Production machine and method for monitoring the number and / or concentration and / or type of particles of a production material in a production machine

Abstract

The invention relates to a production machine, in particular a rotary tablet press or capsule filling machine, in which a pulverulent production material is processed to form a product, in particular tablets (48) or capsules, wherein the production machine comprises a housing (54) which is closed with respect to the surroundings and which surrounds a process chamber (56) in which components (58) of the production machine are arranged which process the production material to form the product, wherein the production machine comprises a first sensor (64) which is arranged within the housing (54) and which measures a number and / or concentration and / or type of particles of the production material in the air situated in the process chamber (56), and the production machine comprises an evaluation device (66) which receives measured values from the first sensor (64) relating to the number and / or concentration and / or type of particles of the production material in the air situated in the process chamber (56).

Description

[0001] Production machine and method for monitoring the number and / or concentration and / or type of particles of a production material in a production machine

[0002] The invention relates to a production machine, in particular a rotary tablet press or capsule filling machine, in which a powdered production material is processed into a product, in particular tablets or capsules, wherein the production machine comprises a housing closed to the environment, which surrounds a process space in which components of the production machine are arranged that process the production material into the product.

[0003] The invention also relates to a method for monitoring the number and / or concentration and / or type of particles of a production material in the air located in a process room of a production machine.

[0004] Production machines, such as rotary presses or capsule filling machines, often process pharmaceutically active materials that can pose health risks to operators. This is especially true for fine particles suspended in the air if an operator inhales them. Containment production machines incorporate special measures to prevent particles from escaping the machine's process chamber.

[0005] WO 2022 / 248667 A1 discloses a method for monitoring the containment of a production plant with a tablet press. WO 2022 / 248667 A1 considers pressure monitoring as the prior art for detecting potential containment leaks. According to WO 2022 / 248667 A1, such pressure loss tests are complex and time-consuming. Furthermore, they necessitate a production stoppage, resulting in significant production downtime due to the regular monitoring requirements. WO 2022 / 248667 A1 proposes a solution involving the installation of a sensor to measure the particle concentration in the air outside the enclosed area of ​​the plant. The recorded sensor signal is then compared with an expected sensor signal in a processing unit.The processing unit determines whether the compared sensor signals differ and outputs a signal indicating whether the measured air particle concentration deviates from the expected air particle concentration. The method described in WO 2022 / 248667 Al allows for an assessment of a potential release of hazardous particles from a production plant.

[0006] For particle monitoring in the vicinity of a production plant, a SMEPAC test (Standardised Measurement for Equipment Particulate Airborne Concentration) can also be performed. The SMEPAC guidelines for measuring particle concentration in air define a standardised method for testing the effectiveness of dust particle containment systems and equipment. Corresponding guidelines can be found in the ISPE Good Practice Guide – Assessing the Particulate Containment Performance of Pharmaceutical Equipment. The test involves measuring a quantity of test material in air and removing swabs from exposed surfaces. The measured exposure is referred to as the OEL (Occupational Exposure Limit), which specifies a maximum permissible exposure over a given period and is expressed in pg / m³. 3 is expressed.

[0007] The process chamber of a production machine is regularly cleaned, particularly after the completion of a production process, so that no health risks arise for an operator entering the process chamber. In practice, however, it has been shown that risks of health hazards cannot be completely eliminated in this way. Based on the prior art described above, the invention therefore aims to provide a production machine and a method of the type mentioned above with which a further increase in operator safety can be achieved.

[0008] The invention solves the problem through independent claims 1 and 21. Advantageous embodiments can be found in the dependent claims, the description and the figures.

[0009] For a production machine of the type mentioned above, the invention solves the problem in that the production machine comprises a first sensor arranged inside the housing, which measures a number and / or concentration and / or type of particles of the production material in the air located in the process room, and that the production machine comprises an evaluation device, which receives measured values ​​from the first sensor regarding the number and / or concentration and / or type of particles of the production material in the air located in the process room.

