Method for controlling a production process that takes place in a production plant for producing in particular pharmaceutical products

Abstract

The invention relates to a method for controlling a production process that takes place in a production plant (1) for producing in particular pharmaceutical products.

Description

[0001] Method for controlling a production process running on a production plant for the manufacture of, in particular, pharmaceutical products

[0002] The invention relates to a method for controlling a production process taking place in a production plant for the manufacture of, in particular, pharmaceutical products.

[0003] Methods, whether operated continuously or discontinuously, for controlling a production process taking place on a production plant for the manufacture of pharmaceutical products in particular and related production plants for carrying out the method have long been known.

[0004] WO 2010 / 128359 A1 discloses a method for the continuous production of tablets, comprising the steps of providing a closed production plant, wherein the production plant has at least two inlets, at least one mixing unit, at least one analytical sensor, a tablet press and at least one outlet for tablets, feeding an active pharmaceutical ingredient (API) via one of the at least two inlets, feeding an excipient via the other of the at least two inlets, mixing the active pharmaceutical ingredient and the excipient in the at least one mixing device to form a material flow, measuring parameters of the material flow with the at least one analytical sensor upstream of the tablet press, controlling the two inlets and / or the mixing device depending on the measured parameters, continuously supplying the tablet press with the material flow,Controlling the speed of the tablet press as a function of the parameters measured upstream of the tablet press, and dispensing tablets at the at least one outlet. Furthermore, WO 2010 / 128359 A1 discloses a production plant for carrying out the method.

[0005] A disadvantage of such processes and their associated production facilities is that at least two qualified and trained operators are required to approve the production process for manufacturing, in particular pharmaceutical products. Both of these operators must inspect the production facility for faulty installation or incorrect use of process units, such as the mixing device or the tablet press. Such an inspection of the process and the production facility is not only cost-intensive but also prone to errors due to human error, such as fatigue, inattention, lack of care or attention to detail, and signing without checking at all.

[0006] The invention is therefore based on the object of taking measures which, in a method for controlling a production process taking place on a production plant for the manufacture of pharmaceutical products in particular, are suitable for eliminating the disadvantages of the prior art and thus meeting the high demands on the quality of the production process taking place. This object is achieved by a method for controlling a production process taking place on a production plant for the manufacture of pharmaceutical products in particular, wherein the production plant has a plurality of process units and a control device controlling the process units, wherein at least one of the process units has or forms at least one process insert which has or forms at least one process insert component,and wherein at least one process insert component is a replaceable process insert component and at least one replaceable process insert component is an identifiable process insert component equipped with a data carrier, wherein the data carrier has process insert component parameters of the replaceable process insert component equipped with it, wherein a configuration plan specific to the production process of the production plant with its respective process inserts is stored in the control device, and wherein the process insert component parameters of the identifiable process insert components respectively installed in the process insert are transmitted to the control device before, during or after the assembly of the process insert components to form a process insert, so that subsequently a check of the process insert component parameters takes place in the control device to this effect,whether at least one identifiable process component has been installed in the respective process component according to the stored configuration plan, and if so, whether the production process running on the production plant is released or can be released.

[0007] The products manufactured in the production facility are preferably pharmaceutical products, fine chemicals and / or food and feed. The pharmaceutical products are designed as various types of dosage form, namely in particular as solid, semi-solid or liquid dosage form. Fine chemicals are particularly complex, individual, pure chemical substances that are manufactured in limited quantities through multi-stage chemical or biotechnological production processes. They are described by precise specifications and used for further processing in the chemical industry.

[0008] The configuration plan specifically includes the identifiable process input components according to the stored configuration plan that are to be installed in the respective process input. In addition, the configuration plan may contain additional information that must be taken into account for the release of the production process running on the production system, such as information regarding the maintenance and safety of the respective process input components. It is particularly preferred that the configuration plan also include the cleaning status or maintenance dates for the respective process input component, e.g., a filter. Thus, in addition to ensuring that the respective process input component has been correctly installed, a check is also carried out to determine whether the respective process input component has been properly cleaned or maintained, or whether, for example, cleaning needs to be carried out again before installation.Furthermore, the configuration plan can also contain information that completely prevents the installation of a process insert component. This could be the case, for example, with a filter that was used in the manufacture of a specific pharmaceutical product and may now, even after cleaning, be used exclusively for the manufacture of this specific pharmaceutical product. Thus, the configuration plan is also suitable for preventing the contamination of pharmaceutical products through the incorrect use of process inserts.

[0009] The proposed method involves the use of only one qualified and trained operator, with the control device checking the correctness of the installed interchangeable process components.

[0010] In a preferred embodiment, the data carrier is designed, for example, as a readable RFID transponder, and the process component parameters are read from the data carrier using an RFID transponder reader and are or can be transmitted to the control device. Furthermore, the RFID transponder reader is designed as a certified and validated reader, i.e., it has, for example, an account personalized for an operator. By reading the RFID transponders of the installed process components with an RFID transponder reader with a personalized account, it is possible to document and log who carried out the installation and when.

[0011] Furthermore, the data carrier can preferably also be designed as a QR code or simple numerical code on the process insert component.

[0012] Furthermore, by reading the data carrier and checking the process component parameters in the control device, the selected replaceable process components are verified as correctly installed in the process unit's process insert. The use of identifiable process components also creates documentation of the use of the process component, which enables easier determination of wear and tear.

[0013] Overall, the method according to the invention increases the reliability of meeting the quality requirements of the production process. When using the method according to the invention, replaceable process components are correctly installed in the production plant with almost 100 percent reliability.

[0014] Notwithstanding the plural used above and below with regard to process units, process feeds, and process feed components, the process may also comprise only one process unit, one process feed, and one process feed component. Reference to an interchangeable process feed component is to be understood as a reference to one or more interchangeable process feed components.

[0015] Advantageous further developments of the invention emerge from the subclaims.

[0016] Preferably, a plurality of specific configuration plans are stored in the control device, which can be individually selected by an operator for the production process running on the production plant. By storing a plurality of configuration plans for the production plant, the production plant can be used for a plurality of production processes, and the time required to convert the production plant to a different production process is significantly reduced. The control device is expediently configured to output a parts list of the identifiable process components to be installed in the production plant on the basis of the configuration plan selected for the production process running on the production plant.By outputting a parts list, whether digitally on an optional display device of the production plant or in the form of a printout on paper, the operator can assemble the exchangeable process components to be replaced and rebuild them in the production plant in a time-saving manner.

[0017] Advantageously, the production plant has a display device that indicates the at least one identifiable process component that has been incorrectly installed in the respective process component according to the stored configuration plan. Such a visual representation of the identifiable process components—e.g., use of the correct, replaceable, identifiable process component shown in green and incorrect use of the replaceable, identifiable process component shown in red—further increases process reliability and thus also the quality of the production process.

[0018] In this regard, the display device, particularly preferably a mobile display device, preferably displays, for each incorrectly installed identifiable process input component, a further identifiable process input component which must be installed in order to obtain approval for the production process. This enables the operator to immediately recognize which process input component is to be installed in the production plant for the incorrectly installed process input component. Particularly preferably, the display device further shows where the further identifiable process input component is stored in a warehouse of the production plant, for example in a warehouse to which identical process input components are assigned, so that, for example, defective process input components can be or are to be replaced directly and in a controlled manner with system-accepted process input components.

[0019] Advantageously, the configuration plan of the production plant specific to the production process, stored in the control device, with its respective process inserts, and / or the process insert component parameters of the identifiable process insert components installed in the process insert, transmitted to the control device before, during, or after assembly of the process insert components, and / or the review of the process insert component parameters following transmission of the process insert component parameters to the control device, are stored as data in a database. All database entries are preferably electronically signed and stamped with the date and time.

