Isolator
Patent Information
- Application Number
- DE102022100598
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2022-01-12
- Publication Date
- 2025-03-20
- Estimated Expiration
- 2042-01-12
Smart Images

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Abstract
Description
[0001] The invention relates to an isolator, with a working space and an anteroom, from which process air can be introduced into the working space via an inlet filter, with an air return area for guiding return air from the working space into the anteroom.
[0002] Isolators of the type mentioned above are known, for example, from the book “Cleanroom Technology”, 4th edition, Springer Vieweg Verlag, Lothar Gail and Udo Rommel, chapter “Isolator Technology in the Chemical-Pharmaceutical Industry”.
[0003] Isolators of the type mentioned above are also used to produce or process living organisms / viruses in the isolator's workspace. This results in contamination not only of the workspace but also of other areas within the isolator. Hydrogen peroxide is known to be used to decontaminate / inactivate the workspace and the other areas mentioned.
[0004] It is possible for the anteroom of an isolator to communicate with an external process air unit (also called an AHU = Air Handling Unit), which supplies fresh process air to the anteroom. This fresh process air flows from the anteroom through an inlet filter into the work area and is then returned (as exhaust air) via an air return area to the external process air unit. For such a configuration, which includes an external process air unit, it is possible to inactivate the work area, the anteroom, and the air return area with hydrogen peroxide.
[0005] As an alternative to providing an external process air unit, it is possible for an isolator to be designed for recirculation operation and not communicate with an external process air unit. In this configuration, process air is introduced from the anteroom via an inlet filter into the workspace. From there, the process air, possibly with the interposition of a so-called "safely replaceable filter," enters the air return area and from there – with the interposition of a catalyst – back into the anteroom. In this configuration, only the workspace and the air return area can be inactivated with hydrogen peroxide, but not the anteroom downstream of the catalyst in the direction of flow.
[0006] EP 2 133 101 A1 discloses an insulator having the features of the preamble of patent claim 1. Further insulators are known from EP 2 609 938 A1, DE 10 2009 012 414 A1, US 2009 / 0 227 008 A1, and WO 2004 / 004 790 A1.
[0007] The present invention is based on the object of providing an isolator suitable for or designed for recirculation operation, which enables simplified decontamination.
[0008] This object is achieved by an insulator having the features of patent claim 1.
[0009] According to the invention, disinfection can already occur during productive operation of the isolator. The radiation source enables continuous decontamination of the exhaust air guided through the air return area, so that the exhaust air recirculated from the air return area into the anteroom is inactivated.
[0010] The disinfection according to the invention in the air return area has the advantage of increasing the isolator's productive peak hours, which can be used for the production or processing of highly active substances. At the same time, the reliability of complete inactivation of the anteroom is increased. The downtime required for decontaminating the isolator can be reduced or completely eliminated.
[0011] For example, the radiation source is a UV-C radiation source. Such a radiation source is particularly suitable for potential inactivation of biological protection level 2.
[0012] The air return area is advantageously arranged spatially adjacent to the workspace. In this way, a compact isolator can be created, particularly if the anteroom is arranged above the workspace. For example, the air return area has at least one air return section arranged to the side of the workspace, i.e., at the level of the workspace. Alternatively or additionally, it is possible for the air return area to have at least one air return section arranged below the workspace and / or at least one air return section arranged above the workspace.
[0013] At least one radiation source is arranged in all or a subset of the aforementioned air return sections. Multiple radiation sources can also be arranged within an air return section.
[0014] To spatially delimit the air return area or an air return section, it is proposed that a first boundary be defined by a wall of the working space, and a second boundary spaced therefrom be defined by an additional wall, which in particular forms an outer side of the isolator. It is possible for the additional wall and / or the wall of the working space to be transparent, i.e., translucent.
[0015] The at least one radiation source comprises at least one radiation element having a longitudinal axis oriented parallel to the flow direction of the return air. In this way, the exposure time during which the return air is exposed to the radiation from the radiation source can be extended by using only one radiation source.
[0016] The exposure time also depends on the speed at which the return air is passed through the air return area. In order to achieve a high degree of inactivation even at higher flow velocities, it is proposed that the at least one radiation source be effective along a portion of at least 40% of the total flow path of the air return area, preferably along a portion of at least 60%. In this context, it should be noted that a radiation source, for example a UV-C radiation source, requires only a small amount of space relative to the flow cross-section of the air return area, so that, in principle, the entire length of the flow path of the air return area is available for the arrangement of at least one radiation source.
[0017] Optionally, the isolator can include a device for introducing hydrogen peroxide. This allows for a complementary and superimposed option for decontamination of at least parts of the isolator, in addition to the effect of the radiation source.
[0018] In particular, it is possible for the introduction of hydrogen peroxide to be spatially restricted to the work area and air return area, or for the introduction of hydrogen peroxide to be spatially restricted to the work area. This allows precisely those areas of the isolator that potentially contain residual contamination to be inactivated as needed, for example, after processing a specific batch of a highly active substance. Any subsequent rinsing phase can be carried out more quickly.
[0019] It is further preferred if a catalyst for separating hydrogen peroxide into water and oxygen is arranged between the air return area and the anteroom. This allows—in the case of using hydrogen peroxide (for the purpose of inactivating the work area or the work area and the air return area)—hydrogen and oxygen to be separated and removed without the need for another, more complex removal of the hydrogen peroxide.
[0020] It is understood that the workspace and the air return area are fluidically connected to enable the discharge of return air from the workspace into the air return area. It is possible that no outlet filter, especially no "safely replaceable filter," is located in this transition area, which could significantly increase the operating costs of an isolator. The absence of an outlet filter also reduces the flow resistance of the recirculating air flow and thus the energy required for recirculating the isolator.
