Pharmaceutical isolator, and method for controlling a ventilation system of the isolator

Abstract

In the case of a pharmaceutical isolator (1) comprising: an inner installation space (2) and a working space (3) separated therefrom; a number of flow devices (4), in particular in the installation space, which are configured to provide an air mass, referred to as an air flow, flowing in the installation space (2) and the working chamber (3); a number of filter units (8) which are configured to filter the air flow before it enters the working chamber (3); a marker injector (5) which is configured to inject a number of marker substances, in particular marker aerosols, into the air flow before the air flow enters the number of filter units (8); and a marker detection device (6), which detects the injected number of marker substances in the air flow, in particular a marker substance quantity; according to the invention the pharmaceutical isolator (1) has a plurality of marker injectors (5) and marker detection devices (6). The invention also relates to a method for controlling a ventilation system in a pharmaceutical isolator (1).

Description

[0001] "Pharmaceutical isolator, and method for controlling a ventilation system of the isolator"

[0002] Description:

[0003] The invention relates to a pharmaceutical isolator, in particular a large-capacity isolator, according to the features in the preamble of claim 1 and a method for controlling a ventilation system in the isolator.

[0004] Pharmaceutical isolators, hereinafter referred to as isolators for short, are used in practice to provide a number of work spaces, preferably a work space, in which, for example, products such as medications or the like are manufactured or filled and packaged in designated containers. The work space is created as a subspace of the interior space enclosed by the isolator housing, wherein the interior space is generally essentially divided by an air distribution level in the manner of a false ceiling into a work space and an installation space, or a number of installation spaces. An installation space can be provided, in particular, for the arrangement of equipment, drives, or the like, or for the guidance of an air mass.

[0005] Cleanroom-like conditions must be created in the workspace to prevent product contamination by particles, germs, microbes, or the like. Isolators are known to have a ventilation system. For this purpose, the isolator has a number of flow devices, i.e., a number of devices such as one or more fans. The number of flow devices is arranged in the installation space and forms a flowing air mass, or air flow for short, within the isolator, particularly within the workspace and the installation space. The air mass within the workspace preferably flows essentially laminarly, preferably from top to bottom.

[0006] In the context of the invention presented, a number is to be understood as a singular or plural number of a corresponding feature.

[0007] As mentioned above, it is known that isolators can have a false ceiling separating the installation space from the work space and in which flow openings are arranged through which the air flows from the installation space into the work space. Fans have also been mentioned as flow devices, whereby the flow devices can be arranged above and / or below the work space.

[0008] Each flow device, in particular each fan, forms a flowing partial air mass, or partial air stream for short, whereby several partial air streams can form a jointly flowing air mass, particularly when several flow devices are arranged in a substantially open installation space, so that several partial air streams influence each other and combine to form a joint air flow or a jointly flowing air mass. Within an effective zone of a flow device, one or more flow openings can be arranged, in particular in the suspended ceiling. For the purposes of the present proposal, the effective zone refers to a part of the installation space which is flow-dependently influenced by a partial air stream of a respective flow device.To meet the high purity requirements, the air masses, which preferably flow in a laminar manner or stream in the workspace, are first filtered before entering. One or more filter units are regularly arranged in the direction of flow in front of the workspace. The filters are optionally replaceable, generally installed in standard sizes, and can cover one or more flow openings. For example, HEPA filters (High Efficiency Particulate Air) are known in practice for the separation of the smallest particle sizes, for example, with an average diameter of 0.3 pm, which is common for fine dust, pollen, spores, and the like.

[0009] To demonstrate the filter performance of the number of filter units, the flowing air mass is mixed with a number of substances or marker substances, particularly marker aerosols or the like, before filtering. After the air mass exits the filter unit, a previously injected number of marker substances can be measured to determine the filter performance.

[0010] If a marker substance concentration in an air mass, for example, before filtration (reference value) is not higher to a certain extent than after filtration, this indicates inadequate removal of marker substances in the filter and thus inadequate filter performance.

[0011] Isolators are known in practice that have a central substance injection or aerosol feed or similar device, i.e., a substance or aerosol injector, hereinafter referred to as an injector, which injects substances into the air mass before the air mass enters the number of filter units. A detection device serves to detect the substances in the air mass in order to derive a substance concentration from this. Furthermore, a detection device can be used to ensure sufficient loading of the air mass with a number of substances. Filter performance can thus be derived from the comparison of a substance concentration before and after filtration.

[0012] High filter performance is essential for creating a contamination-free work environment. However, existing isolators share the problem that their filter performance is not sufficiently traceable. In particular, isolated, localized filter leaks in one or more filter units cannot be detected with sufficient precision; that is, minor quantitative differences in the filter units are not detected, and the spatial resolution is too low.