[0020] It is advisable that the data cannot be modified or altered after being stored in the database, i.e., it is stored in an audit-proof manner. In addition to verifying the process components in the control system, all data required for the production process is completed and validated through a direct electronic database entry of other information before the process starts.

[0021] This eliminates the possibility of incorrect data entry and, for example, ensures that the use of process units, their associated process inputs, and other information are recorded and documented seamlessly and completely, which in turn enables better traceability and recording. This allows for complete tracking of the use of process units, for example, in order to evaluate and / or map their actual use, utilization, and depreciation in downstream evaluation processes.

[0022] In addition, there is the possibility of further standardization of production process protocols, e.g. batch protocols, or recipes to simplify operation, to provide better and more efficient training of operating personnel and to improve compliance with current and future regulations for manufacturing processes, particularly for pharmaceutical products.

[0023] The above-mentioned method is carried out in particular on a production plant for the manufacture of in particular pharmaceutical products by means of a production process running on the production plant, wherein the production plant has a plurality of process units and a control device controlling the process units, wherein at least one of the process units has or forms at least one process insert which has or forms at least one process insert component, and wherein at least one process insert component is an exchangeable process insert component and at least one exchangeable process insert component is an identifiable process insert component equipped with a data carrier, wherein the data carrier has process insert component parameters of the exchangeable process insert component equipped with it,wherein a configuration plan specific to the production process of the production plant with its respective process inserts can be stored in the control device, and wherein the process insert component parameters of the identifiable process insert components installed in the process insert can be transmitted to the control device before, during or after the assembly of the process insert components to form a process insert, so that subsequently a check of the process insert component parameters is carried out in the control device to determine whether the at least one identifiable process insert component has been installed in the respective process insert according to the stored configuration plan, and the control device is configured to release the production process running on the production plant if the answer is yes.

[0024] The proposed production plant can be configured and operated by only a single qualified and trained operator, with the control device checking the correctness of the installed interchangeable process components.

[0025] In a preferred embodiment of the production plant, the data carrier is designed, for example, as a readable RFID transponder, and the process component parameters are read from the data carrier using an RFID transponder reader and are or can be transmitted to the control device. More preferably, the RFID transponder reader is designed as a certified and validated reader, i.e. it has, for example, an account personalized for an operator. By reading the RFID transponders of the installed process components with an RFID transponder reader with a personalized account, it can be documented and logged who carried out the installation and when.In addition, by reading the data carrier and checking the process insert component parameters in the control device, the selected replaceable process insert components are verified as being correctly installed in the process insert of the process unit.

[0026] The use of identifiable process components also creates documentation of the use of the process component, which enables wear and tear to be determined more easily.

[0027] Overall, the production facility further increases the reliability of meeting the quality requirements of the production process. When using the production facility to carry out the process according to the invention, interchangeable process components are correctly installed in the production facility with almost 100 percent reliability.

[0028] In a preferred embodiment of the production plant, the control device has a database designed to store a plurality of specific configuration plans that can be individually selected by an operator for the production process running on the production plant. The ability to store multiple configuration plans for the production plant in the database allows the production plant to be used for a variety of production processes, and the time required to convert the production plant to a different production process is significantly reduced.

[0029] The control device is expediently configured to output a parts list of the identifiable process components to be installed in the production plant, based on the configuration plan selected for the production process running on the production plant. By outputting a parts list, whether digitally on an optional display device of the production plant or in the form of a paper printout, the operator can assemble the interchangeable process components to be replaced and reinstall them in the production plant in a time-saving manner.

[0030] According to a further advantageous embodiment of the production plant, it has a display device that is configured to display the at least one identifiable process input component that has been incorrectly installed in the respective process input according to the stored configuration plan. Such a visual representation of the identifiable process input components—e.g., use of the correct, replaceable, identifiable process input component shown in green and incorrect use of the replaceable, identifiable process input component shown in red—additionally increases process reliability and thus also the quality of the production process.

[0031] In this regard, the display device, particularly preferably a mobile display device, is expediently configured to display, for each incorrectly installed identifiable process component, another identifiable process component that must be installed to obtain approval for the production process. This allows the operator to immediately identify which process component needs to be installed in the production system to replace the incorrectly installed process component.

[0032] Furthermore, the display device is configured to show where the further identifiable process input component is stored in a warehouse of the production plant. In the warehouse, for example, identical process input components are assigned to the respective process input component so that, for example, defective process input components can be or are replaceable directly and in a controlled manner with process input components accepted by the system. In a further preferred embodiment, the display device is suitable for displaying the route to the further identifiable process input component stored in the warehouse. A known GPS signal is used to show the route on the display device.

[0033] If the control device has a database, the production plant is suitable for storing the process component parameters of the identifiable process components installed in the process component transmitted to the control device before, during, or after assembly of the process component into a process component in the database. All database entries are preferably electronically signed and stamped with the date and time.

[0034] It is advisable that the data cannot be modified or altered after being stored in the database, i.e., it is stored in an audit-proof manner. In addition to verifying the process components in the control system, all data required for the production process is completed and validated through a direct electronic database entry of other information before the process starts.

[0035] This eliminates the possibility of incorrect data entry and, for example, ensures that the use of process units, their associated process inputs, and other information are recorded and documented seamlessly and completely, which in turn enables better traceability and recording. This allows for complete tracking of the use of process units, for example, in order to evaluate and / or map their actual use, utilization, and depreciation in downstream evaluation processes.

[0036] In addition, there is the possibility of further standardization of production process protocols, e.g. batch protocols, or recipes to simplify operation, to provide better and more efficient training of operating personnel and to improve compliance with current and future regulations for manufacturing processes, particularly for pharmaceutical products.

[0037] The control device advantageously has a comparator device configured to check the process component parameters in the control device to determine whether the at least one identifiable process component has been installed in the respective process component according to the stored configuration plan. This allows the process running on the production plant to be further automated, thereby further increasing process reliability.

[0038] The control device expediently also has an evaluation device which is designed to evaluate the check carried out in the comparison device in such a way that, if the result is affirmative, the production process running on the production plant is released. The method running on the production plant can also be further automated by the evaluation device, as a result of which process reliability is additionally increased. According to an additional preferred embodiment, the data carrier is designed as a readable RFID transponder and the process input component parameters can be read from the data carrier by means of an RFID transponder reader assigned to the production plant and can be transmitted to the control device. The RFID transponder reader is further preferably designed as a certified and validated reader, i.e. it has, for example:A personalized account for each operator. By reading the RFID transponders of the installed process components with an RFID transponder reader with a personalized account, it is possible to document and log who performed the installation and when.

[0039] In addition, by reading the data carrier and checking the process insert component parameters in the control device, the selected replaceable process insert components are verified as being correctly installed in the process insert of the process unit.

[0040] The use of identifiable process components also creates documentation of the use of the process component, which enables wear and tear to be determined more easily.

[0041] Furthermore, the control device is preferably configured to store the configuration plan of the production plant with its respective process inserts stored in the control device for the production process and / or the process insert component parameters of the identifiable process insert components installed in the process insert transmitted to the control device before, during or after the assembly of the process insert components to a process insert and / or the review of the process insert component parameters carried out following the transmission of the process insert component parameters to the control device as data in a database, wherein the data expediently can no longer be changed or are changeable after being stored in the database.All database entries are preferably electronically signed and stamped with the date and time, which further increases process security.

[0042] The process units are preferably designed as a reactant storage container or as a dosing device or as a mixing device or as a granulator or as a screening device or as a drying device or as a filter device or as an intermediate product transport container or as a product transport container or as a tablet press or as a container cleaning device or as a coating device or as a conveying device or as a packaging machine or as a drive device.