[0010] The production material processed in the production machine according to the invention may include a pharmaceutically active product material. It may also be a product material that poses a health hazard to an operator. Prior art assumes that after cleaning product residues from the surfaces of the process chamber, a residual amount of particles in the airspace is not critical for an operator entering the process chamber. However, it has been shown that this cannot always be assumed. Furthermore, a residual amount of particles that is critical from a health perspective depends on the specific powdered production material being processed. The invention therefore proposes an internal monitoring system for the process chamber of a production machine using a first sensor arranged inside the housing.The first sensor measures the number, concentration, and / or type of particles of the production material in the air within the process chamber. Naturally, for more comprehensive measurements, several first sensors can be arranged within the housing, for example, at different positions. The first sensor is, in particular, a particle sensor for measuring particles, especially of a specific size, in the air within the process chamber. In the integration of a particle sensor into the interior of the production machine according to the invention, it is assumed that the particles measured in the air within the interior of the production machine are particles of the processed production material.

[0011] The first sensor is connected to an evaluation unit, either wired or wirelessly. The sensor readings are transmitted to the evaluation unit, allowing it to record and assess the particle concentration inside the production machine. As explained in more detail below, the evaluation unit can also correlate the particle concentration with a cleaning process. Furthermore, the evaluation unit can log and analyze cleaning results.

[0012] Compared to the prior art, the invention offers enhanced operator protection because, in addition to detecting leaks in the housing, which is sealed from the environment, it can reliably detect any potentially harmful levels of particles from production material in the air within the production machine's process chamber, thus minimizing the operator's health risk. This allows, for example, the reliable detection of even critical particle contamination in the process chamber after a cleaning process. The evaluation unit enables a validated and documented release procedure, particularly real-time monitoring, even during a production process within the machine.

[0013] As explained, the process chamber of production machines is regularly cleaned, particularly after the completion of a production process. The invention enables an evaluation of this cleaning process, especially before an operator gains access to the process chamber. Furthermore, based on the measurement according to the invention of the number, concentration, and / or type of particles of the production material in the air within the process chamber, it is possible to adapt the cleaning process to the determined degree of contamination. For this purpose, the degree of contamination in the air within the process chamber can be determined before carrying out a cleaning process. This allows the cleaning process to be limited to the actual required extent. An intermediate measurement, or several intermediate measurements, can also be carried out during a cleaning process, based on which a decision can be made as to whether the cleaning process can be terminated.

[0014] In one embodiment, the production machine can be a rotary press comprising a rotor arranged in the housing and rotatable by means of a rotary drive, wherein the rotor has an upper punch guide for upper press punches and a lower punch guide for lower press punches, as well as a die disc arranged between the punch guides, wherein the press punches interact with cavities of the die disc, wherein the rotary press further comprises a filling device by which powdered production material to be compressed is filled into the cavities of the die disc, and wherein the rotary press comprises a pressure device with an upper pressure unit and a lower pressure unit which, in operation, interact with the upper press punches and with the lower press punches to compress the production material in the cavities of the die disc into pellets.

[0015] ...16cooperation, wherein the rotary press has an ejection device for ejecting pellets produced in the rotary press.

[0016] Rotary presses typically incorporate a multitude of upper and lower press rams, each pair assigned to a cavity of a die. During operation, the upper and lower press rams rotate together with the die, their axial movement controlled by cams and guided by upper and lower ram guides. As the die rotates, it passes through various components of the rotary press: a filling unit, where powdered material to be compressed is placed into the cavities of the die; and one or more compression units, where the upper and lower press rams are typically pressed into the cavities by upper and lower pressure rollers to compress the material into pellets, such as tablets.Following the pressure device(s), the upper press rams are moved upwards out of the cavities, and the pellets produced in the cavities are pushed by the lower press rams onto the top of the die plate. Such rotary presses also include an ejection device for removing pellets produced in the rotary press. The ejection device directs the pellets to a first or second pellet discharge. The first discharge can, for example, be for pellets identified as good. The second discharge can, for example, be for pellets identified as defective.

