Method for controlling a production process performed on a production plant, in particular for producing pharmaceutical products

Abstract

The invention relates to a method for controlling a production process performed on a production plant (1), in particular for producing pharmaceutical products.

Description

Technical Field

[0001] The present invention relates to a method for controlling a production process performed on production equipment, particularly for the production of pharmaceuticals. Background Technology

[0002] Methods for controlling manufacturing processes (whether continuous or intermittent) performed on production equipment for manufacturing products, particularly pharmaceuticals, and the associated production equipment for implementing these methods have long been known.

[0003] WO 2010 / 128359 A1 discloses a method for continuously manufacturing tablets, comprising the steps of: providing a closed production apparatus having at least two inlets, at least one mixing unit, at least one analytical sensor, a tablet press, and at least one outlet for tablets; supplying an active pharmaceutical ingredient (API) through one of the at least two inlets; supplying excipients through the other of the at least two inlets; mixing the active pharmaceutical ingredient and excipients in the at least one mixing unit to form a material flow; measuring parameters of the material flow upstream of the tablet press using at least one analytical sensor; controlling the two inlets and / or the mixing unit based on the measured parameters; continuously supplying the material flow to the tablet press; controlling the speed of the tablet press based on the parameters measured upstream of the tablet press; and discharging tablets at the at least one outlet. Furthermore, WO 2010 / 128359 A1 also discloses a production apparatus for carrying out this method.

[0004] The drawback of this method and its associated production equipment is that, in order to allow for the manufacturing process, particularly for pharmaceutical products, at least two qualified and trained operators are required. These operators must inspect the production equipment for errors in the installation or use of process units (such as mixing mechanisms or tablet presses). This inspection of the method and equipment is not only costly but also highly susceptible to errors due to human factors, particularly fatigue, inattention, negligence, lack of attention to detail, and signing off without verification. Summary of the Invention

[0005] Therefore, the object of the present invention is to propose measures suitable for eliminating the disadvantages of the prior art in a method for controlling a production process performed on production equipment (for manufacturing products, particularly pharmaceuticals), thereby meeting high quality requirements for the performed production process.

[0006] This objective is achieved by a method for controlling a manufacturing process executed on a production equipment, particularly for manufacturing pharmaceuticals, wherein the production equipment has multiple process units and a control mechanism for controlling these process units, wherein at least one process unit has or forms at least one process plug-in, the process plug-in having or forming at least one process plug-in assembly, wherein at least one process plug-in assembly is a replaceable process plug-in assembly, and at least one replaceable process plug-in assembly is an identifiable process plug-in assembly equipped with a data carrier, wherein the data carrier has process plug-in assembly parameters of the replaceable process plug-in assembly equipped therewith, wherein a process-specific configuration scheme of the production equipment and its corresponding process plug-ins can be stored in the control mechanism, and wherein, before, during, or after the process plug-in assembly is assembled into a process plug-in, the process plug-in assembly parameters of the identifiable process plug-in assemblies respectively installed in the process plug-ins are transmitted to the control mechanism, thereby subsequently checking the process plug-in assembly parameters in the control mechanism to determine whether at least one identifiable process plug-in assembly has been installed in the corresponding process plug-in according to the stored configuration scheme, and, if "yes," allowing or enabling the manufacturing process to be executed on the production equipment.

[0007] The products manufactured on the production equipment are preferably pharmaceutical products, fine chemicals, and / or food and feed. Pharmaceutical products are designed in various dosage forms, particularly solid, semi-solid, or liquid dosage forms. Fine chemicals, in particular, refer to complex, single, and pure chemical substances manufactured in limited quantities through multi-stage chemical or biotechnological production processes. They are specified with precise specifications and are intended for further processing in the chemical industry.

[0008] The configuration scheme specifically includes identifiable process module components that need to be installed in the corresponding process modules according to the stored configuration scheme. Furthermore, the configuration scheme may also include other information relevant to the production processes permitted to be performed on the production equipment, such as information related to the maintenance and safety of the corresponding process module components. Particularly preferably, the configuration scheme also stores the cleaning status or maintenance due date of the corresponding process module components (e.g., filters). Thus, in addition to correctly installing the corresponding process module components, it additionally checks whether the corresponding process module components have been cleaned or maintained as required, or, for example, whether they need to be cleaned again before installation. Furthermore, the configuration scheme may contain information that completely prevents the installation of a certain process module component. This is the case for filters, for example; if a filter is used in the manufacture of a specific pharmaceutical product, even after cleaning, the filter can only be used to manufacture that specific pharmaceutical product. Therefore, this configuration scheme is also suitable for preventing contamination of pharmaceutical products due to incorrect use of process modules.

[0009] The proposed method requires only one qualified and trained operator, with the correctness of the installed replaceable process component checked by a control mechanism.

[0010] In a preferred embodiment, the data carrier is designed, for example, as a readable RFID transponder. The process component parameters are read from the data carrier by an RFID transponder reader and transmitted or are capable of being transmitted to a control mechanism. Furthermore, preferably, the RFID transponder reader is designed as an authenticated and verified reader, i.e., it has, for example, a personalized account for the operator. By using an RFID transponder reader with a personalized account to read the RFID transponder of an installed process component, it is possible to prove and record who installed it and when.

[0011] In addition, the data carrier can preferably be designed as a QR code or a simple digital code on the process plug-in component.

[0012] In addition, by reading the data carrier and checking the process module component parameters in the control mechanism, the selected replaceable process module component is identified as having been correctly installed in the process module of the process unit.

[0013] Furthermore, by using identifiable process component parts, the usage of these parts can be recorded, enabling easy determination of wear and tear.

[0014] In summary, the method according to the invention thus improves the reliability of meeting the quality requirements imposed on the production process. When using the method according to the invention, replaceable process component parts can be correctly installed in the production equipment with almost 100% reliability.

[0015] Although the terms "process unit," "process module," and "process module component" have been used in the preceding and following text, in this method, they may also refer to a single process unit, a single process module, and a single process module component. Referring to a replaceable process module component should be understood as referring to one or more replaceable process module components.

[0016] Advantageous improvements of the invention are set forth in the dependent claims.

[0017] Preferably, a large number of specific configuration schemes are stored in the control mechanism, which can be individually selected by the operator for the production process to be performed on the production equipment. By storing multiple configuration schemes for the production equipment, the production equipment can be used for multiple production processes, thereby significantly reducing the time required to modify the production equipment to another production process.

[0018] Suitablely, the control mechanism is configured to output a list of identifiable process insert components to be installed in the production equipment, based on a configuration scheme selected for the production process executed on the production equipment. By outputting this list (either digitally displayed on an optional display mechanism of the production equipment or shown in printed form), operators can save time by assembling and retrofitting replaceable process insert components in the production equipment.

[0019] Advantageously, the production equipment has a display mechanism that shows at least one identifiable process plug-in component that has been incorrectly installed in the corresponding process plug-in according to a stored configuration scheme. This visual display of identifiable process plug-in components (e.g., green for correct, replaceable, identifiable process plug-in components and red for incorrectly used, replaceable, identifiable process plug-in components) further improves process reliability, thereby also improving the quality of the production process.

[0020] Preferably, the display mechanism (particularly a movable display mechanism) displays, for each incorrectly installed identifiable process component, other identifiable process components that must be installed to obtain production process approval. This allows operators to immediately identify which process component needs to be installed in the production equipment for the incorrectly installed one.

[0021] Particularly preferably, the display mechanism also displays where other identifiable process component parts are stored in the storage section of the production equipment, for example, process component parts with the same structure in the storage section, so that defective process component parts can be replaced, either directly or in a controlled manner, with process component parts that are acceptable in the system.

[0022] Advantageously, the production equipment and its corresponding process modules, stored in the control mechanism, are configured in a process-specific manner. This includes, and / or, the process module component parameters of the identifiable process module components installed within the process modules, transmitted to the control mechanism before, during, or after the process module components are assembled into a process module, and / or the results of checks performed on the process module component parameters after their transmission to the control mechanism. All database entries are preferably electronically signed and dated and timestamped.