[0043] In this respect, the granulator is advantageously designed as a fluidized bed granulator or as a spouted bed granulator or as a rotor granulator.

[0044] In this respect, the packaging machine is particularly advantageously designed as a thermoforming packaging machine or as a blow-fill-seal packaging machine or as a blister machine.

[0045] According to an additional preferred embodiment of the production plant, the process inserts are designed as a mixing unit or as a nozzle arrangement or as a sealing unit or as a sieve unit or as a filter unit or as a hose line or as a pipeline or as a valve arrangement or as a perforated base or as a pump or as a rotor unit or as a sensor unit or as a motor.

[0046] In the production plant, the process feed component is further preferably designed as a mixer or sieve bottom or as a sieve body or as a seal or as a thermocouple or as an analytical sensor or as an inner line or as an outer line or as a nozzle base body or as a nozzle or as a filter or as a pump wheel or as a valve or as a die table or as a stamp or as a rotor disk.

[0047] The following will explain, using the example of medicinal products, i.e. pharmaceutical products, why the process and production plant according to the invention are advantageous:

[0048] The manufacture of medicinal products requires approved, product-specific manufacturing instructions in accordance with national and regional regulations. These manufacturing instructions are binding for the pharmaceutical manufacturer because they are part of the approval dossier on the basis of which the competent authority (e.g., the Federal Institute for Drugs and Medical Devices, US FDA, EMA) approves the medicinal product for market entry.

[0049] The manufacturing specification defines, among other things, the individual process steps as well as the production facilities and their respective configuration in detail. In general, the configuration of a production facility includes, among other things, product feeds, product transport containers, intermediate product transport containers, process units, process inserts and process insert components. A predefined configuration validates the manufacturing process, i.e., provides documented proof that the medicinal product will achieve the specified product quality if the prescribed manufacturing steps are consistently carried out. Correct configuration is therefore an essential quality assurance measure for the manufacture of the medicinal product.

[0050] The method and the production plant according to the invention create the possibility of identifying a faulty or incomplete configuration of the production plant, whereby in the case of a faulty or incomplete configuration of the production plant, the release of a production process running on this plant is prevented by the system and in the case of a correct configuration of the production plant, the release of the production process running on this plant is granted.

[0051] The installation of data carriers, in particular RFID transponders, in individual process components of the prescribed configuration enables the implementation of this quality assurance measure and, in several respects, permits further measures that support and facilitate quality assurance and further reduce any risks that may arise: a) Using a data carrier, each individual process component can be individually identified and uniquely assigned. b) By reading a data carrier built into the replaceable process component, additional information on the life cycle of the process component can be logged. c) By reading a data carrier built into the process component, it can be checked whether the correct (i.e., prescribed) process component has been selected and installed by the operator.d) Predefined usability periods allow monitoring during readout to determine whether the process input component can still be used or needs to be replaced or cleaned. e) The status of a process input component can be visualized using suitable software. The visualization shows directly whether the correct process input component (e.g. green display) or the incorrect one (e.g. red display) has been installed in the process insert of the process unit. f) For each replaceable process input component, identical process input components are assigned to a warehouse so that, for example, defective process input components can be replaced directly with system-accepted ones in a controlled manner. g) By reading the RFID transponders of the installed process input components with an RFID transponder reader with a personalized account, it can be documented and logged who carried out the installation and when.h) The setup process designed in this way does not require the dual control principle or manual documentation; it avoids defective batches due to incorrect configuration of the production system caused by employee errors. The invention is explained in more detail below using the attached drawing and illustrated in it.

[0052] Figure 1 is a schematic representation of a first embodiment of a production plant,

[0053] Figure 2 is a schematic representation of a second embodiment of a production plant,

[0054] Figure 3 is a plan view of an embodiment of the nozzle arrangement,

[0055] Figure 4 is a sectional view of the nozzle arrangement through a section plane AA shown in Fig. 3,

[0056] Figure 5 is an enlarged view of section B of the nozzle arrangement shown in Fig. 4,

[0057] Figure 6 is a bottom view of an embodiment of the nozzle arrangement,

[0058] Figure 7 is a front view of a coupling head on a flexible inner line section,

[0059] Figure 8 is a sectional view of the flexible inner line section through a section plane CC shown in Fig. 7,

[0060] Figure 9 a side view of the coupling head and

[0061] Figure 10 is a sectional view of the coupling head through a cutting plane DD shown in Fig. 9.

[0062] In Fig . 1 a schematic representation of a first

[0063] Embodiment of a production plant 1 for the manufacture of pharmaceutical products in solid dosage form (solids), here tablets, by means of a production process running on the production plant 1 is shown.

[0064] The production plant 1 has a plurality of process units 2 and a control device 3 that controls the process units 2. The control device 3 has a control functionality for controlling the process units 2. Control lines 4, which transmit incoming and outgoing signals from the control device 3 to the process units 2 in order to control and / or regulate the process units 2, are represented by dashed arrows.

[0065] In the first embodiment of the production plant 1, it has the following controllable and adjustable process units 2 connected via pipe and hose connections 22:

[0066] A reactant storage container 5, a granulator 7 designed as a rotor granulator 6, a screening device 8, a drying device 10 having a filter device 9, a storage container 11, an intermediate product transport container 12, a mixing device 13, a tablet press 14, a coating device 15 and a product transport container 16.

[0067] Each process unit 2 can have one or more process inserts 17, which in turn are assembled from one or more replaceable process insert components 18. The replaceable process insert components 18 can be designed as an identifiable process insert component 18 equipped with a data carrier 19, wherein process insert component parameters 20 are stored on the data carrier 19. The reference symbol of the process insert component 18 is given below in parentheses after the reference symbol of the data carrier 19 in order to assign the respective data carrier 19 to a process insert component 18. Essential information of the process insert component is stored on the data carrier 19 as process insert component parameters.

[0068] The reactant storage container 5 forms a process unit 2, which simultaneously forms a process insert 17 and an identifiable process insert component 18 having process insert component parameters 20. The process insert component 18 has a data carrier 19, which is designed as an RFID transponder 21. For example, the nameplate forms the data carrier 19. Essential information of the reactant storage container 5 is stored on the data carrier 19 (Fig. 5) as process insert component parameters, such as the filled reactant, filling volumes, life cycle or the like. The life cycle includes, for example, information about the number of processes that have been completed in which the reactant storage container 5 was used, cleaning information, the service life and other general information.

[0069] The reactants are filled from the reactant storage container 5 into the granulator 7 via the pipe or hose connection 22a. The granulation liquid is fed separately to the granulator 7 via a pipe or hose connection 22b.

[0070] The granulator 7, designed as a rotor granulator 6, has a process insert 17, namely a rotor unit 23. The rotor unit 23 has two replaceable, identifiable process insert components 18, with a rotor disk 24 driven by a drive motor (not shown), and guide vanes 25 arranged on the side walls of the granulator 7. The two aforementioned process insert components 18 each have a data carrier 19 designed as an RFID transponder 21. Essential information relating to the rotor disk 24, such as information about the diameter, the rotor disk thickness, the surface quality, the life cycle of the rotor disk 24, or the like, is stored on the data carrier 19(24) as process insert component parameters. Essential information relating to the guide vanes 25, such as, for example,Information about the angle of attack in the installed state, surface condition, the life cycle of the guide vane a 25 or similar.

[0071] The granulate produced in the granulator 7 is conveyed from the granulator 7 into the screening device 8 via the pipe or hose connection 22c.

