Pharmaceutical apparatus and method of operating a pharmaceutical apparatus

Abstract

The invention relates to a pharmaceutical manufacturing apparatus (12) and a method of operating a pharmaceutical manufacturing apparatus (12).

Description

Technical Field

[0001] This invention relates to a pharmaceutical equipment, particularly a cleanroom, and a method for operating the pharmaceutical equipment. Background Technology

[0002] Pharmaceutical manufacturing facilities are typically designed as relatively sealed barrier systems.

[0003] In pharmaceutical manufacturing facilities with high dust and / or aerosol loads, especially when these loads are also classified as high-efficiency, so-called BIBO (bag-in-bag-out) filtration systems are used for the recirculation or exhaust of air from production areas. These systems are specifically designed to allow for low-contamination replacement of loaded filter elements when maximum filtration load is reached or at the end of a specified replacement interval.

[0004] Alternatively, cleanable filtration systems are used, which do not require filter replacement. However, these systems do not allow for thorough cleaning of the filter media.

[0005] Pharmaceutical equipment must undergo regular purification treatment. This is done by introducing a purifying agent into the pharmaceutical equipment or barrier system, allowing all contaminated elements to come into contact with the purifying agent, thereby achieving the purpose of purification.

[0006] If an environmentally friendly purifying agent is used, it is called biological purification. Hydrogen peroxide (H2O2) is commonly used for this purpose because it can be degraded into water and oxygen.

[0007] Studies have shown that the load on a filtration system affects the (biological) purification effectiveness of a barrier system. This is particularly true in barrier systems used in powder processing plants, where the dust concentration in the recirculated air is high, resulting in a correspondingly high load on the recirculated air filters. Recirculated air refers to the air recirculated from the barrier system.

[0008] Typically, hygroscopic dust is also involved, the effect of which is that during the (biological) purification process, most of the gaseous purifier in the recirculated air is bound to these dust particles. If the barrier system operates in recirculation, the concentration of purifier bound to the dust cannot be reused for the purification of the entire system.

[0009] In practice, the validation and qualification of such plants are carried out using new (unloaded) filters, so the effects only become apparent after several hours of operation. Therefore, it is possible for such plants to operate non-compliantly without anyone noticing. Summary of the Invention

[0010] The objective of this invention is to provide a pharmaceutical device and a method for operating the pharmaceutical device, while eliminating the aforementioned disadvantages.

[0011] This task is accomplished by pharmaceutical equipment according to the invention, particularly a cleanroom, wherein the pharmaceutical equipment comprises:

[0012] A relatively sealed working space and a filtration system having a first flow path and a first filter.

[0013] A first filter is arranged in the first flow path. The first filter is designed to filter air from the workspace. Therefore, air from the workspace that is guided through the first flow path is filtered by the first filter.

[0014] The filtration system includes a second flow path and a switching device. The switching device is designed to guide air from the workspace through the first flow path, and thus through the first filter, during the operation phase of the pharmaceutical equipment.

[0015] The switching device is also designed to guide air from the workspace through a second flow path only during the purification phase of the pharmaceutical equipment. Therefore, during the purification phase, the first filter does not come into contact with the purifying agent.

[0016] The first and second flow paths may overlap in at least one region. The first and second flow paths may extend together in at least one region, for example, within the same duct. The first and second flow paths may fluidly couple with each other in at least one region. However, if the first and second flow paths extend together or overlap within a section, the first filter is located outside the common section and only comes into contact with air from the workspace when air is directed through the first flow path.

[0017] In this application, "guided only through the first flow path" means that air from the workspace flows through the first flow path only along its entire length. For example, air may also flow through a section shared by the first and second flow paths. In any case, air from the workspace will not flow through the second flow path (along its entire length), if we are talking about flowing only through the first flow path, but at most along the section that may be shared with the first flow path.

[0018] Similarly, "guided only through the second flow path" means that only the second flow path has air flowing completely (along its entire length) from the workspace. For example, air may also flow through a section shared by the second and first flow paths. In any case, when the second flow path is referred to as the only flow path, air from the workspace does not flow completely through the first flow path (along its entire length), but at most along the section it may share with the second flow path.