[0023] Ideally, once data is stored in the database, it cannot be changed or modified, i.e., it is stored tamper-proofly. In addition to verifying process plug-in components in the control mechanism, all data required for the production process is perfected and verified before the process begins by directly electronically entering other information into the database.

[0024] This eliminates the possibility of data entry errors and enables complete and seamless recording and archiving of information such as the usage of process units and their related process components, as well as other information, resulting in better traceability and recordability. This allows for complete tracking of, for example, the usage of process units, so that subsequent analyses can assess and / or map their actual usage, utilization rate, and depreciation.

[0025] Furthermore, production process procedures, such as batch procedures or schemes to simplify operations, can be further standardized to better and more efficiently train operators and better comply with current and future regulations for the production processes of pharmaceutical products, in particular.

[0026] The aforementioned method is particularly performed on a production facility for manufacturing products, particularly pharmaceutical products, through a production process executed on the facility. The facility has multiple process units and a control mechanism for controlling these process units. At least one process unit has or forms at least one process plug-in, which has or forms at least one process plug-in assembly. At least one process plug-in assembly is a replaceable process plug-in assembly, and is an identifiable process plug-in assembly equipped with a data carrier containing process plug-in assembly parameters. The control mechanism stores process-specific configuration schemes of the production facility and its corresponding process plug-ins. Before, during, or after the process plug-in assemblies are assembled into process plug-ins, the process plug-in assembly parameters of the identifiable process plug-in assemblies installed in the process plug-ins are transmitted to the control mechanism, whereby the process plug-in assembly parameters are subsequently checked to determine whether at least one identifiable process plug-in assembly has been installed in the corresponding process plug-in according to the stored configuration scheme. The control mechanism is configured to allow the production process to be executed on the production facility if the condition is "yes."

[0027] The proposed production equipment can be configured by only one qualified and trained operator, with the correctness of the installed replaceable process component being checked by a control mechanism.

[0028] In a preferred embodiment of the production equipment, the data carrier is designed, for example, as a readable RFID transponder. Process component parameters are read from the data carrier by an RFID transponder reader and transmitted or are capable of being transmitted to a control mechanism. Furthermore, preferably, the RFID transponder reader is designed to be an authenticated and verified reader; that is, it has, for example, a personalized account for the operator. By using an RFID transponder reader with a personalized account to read the RFID transponder of an installed process component, it is possible to prove and record who installed it and when.

[0029] Furthermore, by reading the data carrier and checking the process module component parameters in the control mechanism, the selected replaceable process module component can be verified as correctly installed in the process module of the process unit. Using the identifiable process module component, a usage document is also generated, which allows for easy determination of wear and tear.

[0030] In summary, this production equipment further improves the reliability of meeting the quality requirements imposed on the production process. When using the production equipment to perform the method according to the invention, replaceable process component parts are correctly installed in the production equipment with almost 100% reliability.

[0031] In a preferred embodiment of the production equipment, the control mechanism has a database designed to store a large number of specific configuration schemes, which can be individually selected by the operator for each production process executed on the production equipment. Because multiple configuration schemes of the production equipment can be stored in the database, the production equipment can be used for various production processes, significantly reducing the time required to switch the production equipment to another production process.

[0032] Suitablely, the control mechanism is configured to output a list of identifiable process insert components to be installed in the production equipment, based on a configuration scheme selected for the production process executed on the production equipment. By displaying the list digitally on an optional display mechanism of the production equipment or showing it on paper, operators can save time by assembling the replaceable process insert components and retrofitting them into the production equipment.

[0033] According to another advantageous design of the production equipment, it has a display mechanism configured to display at least one identifiable process insert component that has been incorrectly installed in a corresponding process insert according to a stored configuration scheme. This visual display of identifiable process insert components (e.g., green for correct, replaceable, identifiable process insert components and red for incorrectly used, replaceable, identifiable process insert components) further improves process reliability, thereby also improving the quality of the production process.

[0034] In this regard, the display mechanism (particularly preferably a movable display mechanism) is suitably configured to display, for each incorrectly installed identifiable process component, other identifiable process component that must be installed to obtain production process approval. This allows operators to immediately identify which process component needs to be installed in the production equipment for the incorrectly installed one.

[0035] Furthermore, the display mechanism is configured to show where other identifiable process component parts are stored in the storage section of the production equipment. In the storage section, corresponding process component parts are assigned, for example, process component parts with identical structures, so that defective process component parts can be directly and controlledly replaced with system-acceptable process component parts. In another preferred embodiment, the display mechanism is adapted to display the path of other identifiable process component parts stored in the storage section. Here, known GPS signals are used to display this path on the display mechanism.

[0036] If the control unit has a database, the production equipment is suitable for storing the parameters of the identifiable process component installed in the process modules, which are transmitted to the control unit before, during, or after the process module components are assembled into a process module. Here, all database entries are preferably electronically signed and dated and timestamped.

[0037] Ideally, once data is stored in the database, it cannot be changed or modified, i.e., it is stored tamper-proofly. In addition to verifying process plug-in components in the control mechanism, all data required for the production process is perfected and verified before the process begins by directly electronically entering other information into the database.

[0038] This eliminates the possibility of data entry errors and enables complete and seamless recording and archiving of information such as the usage of process units and their related process components, as well as other information, resulting in better traceability and recordability. This allows for complete tracking of, for example, the usage of process units, so that subsequent analyses can assess and / or map their actual usage, utilization rate, and depreciation.

[0039] Furthermore, production process procedures, such as batch procedures or schemes to simplify operations, can be further standardized to better and more efficiently train operators and better comply with current and future regulations for the production processes of pharmaceutical products, in particular.

[0040] The control mechanism advantageously includes a comparison mechanism designed to check the parameters of process plug-in components within the control mechanism to determine whether at least one identifiable process plug-in component has been installed in the corresponding process plug-in according to the stored configuration scheme. This enables further automation of the methods executed on the production equipment, thereby additionally improving process reliability.

[0041] The control mechanism also suitably includes an evaluation mechanism designed to assess the results of inspections conducted in the comparison mechanism, and, if the evaluation is successful, permit the production process to be executed on the production equipment. This evaluation mechanism can also further automate the methods executed on the production equipment, thereby additionally improving process reliability.

[0042] According to another preferred embodiment, the data carrier is designed as a readable RFID transponder, and the parameters of the process plug-in components can be read from the data carrier using an RFID transponder reader associated with the production equipment and transmitted to the control mechanism. More preferably, the RFID transponder reader is designed as an authenticated and verified reader, that is, it has, for example, a personalized account for the operator. By using an RFID transponder reader with a personalized account to read the RFID transponder of the installed process plug-in component, it is possible to prove and record who installed it and when.

[0043] In addition, by reading the data carrier and checking the parameters of the process plug-in components in the control mechanism, the selected replaceable process plug-in components are identified as having been correctly installed in the process plug-in of the process unit.

[0044] By using identifiable process plug-in components, documentation on the usage of these components can be generated, enabling easy determination of wear and tear.

[0045] Furthermore, the control mechanism is preferably configured to store the production equipment and its corresponding process components' production process-specific configuration schemes, and / or the process component parameters of identifiable process component parts installed in the process components that are transmitted to the control mechanism before, during, or after the process component parts are assembled into a process component, and / or the results of checks on the process component parameters after they are transmitted to the control mechanism, as data in a database. Suitablely, this data cannot be changed or modified after being stored in the database. Here, all database entries are preferably electronically signed and dated and timestamped, thereby further improving process reliability.

[0046] The process unit is preferably designed as a reactant storage container, a dispensing mechanism, a mixing mechanism, a granulator, a screening mechanism, a drying mechanism, a filtration mechanism, an intermediate product conveying container, a product conveying container, a tablet press, a container cleaning mechanism, a coating mechanism, a conveying mechanism, a packaging machine, or a drive mechanism.

[0047] In this regard, granulators are advantageously designed as fluidized bed granulators, jet bed granulators, or rotor granulators.

[0048] Advantageously, packaging machines are designed in particular as deep-drawing packaging machines, blow-fill-seal packaging machines, or blister packaging machines.