[0013] The present invention is based on the object of providing a simpler and more precise proof of filter performance.

[0014] The object is achieved by an insulator according to the features of claim 1 and by a method according to the features of claim 10. Features of the invention are discussed below, with advantageous embodiments of the invention as well as further advantageous aspects and details emerging from the subclaims and the description.

[0015] These design features may be implemented in conjunction with the invention or may be inventive in their own right, independent of the invention, and they may be implemented either individually and independently of one another or in any combination, including the implementation of all of the features mentioned, unless a combination is expressly or technically necessarily excluded.

[0016] According to a first aspect, the invention provides a pharmaceutical isolator, comprising an internal installation space and a work space separated therefrom, comprising a number of flow devices, in particular in the installation space, which are configured to form a flowing air mass referred to as an air flow in the installation space and the work space, comprising a number of filter units configured to filter the air flow before it enters the work space, comprising a marker injector configured to inject a number of marker substances, in particular marker aerosols, into the air flow before the air flow enters the number of filter units, and comprising a marker detection device which detects the injected number of marker substances in the air flow, in particular a quantity of marker substance, wherein the pharmaceutical isolator has a plurality of marker injectors and marker detection devices in each case.

[0017] In other words, an isolator is proposed in which an air mass mixed with one or more marker substances is formed, wherein the number of marker substances is homogeneously distributed in the air mass, i.e. a substantially homogeneous concentration distribution is present, and wherein the homogeneous marker substance distribution is already ensured before the air mass enters a number of filter units.

[0018] Preferably, a comparatively low minimum substance concentration is provided in each part of the air flow in order, on the one hand, to always be able to detect filter leaks or filter malfunctions of any kind with the number of filter units and, on the other hand, to not expose a filter unit to a marker substance beyond the required level.

[0019] According to the proposal, the isolator has a plurality of marker injectors and marker detection devices, i.e., two or more. For linguistic reasons, the terms "injector" and "detection device" are used in the context of the invention to represent the terms "marker injector" and "marker detection device." The term "substance" is also used here for the sake of simplicity for marker substances. Initial studies have shown that very precise substance distribution can be achieved with multiple injectors, preferably in conjunction with a flow device. Furthermore, it has been determined that multiple injectors also enable precise substance distribution in conjunction with multiple flow devices.For example, for the latter embodiment, it may be provided that a first injector injects substantially into the partial air flow of the first flow device and a second injector injects substantially into the partial air flow of a second flow device.

[0020] Preferably, the number of flow devices is arranged in the installation space, so that an air flow is preferably formed from the installation space into the work space. If present. Within the meaning of the invention, the installation space and / or the work space can each be subdivided, forming several installation (sub)spaces or work (sub)spaces, whereby the terms installation space and work space are used for simplification.

[0021] In principle, the flow properties of an air flow, for example the flow velocity, can be influenced by the structural design of the isolator, for example in such a way that a flow velocity can be increased with decreasing flow cross-section.

[0022] It should be noted that the specific effective zones of multiple flow devices do not usually have to be designed identically, but can sometimes differ significantly in terms of size, arrangement, flow conditions, etc. Surprisingly, however, it has been discovered that, contrary to popular belief, a homogeneous substance distribution can still be achieved by arranging multiple injectors.

[0023] Initial tests have also shown that, based on a homogeneous marker substance distribution, further state variables in the insulator can be derived, for example a humidity and / or temperature distribution.

[0024] In the context of the present invention, in the simplest case, an end element, for example a piece of hose, a nozzle unit, or the like, which opens into an air flow and through which a number of substances can be injected into the air mass, is referred to as an injector. Several end elements, supplied by a common substance supply, form an injector assembly with multiple injectors.

[0025] The number of injectors can be configured to spray the number of substances into the air flow or into a number of partial air flows. For this purpose, nozzles can be provided, for example, that have nozzle geometries that depend on requirements. Furthermore, a number of injectors can be configured to drip the number of substances into the air flow or into a number of partial air flows. During dripping, a number of droplets are introduced without being significantly accelerated beforehand. The acceleration, and thus advantageously associated atomization, of the number of droplets is essentially achieved by the air flow itself or by the number of partial air flows.

[0026] The aforementioned detection devices serve to detect the quantity of substances in the air flow in the direction of flow before and after the filter units in order to derive a substance concentration from this. Substance detection before the air mass enters the filter units enables the determination of a substance concentration in the form of a reference value, with which the homogeneous substance distribution can be verified. Substance detection after filtration, preferably immediately after filtration, enables the determination of a substance concentration in the form of a control value, based on which the filter performance can be verified, preferably the respective filter performance of the filter units.