[0019] In this application, guiding air through or flowing through the first flow path means that the air flows completely through the first flow path, i.e., along its entire length.

[0020] Similarly, when air is directed through or flows through the second flow path, it means that the air flows completely through the second flow path.

[0021] Purification can be achieved by introducing a purifying agent into the workspace. The purifying agent can be a gas. It can be a biological purifying agent. In particular, the purifying agent can be hydrogen peroxide (H₂O₂). Similarly, the purifying agent can be a mixture of hydrogen peroxide and air. It is conceivable that the purifying agent can also be a mixture of hydrogen peroxide and at least one gas.

[0022] In this way, the purifying agent is diverted at the first filter. Therefore, no purifying agent enters or passes through the first filter, which may already be loaded. In other words, the first filter is bypassed. In other words, during or in the purification process, the purifying agent and / or air will not flow through the first flow path.

[0023] Therefore, especially in sterile powder applications, the purifying agent is not filtered out of the purification process by the first filter (which is already loaded), and can be fully used in the purification process during the purification phase.

[0024] Being filtered out means that the purifying agent is bound or retained (chemically or physically) by the first filter or its load and is no longer available for the purification process.

[0025] The air can be recirculated air from the workspace, or it can be exhaust air from the workspace. Recirculated air refers to the air that remains in the workspace (that is being recirculated). Exhaust air refers to the air that is being discharged from the workspace. Similarly, it can be imagined that the air is outside air introduced into the workspace and / or outside air that has been treated (e.g., pre-filtered). Of course, another gas or gas mixture can also be used instead of air.

[0026] The filtration system may include a second filter configured to filter the air in the workspace. The second filter may be arranged in a second flow path, such that air from the workspace is guided through the second flow path and filtered by the second filter.

[0027] This means that during the (biological) purification phase, a potentially loaded first filter can be bypassed by a second, unloaded filter. This ensures that the (biological) purifying agent is available for the purification process, with maximum repeatability even after recirculation.

[0028] The switching device may include at least one valve. This valve may be designed to couple or decouple from the first flow path and the fluid in the workspace. Alternatively or additionally, the valve may be configured to couple or decouple a second flow path from the fluid in the workspace. In particular, the switching device may include two valves configured such that a first valve couples or decouples the first flow path from the fluid in the workspace, and a second valve couples or decouples the second flow path from the fluid in the workspace.

[0029] Fluid coupling means that a fluid (gas or liquid) can flow freely between at least two fluidly coupled elements. Conversely, fluid decoupling means that a fluid (gas or liquid) cannot flow between two fluidly decoupled elements.

[0030] The first filter can be arranged inside the pharmaceutical equipment, particularly within the workspace. Alternatively or additionally, the second filter can also be arranged inside the pharmaceutical equipment, particularly within the workspace. In particular, all components of the entire filtration system can be arranged inside the pharmaceutical equipment, particularly within the workspace.

[0031] However, it is conceivable that the first filter can also be arranged outside the working space, particularly outside the pharmaceutical equipment. Alternatively or additionally, the second filter can also be arranged outside the working space, particularly outside the pharmaceutical equipment. In particular, all components of the entire filtration system can be arranged outside the working space, particularly outside the pharmaceutical equipment. The filtration system or its components can be fluidly coupled, particularly via piping, to the pharmaceutical equipment, particularly to the working space.

[0032] The filtration system can be designed to direct air from the workspace through a first filter and a second filter during the operation phase of the pharmaceutical equipment. This allows the second filter to take over the function of the first filter during operation.

[0033] The first and second filters can be arranged in series. The second filter can be connected downstream of the first filter. In particular, the second filter can be a warning filter. Therefore, the second filter can perform additional filtration functions as well as a backup function. If the first filter fails, the second filter can take over the filtration function of the first filter, thus maintaining proper filtration. In doing so, a second flow path can guide air from the workspace parallel to bypass the first filter and pass through the second filter.