[0049] According to another preferred embodiment of the production equipment, the process insert is designed as a mixing unit or nozzle device or sealing unit or screening unit or filtering unit or hose line or pipeline or valve device or perforated plate or pump or rotor unit or sensor unit or motor.

[0050] For production equipment, the process plug-in component is further preferably designed as a mixer or screen bottom or screen body or seal or thermocouple or analytical sensor or internal pipeline or external pipeline or nozzle base or nozzle or filter or pump impeller or valve or die table or punch or rotor disc.

[0051] The following example of pharmaceutical products illustrates why the method and production equipment according to the present invention are advantageous:

[0052] To manufacture pharmaceuticals, product-specific instructions for manufacturing are required, in accordance with national and regional regulations. These instructions for manufacturing are binding on pharmaceutical manufacturers because they are part of the marketing authorization application documents, and regulatory authorities (such as the German Federal Institute for Drugs and Medical Products, the US FDA, and the European Medicines Agency EMA) use these documents to approve the marketing of pharmaceuticals.

[0053] The production manual specifies in particular detail each process step, as well as the production equipment and its corresponding configuration. Typically, this includes product feeders, product conveying containers, intermediate product conveying containers, process units, process inserts, and process insert assemblies, which are considered part of the production equipment configuration.

[0054] By using a pre-defined configuration, the manufacturing process is validated, providing written evidence that the drug achieves the specified product quality when the prescribed production steps are performed consecutively. Therefore, proper configuration is a crucial quality assurance measure for drug manufacturing.

[0055] The method and production equipment according to the invention can identify faulty or incomplete configurations of the production equipment, wherein when the configuration of the production equipment is faulty or incomplete, the system will prevent the production process to be executed on the production equipment; while when the configuration of the production equipment is correct, the system will approve the production process to be executed on the production equipment.

[0056] Integrating data carriers (especially RFID transponders) into the various process component modules with a prescribed configuration enables the implementation of such quality assurance measures and allows for other measures in several ways that support and facilitate quality assurance, and further reduce the risks that may arise.

[0057] a) Using a data carrier, each process module component can be individually identified and uniquely assigned;

[0058] b) By reading the data carrier integrated into the replaceable process module component, information about the life cycle of the process module component can be additionally recorded;

[0059] c) By reading the data carrier installed in the process plug-in component, it is possible to check whether the operator has selected and installed the correct (i.e., the specified) process plug-in component;

[0060] d) By pre-defining the validity period, it is possible to monitor whether the process plug-in components are still usable, need to be replaced, or need to be cleaned during the reading process;

[0061] e) The status of process plug-in components can be visualized using appropriate software. The visualization results can directly indicate whether the correct process plug-in component has been installed in the process unit's process plug-in (e.g., displayed in green) or the incorrect process plug-in component (e.g., displayed in red);

[0062] f) For each replaceable process component, process components with the same structure are assigned to the warehouse department, so that, for example, defective process components can be directly and in a controlled manner replaced by process components accepted on the system side.

[0063] g) By using an RFID transponder reader with a personalized account to read the RFID transponder of the installed process plug-in component, it is possible to prove and record who installed it and when.

[0064] h) This assembly process design eliminates the need for four-eye inspection or manual recording; it avoids batch defects caused by incorrect equipment configuration due to employee operational errors. Attached Figure Description

[0065] The invention will now be described in more detail with the aid of the accompanying drawings, in which:

[0066] Figure 1 This is a schematic diagram of the first embodiment of the production equipment;

[0067] Figure 2 This is a schematic diagram of a second embodiment of the production equipment;

[0068] Figure 3 A top view of an embodiment of the nozzle device;

[0069] Figure 4 For the nozzle device along Figure 3 The sectional view of section AA shown;

[0070] Figure 5 For the nozzle device Figure 4 A magnified view of part B shown;

[0071] Figure 6 This is a bottom view of an embodiment of the nozzle device;

[0072] Figure 7 A front view of a flexible internal piping section with couplings;

[0073] Figure 8 For the flexible inner pipeline section along Figure 7 A sectional view of section CC shown;

[0074] Figure 9 A side view of the coupling; and

[0075] Figure 10 For the edge of the coupling element Figure 9 The cross-sectional view of section DD shown. Detailed Implementation

[0076] Figure 1 The diagram shown is a schematic of a first embodiment of production equipment 1, which is used to manufacture (solid) pharmaceutical products in solid dosage form, here tablets, by means of a production process performed on production equipment 1.

[0077] Production equipment 1 has multiple process units 2 and control mechanisms 3 that control these process units 2. Control mechanisms 3 have the function of regulating process units 2. The control circuit 4 is indicated by a dashed arrow, which transmits input and output signals from control mechanism 3 to process units 2 to control and / or regulate process units 2.

[0078] In a first embodiment of the production equipment 1, it has the following process units 2, which are all controllable and adjustable and connected via pipe and hose connections 22:

[0079] The reactor includes: 5. a reactant storage container; 7. a granulator designed as a rotor granulator; 8. a screening mechanism; 10. a drying mechanism with a filtration mechanism; 11. a storage container; 12. an intermediate product conveying container; 13. a mixing mechanism; 14. a tablet press; 15. a coating mechanism; and 16. a product conveying container.

[0080] Each process unit 2 may have one or more process inserts 17, which are assembled from one or more replaceable process insert components 18. The replaceable process insert components 18 may be designed as identifiable process insert components 18 equipped with a data carrier 19, on which process insert component parameters 20 are stored. Below, reference symbols for process insert components 18 are indicated in parentheses after the reference symbol for the data carrier 19 to establish the corresponding correspondence between the data carrier 19 and the process insert components 18. Basic information of the process insert components, as process insert component parameters, is stored on the data carrier 19.

[0081] Reactant container 5 constitutes process unit 2, which in turn constitutes process plug-in 17 and identifiable process plug-in assembly 18 having process plug-in assembly parameters 20. Process plug-in assembly 18 has a data carrier 19, which is designed as an RFID transponder 21. For example, a nameplate constitutes data carrier 19. Basic information about reactant container 5 as process plug-in assembly parameters is stored on data carrier 19 (5), such as the reactant filled, filling amount, lifespan, or similar information. Lifespan includes, for example, information about the number of processes performed in which reactant container 5 was used, cleaning information, lifespan, and other general information.

[0082] The reactants are filled from the reactant container 5 into the granulator 7 via a pipe or hose connection 22a. The granulation solution is supplied separately to the granulator 7 via a pipe or hose connection 22b.

[0083] The pelletizer 7, designed as a rotor-type pelletizer 6, has a process insert 17, namely a rotor unit 23. The rotor unit 23 has two replaceable and identifiable process insert assemblies 18: a rotor disk 24 driven by a drive motor (not shown) and guide vanes 25 arranged on the side wall of the pelletizer 7. Both process insert assemblies 18 have a data carrier 19 designed as an RFID transponder 21. Basic information concerning the rotor disk 24 is stored on the data carrier 19 (24) as process insert assembly parameters, such as information about the diameter, thickness, surface finish, and lifespan of the rotor disk 24. Similarly, basic information concerning the guide vanes 25 is stored on the data carrier 19 (25) as process insert assembly parameters, such as the angle of attack, surface finish, and lifespan of the guide vanes 25 in the installed state, and similar information.

[0084] The granules produced in the granulator 7 are transported from the granulator 7 to the screening mechanism 8 through the pipe or hose connection 22c.

[0085] The screening mechanism 8 has a screening unit 26 as a process insert 17, which has two replaceable and identifiable process insert components 18, namely a screen bottom 27 and a screen body 28. The screen body 28 interacts with the screen bottom 27 to screen out the granules produced in the granulator 7 and obtain uniformly sized particles. The screen bottom 27 and the screen body 28 each have a data carrier 19 designed as an RFID transponder 21. Basic information about the screen bottom 27 is stored on the data carrier 19 (27) as process insert component parameters, such as the shape, diameter, aperture size, and lifespan of the screen bottom 27. Basic information about the screen body 28 is also stored on the data carrier 19 (28), such as the diameter, weight, surface finish, and lifespan of the screen body 28.