[0027] The proposed solution enables the targeted injection of a number of marker substances or substances, so that, particularly based on the detection of a specific amount of substance, a target substance concentration in the air flow can be set with high spatial resolution and quantitative precision, even if diverging flow conditions prevail within several zones of action. Any concentration fluctuations within the air mass around a target value are a maximum of 20%, preferably a maximum of 15%, particularly preferably a maximum of 10%.

[0028] The marker substances can expediently form a defined, in particular uniform (particle) size, preferably with an average diameter between 0.2 pm and 0.4 pm, particularly preferably substantially 0.3 pm. Furthermore, the number of substances can each be provided and injected in a largely uniform substance concentration, wherein, for example, at least one aerosol generator is provided to provide the number of substances. Preferably, however, no marker substance with a substantially uniform concentration and particle size is used. In a further development, one or more generators can provide the number of substances.As already indicated, the respective flow conditions within the effective zones can differ from one another, for example, due to the structural design of an isolator, in particular due to the arrangement of the flow device within the installation space, which in principle has a direct impact on the substance distribution in the air flow. Consequently, it can advantageously be provided that a number of injectors can be supplied with an individual, preferably independent, amount of substance. In this way, a homogeneous substance distribution in the air flow can be achieved even with diverging flow conditions in the effective zones.

[0029] Furthermore, it can be provided that a number of marker injectors are connected to a number of substance supplies in a flow-through manner, wherein a number of substance supplies have a quantity limiter which regulates, in particular regulates in each case, the quantity of the number of marker substances supplied to a number of marker injectors.

[0030] In a further development, a number of injectors can be connected to a number of substance supplies, preferably to a common substance supply, such that several injectors are supplied from the same substance supply. A number of substance supplies can also each have a flow limiter that selectively regulates the quantity of the number of substances supplied to a number of injectors. For example, the flow limiter can be designed in the form of a valve system or the like with a control system connected to the valve system for signal transmission. This allows for individual, locally adjusted, particularly quantitatively adjusted substance injection.In a further development, it can be provided that a number of marker injectors inject the air flow in a suction plenum with a number of substances, wherein the suction plenum comprises a flow space between the working space and a number of air inlets of the number of flow devices, and / or that in a pressure plenum a number of detection devices detect a number of substances in the air flow, wherein the pressure plenum comprises a flow space between a number of air outlets of the number of flow devices and the working space.

[0031] A particularly high level of precision with which a filter performance can be determined in this case can be related to further measures which can be provided individually or in combination and are explained below: Firstly, in one embodiment, the isolator can have at least three flow devices, in particular fans, with at least one injector in each case opening into a respective partial air flow. Secondly, alternatively or additionally, it can be provided that the number of injectors corresponds to the number of flow openings or the number of filter units, so that the flow conditions at each flow opening or each filter unit can be taken into account for the substance injection. The latter measure in particular enables a very precise influencing of the substance concentration in the air mass or in the air flow, as a result of which a very precise substance distribution can be achieved.

[0032] Flow openings are usually arranged in a suspended ceiling or the like and can, for example, serve to accommodate a number of filter units. The suspended ceiling or a partition wall separates an installation space from a work space, so that the flow openings connect the installation space with the work space in a flow-through manner. Furthermore, it can be provided that a number of injectors inject the air mass in the intake plenum with a number of substances, and that a number of detection devices detect a number of substances in the discharge plenum.

[0033] In the context of the present invention, the suction plenum comprises a flow space between the working space and a number of air inlets of the number of flow devices. The pressure plenum, in contrast, comprises a flow space between a number of air outlets of the number of flow devices and the working space.

[0034] Advantageously, a number of injectors can thus be arranged upstream of a number of flow devices in the flow direction, and a number of detection devices can be arranged downstream of a number of flow devices in the flow direction.

[0035] In the context of the present invention, details are given of features which depend on a flow direction of the air flow, related to a flow path which begins in the suction plenum and ends in the pressure plenum.

[0036] By injecting the various substances into the air mass immediately before the air mass is drawn in and accelerated by a number of flow devices, each forming a partial air flow, which can merge into a single air flow in the case of multiple partial air flows, a sufficient substance distribution can be achieved within the respective partial air mass. This is advantageous because it reduces the risk of misjudging a substance concentration.

[0037] In an advantageous embodiment, the isolator can be designed particularly simply in that the installation space, in particular a fan space in which a number of flow devices are arranged, is designed to be open, i.e., there is essentially no structural separation of the effective zones from one another, as a result of which a mutual influence of several partial air flows can occur. Alternatively, it can be provided that a number of effective zones in the installation space are structurally separated from the other effective zones by means of an enclosure. Independently of the measures discussed here, a plurality of fans can advantageously be provided, the rotors of which each have essentially the same direction of rotation; particularly preferably, all rotors have the same direction of rotation.