[0034] The first and second filters can be arranged parallel to each other in the fluid. Therefore, air can be directed through a first flow path (e.g., during operation) and thus through the first filter, or directed through a second flow path (e.g., during purification) and thus through the second filter.

[0035] The switching device can be designed to direct air from the workspace through only the first flow path during the operation phase of the pharmaceutical equipment. In other words, during the operation phase of the pharmaceutical equipment, no air from the workspace is directed through the second flow path, and thus through the second filter. In this way, the second flow path or the second filter can be prevented from becoming loaded (contaminated), or at least minimized.

[0036] Furthermore, the task to be solved is to be addressed by a method of operating a pharmaceutical device having a relatively environmentally sealed working space, wherein the pharmaceutical device also includes a filtration system having a first flow path and a first filter.

[0037] In this respect, the first filter is disposed in the first flow path and configured to filter air from the workspace that is guided through the first flow path.

[0038] The filtration system includes a second flow path and a switching device. The switching device can be used to switch the airflow from the workspace between the first and second flow paths.

[0039] The method includes:

[0040] During the operation phase of the pharmaceutical equipment, air from the workspace is guided through a first flow path. During the purification phase of the pharmaceutical equipment, air from the workspace is guided through a second flow path, specifically through a second filter.

[0041] Purification can be achieved by introducing a purifying agent into the workspace. The purifying agent can be gaseous. It can be a biological purifying agent. In particular, the purifying agent can be hydrogen peroxide (H₂O₂). Similarly, the purifying agent can be a mixture of hydrogen peroxide and air. It is conceivable that the purifying agent can also be a mixture of hydrogen peroxide and at least one gas.

[0042] The operation of pharmaceutical equipment includes the operation phase and the purification phase.

[0043] During the operation phase of the pharmaceutical equipment, air from the workspace can be guided through only the first flow path and the first filter, and thus can be filtered by means of only the first filter.

[0044] During the operation of the pharmaceutical equipment, air from the workspace can be guided through a first flow path and a first filter, and additionally through a second flow path and a second filter. Therefore, during the operation of the pharmaceutical equipment, air from the workspace can be filtered by means of the first filter and additionally by means of the second filter. The second filter is arranged downstream of the first filter in the flow direction. Therefore, when air passes through the first flow path, the second filter is only exposed to air that has already been filtered by the first filter.

[0045] To perform this method, pharmaceutical equipment with the above-mentioned characteristics, especially clean rooms, can be used. Attached Figure Description

[0046] Other features, details, and advantages of the invention will become apparent from the wording of the claims and the following description of embodiments based on the accompanying drawings. Wherein:

[0047] Figure 1 This is a schematic diagram of pharmaceutical equipment during the operation phase;

[0048] Figure 2 It is based on Figure 1 A schematic diagram of pharmaceutical equipment in the purification stage;

[0049] Figure 3 This is a schematic diagram of another embodiment of the pharmaceutical equipment;

[0050] Figure 4 It is based on Figure 3 A schematic diagram of pharmaceutical equipment during the operation phase;

[0051] Figure 5 It is based on Figure 3 A schematic diagram of pharmaceutical equipment in the purification stage;

[0052] Figure 6 This is a schematic diagram of another embodiment of a pharmaceutical equipment.

[0053] In the accompanying drawings and the following description, corresponding parts and elements have the same reference numerals. For better understanding, not all reference numerals are shown in all drawings. Detailed Implementation

[0054] Figure 1 A schematic diagram of the pharmaceutical equipment 12 during its operation is shown. In this example, the pharmaceutical equipment 12 is designed in the form of a cleanroom 14. The cleanroom 14 has a workspace 16, which is relatively enclosed.

[0055] The cleanroom 14 also includes a filtration system 10. Currently, the filtration system 10 is arranged within the workspace 16. The filtration system 10 includes a first flow path 11 and a first filter 18.

[0056] The filtration system 10 also includes a second flow path 13 and a switching device 22. The switching device 22 is designed such that air from the workspace 16 can be selectively directed through the first flow path 11 and thus through the first filter 18, or directed through the second flow path 13. For this purpose, the switching device 22 includes two valves 24. In the illustrated embodiment, a first valve 23 is arranged within the first flow path 11, and a second valve 25 is arranged within the second flow path 13.