[0086] The sieved particles are transported from the screening mechanism 8 to the drying facility 10 through the pipe or hose connection 22d.

[0087] The drying facility 10 is designed as a fluidized bed dryer 29. The fluidized bed dryer 29 has multiple process inserts 17, namely a distribution chamber 30, a fluidization chamber 31, a perforated bottom 32 arranged between the distribution chamber 30 and the fluidization chamber 31, a filter unit 33, and a sealing unit 34 (designed as an inflatable seal, which, after assembly, seals between the distribution chamber 30 and the fluidization chamber 31). Except for the filter unit 33, each of the above process inserts 17 simultaneously constitutes a replaceable and identifiable process insert assembly 18. As a replaceable and identifiable process insert assembly 18, the filter unit 33 has a filter 35, which can also be designed as a textile filter or a metal filter.

[0088] A perforated bottom 32 (also called an inflow bottom) separates the fluidization chamber 31 from the distribution chamber 30, wherein the fluidization chamber 31 is arranged above the distribution chamber 30. Drying gas flows into the distribution chamber 30 through the drying gas supply section 36, and then flows through the perforated bottom 30 and the vortex chamber 31 with the filter unit 33 to the drying gas discharge section 37 and is discharged there. Particles conveyed from the screening mechanism 8 to the vortex chamber 31 are dried by the drying gas and then conveyed to the storage container 11 through the pipe or hose connection 22e.

[0089] The distribution chamber 30, the eddy current chamber 31, the perforated bottom 32, the filter 35 of the filter unit 33, and the sealing unit 34 all have a data carrier 19 designed as an RFID transponder 21, as a replaceable process plug-in component 18.

[0090] Basic information concerning the dispensing cavity 30 is stored on data carrier 19 (30) as process insert component parameters, including, in particular, information about the shape, diameter, dimensions, and lifespan of the dispensing cavity 30. Basic information concerning the vortex cavity 31 is also stored on data carrier 19 (31) as process insert component parameters, including, for example, information about the shape, diameter, height, filter unit 33, and lifespan of the vortex cavity 31. Basic information concerning the perforation bottom 32 is stored on data carrier 19 (32) as process insert component parameters, including, for example, information about the diameter, aperture, outflow angle, and lifespan of the perforation bottom 32. Basic information concerning the sealing unit 34, designed as a seal, is stored on data carrier 19 (34) as process insert component parameters. Specifically, information such as the service life of the seal, the material of the seal, the maximum contact pressure, and the seal dimensions (e.g., diameter, cross-section, and wall thickness) are stored there. Finally, information about the filter 35 of the filter unit 33 is stored on the data carrier 19 (35) as process plug-in component parameters, such as filter material, pore size, life cycle, etc.

[0091] During the production process, the dried granules are temporarily stored in storage container 11 to compensate for fluctuations during granulation if necessary. Additionally, other granules can be added. Here, storage container 11 constitutes process insert 17 and also forms a replaceable, identifiable process insert assembly 18. Storage container 11 has a data carrier 19 designed as an RFID transponder 21, which stores basic information related to storage container 11 as parameters of the process insert assembly.

[0092] Particles are filled from storage container 11 to intermediate product delivery container 12 via pipe or hose connection 22f, and then the particles are delivered to mixing mechanism 13 designed as a lifting column.

[0093] Intermediate product transport container 12 constitutes process unit 2, which in turn constitutes process insert 17 and identifiable process insert assembly 18 having process insert assembly parameters 20. Process insert assembly 18 has a data carrier 19, which is designed as an RFID transponder 21. For example, a nameplate constitutes data carrier 19. Basic information of intermediate product transport container 12, such as the filling particles, filling amount, life cycle, or similar information, is stored on data carrier 19 (12) as process insert assembly parameters. Intermediate product transport container 12 also has process insert 17 designed as a valve device 38. Valve device 38 has a valve 40 specially designed as a sealing baffle 39, which constitutes identifiable process insert assembly 18 having process insert assembly parameters 20. Valve 40 has a data carrier 19, which is designed as an RFID transponder 21. Basic information of valve 40, such as life cycle, frequency of use, sealing performance, or similar information, is stored on data carrier 19 (40) as process insert assembly parameters.

[0094] The granules conveyed in the intermediate product conveying container 12 are mixed in the mixing mechanism 13, and then conveyed to the tablet press 41 via valve device 38 and valve device 42. Valve device 42 belongs to the tablet press 41, matches valve device 38, and is designed as a process insert 17. Valve device 42 also has a valve 40 designed as a sealing baffle 39 as a process insert assembly 18.

[0095] In addition to the process insert 17 designed as valve device 42, the tablet press also has at least one other process insert 17, namely tableting unit 43. Tableting unit 43 has replaceable and identifiable process insert components 18, namely die 44 and punch 47, the punch 47 being designed as a lower punch 45 and an upper punch 46. All of the above process insert components 18 have a data carrier 19 designed as an RFID transponder 21 as replaceable and identifiable process insert components 18. Basic information of valve 40 is stored on data carrier 19 (40) as process insert component parameters, such as life cycle, usage frequency, sealing performance or similar information. Basic information of die 44 is stored on data carrier 19 (44) as process insert component parameters, such as die cavity diameter, die cavity filling amount, usage frequency, rotation speed, life cycle, etc. In addition, the data carriers 19 (45, 46, 47) also store the basic information of the corresponding punches 45, 46, 47 as process plug-in component parameters, such as punch material, punch diameter, punch length, maximum punch contact pressure, life cycle and other information.

[0096] In tableting machine 41, granules are compressed into tablets, which are then conveyed to coating unit 15, where the tablets receive a coating, such as enteric coating. Coating unit 15 has two process inserts 17, namely coating roller 48 and nozzle device 49.

[0097] Here, the coating roller 48 also constitutes a replaceable and identifiable process insert assembly 18, which has a data carrier 19 designed as an RFID transponder 21. Basic information of the coating roller 48 is stored on the data carrier 19 (48) as process insert assembly parameters, such as life cycle, usage frequency, roller diameter, roller length, roller capacity, diameter of roller wall holes, or similar information.

[0098] The nozzle assembly 49 also includes replaceable and identifiable process insert components 18, specifically the inner tubing 50, the outer tubing 51, the nozzle substrate 52, and / or the nozzle 53. All of the aforementioned process insert components 18 of the nozzle assembly 49 also have data carriers 19 designed as RFID transponders 21.

[0099] Basic information about the inner pipeline 50 is stored on data carrier 19 (50) as process component parameters, such as inner pipeline length, inner pipeline diameter, inner pipeline material, and inner pipeline usage frequency. Basic information about the outer pipeline 51 is stored on data carrier 19 (51) as process component parameters, such as outer pipeline length, outer pipeline diameter, outer pipeline material, and outer pipeline usage frequency. Basic information about the nozzle base 52 is stored on data carrier 19 (52) as process component parameters, such as the number of nozzles 53 that can be installed in the nozzle base 52, the number of usable nozzles 53, the nozzle base material, the usage frequency of the nozzle base 52, or similar information. Basic information about the nozzle 53 is stored on data carrier 19 (53) as process component parameters, such as nozzle outer diameter, nozzle type (single-component / multi-component nozzle), nozzle inner diameter, maximum injection pressure, and minimum or maximum droplet size during injection.

[0100] exist Figures 3 to 10 The document describes in detail an exemplary arrangement of a nozzle device 49 as an example of a process insert 17 and a data carrier 19 designed as an RFID transponder 21.

[0101] The coated tablets are then conveyed from the coating mechanism 15 to the product delivery container 16. The product delivery container 16 also constitutes the process insert 17 and the process insert assembly 18, which has a data carrier 19 designed as an RFID transponder 21. For example, a nameplate constitutes the data carrier 19. Basic information about the product delivery container 16 is stored on the data carrier 19 (16) as parameters of the process insert assembly, such as the product being filled, production date, batch number, filling quantity, lifespan, etc.