[0038] In a further development, the isolator can comprise a plurality of flow devices, wherein each flow device forms a flowing partial air mass referred to as a partial air flow, and preferably the partial air flows create a common air flow, in particular a common air mass flowing in the working space.

[0039] For a further development, it can be provided that a number of marker injectors are assigned to each flow device in such a way that a number of marker injectors each inject a number of marker substances into the partial air flow.

[0040] Furthermore, a plurality of flow devices, preferably each flow device of a plurality of flow devices, can each be assigned a number of injectors. In this way, a number of substances can be injected into the partial air streams, preferably into each partial air stream of the plurality of flow devices. This promotes particularly precise substance distribution. The positioning of a plurality of flow devices relative to one another can result in a local measurement variable distribution of the marker substances, which should preferably be taken into account. Within the scope of a further development, it can be provided that each filter unit of the plurality of filter units is assigned a number of marker detection devices such that a number of marker detection devices detects the injected number of marker substances in the air stream entering an individual filter unit.

[0041] According to the proposal, the isolator has a plurality of detection elements, so that a number of substances can advantageously be detected at a plurality of positions, in particular with respect to a number of filter units. It can be provided that a number of detection devices are assigned to a number of filter units, preferably to each filter unit of the number of filter units, such that a number of detection devices detects the number of injected substances in the air flow entering a single filter unit. This type of substance detection can, in particular, contribute to a comparatively high spatial resolution of the detected substance concentrations, with the result that the filtering quality or filter performance can also be mapped with a high spatial resolution.

[0042] For the present invention, the detection device can be designed as a qualitatively effective sensor that detects one or more substances, for example, optically. Either a single detection device and / or in conjunction with another sensor can provide quantitative substance detection, for example, in relation to an air mass or air volume and / or per unit of time.

[0043] Furthermore, an improved substance distribution can be achieved in that at least one injector and / or one detection device can be provided for each flow opening or for each filter unit, so that a number of substances can be detected at various positions and a substance injection can take place as needed, particularly preferably before the air flow mixed with a number of substances is filtered.

[0044] Advantageously, it can be provided that a number of flow devices are arranged above the working space and / or that a number of flow devices are arranged below the working space.

[0045] Furthermore, it can be provided that a number of guide elements in the installation space, which guide the air flow or a part of the air flow, such that the number of guide elements feeds a number of parts of the air flow to a number of filter elements.

[0046] In a particularly inventive embodiment, a number of guide elements can be arranged in the installation space, which guide or deflect the air flow, i.e. the flowing air mass, or parts of the air mass, so that the flow direction of at least part of the air mass is changed and is preferably fed to a number of filter elements.

[0047] In this way, for example, a first air stream or a first portion of the air mass, which, for example, has a high degree of loading, i.e., a high concentration of substances, can be selectively fed to or mixed with a second air stream, which, for example, has a lower degree of loading. Preferably, taking into account the characteristics of any effective zones, this allows for particularly homogeneous substance distributions.

[0048] Furthermore, it can be provided that the air flow, at least partially, for example, a partial air mass, circulates within the isolator in such a way that air masses flow through the work space several times. This saves energy, in particular.

[0049] The isolator may comprise a number of catalysts, wherein the number of catalysts is preferably arranged in a number of flow openings, upstream of a number of filter units in the flow direction.

[0050] The measures presented here for homogenizing a substance distribution essentially relate to the quantity of a number of injected substances as well as the number and arrangement of guide elements and injectors, whereby the measures can be implemented independently of one another or in any combination within the meaning of the present invention.

[0051] From an economic perspective, it may be desirable to minimize the number of flow devices in an isolator. However, a smaller number can result in larger overlap areas of the effective zones of the flow devices used and a more intense mutual influence of the partial air flows. This can result in locally very heterogeneous flow conditions. Firstly, guide elements or the like can be provided to separate effective zones from one another, at least in sections, or to be able to specifically control the flow conditions within an effective zone. Secondly, however, in a particularly inventive embodiment, it can be provided that several injectors inject into the same partial air flow and / or that several capture elements in the same effective zone capture a number of substances.The latter measure, in particular, enables a detailed mapping of the flow conditions within an effective zone. High-resolution mapping of the flow conditions within one or more effective zones, especially effective zones with overlapping areas, can be particularly advantageously implemented in a further development in conjunction with a drive power control system, for example, in the form of fan speed control.

[0052] The number of flow devices creates a directed airflow, whereby each flow device can be assigned an individual orientation, so that several partial air flows combine locally to form a common air mass or air flow. Particularly advantageous is the ability to change the direction of flow of a number of flow devices, for example, if several flow devices can be pivoted around a rotation axis. This can further improve the homogenization of the marker substance distribution.