[0072] The screening device 8 has a screening unit 26 as a process insert 17, which has two replaceable, identifiable process insert components 18, namely a screen plate 27 and a screen body 28 interacting with the screen plate 27 to screen the granulate produced in the granulator 7 and obtain uniformly sized particles. The screen plate 27 and the screen body 28 each have a data carrier 19 designed as an RFID transponder 21. Essential information about the screen plate 27, such as information about the shape, diameter, hole sizes of the screen plate 27, the life cycle of the screen plate 27, or similar, is stored on the data carrier 19(27) as process insert component parameters. Furthermore, essential information concerning the sieve body 28 is stored on the data carrier 19(28), such as information about the diameter, the weight, the surface quality, the life cycle of the sieve body 28 or the like.From the screening device 8, the screened particles are conveyed into the drying apparatus 10 via a pipe or hose connection 22d.

[0073] The drying apparatus 10 is designed as a fluidized bed dryer 29. The fluidized bed dryer 29 has a plurality of process inserts 17, namely a distribution chamber 30, a vortex chamber 31, a perforated base 32 arranged between the distribution chamber 30 and the vortex 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 vortex chamber 31. The aforementioned process inserts 17, with the exception of the filter unit 33, each simultaneously form the replaceable, identifiable process insert component 18. The filter unit 33 has a filter 35 as a replaceable, identifiable process insert component 18, which filter can in turn be designed as a textile or metal filter.

[0074] The perforated bottom 32, also referred to as the inflow bottom, separates the vortex chamber 31 from the distribution chamber 30, the vortex chamber 31 being arranged above the distribution chamber 30. A drying gas flows into the distribution chamber 30 via a drying gas supply 36, which then flows via the perforated bottom 30 and the vortex chamber 31 having the filter unit 33 in the direction of the drying gas discharge 37 and exits there. The particles conveyed from the screening device 8 into the vortex chamber 31 are dried by the drying gas and then transported via a pipe or hose connection 22e into a storage container 11.

[0075] The distribution chamber 30, the vortex chamber 31, the perforated base 32, the filter 35 of the filter unit 33 and the sealing unit 34 each have a data carrier 19 designed as an RFID transponder 21 as replaceable process insert components 18.

[0076] Essential information relating to the distribution chamber 30 is stored on the data carrier 19(30) as process component parameters, in particular information relating to the shape, diameter, size, life cycle of the distribution chamber 30, or the like. Essential information relating to the vortex chamber 31, such as the shape, diameter, height, filter unit 33, the life cycle of the vortex chamber 31, or the like, is also stored on the data carrier 19(31) as process component parameters. Essential information relating to the perforated base 32 is stored on the data carrier 19(32) as process component parameters, such as information relating to the diameter, the hole diameters, the outflow angle, the life cycle of the perforated base 32, or the like. Essential information relating to the sealing unit 34 designed as a seal is stored on the data carrier 19(34) as process component parameters.In particular, information such as the age of the seal, seal material, maximum contact pressure, seal dimensions such as diameter, cross-section, and wall thickness, etc., can be found there. Finally, information about the filter 35 of the filter unit 33, such as filter material, pore size, life cycle, or similar, is stored on the data carrier 19(35) as process component parameters.

[0077] The dried particles are temporarily stored in the storage container 11 during the production process to compensate for any fluctuations in the particle production. Additional particles can also be added. The storage container 11 forms a process insert 17 and, at the same time, a replaceable, identifiable process insert component 18. The storage container 11 has a data carrier 19 designed as an RFID transponder 21, on which the essential information concerning the storage container 11 is stored as process insert component parameters.

[0078] From the storage container 11, an intermediate product transport container 12 is filled with the particles via a pipe or hose connection 22f, which is then transferred to a mixing device 13 designed as a lifting column.

[0079] The intermediate product transport container 12 forms a process unit 2, which simultaneously forms a process insert 17 and an identifiable process insert component 18 having process insert component parameters 20. The process insert component 18 has a data carrier 19, which is designed as an RFID transponder 21. For example, the nameplate forms the data carrier 19. Essential information of the intermediate product transport container 12, such as filled particles, filling volumes, life cycle, or the like, is stored on the data carrier 19(12) as process insert component parameters. The intermediate product transport container 12 further has a process insert 17 designed as a valve arrangement 38. The valve arrangement 38 has a valve 40, designed in particular as a containment flap 39, which forms the identifiable process insert component 18 having process insert component parameters 20.The valve 40 has a data carrier 19, which is designed as an RFID transponder 21. Essential information of the valve 40, such as life cycle, frequency of use, leak tightness, or the like, is stored on the data carrier 19(40) as process insert component parameters. The particles transported in the intermediate product transport container 12 are mixed in the mixing device 13 and then transferred to the tablet press 41 via the valve arrangement 38 and the valve arrangement 42 belonging to the tablet press 41, matching the valve arrangement 38, and designed as a process insert 17. The valve arrangement 42, as process insert component 18, also has a valve 40 designed as a containment flap 39.

[0080] In addition to the process insert 17 designed as a valve arrangement 42, the tablet press has at least one further process insert 17, namely the tablet pressing unit 43. The tablet pressing unit 43 has replaceable, identifiable process insert components 18, namely a die table 44 and punches 47 designed as lower punches 45 and upper punches 46. The aforementioned process insert components 18 each have a data carrier 19 designed as an RFID transponder 21 as replaceable, identifiable process insert components 18. Essential information of the valve 40, such as life cycle, frequency of use, tightness, or the like, is stored on the data carrier 19(40) as process insert component parameters. Essential information of the die table 44, such asCavity diameter, cavity fill volume, frequency of use, rotation speed, life cycle, or similar. Furthermore, key information on the corresponding punches 45, 46, 47 can be found on the data carrier 19 (45, 46, 47) as process component parameters, such as punch material, punch diameter, punch length, maximum punch contact pressure, life cycle, or similar. In the tablet press 41, the particles are compressed into tablets, which are then transferred to a coating device 15, in which the tablets receive a further coating, e.g., an enteric coating. The coating device 15 has two process inserts 17, namely a coating drum 48 and a nozzle arrangement 49.

[0081] The coating drum 48 simultaneously forms a replaceable, identifiable process component 18, which has a data carrier 19 designed as an RFID transponder 21. Essential information of the coating drum 48, such as life cycle, frequency of use, drum diameter, drum length, drum capacity, hole diameter of the drum wall bores, or the like, is stored on the data carrier 19(48) as process component parameters.

[0082] The nozzle arrangement 49 also has replaceable, identifiable process insert components 18, namely in particular an inner line 50, an outer line 51, a nozzle base body 52 and / or a nozzle 53. The aforementioned process insert components 18 of the nozzle arrangement 49 also each have a data carrier 19 designed as an RFID transponder 21.

[0083] On the data carrier 19(50), essential information about the inner line 50 is stored as process component parameters, such as the inner line length, inner line diameter, inner line material, frequency of use of the inner line, or the like. On the data carrier 19(51), essential information about the outer line 51 is stored as process component parameters, such as the outer line length, outer line diameter, outer line material, frequency of use of the outer line, or the like. On the data carrier 19(52), essential information about the nozzle base body 52 is stored as process component parameters, such as the number of nozzles 53 that can be inserted into the nozzle base body 52, usable nozzles 53, nozzle base body material, frequency of use of the nozzle base body 52, or the like. On the data carrier 19(53), essential information about the nozzle 53 is stored as process component parameters, such asNozzle outer diameter, type of nozzle (single-component / multi-component nozzle), nozzle inner diameter, max. spray pressure, min. or max. droplet size when spraying or similar.

[0084] A detailed description of the nozzle arrangement 49 as an example of a process insert 17 with an exemplary arrangement of the data carriers 19 designed as RFID transponders 21 is described in Figs. 3 to 10.

[0085] The coated tablets are then transferred from the coating device 15 to a product transport container 16. The product transport container 16 also simultaneously forms a process insert 17 and a process insert component 18, which has a data carrier 19 designed as an RFID transponder 21. For example, the nameplate forms the data carrier 19. Essential information of the product transport container 16, such as the filled product, date of manufacture, batch number, filling volumes, life cycle, or the like, is stored on the data carrier 19(16) as process insert component parameters.