[0102] Data carrier 19 can be read alternatively via control line 4, or as... Figure 1 As shown, the RFID transponder is read by the verified RFID transponder reader 54 assigned to production equipment 1.

[0103] The control unit 3 stores configuration schemes specific to the production process (here, the tablet manufacturing process) for the production equipment 1 and its corresponding process modules 17. For this purpose, the control unit 3 has a database 55 designed to store a large number of specific configuration schemes that can be individually selected by the operator for the production process executed on the production equipment 1.

[0104] Before, during, or after assembling process plug-in components 18 into process plug-in 17, the process plug-in component parameters of the identifiable process plug-in components 18 installed in the process plug-in 17 are transmitted to the control mechanism 3. The control mechanism 3 then checks the process plug-in component parameters to determine whether at least one identifiable process plug-in component 18 has been installed in the corresponding process plug-in 17 according to a stored configuration scheme, and the control mechanism 3 is configured to allow the production process to be executed on the production equipment 1 if "yes".

[0105] If an operator incorrectly installs a replaceable, identifiable process component 18 in the production equipment 1, or forgets to install the replaceable, identifiable process component 18 due to negligence, the production equipment 1 has a display mechanism 56 (particularly a mobile display mechanism, such as a tablet computer) configured to display at least one identifiable process component 18 that has been incorrectly installed or not installed at all in the corresponding process component 17 according to a stored configuration scheme.

[0106] Furthermore, production equipment 1 has a storage section 57 in which other replaceable and identifiable process component 18 of production equipment 1 are stored. The other replaceable and identifiable process component 18 stored in storage section 57 are preferably structurally identical process component 18. Particularly preferably, the display mechanism 56 also indicates the storage location of the other identifiable process component 18 in storage section 57 of production equipment 1, thereby enabling, for example, the direct and controlled replacement of defective process component 18 with process component 18 accepted by the system.

[0107] On the display unit 56, a list of recognizable process plug-in components 18 to be installed in the production equipment 1 can be output based on the configuration scheme selected for the production process executed on the production equipment 1.

[0108] Database 55 is also suitable for storing process plug-in component parameters of identifiable process plug-in components 18 respectively installed in process plug-in 17 in the database, and these process plug-in component parameters are transmitted to the control mechanism 3 before, during or after the process plug-in components 18 are assembled into process plug-in 17.

[0109] In order to check the parameters of the process plug-in components in the control mechanism 3, the control mechanism 3 has a comparison mechanism 58. In addition to comparison, the comparison results are also evaluated. For this purpose, the control mechanism 3 has an evaluation mechanism 59, which is designed to evaluate the checks performed in the comparison mechanism 58, so that the production process can be allowed to be executed on the production equipment 1 if the condition is "yes".

[0110] Figure 2 The diagram shown is a schematic of a second embodiment of the production equipment 1, which is used to manufacture a pharmaceutical product, here a tablet, by means of a production process performed on the production equipment 1.

[0111] Production equipment 1 has multiple process units 2 and control mechanisms 3 that control these process units 2. Control mechanisms 3 have the function of regulating process units 2. The control circuit 4 is indicated by a dashed arrow, which transmits input and output signals from control mechanism 3 to process units 2 to control and / or regulate process units 2.

[0112] In a second embodiment of the production equipment 1, it has the following process units 2, which are all controllable and adjustable and connected via pipe and hose connections 22:

[0113] A dispensing mechanism 60 for the active pharmaceutical ingredient; a conveying mechanism 61 for conveying the binder; a mixing mechanism 13 for producing a suspension of the active pharmaceutical ingredient and the binder; a granulator 7 (with a filtration mechanism 9) designed as a fluidized bed granulator 64; a storage container 11; and a tablet press 14.

[0114] As mentioned above (refer to the previous text) Figure 1 Each process unit 2 may have one or more process inserts 17, which are assembled from one or more replaceable process insert components 18. The replaceable process insert component 18 may be designed as an identifiable process insert component 18 equipped with a data carrier 19, on which process insert component parameters 20 are stored. Below, reference symbols for process insert components 18 are indicated in parentheses after the reference symbol for the data carrier 19 to establish the corresponding correspondence between the data carrier 19 and the process insert component 18. Basic information of the process insert components, as process insert component parameters, is stored on the data carrier 19.

[0115] The dispensing mechanism 60 constitutes process unit 2, which in turn constitutes process insert 17 and identifiable process insert assembly 18 having process insert assembly parameters 20. Process insert assembly 18 has a data carrier 19, which is designed as an RFID transponder 21. For example, a nameplate constitutes data carrier 19. Basic information of the dispensing mechanism 60 as process insert assembly parameters is stored on data carrier 19 (60), such as the active pharmaceutical ingredient being filled, the filling amount, the lifespan, or similar information.

[0116] The active pharmaceutical ingredient is dispensed into the mixing unit 13 via a pipe or hose connection 22a through a dispensing mechanism 60. The adhesive is supplied separately to the mixing unit 13 via a pipe or hose connection 22b, which is conveyed by a delivery mechanism 61 having a process insert 17.

[0117] Process module 17 has a pump impeller 62 with a replaceable, identifiable process module assembly 18 having process module assembly parameters 20. The process module assembly 18 has a data carrier 19 designed as an RFID transponder 21. Basic information about the pump impeller 62, such as impeller diameter, minimum or maximum flow rate, lifespan, or similar information, is displayed on the data carrier 19 (62) as process module assembly parameters.

[0118] In a mixing mechanism 13, the active pharmaceutical ingredient is mixed with a binder to form a suspension. This mixing mechanism has a process insert 17 designed as a mixing unit 63, which has a process insert assembly 18 designed as a mixer 151. The mixer 151 has a replaceable and identifiable process insert assembly 18. The mixer 151 also has a data carrier 19 designed as an RFID transponder 21. Basic information about the mixer 151, such as mixer diameter, minimum or maximum torque, mixer type, mixing blade size, lifespan, or similar information, is displayed on the data carrier 19 (151) as parameters of the process insert assembly.

[0119] The suspension is conveyed from the mixing mechanism 13 to the granulator 7.

[0120] The granulator 7, designed as a fluidized bed granulator 64, has multiple process inserts 17, namely a distribution chamber 30, a fluidization chamber 31, a perforated bottom 32 disposed between the distribution chamber 30 and the fluidization chamber 31, a nozzle assembly 49 disposed within the fluidization chamber 31, a filter unit 33, and a sealing unit 34 (designed as an inflatable seal, which, after assembly, seals between the distribution chamber 30 and the fluidization chamber 31). Except for the filter unit 33, each of the aforementioned process inserts 17 also constitutes a replaceable and identifiable process insert assembly 18. As a replaceable and identifiable process insert assembly 18, the filter unit 33 has a filter 35, which can also be designed as a textile filter or a metal filter. The nozzle assembly 49 also has replaceable and identifiable process insert assemblies 18, namely, specifically an inner conduit 50, an outer conduit 51, a nozzle base 52, and / or a nozzle 53. The aforementioned process insert assemblies 18 of the nozzle assembly 49 also each have a data carrier 19 designed as an RFID transponder 21.

[0121] Basic information about the inner pipeline 50 is stored on data carrier 19 (50) as process component parameters, such as inner pipeline length, inner pipeline diameter, inner pipeline material, inner pipeline usage frequency, or similar information. Basic information about the outer pipeline 51 is stored on data carrier 19 (51) as process component parameters, such as outer pipeline length, outer pipeline diameter, outer pipeline material, outer pipeline usage frequency, or similar information. Basic information about the nozzle base 52 is stored on data carrier 19 (52) as process component parameters, such as the number of nozzles 53 that can be installed in the nozzle base 52, the number of usable nozzles 53, the nozzle base material, the usage frequency of the nozzle base 52, etc. Basic information about the nozzle 53 is stored on data carrier 19 (53) as process component parameters, such as nozzle outer diameter, nozzle type (single-component / multi-component nozzle), nozzle inner diameter, maximum injection pressure, minimum or maximum droplet size during injection, and similar information.