[0053] In a further development, the isolator can have a control device that detects incoming signals, in particular automatically detects them, such as the determined quantity data of the injected number of substances, and outputs control signals, for example, directed to the number of flow devices, injectors, substance supplies, and / or quantity limits to influence the marker substance distribution in the air mass. Particularly preferably, data on detected substance quantities can also be processed, which were recorded in the flow direction according to the number of filter units, so that, for example, a filter performance can be derived from the data or a filter performance can be specified.

[0054] A further aspect of the invention relates to a method for controlling a ventilation system in a pharmaceutical isolator, wherein the ventilation system comprises a number of flow devices for forming a flowing air mass referred to as an air flow, and a number of marker injectors for injecting a number of marker substances into the air flow, and a number of marker detection devices for detecting the injected number of marker substances, and wherein the method comprises: a) generating an air flow by means of a number of flow devices (4), b) injecting a number of marker substances into the air flow, c) detecting the number of marker substances in the air flow, d) deriving an actual marker substance concentration and comparing the actual marker substance concentration with a target marker substance concentration, e) approximating the actual marker substance concentration to the target marker substance concentration, wherein the injection is carried out using a plurality of marker injectors,and wherein the detection is carried out with a plurality of marker detection devices.,

[0055] The ventilation system of the isolator, in particular a large-space isolator, comprises a number of flow devices that form a flowing air mass referred to as an air flow. With a plurality of flow devices, each flow device generates a flowing partial air mass referred to as a partial air flow, with several partial air flows preferably combining to form a common air flow within the isolator, in particular within a number of installation spaces and a number of work spaces.

[0056] The ventilation system further comprises a number of injectors for injecting a number of substances into the airflow, as well as a number of detection devices for detecting the injected number of substances. The method aims to provide a substantially homogeneous distribution of a number of substances within the airflow.

[0057] According to the proposal, the method first comprises generating an air flow using a number of flow devices. A number of substances, preferably one substance, namely a specific marker aerosol, are injected into the air flow using a plurality of injectors. The number of substances in the air flow is measured using a plurality of detection devices. Furthermore, an actual substance concentration is determined from the detected quantity of the number of substances. According to the proposal, a number of target substance concentrations are stored in an electronic database, which are compared with a number of actual substance concentrations.

[0058] In one embodiment, it can be provided that a plurality of target substance concentrations are stored. For example, the target substance concentrations can differ depending on the respective effective zone, so that a corresponding number of target substance concentrations is preferably stored in an electronic database for the number of effective zones. Particularly preferably, a number of threshold values, in particular a plurality of threshold values, can be assigned to each effective zone in addition to a target substance concentration.In this way, it can be provided that regulation is adapted to the quantity of the number of substances, provided, for example, that specific threshold values ​​are detected as the actual substance concentration: firstly, it can be provided that, at comparatively low actual substance concentrations, a particularly rapid regulation takes place with a preferably high injection quantity of a number of substances, whereby at comparatively higher actual substance concentrations, when a threshold value is only a small distance from the target substance concentration, the injection quantity is comparatively small. Secondly, a visual, acoustic, or similar alarm can be provided if specific threshold values ​​are detected, so that a handler is informed.

[0059] In the same way as previously described for a number of action zones, a number of target substance concentrations and / or a number of threshold values ​​can be provided for detection in a number of partial air flows, for detection in the flow direction before or after a number of filter units and / or for detection in the flow direction before and / or after a number of flow openings.

[0060] According to the proposal, the actual substance concentration is brought closer to the target substance concentration if an unintentional divergence is detected between a number of actual substance concentrations and a number of target substance concentrations.

[0061] In particular, it can be provided that the process steps of injecting, detecting, discharging and approaching are implemented several times, preferably permanently in control mode, in the manner of a control loop in order to ensure a permanently homogeneous marker substance distribution, in particular in order to be able to demonstrate or guarantee the filter performance over a period of time.

[0062] In the context of further training, it may be provided that the proposed approach continues to include:

[0063] ■ Injecting a number of marker substances into the air flow,

[0064] ■ and / or supplying an air mass into the air flow,

[0065] ■ and / or controlling a drive power of a number of flow devices, wherein the supplied air mass contains substantially no number of marker substances.

[0066] In one embodiment, the approach can thus comprise injecting a number of substances into the air flow or into a number of partial air flows. Likewise, the supply of an air mass into the air flow can occur, for example in the manner of dilution, wherein the supplied air mass essentially comprises no number of substances, preferably none. Furthermore, the approach can comprise regulating the drive power of a number of flow devices, for example a rotor speed control for a number of fans. After the approach, a further or renewed detection of the number of marker substances in the air flow can preferably be provided, in particular to monitor an approach that has taken place, by carrying out the further method steps, as described above, in the manner of a control loop.