[0021] Further features and advantages of the invention are the subject of the following description and the drawing of a preferred embodiment.
[0022] The drawing shows Fig. 1 is a perspective view of an embodiment of an insulator; and Fig. 2 a schematic side view of the insulator according to Fig. 1.
[0023] An embodiment of an isolator is designated in the drawings by reference numeral 10. The isolator has a work chamber 12 for the production or processing of highly active substances.
[0024] The isolator 10 further comprises an anteroom 14 in which a recirculation drive 16 is arranged, which supplies process air to an inlet filter 18. The process air passes through the inlet filter 18 into the work chamber 12.
[0025] The working chamber 12 is fluidically connected to an air return area 20, for example through an opening 58 formed in a wall 52 of the working chamber 12. The air return area 20 serves to remove exhaust air from the working chamber 12 and return the exhaust air to the anteroom 14.
[0026] The air return area 20 has a plurality of air return sections, for example an air return section 22 arranged below the working space 12 (see Fig. 1) and / or an air return section 24 arranged to the side of the working space and / or an air return section 26 arranged above the working space 12.
[0027] Preferably, the air return area 20 is bounded at least partially by the wall 52 of the work space 12 and by an outer additional wall 54. The wall 52 and the additional wall 54 can, in particular, be transparent. In this case, the wall 52 and the additional wall 54 form a double-pane arrangement.
[0028] In at least one of the aforementioned air return sections 22, 24, 26, at least one radiation source is arranged, which disinfects return air introduced from the working space 12 into the air return area 20 by means of radiation.
[0029] For example, two radiation sources 28 and 30 are arranged in the lower air return section 22. For example, two radiation sources 32 and 34 are arranged in the upper air return section 26.
[0030] For example, a radiation source 36 is arranged in the lateral air return section 26 (see Fig. 1) or a plurality of radiation sources, for example radiation sources 36a and 36b.
[0031] A radiation source (e.g. 36, 36a, 36b) has at least one radiation element 38, 40, which preferably extends along a longitudinal axis 42, 44, which is parallel to a (in Fig. 2 (designated 46). The radiation elements 38, 40 are preferably UV-C radiation elements.
[0032] A catalyst 50 is optionally arranged in a transition region 48 between the air return section 20 and the anteroom 14. In this case, it is advantageous if the isolator comprises a device 56 for introducing hydrogen peroxide at least into the working chamber 12, preferably also into the air return region 20. By means of the catalyst 50, hydrogen peroxide can be separated into hydrogen and oxygen and removed.
[0033] During productive operation of the isolator 10, process air from the anteroom 14 is introduced into the workspace 12 via the recirculation drive 16 and the inlet filter 18, where it is potentially contaminated with germs due to the production or processing of highly active substances. Such germs can enter the air return area 20 as part of the exhaust air, where they are killed along their flow path toward the anteroom 14 by means of at least one radiation source 36.
[0034] The thus disinfected exhaust air enters the anteroom 14, possibly with the interposition of the catalyst 50, and from there is fed back into the working chamber 12 by means of the recirculation drive 16 and with the interposition of the inlet filter 18. The isolator 10 thus operates in recirculation mode.
[0035] During a non-productive cleaning phase, it is possible for the device 56 to introduce hydrogen peroxide at least into the work chamber 12 and for the hydrogen peroxide (using the recirculation drive 16) to be fed together with air through the air return area 20 to the catalyst 50, which separates the hydrogen peroxide into water and oxygen. This cleaning operation can therefore also be carried out using a recirculation process.
Claims
[1] Isolator (10), with a working space (12) and an anteroom (14), from which process air can be introduced into the working space (12) via an inlet filter (18), with an air return area (20) for guiding return air from the working space (12) into the anteroom (14), with at least one radiation source (36) arranged in the air return area (20) which disinfects the return air in the air return area (20) by means of radiation, characterized by that the air return area (20) is delimited at least in sections by a wall (52) of the working space (12) and by an additional wall (54) and that the radiation source (36) has at least one radiation element (38, 40) which has a longitudinal axis (42, 44) which is oriented parallel to the flow direction (46) of the return air. [2] Insulator (10) according to claim 1, characterized by that the radiation source (36) is a UV-C radiation source. [3] Insulator (10) according to one of the preceding claims, characterized by that the air return area (20) has at least one air return section (24) arranged laterally of the working space (12). [4] Insulator (10) according to one of the preceding claims, characterized by that the air return area (20) has at least one air return section (22) arranged below the working space (12) and / or at least one air return section (26) arranged above the working space (12). [5] Insulator (10) according to one of the preceding claims, characterized by that the at least one radiation source (36) is effective along a portion of at least 40% of a total flow path of the air return region (20), preferably along a portion of at least 60%. [6] Insulator (10) according to one of the preceding claims, characterized by that the insulator (10) comprises a device (56) for introducing hydrogen peroxide. [7] Insulator (10) according to claim 6, characterized by that the introduction of hydrogen peroxide is spatially limited to the working space (12) and the air return area (20) or that the introduction of hydrogen peroxide is spatially limited to the working space (12). [8] Insulator (10) according to one of the preceding claims, characterized by that a catalyst (50) for separating hydrogen peroxide into hydrogen and oxygen is arranged between the air return area (20) and the anteroom (14). [9] Insulator (10) according to one of the preceding claims, characterized by that no output filter is arranged between the working space (12) and the air return area (20).
Citation Information
Patent Citations
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System for maintaining sterile environment
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Isolator with sterilant reduction unit
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Culture apparatus
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