[0122] exist Figures 3 to 10 The document describes in detail an exemplary arrangement of a nozzle device 49 as an example of a process insert 17 and a data carrier 19 designed as an RFID transponder 21.

[0123] A perforated bottom 32 (also called an inflow bottom) separates the fluidization chamber 31 from the distribution chamber 30, wherein the fluidization chamber 31 is arranged above the distribution chamber 30. Drying gas flows into the distribution chamber 30 through the drying gas supply section 36, and then flows through the perforated bottom 30 and the vortex chamber 31 with a filter unit 33 to the drying gas discharge section 37 and is discharged there. The drying gas fluidizes the auxiliary material prepared in the vortex chamber 31 via the pre-feeding mechanism 65, and sprays the auxiliary material onto the suspension atomized by the nozzle device 49. Thus, granules are formed in spray granulation, spray agglomeration, or spray coating, and the granules are then transported through a pipe or hose connection 22b to the storage container 11 for temporary storage.

[0124] The distribution chamber 30, the eddy current chamber 31, the perforated bottom 32, the filter 35 of the filter unit 33, and the sealing unit 34 all have a data carrier 19 designed as an RFID transponder 21, as a replaceable process plug-in component 18.

[0125] Basic information concerning the dispensing cavity 30 is stored on data carrier 19 (30) as process insert component parameters, including, in particular, information about the shape, diameter, dimensions, and lifespan of the dispensing cavity 30. Basic information concerning the vortex cavity 31 is also stored on data carrier 19 (31) as process insert component parameters, including, for example, information about the shape, diameter, height, filter unit 33, and lifespan of the vortex cavity 31. Basic information concerning the perforation bottom 32 is stored on data carrier 19 (32) as process insert component parameters, including, for example, information about the diameter, aperture, outflow angle, and lifespan of the perforation bottom 32. Basic information concerning the sealing unit 34, designed as a seal, is stored on data carrier 19 (34) as process insert component parameters. Specifically, information such as the service life of the seal, the material of the seal, the maximum contact pressure, and the seal dimensions (e.g., diameter, cross-section, and wall thickness) are stored there. Finally, information about the filter 35 of the filter unit 33 is stored on the data carrier 19 (35) as process plug-in component parameters, such as filter material, pore size, life cycle, etc.

[0126] During production, the granules are temporarily stored in storage container 11 to compensate for fluctuations during granule manufacturing if necessary. Here, storage container 11 constitutes process insert 17 and also constitutes replaceable and identifiable process insert assembly 18. Storage container 11 has a data carrier 19 designed as an RFID transponder 21, which stores basic information related to storage container 11 as parameters of the process insert assembly.

[0127] Granules are fed from storage container 11 to tablet press 41 via pipe or hose connection 22f. The tablet press also has at least one other process insert 17, namely tableting unit 43. Tableting unit 43 has replaceable and identifiable process insert components 18, namely die 44 and punch 47, which is designed as a lower punch 45 and an upper punch 46. All of the above process insert components 18 have data carriers 19 designed as RFID transponders 21 as replaceable and identifiable process insert components 18. Basic information of die 44 as process insert component parameters is stored on data carrier 19 (44), such as die cavity diameter, die cavity filling amount, usage frequency, rotation speed, life cycle, etc. In addition, basic information of the corresponding punches 45, 46, 47 as process insert component parameters is also stored on data carrier 19 (45, 46, 47), such as punch material, punch diameter, punch length, maximum punch contact pressure, life cycle, etc.

[0128] In tablet press 41, granules are compressed into tablets and then leave tablet press 41 as a product.

[0129] This method is performed in accordance with the method of the first embodiment concerning production equipment 1. The operator installs a replaceable and identifiable process plug-in component 18 in production equipment 1, the control mechanism 3 checks the installation, and if the installation is successful, allows the production process to be executed on production equipment 1.

[0130] Figure 3 The figure shows a top view of one embodiment of the nozzle device 49.

[0131] Figure 3 The nozzle assembly 49 shown has a piping assembly 66 with an external piping 51 for conveying a gaseous medium. A connector 68 is connected to the feed side 67 of the piping assembly 66, and a nozzle base 52 having at least one nozzle 53 is connected to the outlet side 69 of the piping assembly 66 opposite to the feed side 67. Furthermore, the external piping 66 has a data carrier 19 designed as an RFID transponder 21, which is inserted into an opening. Information (referred to as process insert assembly parameters) of the external piping 51 (referred to as process insert assembly 18) can be stored on the data carrier 19.

[0132] Figure 4 For nozzle device 49 along Figure 3 The cross-sectional view of section AA shown.

[0133] A piping device 66 has an outer pipe 51 for conveying a gaseous medium and an inner pipe 69 disposed inside the outer pipe 51, the inner pipe 69 conveying the medium to be injected. An annular gap 145 is formed between the outer pipe 51 and the inner pipe 69, serving as a flow channel 144 for the outer pipe. In the illustrated embodiment, the inner pipe 50, disposed inside the outer pipe 51 and forming the flow channel 146 for the inner pipe, is coaxially surrounded by the outer pipe 51.

[0134] The inner conduit 50 has a multi-segment structure. Therefore, the inner conduit 50 has a rigid inner conduit section 70 (preferably a straight pipe made of metal) and a flexible inner conduit section 71 adjacent to the rigid inner conduit section 70 (preferably designed as a fabric-reinforced silicone hose or synthetic rubber hose). The rigid inner conduit section 70 is held within the outer conduit 51 at the feed side 67 of the conduit assembly 66 by a connector 68, and is connected to a connecting element 73 on the side 72 of the rigid inner conduit section 70 opposite to the feed side 67. The flexible inner conduit section 71 is connected to the connecting element 73 on the feed side and to the nozzle base 52 on the outlet side 69 of the conduit assembly 66.

[0135] A mounting flange 74 is provided on the outer pipe 51 of the piping assembly 66. This mounting flange is arranged on the mounting plane CC perpendicular to the section AA on the processing module (not shown in detail). Figure 4 Within the conical housing section 75, which is exemplarily shown in the diagram. In the processing module, the illustrated embodiment of the nozzle device 49 is particularly used to generate a top spray. The processing module is preferably designed as a coating device, such as a roller coating machine, or as a fluidizing device, such as a vortex device or a spray layer device. Furthermore, the outer piping 51 has a data carrier 19 designed as an RFID transponder 21, which is inserted into a hole on the mounting flange 74. Information (referred to as process insert assembly parameters) of the outer piping 51 (referred to as process insert assembly 18) can be stored on the data carrier 19.

[0136] The connector 68 has double flanges 76 forming a double-flange flow passage 147. The outlet flange 77 of the double flanges is connected to an outer pipe end section flange 79 arranged on the feed side outer pipe end section 78, so that the inner pipe 50 and outer pipe 51 of the piping assembly 66 are sealed on the feed side 67. For this purpose, flanges 77 and outer pipe end section flange 79 are clamped in the axial direction by a clamping mechanism 81 designed as a tee clamp 80. In addition, the inner pipe 50 has a data carrier 19 designed as an RFID transponder 21, which is inserted into a hole on flange 77. Information of the inner pipe 50 (referred to as process insert assembly 18) (referred to as process insert assembly parameters) can be stored on the data carrier 19. In addition to the double flange 76, the connector 68 also has an inner pipe coupling 83, which has an outlet-side inner pipe coupling flange 82 and forms an inner pipe flow channel 148. The inner pipe coupling flange 82 is connected to the inlet-side flange 84 of the double flange 76 and is clamped axially by a clamping mechanism 86 designed as a tee clamp 85, thereby sealing the double flange 76, which extends the inner pipe 50 of the piping device 66, at the inlet side 67 of the piping device 66. The inner pipe flow channel 146 is in fluid-technical communication with the double flange flow channel 147 and the inner pipe coupling flow channel 148.

[0137] The inner piping coupling 83 has a coupling port 87 for feeding the medium to be sprayed (suitably a liquid, dispersion, emulsion, or suspension) and a coupling port 88 for feeding the flushing medium (suitably designed as flushing air). The design of the coupling 68 allows for very simple replacement of the inner piping coupling 83, thereby enabling efficient replacement of coupling ports 87 and 88.