[0057] The first flow path 11 can be opened / closed by opening / closing the first valve 23. In other words, the first flow path 11 can be fluidly coupled or decoupled from the working space 16 by means of the first valve 23.

[0058] Therefore, the second flow path 13 can be opened or closed by opening / closing the second valve 25. In other words, by means of the second valve 25, the second flow path 13 can be fluidly coupled or decoupled from the working space 16.

[0059] Figure 1 The cleanroom 14 is shown during the operational phase. Air is drawn from the workspace 16 into the filtration system 10 and guided through a first flow path 11 and a first filter 18. Figure 1 In the diagram, the first flow path 11 is roughly marked, and the path of air through the first flow path 11 is indicated by three thick arrows.

[0060] In the illustrated state (operation phase), the first valve 23 is open, so air can flow from the working space 16 through the first flow path 11 and thus through the first filter 18. In other words, the first flow path 11 is fluidly coupled to the working space 16 by means of the open first valve 23.

[0061] In the illustrated state (operation phase), the second valve 25 is closed, so air from the workspace 16 cannot flow through the second flow path 13. In other words, the second flow path 13 is fluidly decoupled from the workspace 16 by means of the closed second valve 25.

[0062] Figure 2 It is based on Figure 1 This is a schematic diagram of the pharmaceutical equipment during the purification stage. The second flow path 13 is indicated by a thick line.

[0063] During the purification phase, the pharmaceutical equipment, especially the workspace 16, is purified.

[0064] During the purification phase, a purifying agent (particularly gaseous hydrogen peroxide) is introduced into the working space 16. Alternatively or additionally, the purifying agent may be introduced into the filtration system 10, particularly into the second flow path 13.

[0065] Air, particularly air purification agent, from workspace 16 is drawn into filtration system 10 and guided through second flow path 13. The air or air purification agent travels along the path of second flow path 13... Figure 2 The middle is indicated by three thick arrows.

[0066] In the illustrated state (purification phase), the second valve 25 is open, allowing air to flow from the workspace 16 through the second flow path 13. In other words, the second flow path 13 is fluidly coupled to the workspace 16 by means of the open second valve 25.

[0067] In the illustrated state (purification phase), the first valve 23 is closed, so air from the workspace 16 cannot flow through the first flow path 11 and thus through the first filter 18. In other words, by means of the closed first valve 23, the first flow path 11 and the first filter 18 are fluidly decoupled from the workspace 16.

[0068] In other words, during the purification phase, neither air nor the purifying agent flows through the first filter 18. Therefore, during operation, the load on the first filter 18 or the particles filtered out of the filter 18 cannot interact with the air or the purifying agent. Thus, during the purification phase, the purifying agent can be fully utilized in the purification process.

[0069] exist Figures 1 to 6 In the illustrated embodiment, the first flow path 11 and the second flow path 13 have a first common section 17 and a second common section 19. In this example, the first flow path 11 and the second flow path 13 extend along a common conduit in the two common sections 17, 19. In other words, the first flow path 11 and the second flow path 13 are fluidly coupled along the common sections 17, 19. Of course, it is conceivable that the first flow path 11 and the second flow path 13 do not have a common section and are formed separately from each other.

[0070] Figure 3 A schematic diagram of another embodiment of the pharmaceutical device 12 is shown. The embodiment shown differs from the previous one in that a second filter 20 is arranged within a second flow path 13. As air from the workspace 16 is guided through the second flow path 13, it also flows through the second filter 20.

[0071] Figure 4 It shows that according to Figure 3 A schematic diagram of the pharmaceutical equipment 12 during the operation phase.

[0072] During operation, air is drawn from the workspace 16 into the filtration system 10 and guided through the first flow path 11, thereby passing through the first filter 18. For this purpose, the first flow path 11 is fluidly coupled to the workspace 16 by means of an open first valve 23.