[0086] The data carriers 19 can be read either via the control lines 4 or, as shown in Fig. 1, via a verified RFID transponder reader 54 assigned to the production plant 1. A configuration plan specific to the production process, in this case a tablet production process, of the production plant 1 with its respective process inserts 17 is stored in the control device 3. For this purpose, the control device 3 has a database 55 designed to store a plurality of specific configuration plans that can be individually selected by an operator for the production process running on the production plant 1.

[0087] Before, during or after the assembly of the process insert components 18 to form a process insert 17, the process insert component parameters of the identifiable process insert components 18 respectively installed in the process insert 17 are transmitted to the control device 3, so that subsequently a check of the process insert component parameters is carried out in the control device 3 to determine whether the at least one identifiable process insert component 18 has been installed in the respective process insert 17 in accordance with the stored configuration plan, and the control device 3 is configured to release the production process running on the production plant 1 if the answer is yes.

[0088] In the event that an operator incorrectly installs a replaceable, identifiable process insert component 18 in the production plant 1 or forgets to install a replaceable, identifiable process insert component 18 due to an oversight, the production plant 1 has a display device 56, in particular a mobile display device such as a tablet, which is configured to display the at least one identifiable process insert component 18 that has been installed incorrectly or not at all in the respective process insert 17 according to the stored configuration plan.

[0089] In addition, the production plant 1 has a warehouse 57 in which further replaceable, identifiable process input components 18 of the production plant 1 are stored. The further replaceable, identifiable process input components 18 stored in the warehouse 57 are preferably identical process input components 18. Particularly preferably, the display device 56 further shows where the further identifiable process input component 18 is stored in a warehouse 57 of the production plant 1, so that, for example, defective process input components 18 can be replaced directly and in a controlled manner with system-accepted process input components 18.

[0090] On the display device 56, a parts list of the identifiable process components 18 to be installed in the production plant 1 can be output on the basis of the configuration plan selected for the production process running on the production plant 1.

[0091] The database 55 is further suitable for storing the process insert component parameters of the identifiable process insert components 18 respectively installed in the process insert 17, which are transmitted to the control device 3 before, during or after the assembly of the process insert components 18 to form a process insert 17, in the database.

[0092] For the verification of the process input component parameters in the control device 3, the control device 3 has a comparator device 58. In addition to the comparison, an evaluation of the comparison also takes place. For this purpose, the control device 3 has an evaluation device 59, which is designed to evaluate the verification performed in the comparator device 58 to the effect that, if the result is affirmative, the production process running on the production plant 1 is released.

[0093] Fig. 2 shows a schematic representation of a second embodiment of a production plant 1 for producing pharmaceutical products, here tablets, by means of a production process running on the production plant 1.

[0094] The production plant 1 has a plurality of process units 2 and a control device 3 that controls the process units 2. The control device 3 has a control functionality for controlling the process units 2. Control lines 4, which transmit incoming and outgoing signals from the control device 3 to the process units 2 in order to control and / or regulate the process units 2, are represented by dashed arrows.

[0095] In the second embodiment of the production plant 1, it has the following controllable and adjustable process units 2 connected via pipe and hose connections 22:

[0096] A dosing device 60 for pharmaceutically active ingredients, a conveying device 61 for conveying binder, a mixing device 13 for producing a suspension from the pharmaceutically active ingredient and the binder, a granulator 7 designed as a fluidized bed granulator 64, which has a filter device 9, a storage container 11, and a tablet press 14. Each process unit 2 can, as already explained with reference to Fig. 1, have one or more process inserts 17, which in turn are assembled from one or more replaceable process insert components 18. The replaceable process insert components 18 can be designed as an identifiable process insert component 18 equipped with a data carrier 19, wherein process insert component parameters 20 are stored on the data carrier 19.The reference number of the process input component 18 is indicated below in parentheses after the reference number of the data carrier 19 in order to assign the respective data carrier 19 to a process input component 18. Essential information of the process input component is stored on the data carrier 19 as process input component parameters.

[0097] The dosing device 60 forms a process unit 2, which simultaneously forms a process insert 17 and an identifiable process insert component 18 having process insert component parameters 20. The process insert component 18 has a data carrier 19, which is designed as an RFID transponder 21. For example, the nameplate forms the data carrier 19. Essential information of the dosing device 60, such as the filled active pharmaceutical ingredient, fill quantity, life cycle, or the like, is stored on the data carrier 19 (60) as process insert component parameters.

[0098] The active pharmaceutical ingredient is metered into the mixing device 13 via the dosing device 60 via the pipe or hose connection 22a. The binder is supplied separately to the mixing device 13 via a pipe or hose connection 22b, which is transported by a conveyor device 61 having a process insert 17.

[0099] The process insert 17 has a pump impeller 62 having a replaceable, identifiable process insert component 18 with process insert component parameters 20. The aforementioned process insert component 18 has a data carrier 19, which is designed as an RFID transponder 21. Essential information about the pump impeller 62, such as pump impeller diameter, min. or max. pump impeller throughput, life cycle, or the like, can be found on the data carrier 19(62) as process insert component parameters.

[0100] The mixing device 13, in which the pharmaceutically active ingredients are mixed with the binder to form a suspension, has a process insert 17, which is designed as a mixing unit 63 and has the process insert component 18 designed as a mixer 151. The mixer 151 has a replaceable, identifiable process insert component 18. The mixer 151 also has a data carrier 19, which is designed as an RFID transponder 21. Essential information of the mixer 151, such as mixer diameter, min. or max. torque, mixer type, mixing blade size, life cycle, or the like, can be found on the data carrier 19(151) as process insert component parameters.

[0101] The suspension is conveyed from the mixing device 13 into the granulator 7 .

[0102] The granulator 7, designed as a fluidized bed granulator 64, has a plurality of process inserts 17, namely, a distribution chamber 30, a vortex chamber 31, a perforated plate 32 arranged between the distribution chamber 30 and the vortex chamber 31, a nozzle arrangement 49 arranged in the vortex 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 vortex chamber 31. With the exception of the filter unit 33, the aforementioned process inserts 17 each simultaneously form the replaceable, identifiable process insert component 18. The filter unit 33 has a filter 35 as the replaceable, identifiable process insert component 18, which in turn can be designed as a textile or metal filter.The nozzle arrangement 49 also has replaceable, identifiable process insert components 18, namely in particular an inner line 50, an outer line 51, a nozzle base body 52 and / or a nozzle 53. The aforementioned process insert components 18 of the nozzle arrangement 49 also each have a data carrier 19 designed as an RFID transponder 21.

[0103] On the data carrier 19(50), essential information about the inner line 50 is stored as process component parameters, such as the inner line length, inner line diameter, inner line material, frequency of use of the inner line, or the like. On the data carrier 19(51), essential information about the outer line 51 is stored as process component parameters, such as the outer line length, outer line diameter, outer line material, frequency of use of the outer line, or the like. On the data carrier 19(52), essential information about the nozzle base body 52 is stored as process component parameters, such as the number of nozzles 53 that can be inserted into the nozzle base body 52, usable nozzles 53, nozzle base body material, frequency of use of the nozzle base body 52, or the like. On the data carrier 19(53), essential information about the nozzle 53 is stored as process component parameters, such asNozzle outer diameter, type of nozzle (single-component / multi-component nozzle), nozzle inner diameter, max. spray pressure, min. or max. droplet size when spraying or similar.

[0104] A detailed description of the nozzle arrangement 49 as an example of a process insert 17 with an exemplary arrangement of the data carriers 19 designed as RFID transponders 21 is described in Figs. 3 to 10.