[0138] The external pipeline 51 is connected to the connecting pipe 89, and an external pipeline coupling (not shown) can be inserted into the connecting pipe. Pressurized gaseous medium (suitable for spraying air) can be fed in through the external pipeline coupling.

[0139] On the outlet side, an outer conduit 51 and an inner conduit 50 are connected to a two-section nozzle base 52. The outer conduit 51 is connected to the nozzle base cover 90, and the inner conduit 50 (preferably a flexible inner conduit element 71) is connected to the nozzle base top 91. The nozzle base 52 has a data carrier 19 designed as an RFID transponder 21, which is inserted into a hole on the nozzle base top 91. Information (referred to as process insert assembly parameters) of the nozzle base top 91 (referred to as process insert assembly 18) can be stored on the data carrier 19. The nozzle base cover 90 and the nozzle base top 91 are interconnected by a bayonet connector, which is sealed by sealing elements 93a and b designed as annular seals 92a and b. The sealing elements 93a and b are respectively disposed in grooves 94a and b belonging to the nozzle base cover 90 or the nozzle base top 91. In an embodiment not shown, the connection between the nozzle base top 91 and the nozzle base cover 90 is achieved by threads, wherein the nozzle base cover 90 suitably has external threads, while the nozzle base top 91 has internal threads.

[0140] In order to achieve top spraying, the medium needs to be deflected from the horizontal mounting surface CC to the vertical spray surface DD, which takes place in the area of ​​the bend 95 of the piping assembly 66, which is particularly formed by a 90° pipe bend 96 as shown in the illustrated embodiment.

[0141] Within the region of the bend 95, the inner conduit 50, arranged within the outer conduit 51, has a flexible inner conduit section 71, wherein the flexible inner conduit section 71 is suitably guided within the outer conduit 51 by a gasket 97, as shown in this embodiment. Three gaskets 97 are used in this embodiment.

[0142] Figure 5 For nozzle device 49 Figure 4 The enlarged view of part B is shown. The nozzle base 52 is connected to the outer conduit 51 via a nozzle base cap 90, particularly by welding. Furthermore, the nozzle base 52 is detachably connected to the inner conduit 50 via a nozzle base top 91. To achieve this detachable connection between the inner conduit 50 and the nozzle base 52, coupling elements 99 are provided on the outlet side of the inner conduit end section 98 and on the nozzle base top 91, respectively. In this regard, one coupling element 99 is designed as a first coupling element 99a, and another coupling element 99 is designed as a second coupling element 99b, wherein these coupling elements 99 can be coupled to each other via a plug connection. In the illustrated embodiment, the first coupling element 99a is provided on the inner conduit end section 98 of the inner conduit 50, and the second coupling element 99b is provided on the nozzle base 52. Since the flexible inner pipe section 71 of the inner pipe 50, which is equipped with the first coupling element 99a, is in a pre-tightened state, the first coupling element 99a is fixed in the second coupling element 99b.

[0143] The first coupling element 99a is designed as a coupling connector 101 penetrated by the coupling connector channel system 100; the second coupling element 99b is designed as a receiving bushing 103 with a receiving cavity 102, so that in the assembled state of the nozzle assembly 49, the inner conduit 50 is connected to the nozzle base 52, preferably to the top 91 of the nozzle base. The medium to be sprayed can thus flow through the inner conduit flow channel 146 and the coupling connector channel system 100 to the three nozzles 53. In this embodiment, the receiving cavity 102 of the receiving bushing 103 is defined by the receiving socket wall 104 and the receiving socket bottom 105. Each nozzle 53 has a data carrier 19 within an insertion hole, which is designed as an RFID transponder 21. Information of the corresponding nozzle 53 (referred to as process insertion assembly 18) (referred to as process insertion assembly parameters) can be stored on the data carrier 19 of the nozzle 53.

[0144] The coupling connector channel system 100 has an input channel 106 with a longitudinal axis EE, transitioning within a transition region 107 to a plurality of output channels 109 that open onto the outer surface 108 of the coupling connector 101. In the illustrated embodiment, the plurality of output channels 109 are arranged at an angle to the longitudinal axis EE of the input channel 106. Furthermore, as in... Figure 9 As can be seen more clearly, the output channels are evenly distributed along the circumference of the coupling connector 101. Furthermore, the cross-sectional area 110 of each output channel 109 is several times smaller than the cross-sectional area 111 of the input channel. Because the cross-sectional area 110 of the output channel is smaller than the cross-sectional area 111 of the input channel, a sieving effect is generated, which filters out coarse impurities in the sprayed medium. In addition, the cross-sectional area 110 of each output channel 109 is suitably smaller than the cross-sectional area 149 of the nozzle outlet 150 of the nozzle 53. This further ensures that impurities not intercepted by the output channels 109 can also flow unimpeded through the nozzle outlet 150 and be sprayed out without clogging the nozzle 53, especially at its nozzle outlet 150, or, in the worst case, completely blocking it.

[0145] The coupling connector 101 has a coupling connector fixing mechanism 112 for the inner conduit 50, wherein suitably, the coupling connector fixing mechanism 112 is designed as a coupling connector fixing sleeve 115 having a first locking element 114 having a locking lug 113. Here, the coupling connector fixing mechanism 112 is passed through the coupling connector channel system 100, particularly through the input channel 106.

[0146] Furthermore, the coupling connector 101 also has a flip-top element 116 mounted on the coupling connector fixing sleeve 115, which passes through the coupling connector fixing mechanism 112 at the rear via the coupling connector connecting nozzle 117. The flip-top element 116 is preferably made of a plastic material designated PA2200, particularly as a 3D component manufactured using laser sintering. PA2200, based on PA12, offers a wide range of applications and meets all biocompatibility requirements. In the illustrated embodiment, the coupling connector connecting nozzle 117 is coaxially surrounded by the coupling connector fixing mechanism 112 (particularly the coupling connector fixing sleeve 115). Simultaneously, the input channel 106 is also coaxially surrounded by the coupling connector connecting nozzle 117.

[0147] The design of the coupling connector 101 creates a space 118 between the coupling connector connecting nozzle 117 and the coupling connector fixing sleeve 115, into which the inner conduit 50 can be inserted. The inner conduit 50 has a second locking element 120 on its inner conduit end section 98. The second locking element is designed to receive a locking recess of the first locking element 114, thereby enabling the first locking element 114 of the coupling connector fixing sleeve 115 and the second locking element 120 of the inner conduit 50 (particularly the flexible inner conduit section 71) to interact and connect. The coupling connector 101 can also be connected to the outlet side inner conduit end section 98 of the inner conduit 50 using different connection techniques (e.g., by threads), wherein the coupling connector fixing sleeve 115 has internal threads and the inner conduit end section 98 of the inner conduit 50 has external threads.

[0148] The first coupling element 99a of the coupling connector 101 has a coupling connector sealing element 125 that seals between the first and second coupling elements 99a and 99b in the assembled state, such that the coupling connector 101 and the receiving bushing 103 define a dispensing cavity 126, wherein suitably, the coupling connector 101 has a coupling connector groove 127 on its entire circumference for receiving the coupling connector sealing element 125. The coupling connector sealing element 125 is preferably designed as an annular seal 128. By introducing the medium to be sprayed into the dispensing cavity 126, the medium is uniformly distributed to the individual nozzles 53 arranged in the nozzle body 52.

[0149] To supply the nozzles 53, which are arranged on a two-section nozzle base 52, with the medium supplied via the piping system 66, the nozzle base 52 is permeated by a first nozzle base channel system 121 (for conveying gaseous medium) and a second nozzle base channel system 122 (for the medium to be sprayed). This ensures that the respective media can be guided separately from each other from the piping system 66 to the nozzles 53. Each nozzle 53 has a data carrier 19 designed as an RFID transponder 21, which is inserted into the orifice.