[0067] Particularly preferably, a specific control of a drive power can be provided, in particular a rotor speed control, in such a way that the drive power of a plurality of flow devices can be adjusted independently of one another.

[0068] Advantageously, it can be provided that during injection, a first marker injector injects a first quantity of the number of marker substances and a second marker injector injects a second quantity of the number of marker substances, wherein the first quantity differs from the second quantity.

[0069] The following measures can be provided for both the initial injection and the injection during approach: firstly, a first injector can inject a first quantity of the number of substances, and a second injector can inject a second quantity of the number of substances, wherein the first quantity preferably differs from the second quantity. This enables highly targeted injection. Secondly, a first injector can inject into a first partial air stream, and a second injector can inject into a second partial air stream. Thirdly, the number of substances can be sprayed and / or dripped into the air stream; with regard to the details of these application measures, reference is made to the previous explanations. Advantageously, the ventilation system has a number of filter units for filtering the air stream.It may be provided that the number of substances is recorded before entering a number of filter units and / or after exiting a number of filter units.

[0070] In a further development, it can be provided that the number of flow devices each forms a flowing partial air mass referred to as a partial air flow, and that during injection, a first marker injector injects into a first partial air flow and a second marker injector injects into a second partial air flow.

[0071] Furthermore, it can be provided that the number of marker substances is sprayed and / or dripped into the air flow during injection.

[0072] Conveniently, the ventilation system can have a number of filter units for filtering the air flow, and / or the number of marker substances can be detected before entering a number of filter units (8) and / or after exiting a number of filter units (8).

[0073] Particularly preferably, the described method can be used with one or more of the claimed or described features in an insulator according to the present claims and / or the description.

[0074] Embodiments of the invention are explained in more detail below using purely schematic illustrations, whereby individual features or a combination of features of the illustrated embodiments can also be implemented independently of the other embodiments in a proposed insulator. Fig. 1 shows a first embodiment of an insulator in vertical section,

[0075] Fig. 2 a second embodiment in section-wise vertical section,

[0076] Fig. 3 shows the embodiment from Fig. 2 in horizontal section in a plan view, and Fig. 4 shows a schematic sequence of a method example.

[0077] Fig. 1 shows a first embodiment of an isolator 1, specifically in a vertical section. Inside, the isolator 1 has a working space 3 and an installation space 2. Below the working space 3, a flow device 4 in the form of a fan is shown. The fan generates an air flow, with the air flow essentially circulating in the isolator 1. The air flow, in particular the flow direction, is indicated by dashed arrows.

[0078] A suction plenum 9 is formed between the working chamber 3 and the air inlet 40 of the fan. In contrast, a pressure plenum 10 is formed between the air outlet 41 of the fan and the working chamber 3.

[0079] Several injectors 5 are arranged in the suction plenum 9 (only one is shown), which inject a substance, namely a marker aerosol, into the air flow by spraying it. Immediately after injection, the substance-laden air mass is sucked in through the air inlet 40, accelerated, and released into the pressure plenum 10 via the air outlet 41. The substance is atomized and distributed throughout the air mass. By spraying the substance using several injectors 5, a correspondingly homogeneous substance distribution is achieved. By increasing the rotor speed, atomization and distribution can be optimized. The substance-laden air mass flows in the pressure plenum 10 through the installation space 2, initially to the catalysts 7. Detection devices 6, which detect the substance in the air flow, are arranged upstream of the catalysts 7 in the direction of flow.Taking the air mass volume flow into account, a loading level or substance concentration is derived. If the determined substance concentration falls below a specified target concentration, additional substance is injected into the air flow in intake plenum 9.

[0080] Depending on requirements, the rotor speed can be increased or decreased.

[0081] After flowing through the catalysts 7, the air mass enters the filter units 8 for filtering the air mass and providing an air mass suitable for cleanrooms. Before the filtered air flow is directed into the work chamber 3 via the air outlet surface 20, further substance detection takes place using detection devices 6. If an actual substance concentration above a concentration threshold is detected during this detection, this may indicate a filter malfunction or insufficient filter performance.

[0082] In one embodiment, regardless of the further features of the presented embodiment, it can be provided that the actual substance concentration is recorded, in particular of the filtered air flow, if necessary exclusively. This can then be the case if a respective actual substance concentration resulting from the combination of measures and empirically determined, for example, is stored in the control system of the ventilation system for a large number of specific injection quantities, preferably in combination with a large number of performance parameters of the drives of a number of flow devices 4 and the arrangement of any guide elements. Within the work space 3, the air mass flows essentially laminarly from the ceiling to the floor of the work space 3. After the air flow exits the work space 3, the air flow enters the suction plenum 9. Depending on a detected loading level, a further injection can take place.