[0105] The perforated bottom 32, also referred to as the inflow bottom, separates the vortex chamber 31 from the distribution chamber 30, with the vortex chamber 31 being arranged above the distribution chamber 30. A drying gas flows into the distribution chamber 30 via a drying gas supply 36, which then flows via the perforated bottom 30 and the vortex chamber 31, which has the filter unit 33, in the direction of the drying gas outlet 37 and exits there. The drying gas fluidizes the auxiliary materials introduced into the vortex chamber 31 via the feed device 65 and sprays them with the suspension atomized via the nozzle arrangement 49. As a result, the granules are formed in a spray granulation, spray agglomeration, or spray encapsulation process, which are then passed on to the storage container 11 via a pipe or hose connection 22b for temporary storage there.

[0106] The distribution chamber 30, the vortex chamber 31, the perforated base 32, the filter 35 of the filter unit 33 and the sealing unit 34 each have a data carrier 19 designed as an RFID transponder 21 as replaceable process insert components 18.

[0107] Essential information relating to the distribution chamber 30 is stored on the data carrier 19(30) as process component parameters, in particular information relating to the shape, diameter, size, life cycle of the distribution chamber 30, or the like. Essential information relating to the vortex chamber 31, such as the shape, diameter, height, filter unit 34, the life cycle of the vortex chamber 31, or the like, is also stored on the data carrier 19(31) as process component parameters. Essential information relating to the perforated base 32 is stored on the data carrier 19(32) as process component parameters, such as information relating to the diameter, the hole diameters, the outflow angle, the life cycle of the perforated base 32, or the like. Essential information relating to the sealing unit 34 designed as a seal is stored on the data carrier 19(34) as process component parameters.In particular, information such as the age of the seal, seal material, maximum contact pressure, seal dimensions such as diameter, cross-section, and wall thickness, etc., can be found there. Finally, information about the filter 35 of the filter unit 33, such as filter material, pore size, life cycle, or similar, is stored on the data carrier 19(35) as process component parameters.

[0108] The granules are temporarily stored in the storage container 11 during the production process in order to compensate for any fluctuations in the production of the granules. The storage container 11 forms a process insert 17 and, at the same time, a replaceable, identifiable process insert component 18. The storage container 11 has a data carrier 19 designed as an RFID transponder 21, on which the essential information concerning the storage container 11 is stored as process insert component parameters.

[0109] The tablet press 41 is filled with granules from the storage container 11 via a pipe or hose connection 22f. The tablet press has at least one further process insert 17, namely the tablet pressing unit 43. The tablet pressing unit 43 has replaceable, identifiable process insert components 18, namely a die table 44 and punches 47 designed as lower punches 45 and upper punches 46. The aforementioned process insert components 18 each have, as replaceable, identifiable process insert components 18, a data carrier 19 designed as an RFID transponder 21. Essential information of the die table 44, such as cavity diameter, fill quantity of the cavities, frequency of use, rotation speed, life cycle, or the like, is stored on the data carrier 19(44) as process insert component parameters.Furthermore, essential information of the corresponding punches 45, 46, 47 can be found on the data carrier 19(45, 46, 47) as process component parameters, such as punch material, punch diameter, punch length, max. punch contact pressure, life cycle or the like.

[0110] In the tablet press 41, the particles are pressed into tablets and then leave the tablet press 41 as products.

[0111] The method proceeds according to the method for the first embodiment of the production plant 1. An operator installs the replaceable, identifiable process input components 18 in the production plant 1, and the control device 3 checks the installation and, if approved, releases the production process running on the production plant 1.

[0112] Fig. 3 shows a plan view of an embodiment of the nozzle arrangement 49. The nozzle arrangement 49 shown in Fig. 3 has a line arrangement 66 which has an outer line 51 carrying a gaseous medium. A connection piece 68 is connected to a supply side 67 of the line arrangement 66, while a nozzle base body 52 having at least one nozzle 53 is connected to an outlet side 69 of the line arrangement 66 opposite the supply side 67. Furthermore, the outer line 66 has a data carrier 19 designed as an RFID transponder 21 which is inserted into a bore. The information referred to as process feed component parameters of the outer line 51 referred to as process feed component 18 can be stored on the data carrier 19.

[0113] Fig. 4 shows a sectional view of the nozzle arrangement 49 through a sectional plane AA shown in Fig. 3.

[0114] The outer line 51 carrying the gaseous medium has an inner line 69 arranged within the outer line 51 and carrying a medium to be sprayed. An annular gap 145 serving as an outer line flow channel 144 is formed between the outer line 51 and the inner line 69. The inner line 50, arranged within the outer line 51 and forming an inner line flow channel 146, is coaxially enclosed by the outer line 51 in the embodiment shown.

[0115] The inner line 50 is made up of several parts. Accordingly, the inner line 50 has a rigid inner line section 70, preferably a straight tube made of metallic material, and a flexible inner line section 71 which adjoins the rigid inner line section 70 and is preferably designed as a fabric-reinforced silicone hose or as a Guttasyn hose. The rigid inner line section 70 is held in the outer line 51 on the supply side 67 of the line arrangement 66 by the connecting piece 68 and is connected to a connecting element 73 on a side 72 of the rigid inner line section 70 facing away from the supply side 67. The flexible inner line section 71 is connected to the connecting element 73 on the supply side and to the nozzle base body 52 on the outlet side 69 of the line arrangement 66.

[0116] A mounting flange 74 is arranged on the outer line 51 of the line arrangement 66 and is arranged in a conical outer casing section 75, shown exclusively as an example in Fig. 4, of a treatment module (not shown in detail), in a mounting plane CC oriented perpendicular to the sectional plane AA. In the treatment module, the embodiment of the nozzle arrangement 49 shown is used in particular to generate a top spray. The treatment module is preferably designed as a coating device, such as a drum coater, or as a fluidization apparatus, such as a fluidized bed or spouted bed apparatus. Furthermore, the outer line 51 has a data carrier 19 designed as an RFID transponder 21, which is inserted into a bore in the mounting flange 74.The information referred to as process input component parameters of the external line 51 referred to as process input component 18 can be stored on the data carrier 19.

[0117] The connecting piece 68 has a double flange 76 forming a double-flange flow channel 147, the outlet-side flange 77 of which is connected to an outer line end section flange 79 arranged on a supply-side outer line end section 78 in such a way that the inner line 50 and the outer line 51 of the line arrangement 66 are sealed on the supply side 67. For this purpose, the flange 77 and the outer line end section flange 79 are clamped in the axial direction by means of a clamping device 81 designed as a Tri-Clamp 80. Furthermore, the inner line 50 has a data carrier 19 designed as an RFID transponder 21, which is inserted into a bore in the flange 77. The information referred to as process input component parameters of the inner line 50 referred to as process input component 18 can be stored on the data carrier 19.In addition to the double flange 76, the connecting piece 68 further has an inner line coupling piece 83 having an outlet-side inner line coupling piece flange 82 and forming an inner line piece flow channel 148, wherein the inner line coupling piece flange 82 is connected to the supply-side flange 84 of the double flange 76 and is clamped in the axial direction by means of a clamping device 86 designed as a Tri-Clamp 85, so that the double flange 76 extending the inner line 50 of the line arrangement 66 is sealed on the supply side 67 of the line arrangement 66. The inner line flow channel 146 is fluidically connected in this regard to the double flange flow channel 147 and the inner line coupling piece flow channel 148.

[0118] The inner line coupling piece 83 has a coupling piece connection 87 for feeding the medium to be sprayed, expediently a liquid, a dispersion, an emulsion, or a suspension, and a coupling piece connection 88 for feeding a flushing medium, expediently designed as flushing air. The described design of the connecting piece 68 enables a very simple replacement of the inner line coupling piece 83, whereby the coupling piece connections 87, 88 can be exchanged efficiently.