[0073] In this example, during the operation phase, the second flow path 13 and the second filter 20 are fluidly decoupled from the working space 16 by means of a closed second valve 25. In other words, during the operation phase, no air flows through the second flow path 13 or the second filter 20. In this way, the second flow path 13, and in particular the second filter 20, can be prevented from being loaded during the operation phase, for example, by particulate loading generated during the operation phase.

[0074] Figure 5 It is based on Figure 3 A schematic diagram of pharmaceutical equipment 12 in the purification stage.

[0075] During the purification phase or process, air is drawn from the workspace 16 into the filtration system 10 and guided through the second flow path 13, thereby passing through the second filter 20. The path of the air through the second flow path 13 is... Figure 5 The middle is indicated by three thick arrows.

[0076] During the purification phase, the first flow path 11 is fluidly decoupled from the working space 16 by means of the closed first valve 23.

[0077] During the purification phase, the second flow path 13 and the second filter 20 are fluidly coupled to the working space 16 by means of the opened second valve 25.

[0078] Therefore, the purifying agent is directed only through the second flow path 13, and thus only through the second filter 20. The purifying agent does not pass through the first flow path 11, and therefore does not enter the first filter 18. Therefore, the purifying agent cannot interact with the load of the first filter 18, so the purifying agent cannot be filtered out (see above), and thus can be fully utilized in the purification process during the purification phase.

[0079] Figure 6 A schematic diagram of another embodiment of the pharmaceutical device 12 is shown. Here, the first filter 18 and the second filter 21 are connected in series in terms of fluid flow.

[0080] Here, the first filter 18 is arranged within the first flow path 11. The second filter 21 is arranged downstream of the first filter 18 and is located in the common section 19 of the first flow path 11 and the second flow path 13.

[0081] In the illustrated device, the second filter 20 performs the function of the so-called warning filter 21. During operation, air is drawn from the workspace 16 into the filtration system 10 and guided through the first flow path 11.

[0082] Therefore, the first valve 23 is opened to fluidly couple the first flow path 11 with the working space 16. The second valve 25 is closed to fluidly decouple the second flow path 13 from the working space 16.

[0083] Air guided through the first flow path 11 is filtered by a first filter 18. The filtered air is then further guided through a common section 19 and a second filter 20. The second filter 20 serves as a backup. If the first filter 18 fails during operation, the second filter 20 (as a warning filter 21) can take over the function of the first filter 18, thereby ensuring the filtration function of the filtration system 10.

[0084] During the purification phase, the first valve 23 is closed and the second valve 25 is opened. This directs the air or purifier drawn in from the workspace 16 through the second flow path 13 into the filtration system 10, thus bypassing the first filter 18.

[0085] In this example, the second flow path 13 leads to the common section 19 upstream of the second filter 20, thereby bypassing the first filter 18 during the purification stage, so that air or purifier is only guided through the second filter 20.

[0086] In other words, during the purification phase, the air or purifying agent is diverted via the second flow path 13 to bypass the first filter 18. For example... Figure 6 The first valve 23 shown is closed during the purification phase to prevent air or purifying agent from flowing through the first filter 18. In other words, during the purification process, the closed first valve 23 fluidly decouples the first filter 18 from the working space 16.

[0087] During the purification process, the purifying agent or air from the workspace 16 is only directed through the second filter 20. Therefore, the purifying agent will not come into contact with the first filter 18 or its load.

Claims

1. A pharmaceutical manufacturing device (12), comprising: - A sealed workspace relative to its environment (16); - A filtration system (10) including a first flow path (11) and a first filter (18). The first filter (18) is disposed in the first flow path (11) and configured to filter air from the workspace (16) that is guided through the first flow path (11). The filtration system (10) is characterized by comprising a second flow path (13) and a switching device (22) designed to guide air from the workspace (16) through the first flow path (11) and thus through the first filter (18) during the operation phase of the pharmaceutical equipment (12), while guiding air from the workspace (16) through only the second flow path (13) during the purification phase of the pharmaceutical equipment (12), in which a purifying agent is supplied to the workspace (16) so that the first filter (18) does not come into contact with the purifying agent during the purification phase, wherein the air is recirculated air recirculated in the workspace (16). The filtration system (10) includes a second filter (20) arranged in the second flow path (13) and designed to filter air from the workspace (16) that is guided through the second flow path (13). The first filter (18) and the second filter (20) are arranged in series with each other in the fluid, the second filter (20) is arranged downstream of the first filter (18), and the second flow path (13) guides the air from the workspace (16) to bypass the first filter (18) and pass through the second filter (20) in parallel.