[0083] Likewise in a vertically sectioned view, Fig. 2 shows a second embodiment, namely in the form of a large-capacity insulator 1, wherein sections of the insulator 1 are not shown for illustration reasons.

[0084] A plurality of flow devices 4 in the form of fans are arranged above the work space 3. Each fan generates a partial airflow, which acts within a specific zone of operation. The installation space 2 is designed to be open, i.e., without any significant structural separation between the fans or the zones of operation, so that the zones of operation partially overlap and partial airflows influence each other, forming a common, essentially circulating airflow. The airflow in the isolator 1, in particular the flow direction, is indicated by dashed arrows.

[0085] After exiting the air mass from the air outlet surface 20, the air mass flows essentially laminarly from the ceiling to the floor in the working space 3. From the working space 3, the air mass enters the intake plenum 9 in the installation space 2 and is again directed to the fans.

[0086] In installation space 2, in the direction of flow between the fan's air outlet 41 and the catalysts 7, guide elements are arranged that influence the air flow and thus influence the distribution of the marker in the air flow. The guide elements are not shown for illustrative purposes.

[0087] Fig. 3 shows that several injectors 5 are arranged in the suction plenum 9, with each flow device 4 (for reasons of illustration, not all flow devices 4 are identified by a reference numeral, in the exemplary embodiment as a fan) being assigned at least one injector 5, so that each partial air flow can be individually loaded with a marker. The ventilation system also has a quantity limiter, so that a specific quantity of the marker can be supplied to each injector 5. Some injectors 5 are supplied by a common material supply 50.

[0088] A plurality of detection devices 6 are arranged in the flow direction upstream of the catalysts 7 (for illustrative reasons, not all catalysts 7 are identified with a reference symbol) and downstream of the fans, specifically in such a way that a substance loading level is determined in at least each partial air stream. Further detection devices 6 are arranged downstream of the filter units 8 in the flow direction. However, these are not shown for illustrative reasons. Regarding the control of the actual substance concentration and the verification of filter performance, reference is made to the preceding explanations.

[0089] Fig. 4 shows schematically the sequence of an example method for the control method 100 of a ventilation system in a pharmaceutical isolator.

[0090] First, an air flow is generated 110 by means of a plurality of flow devices 4. A marker substance is injected 120 into the air flow by means of several marker injectors 5 and then preferably measured 130 in terms of quantity using a plurality of marker detection devices. An actual marker substance concentration is derived 140a from the marker substance quantity and compared 140b with a target marker substance concentration. If the actual and target concentrations differ, the actual marker substance concentration is approximated 150 to the target marker substance concentration. The approximation 150 can be achieved by injecting 120 a number of marker substances into the air flow, by supplying 160 an air mass into the air flow, and / or by regulating 170 the drive power of a number of flow devices 4.

[0091] The described method 100 is carried out in a pharmaceutical isolator 1, with an internal installation space 2 and a work space 3 separated therefrom, with a number of flow devices 4, in particular in the installation space, which are configured to form a flowing air mass referred to as an air flow in the installation space 2 and the work space 3, with a number of filter units 8, which are configured to filter the air flow before it enters the work space 3, with a plurality of marker injectors 5, which are configured to inject a number of marker substances, in particular marker aerosols, into the air flow before the air flow enters the number of filter units 8, and with a plurality of marker detection devices 6, which detect the injected number of marker substances in the air flow, in particular a quantity of marker substance.

[0092] The invention is not limited to one of the embodiments described above, but can be modified in many ways.

[0093] All features and advantages arising from the claims, the description and the drawings, including design details, spatial arrangements and method steps, can be essential to the invention both individually and in a wide variety of combinations.

[0094] Reference symbol:

[0095] 1 Isolator Installation space Working space Flow device Injector Detection device Catalyst Filter unit Suction plenum

[0096] 10 Pressure plenum 0 Air outlet area 0 Air inlet 1 Air outlet 0 Material supply

[0097] 100 regulatory procedures

[0098] 110 Generating an air flow

[0099] 120 Injecting a number of marker substances

[0100] 130 Recording a number of marker substances

[0101] 140a, b Derivation and adjustment of substance concentrations

[0102] 150 Approximation of substance concentrations

[0103] 160 Supplying an air mass

[0104] 170 rules of a drive power

Claims

Claims:

1. Pharmaceutical isolator (1) comprising an internal installation space (2) and a separate working space (3), comprising a number of flow devices (4), particularly in the installation space, which are configured to form a flowing air mass referred to as an air flow in the installation space (2) and the working space (3), comprising a number of filter units (8) configured to filter the air flow before it enters the working space (3), comprising a marker injector (5) configured to inject a number of marker substances, particularly marker aerosols, into the air flow before the air flow enters the number of filter units (8), and comprising a marker detection device (6) which detects the injected number of marker substances in the air flow, particularly a quantity of marker substance, characterized in thatthat the pharmaceutical isolator (1) has a plurality of marker injectors (5) and marker detection devices (6).