[0119] The external line 51 is connected to a connecting piece 89, onto which an external line coupling piece (not shown) can be plugged, via which the pressurized gaseous medium, expediently spray air, can be fed.

[0120] On the outlet side, the outer line 51 and the inner line 50 are connected to the two-part nozzle base body 52, wherein the outer line 51 is connected to a nozzle base body cover 90 and the inner line 9, preferably the flexible inner line element 71, is connected to a nozzle base body pot 91. The nozzle base body 52 has a data carrier 19 designed as an RFID transponder 21, which is introduced into a bore in the nozzle base body pot 91. The information referred to as process input component parameters of the nozzle base body pot 91, referred to as process input component 18, can be stored on the data carrier 19. The nozzle base body cover 90 and the nozzle base body pot 91 are connected to one another by means of a bayonet closure, wherein the bayonet closure is sealed by sealing elements 93a, b designed as ring seals 92a, b.The sealing elements 93a, b are each arranged in a groove 94a, b associated with the nozzle base body cover 90 or the nozzle base body cup 91. In an embodiment not shown, the connection between the nozzle base body cup 91 and the nozzle base body cover 90 was established by means of a thread, wherein the nozzle base body cover 90 expediently has an external thread and the nozzle base body cup 91 has an internal thread.

[0121] The deflection of the media from a horizontal mounting plane CC into a vertical spray plane DD, which is necessary for a top spray, takes place in the region of a bend 95 in the line arrangement 66, which, as in the embodiment shown, is formed by a 90° pipe bend 96. In the region of the bend 95, the inner line 50 arranged within the outer line 51 has the flexible inner line section 71, wherein the flexible inner line section 71 is expediently guided by spacers 97 within the outer line 51, as shown in the embodiment. In the embodiment, three spacers 97 are used.

[0122] An enlarged view of section B of the nozzle arrangement 49 shown in Fig. 4 is shown in Fig. 5. The nozzle base body 52 is connected, in particular welded, to the outer line 51 by means of the nozzle base body cover 90. Furthermore, the nozzle base body 52 is detachably connected to the inner line 50 by means of the nozzle base body cup 91. For the detachable connection between the inner line 50 and the nozzle base body 52, a coupling element 99 is arranged on an outlet-side inner line end section 98 of the inner line 50 and on the nozzle base body cup 91. In this regard, one coupling element 99 is designed as a first coupling element 99a and one coupling element 99 as a second coupling element 99b, wherein the coupling elements 99 can be coupled to one another by means of a plug connection.In the embodiment shown, the first coupling element 99a is arranged on the inner line end section 98 of the inner line 50, and the second coupling element 99b is arranged on the nozzle base body 52. ​​Due to the fact that the flexible inner line section 71 of the inner line 50, on which the first coupling element 99a is arranged, is prestressed, the first coupling element 99a is fixed in the second coupling element 99b.

[0123] The first coupling element 99a is designed as a coupling head 101 through which a coupling head channel system 100 passes, and the second coupling element 99b is designed as a receiving bushing 103 having a receiving space 102, so that in the assembled state of the nozzle arrangement 49, the inner line 50 is connected to the nozzle base body 52, preferably the nozzle base body cup 91. The medium to be sprayed can thus flow through the inner line flow channel 146 and the coupling head channel system 100 in the direction of the three nozzles 53. The receiving space 102 of the receiving bushing 103 is delimited in the embodiment by a receiving bushing wall 104 and a receiving bushing base 105. Each of the nozzles 53 has a data carrier 19 designed as an RFID transponder 21, which is inserted into a bore.The information referred to as process input component parameters of the respective nozzle 53 referred to as process input component 18 can be stored on the data carrier 19 of a nozzle 53.

[0124] The coupling head channel system 100 has an input channel 106 having a longitudinal axis EE, which in a transition region 107 is divided into a plurality of on a jacket surface

[0125] 108 of the coupling head 101. In the embodiment shown, the plurality of output channels 109 are arranged at an angle to the longitudinal axis EE of the input channel 106. Furthermore, the output channels are evenly distributed in the circumferential direction of the coupling head 101, as can be seen better in Fig. 9. In addition, each output channel 109 has an output channel cross-sectional area 110 which is many times smaller than an input channel cross-sectional area 111. Due to the smaller output channel cross-sectional area 110 in comparison to the input channel cross-sectional area 111, a sieve effect is produced, by means of which coarse impurities in the medium to be sprayed can be filtered out. Furthermore, each output channel

[0126] 109 expediently an output channel cross-sectional area

[0127] 110 which is smaller than a nozzle outlet cross-sectional area 149 at the nozzle outlet 150 of the nozzle 53. This additionally ensures that impurities not retained by the outlet channels 109 can also flow through a nozzle outlet 150 unhindered and be sprayed without clogging the nozzle 53, in particular at its nozzle outlet 150, or in the worst case, blocking it.

[0128] The coupling head 101 has a coupling head fastening device 112 for the inner line 50, wherein the coupling head fastening device 112 is expediently designed as a coupling head fastening sleeve 115 having a first locking element 114 with a locking lug 113. The coupling head fastening device 112 is penetrated by the coupling head channel system 100, in particular by the input channel 106.

[0129] In addition, the coupling head 101 has a cap element 116 placed on the coupling head fastening sleeve 115, which penetrates the rear of the coupling head fastening device 112 with a coupling head connection sleeve 117. The cap element 116 is preferably a plastic with the material designation PA2200 and is manufactured in particular as a 3D component using a laser sintering process. PA2200, which is based on PA12, offers a wide range of possible applications. In addition, it meets all requirements for biocompatibility. In the embodiment shown, the coupling head connection sleeve 117 is coaxially enclosed by the coupling head fastening device 112, in particular by the coupling head fastening sleeve 115. At the same time, the input channel 106 is also coaxially enclosed by the coupling head connection sleeve 117.

[0130] The structural design of the coupling head 101 results in a space 118 being created between the coupling head connection sleeve 117 and the coupling head fastening sleeve 115, into which space the inner line 50 can be inserted, said space having a second locking element 120 on its inner line end section 98 which is designed as a locking recess 119 receiving the first locking element 114, so that the first locking element 114 of the coupling head fastening sleeve 115 and the second locking element 120 of the inner line 50, in particular of the flexible inner line section 71, are operatively connected to one another. The coupling head 101 can also be connected to the outlet-side inner line end section 98 of the inner line 50 using a different connection technology, e.g. by a thread , an internal thread being arranged on the coupling head fastening sleeve 115 and an external thread being arranged on the inner line end section 98 of the inner line 50 .

[0131] The first coupling element 99a, designed as a coupling head 101, has a coupling head sealing element 125 which, in the assembled state, seals between the first and the second coupling element 99a, b, so that the coupling head 101 and the receiving bushing 103 delimit a distribution chamber 126, wherein the coupling head 101 expediently has a coupling head groove 127 over its entire circumference for receiving the coupling head sealing element 125. The coupling head sealing element 125 is preferably designed as an annular seal 128. By introducing the medium to be sprayed into the distribution chamber 126, said medium is distributed evenly between the individual nozzles 53 arranged in the nozzle base body 52.

[0132] To supply the nozzles 53 arranged on the two-part nozzle base body 52 with the media provided via the line arrangement 66, the nozzle base body 52 is penetrated by a first nozzle base body channel system 121 for the gaseous medium and a second nozzle base body channel system 122 for the medium to be sprayed. This ensures that the corresponding media can be guided separately from one another by the line arrangement 66 to the nozzle 53. Each nozzle 53 has a data carrier 19 designed as an RFID transponder 21, which is inserted into a bore.