[0150] The first nozzle substrate channel system 121 has at least one nozzle substrate feed line 123, the number of which is equal to the number of nozzles 53 arranged in the nozzle substrate 52, to guide the gaseous medium to the corresponding nozzle 53. In the illustrated embodiment, each nozzle is equipped with two nozzle substrate feed lines 123. At the nozzle outlet 150 of the nozzle 53, the two nozzle substrate feed lines 123 ensure a more uniform air distribution for atomizing the medium to be sprayed. This further reduces the deposition of the medium to be sprayed at the nozzle outlet. The gaseous medium thus flows through the nozzle substrate feed line 123 and the outer flow channel 144 to the nozzle 53. The above-described connection of all flow channels for the gaseous medium is also referred to as the outer flow channel. The second nozzle substrate channel system 122 also has a number of nozzle substrate feed lines 124, the number of which is equal to the number of nozzles 53 arranged in the nozzle substrate 52, to guide the medium to be sprayed to the corresponding nozzle 53. Here, the nozzle base feed line 124 of the second nozzle base channel system 122 interconnects the distribution chamber 126 and the corresponding nozzle 53. The medium to be sprayed flows accordingly through the inner pipeline coupling flow channel 146, the double flange flow channel 147, the inner pipeline flow channel 146, and the coupling channel system 100 into the distribution chamber 126, and from there reaches the nozzle 53 via the nozzle base feed line 124. The above-mentioned connection of all flow channels for the gaseous medium to be sprayed is also referred to as the internal flow channel. In this embodiment, the nozzle base 52 is thus penetrated by three nozzle base feed lines 123 and three nozzle base feed lines 124, respectively.

[0151] The nozzle base 52 (referring to the top 91 of the nozzle base) has three nozzles 53, as in the nozzle assembly 49. Figure 4 The bottom view is shown in the figure. Other numbers of nozzles can be considered and implemented, such as four, five, six or more nozzles.

[0152] Figure 7 This is a front view of the flexible inner piping section 71 with coupling connector 101.

[0153] A coupling 101 is provided at the inner pipe end section 98 of the inner pipe 50. Three spacers 97 with through holes 129 are arranged coaxially around the flexible inner pipe section 71. The through holes 129 allow the gaseous medium to flow almost undisturbed through the outer pipe flow channel 144 between the outer pipe 51 and the inner pipe 50, and to the nozzle 53 arranged in the nozzle body 52.

[0154] Figure 8 For the flexible internal pipeline section 71 along Figure 7The cross-sectional view of section CC is shown. The coupling connector 101 has a data carrier 19 designed as an RFID transponder 21, which is inserted into a hole on the coupling connector 101. Information about the coupling connector 101 (referred to as process insert assembly 18), referred to as process insert assembly parameters, can be stored on the data carrier 19.

[0155] For example, regarding Figure 4 As described above, in order to connect the rigid inner pipeline section 70 with the flexible inner pipeline section 71, a connecting element 73 is provided in the outer pipeline 51. The connecting element 73 has a connecting element channel 130 belonging to the inner pipeline channel 146, which extends through the connecting element 73 along the flow direction of the medium to be sprayed.

[0156] To connect the rigid inner tubing section 70 to the connecting element 73, the rigid inner tubing section 70 has an external thread 132 on its outlet-side end section 131. This external thread screws into the connecting element channel section 134 with fins 133, such that an internal thread (not shown) corresponding to the external thread 132 cuts into the fins 133. Thus, the rigid inner tubing section 70 is secured in the connecting element 73.

[0157] Furthermore, the connecting element 73 also has a connecting element fixing mechanism 137 designed as a connecting element fixing sleeve 136 for accommodating the flexible inner tubing section 71 through which the connecting element connecting nozzle 138 of the connected element 73 passes. The connecting element fixing sleeve has an internal thread 75. Meanwhile, an external thread 140 is provided on the end section 139 on the feed side of the flexible inner tubing section 71.

[0158] A space 141 is formed between the connecting element connecting nozzle 138 and the connecting element fixing sleeve 136. A flexible inner tube section 71 with external threads 140 on its end section 139 can be inserted into this space, thereby enabling the internal thread 135 of the connecting element fixing sleeve 136 to act in connection with the external thread 140 of the flexible inner tube section 71 of the inner tube 50, and fixing the flexible inner tube section 71 in the connecting element 73.

[0159] The connecting element 73 can also be connected to the rigid inner pipe section 70 or the flexible inner pipe section 71 using other connection techniques. Thus, whether the connection between the rigid inner pipe section 70 and the connecting element 73 or the connection between the flexible inner pipe section 71 and the connecting element 73, it can be achieved, for example, by using a snap-fit ​​connection.

[0160] The connecting element 73 additionally has a through hole 143 in its outer region 142, thereby allowing a gaseous medium to flow through the connecting element 73 located in the outer conduit 51 to the nozzle 53 via the through hole 143.

[0161] Figure 9 This is a side view of the coupling connector 101. Figure 10 For the coupling connector 101 along Figure 9 The cross-sectional view of section DD shown, wherein, Figure 9 and Figure 10 A detailed description has been given in the above explanation. However, Figure 9 and Figure 10 Especially for making things clearer.

Claims

1. A method for controlling a production process performed, particularly on production equipment (1) for producing pharmaceuticals, wherein, The production equipment (1) has multiple process units (2) and a control mechanism (3) for controlling the process units (2), wherein at least one process unit (2) has or forms at least one process plug-in (17), the process plug-in has or forms at least one process plug-in assembly (18), wherein at least one process plug-in assembly (18) is a replaceable process plug-in assembly (18), and at least one replaceable process plug-in assembly (18) is an identifiable process plug-in assembly (18) equipped with a data carrier (19), wherein the data carrier (19) has process plug-in assembly parameters of the replaceable process plug-in assembly (18) equipped therewith, wherein the control mechanism (3) stores The storage provides a process-specific configuration scheme for the production equipment (1) and its corresponding process plug-in (17), wherein, before, during, or after the process plug-in component (18) is assembled into the process plug-in (17), the process plug-in component parameters of the identifiable process plug-in component (18) installed in the process plug-in (17) are transmitted to the control mechanism (3), thereby subsequently checking the process plug-in component parameters in the control mechanism (3) to determine whether the at least one identifiable process plug-in component (18) has been installed in the corresponding process plug-in (17) according to the stored configuration scheme, and if "yes", the production process executed on the production equipment (1) is permitted or can be permitted.

2. The method according to claim 1, characterized in that, The control mechanism (3) stores a large number of specific configuration schemes, which can be individually selected by the operator for each production process performed on the production equipment (1).

3. The method according to claim 2, characterized in that, The control mechanism (3) is configured to output a list of recognizable process plug-in components (18) to be installed in the production equipment (1) based on a configuration scheme selected for the production process executed on the production equipment (1).

4. The method according to any one of the preceding claims, characterized in that, The production equipment (1) has a display mechanism (56) that displays at least one recognizable process plug component (18) that has been incorrectly installed in the corresponding process plug (17) according to a stored configuration scheme.

5. The method according to claim 4, characterized in that, The display mechanism (56) displays, for each incorrectly installed identifiable process plug-in component (18), other identifiable process plug-in components (18) that must be installed to obtain permission for the production process.

6. The method according to claim 5, characterized in that, The display mechanism (56) also displays where the other identifiable process component (18) is stored in the storage section (57) of the production equipment (1).

7. The method according to any one of the preceding claims, characterized in that, The data carrier (19) is designed as a readable RFID transponder (21), and the process plug-in component parameters are read from the data carrier (19) and transmitted or can be transmitted to the control mechanism (3) using an RFID transponder reader (54).

8. The method according to any one of the preceding claims, characterized in that, The production equipment (1) and its corresponding process plug-in (17), the process-specific configuration scheme stored in the control mechanism (3), and / or the process plug-in component parameters of the identifiable process plug-in components (18) respectively installed in the process plug-in (17) that are transmitted to the control mechanism (3) before, during or after the process plug-in components are assembled into the process plug-in (17), and / or the results of the checks performed on the process plug-in component parameters after they are transmitted to the control mechanism (3) are stored as data in the database (55), wherein suitably, the data cannot be changed or modified after being stored in the database (55).

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