and 58 is omitted, an isolator compartment 12 with a relatively low protection level is provided, see [reference]. Figure 16 It has an open access opening 24 in panel 74 or door 48, and optionally also has an open additional opening 80.

[0076] As referenced above Figures 6 to 11 The explanation is based on Figure 12 and Figure 15 Isolator compartment 12 belongs to the category of... Figure 14 and Figure 17 The isolator compartment has a higher level of protection (12).

Claims

1. An isolator system having an isolator (10) having an internal space (22) for processing a substance, the internal space (22) being defined by a base-side mounting surface (14) for arranging a substance processing unit (20) and an isolator compartment (12) having at least one access opening (24), the base-side mounting surface (14) being arranged on a support (16), the substance processing unit (20) being a capsule filling machine or a tablet press, the access opening (24) being provided with at least one closing device (54) for selectively opening or blocking the access opening, characterized in that, The base-side mounting surface remains a fixed component of the isolator system, which includes an additional compartment for replacing the isolator compartment (12), the additional compartment having a different protection level than the isolator compartment (12), the isolator compartment (12) being able to be placed on or placed on the base-side mounting surface (14), and the isolator system having at least one quick-change interface (34) for replacing the isolator compartment (12) with the additional compartment.

2. The isolator system according to claim 1, characterized in that, The quick-change interface (34) has a fixed interface section (28) that interacts with or is releasably connected to the mobile interface section (32).

3. The isolator system according to claim 2, characterized in that, The fixed interface section (28) interacts with the mobile interface section (32) in a form-fitting manner or is releasably connected to the mobile interface section (32).

4. The isolator system according to claim 2 or 3, characterized in that, The fixed interface section (28) is driven by an electric motor or pneumatically.

5. The isolator system according to any one of the preceding claims, characterized in that, The quick-change interface (34) has at least one fixed contact section (40) for electrical contact with the moving contact section (42).

6. The isolator system according to any one of the preceding claims, characterized in that, The quick-change interface (34) has at least one fixed fluid supply section for fluid supply to the moving fluid pipeline section.

7. The isolator system according to any one of the preceding claims, characterized in that, The base-side mounting surface (14) has a sealing section (26) that extends in a closed manner on the circumferential side and selectively interacts with a mating section (30) of the isolator compartment (12) or the auxiliary compartment that extends in a closed manner on the circumferential side.

8. The isolator system according to any one of the preceding claims, characterized in that, The isolator system has at least one quick-change interface (34) for replacing the shut-off device (54) with an additional shut-off device (58) having a higher protection level than the additional shut-off device (58).

9. The isolator system according to claim 8, characterized in that, The closing device (54) and the additional closing device (58) are each arranged on the support (52, 56), which forms or has a movable interface section (62) of the quick-change interface (34).

10. The isolator system according to claim 8 or 9, characterized in that, The additional shut-off device (58) has fluid-permeable operational protection.

11. The isolator system according to any one of the preceding claims, characterized in that, The closing device (54) has a glove port and / or a fluid-impermeable cover (72).

12. The isolator system according to any one of the preceding claims, characterized in that, The isolator compartment (12) and / or the additional compartment have a suction area (68) with a fluid opening (70) selectively connected to a suction device for drawing fluid from the interior space (22) or to a fluid barrier to prevent fluid from escaping from the interior space.

13. A method for manufacturing an isolator using an isolator system according to any one of the preceding claims, providing an isolator (10) having a first protection level, characterized in that, Isolators with different levels of protection can be provided by replacing the isolator compartment (12) with the additional compartment.

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