[0133] The first nozzle base body channel system 121 has at least one nozzle base body supply line 123 corresponding to the number of nozzles 53 arranged in the nozzle base body 52, in order to conduct the gaseous medium to the respective nozzle 53. In the embodiment shown, two nozzle base body supply lines 123 are assigned to each nozzle. At the nozzle outlet 150 of the nozzle 53, the two nozzle base body supply lines 123 ensure better air distribution for atomizing the medium to be sprayed. Any deposits of the medium to be sprayed that may occur at the nozzle outlet are also further reduced as a result. The gaseous medium thus flows through the outer line flow channel 144 via the nozzle base body supply lines 123 to the nozzle 53. The aforementioned connection of all flow channels for the gaseous medium is also called the outer flow channel.The second nozzle base body channel system 122 also has a number of nozzle base body supply lines 124 corresponding to the number of nozzles 53 arranged in the nozzle base body 52, in order to guide the medium to be sprayed to the respective nozzle 53. The nozzle base body supply lines 124 of the second nozzle base body channel system 122 connect the distribution chamber 126 and the respective nozzle 53 to one another. The medium to be sprayed flows accordingly through the inner line coupling piece flow channel 146, the double flange flow channel 147, the inner line flow channel 146 and the coupling head channel system 100 into the distribution chamber 126 and from there via the nozzle base body supply lines 124 to the nozzle 53. The aforementioned connection of all flow channels for the medium to be sprayed is also called the inner flow channel.In the exemplary embodiment, the nozzle base body 52 is thus penetrated by three nozzle base body supply lines 123 and three nozzle base body supply lines 124.

[0134] The nozzle base body 52, here the nozzle base body pot 91, has three nozzles 53, as shown in the bottom view of the nozzle arrangement 49 shown in Fig. 4. A different number of nozzles, e.g. four, five, six or more nozzles, is conceivable and feasible.

[0135] Fig. 7 shows a front view of the flexible inner line section 71 having a coupling head 101.

[0136] The coupling head 101 is arranged on the inner line end section 98 of the inner line 50. Three spacers 97 having through-openings 129 are arranged coaxially around the flexible inner line section 71. The through-openings 129 allow the gaseous medium to flow almost unhindered through the outer line flow channel 144 between the outer line 51 and the inner line 50 in the direction of the nozzles 53 arranged in the nozzle base body 52.

[0137] A sectional view of the flexible inner line section 71 through a sectional plane CC shown in Fig. 7 is shown in Fig. 8. The coupling head 101 has a data carrier 19 designed as an RFID transponder 21, which is introduced into a bore in the coupling head 101. The information referred to as process input component parameters of the coupling head 101 referred to as process input component 18 can be stored on the data carrier 19. As already explained in Fig. 4, the connecting element 73 is arranged in the outer line 51 to connect the rigid inner line section 70 to the flexible inner line section 71. The connecting element 73 has a connecting element channel 130 which is assigned to the inner line channel 146 and passes through the connecting element 73 in the flow direction of the medium to be sprayed.

[0138] To connect the rigid inner line section 70 to the connecting element 73, the rigid inner line section 70 has an external thread 132 on its outlet-side end section 131, which is screwed into a connecting element channel section 134 having slats 133, so that an internal thread (not shown) corresponding to the external thread 132 cuts into the slats 133. Thus, the rigid inner line section 70 is fixed in the connecting element 73.

[0139] Furthermore, the connecting element 73 has a connecting element fastening device 137 designed as a connecting element fastening sleeve 136 having an internal thread 75 for receiving the flexible inner line section 71, which is penetrated by a connecting element connection sleeve 138 of the connecting element 73. At the same time, an external thread 140 is arranged on a supply-side end section 139 of the flexible inner line section 71.

[0140] A space 141 is created between the connecting element connection sleeve 138 and the connecting element fastening sleeve 136, into which space the flexible inner line section 71, which has the external thread 140 on its end section 139, can be introduced, so that the internal thread 135 of the connecting element fastening sleeve 136 and the external thread 140 of the flexible inner line section 71 of the inner line 50 are operatively connected to one another and the flexible inner line section 71 is fixed in the connecting element 73.

[0141] The connecting element 73 can also be connected to the rigid inner line section 70 or the flexible inner line section 71 using a different connection technique. For example, both the connection of the rigid inner line section 70 to the connecting element 73 and the connection of the flexible inner line section 71 to the connecting element 73 can be established by means of a snap-in connection.

[0142] The connecting element 73 additionally has passage openings 143 in its outer region 142, whereby the gaseous medium can pass through the connecting element 73 positioned in the outer line 51 by flowing through the passage openings 143 in the direction of the nozzle 53.

[0143] Fig. 9 shows a side view of the coupling head 101, and Fig. 10 shows a sectional view of the coupling head 101 through a sectional plane DD shown in Fig. 9. A detailed description of Figs. 9 and 10 has already been anticipated by the previous description. However, Figs. 9 and 10 serve in particular to provide a better overview.

Claims

Claims 1. A method for controlling a production process running on a production plant (1) for the manufacture of, in particular, pharmaceutical products, wherein the production plant (1) has a plurality of process units (2) and a control device (3) controlling the process units (2), wherein at least one of the process units (2) has or forms at least one process insert (17) which has or forms at least one process insert component (18), and wherein at least one process insert component (18) is a replaceable process insert component (18) and at least one replaceable process insert component (18) is an identifiable process insert component (18) equipped with a data carrier (19), wherein the data carrier (19) has process insert component parameters of the replaceable process insert component (18) equipped with it,wherein a configuration plan of the production plant (1) with its respective process inserts (17) is stored in the control device (3) and wherein the process insert component parameters of the identifiable process insert components (18) respectively installed in the process insert (17) are transmitted to the control device (3) before, during or after the assembly of the process insert components (18) to form a process insert (17), so that subsequently a check of the process insert component parameters is carried out in the control device (3) to determine whether the at least one identifiable process insert component, (18) has been installed in the respective process insert (17) in accordance with the stored configuration plan, and if so, the production process running on the production plant (1) is released or can be released.

2. Method according to claim 1, characterized in that a plurality of specific configuration plans are stored in the control device (3), which can be individually selected by an operator for the production process running on the production plant (1).

3. Method according to claim 2, characterized in that the control device (3) is configured to output a parts list of the identifiable process input components (18) to be installed in the production plant (1) on the basis of the configuration plan selected for the production process running on the production plant (1).

4. Method according to one of the preceding claims, characterized in that the production plant (1) has a display device (56) which displays the at least one identifiable process insert component (18) which has been incorrectly installed in the respective process insert (17) according to the stored configuration plan.

5. Method according to claim 4, characterized in that the display device (56) displays, for each incorrectly installed identifiable process input component (18), a further identifiable process input component (18) which must be installed in order to obtain approval for the production process.

6. Method according to claim 5, characterized in that the display device (56) further displays where the further identifiable process input component (18) is stored in a warehouse (57) of the production plant (1).

7. Method according to one of the preceding claims, characterized in that the data carrier (19) is designed as a readable RFID transponder (21) and the process component parameters are read out from the data carrier (19) by means of an RFID transponder reader (54) and are transmitted or can be transmitted to the control device (3).

8. Method according to one of the preceding claims, characterized in that the configuration plan of the production plant (1) with its respective process inserts (17) stored in the control device (3) which is specific for the production process and which is / or the process insert component parameters of the identifiable process insert components (18) respectively installed in the process insert (17) which are transmitted to the control device (3) before, during or after the assembly of the process insert components to form a process insert (17) and / or the checking of the process insert component parameters carried out following the transmission of the process insert component parameters to the control device (3) are stored as data in a database (55), wherein expediently the data cannot be changed or are changeable after storage in the database (55).

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