2. Isolator (1) according to claim 1, characterized in that a number of marker injectors (5) are connected to a number of substance supplies (50) in a flow-through manner, wherein a number of substance supplies (50) have a quantity limiter which regulates, in particular respectively regulates, the quantity of the number of marker substances supplied to a number of marker injectors (5).

3. Insulator (1) according to claim 1 or 2, characterized in that that a number of marker injectors (5) inject the air flow in a suction plenum (9) with a number of marker substances, wherein the suction plenum (9) comprises a flow space between the working space (3) and a number of air inlets (40) of the number of flow devices (4), and / or that in a pressure plenum (10) a number of detection devices detect a number of marker substances in the air flow, wherein the pressure plenum (10) comprises a flow space between a number of air outlets (41) of the number of flow devices (4) and the working space (3).

4. Isolator (1) according to one of the preceding claims, characterized by a plurality of flow devices (4), wherein each flow device (4) forms a flowing partial air mass referred to as a partial air flow and the partial air flows create a common air flow.

5. Isolator (1) according to claim 4, characterized in that each flow device (4) is assigned a number of marker injectors (5) such that a number of marker injectors (5) each inject a number of marker substances into the partial air flow.

6. Isolator (1) according to one of the preceding claims, characterized in that each filter unit (8) of the number of filter units (8) is assigned a number of marker detection devices (6), such that a number of marker detection devices (6) detects the injected number of marker substances in the air flow entering a single filter unit (8).

7. Insulator (1) according to one of the preceding claims, characterized in that that a number of flow devices (4) are arranged above the working space (3) and / or that a number of flow devices (4) are arranged below the working space (3).

8. Isolator (1) according to one of the preceding claims, characterized by a number of guide elements in the installation space (2) which guide the air flow or a part of the air flow in such a way that the number of guide elements feeds a number of parts of the air flow to a number of filter elements.

9. Isolator (1) according to one of the preceding claims, characterized in that the air flow circulates at least partially within the insulator (1) in such a way that air masses flow through the working space (3) several times.

10. A method (100) for controlling a ventilation system in a pharmaceutical isolator (1), wherein the ventilation system comprises a number of flow devices (4) for forming a flowing air mass referred to as air flow and a number of marker injectors (5) for injecting a number of marker substances into the air flow and a number of marker detection devices (6) for detecting the injected number of marker substances, and wherein the method (100) comprises: a) generating (110) an air flow by means of a number of flow devices (4), b) injecting (120) a number of marker substances into the air flow, c) detecting (130) the number of marker substances in the air flow, d) deriving (140a) an actual marker substance concentration and comparing (140b) the actual marker substance concentration. Concentration with a marker substance target concentration, e) approximating (150) the marker substance actual concentration to the marker substance target concentration, wherein the injection (120) is carried out with a plurality of marker injectors (5), and wherein the detection (130) is carried out with a plurality of marker detection devices (6).

11. The method (100) according to claim 10, characterized in that the approaching (150) comprises: • Injecting (120) a number of marker substances into the air flow, • and / or supplying (160) an air mass into the air flow, • and / or regulating (170) a drive power of a number of flow devices (4), wherein the supplied air mass preferably contains substantially no number of marker substances.

12. Method (100) according to claim 10 or 11, characterized in that during injection (120) a first marker injector (5) injects a first quantity of the number of marker substances (120) and a second marker injector (5) injects a second quantity of the number of marker substances (120), wherein the first quantity differs from the second quantity.

13. Method (100) according to one of claims 10 to 12, characterized in that the number of flow devices (4) each form a flowing partial air mass referred to as a partial air flow, and that during injection (120) a first marker injector (5) injects (120) into a first partial air flow and a second Marker injector (5) injected into a second partial air stream (120).

14. Method (100) according to one of claims 10 to 13, characterized in that during injection (120) the number of marker substances is sprayed and / or dripped into the air flow.

15. Method (100) according to one of claims 10 to 14, characterized in that the ventilation system has a number of filter units (8) for filtering the air flow, and that the number of marker substances is detected (130) before entering a number of filter units (8) and after exiting a number of filter units (8).

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