2. The pharmaceutical equipment (12) according to claim 1, characterized in that, The pharmaceutical equipment (12) is a clean room (14); and / or The purifying agent is a gaseous purifying agent; and / or The first filter (18) does not come into contact with air from the workspace (16) during the purification phase; and / or The purification stage is a biological purification stage, in which hydrogen peroxide is introduced into the workspace (16).

3. The pharmaceutical equipment (12) according to claim 1 or 2, characterized in that, The switching device (22) includes at least one valve (24, 23, 25) designed to allow the first flow path (11) and / or the second flow path (13) to be fluidly coupled and / or decoupled from the workspace (16).

4. The pharmaceutical equipment (12) according to claim 1 or 2, characterized in that, The first filter (18) is arranged inside the pharmaceutical equipment (12).

5. The pharmaceutical equipment (12) according to claim 4, characterized in that, The first filter (18) is arranged in the workspace (16).

6. The pharmaceutical equipment (12) according to claim 1 or 2, characterized in that, The second filter (20) is arranged inside the pharmaceutical equipment (12).

7. The pharmaceutical equipment (12) according to claim 6, characterized in that, The second filter (20) is arranged within the workspace (16).

8. The pharmaceutical equipment (12) according to claim 1 or 2, characterized in that, The first filter (18) is located outside the workspace (16).

9. The pharmaceutical equipment (12) according to claim 8, characterized in that, The first filter (18) is arranged outside the pharmaceutical equipment (12).

10. The pharmaceutical equipment (12) according to claim 1 or 2, characterized in that, The second filter (20) is arranged outside the workspace (16).

11. The pharmaceutical equipment (12) according to claim 10, characterized in that, The second filter (20) is disposed outside the pharmaceutical equipment (12).

12. The pharmaceutical equipment (12) according to claim 1 or 2, characterized in that, The switching device is designed to guide air from the workspace (16) through the first filter (18) and the second filter (20) during the operation phase of the pharmaceutical equipment (12).

13. The pharmaceutical equipment (12) according to claim 1 or 2, characterized in that, The second filter (20) is an alert filter (21).

14. The pharmaceutical equipment (12) according to claim 1 or 2, characterized in that, The first filter (18) and the second filter (20) are arranged parallel to each other in the fluid.

15. A method of operating a pharmaceutical device (12), said pharmaceutical device comprising a workspace (16) sealed relative to its environment, said pharmaceutical device (12) further comprising a filtration system (10) having a first flow path (11) and a first filter (18), wherein, The first filter (18) is disposed in the first flow path (11) and configured to filter air from the workspace (16) guided through the first flow path (11). The filtration system (10) further includes a second flow path (13) and a switching device (22) by means of the switching device, which allows airflow from the workspace (16) to switch between the first flow path (11) and the second flow path (13). The filtration system (10) includes a second filter (20) disposed in the second flow path (13) and designed to filter air from the workspace (16) guided through the second flow path (13). The first filter (18) and the second filter (20) are arranged in series with each other in fluid flow. The second filter (20) is disposed downstream of the first filter (18). The second flow path (13) guides air from the workspace (16) parallel around the first filter (18) and through the second filter (20). The method includes: During the operation phase of the pharmaceutical equipment (12), air from the workspace (16) is guided through the first flow path (11). During the purification phase of the workspace (16), air from the workspace (16) is guided through the second flow path (13) only. During the purification phase, a purifying agent is introduced into the workspace (16), wherein the air is recirculated air that is recirculated in the workspace (16).

16. The method according to claim 15, characterized in that, The purifying agent is a gaseous purifying agent.

17. The method according to claim 15 or 16, characterized in that, During the operation phase of the pharmaceutical equipment (12), air from the workspace (16) is additionally guided through the second flow path (13).

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