[0017] As explained, the upper and lower ram guides direct the press rams during their axial movement. The ram heads interact with cam tracks that move the press rams axially as they rotate with the rotor, specifically towards and away from each other. The cam tracks are generally composed of several cam elements. They can control the ram heads.

[0018] The press heads are either mounted in corresponding guide recesses or simply rest against a mirror surface of the punch heads. The press unit typically comprises an upper press roller and a lower press roller, which interact with the punch heads of the upper and lower press punches, respectively. Multiple press units of this type may also be provided, for example, pre-press units and main press units. The ejector cam, as part of the control cams, moves the lower press punches upwards after the press units have been formed in the respective cavity, so that the press units reach the top of the die plate, from where they can be conveyed to a first or second press unit output. The press units can be tablets. The rotary press can accordingly be a rotary tablet press. The tablets can be, for example, pharmaceutical tablets.

[0019] The production machine can also be part of a production plant with multiple inlets for several production materials, for example, at least one active pharmaceutical ingredient (API) and at least one excipient, as well as a mixer in which the production materials supplied via the inlets are mixed, and from which the product mixture is fed to the production machine, for example, the rotary press. The production plant can be a continuously operating production plant. Furthermore, the production plant can be a containment production plant. However, the invention can also be used with production machines without containment. A combination of a rotary press and an isolator is also possible, for example.

[0020] In a further embodiment, the production machine can be a capsule filling machine for filling capsules composed of a capsule top and a capsule bottom, comprising a machine table arranged in the housing and a conveyor wheel, on the circumference of which a

[0021] ,.. / 8 a plurality of capsule holders, each having a plurality of capsule receptacles for one capsule each, further comprising a conveyor wheel drive also arranged in the housing, with which the conveyor wheel can be rotated intermittently so that the capsule holders move intermittently along a conveyor track, and comprising a plurality of process stations arranged along the conveyor track on or at the machine table and also arranged in the housing, wherein the process stations include at least one feeding station for feeding capsules to be filled into the capsule receptacles, at least one opening station for opening the capsules to be filled by separating the capsule tops from the capsule bottoms, at least one filling station for filling the capsule bottoms with powdered production material, at least one closing station for closing the filled capsules by joining the capsule tops to the capsule bottoms,and include at least one ejection station for the filled capsules. Such capsule filling machines also process pharmaceutically active and potentially hazardous production materials.

[0022] For particularly reliable particle measurement, the measuring head of the first sensor is specifically oriented towards the process chamber. The first sensor can be located on an inner surface of the housing, particularly on a column, a window, a central section, or the housing's ceiling.

[0023] According to a particularly practical embodiment, the first sensor can comprise an optical sensor that measures the number and / or concentration and / or type of particles based on the scattering of optical radiation by the particles.

[0024] In a further embodiment, the first sensor can be arranged in or on an extraction line connected to the process chamber, in particular one forming part of the housing, for extracting air from the process chamber. The first

[0025] ...19The sensor can, according to a further embodiment, comprise a flow sensor, in particular a triboelectric sensor. Even with these embodiments, a reliable measurement of the particles present in the air in the process chamber is possible based on extraction through the extraction line.

[0026] A combination of one or more flow sensors and one or more optical sensors can also be used for particularly reliable measurement of airborne particles in the process chamber. Preferably, at least one flow sensor is located in or on the extraction system and at least one optical sensor is located in the tablet press housing.

[0027] The particle sizes of the active ingredient in a pharmaceutical product, for example, a tablet, capsule, or powder, are usually known. It is therefore possible to monitor specific particle sizes using the sensor measurement according to the invention. Common particle sizes range from 0.1 pm to 2.5 mm. Particles suspended in the air are typically small. Larger particles fall to the ground more quickly and accumulate on surfaces in the process chamber, from which they can be reliably removed during a cleaning process. Airborne particles are the primary health hazard for operators. Therefore, according to a further embodiment, the first sensor can measure the number, concentration, and / or type of particles with a size between 1 nm and 200 pm, preferably between 1 nm and 100 pm.Particles of this size regularly float in the air and can also be stirred up during a cleaning process.

[0028] The evaluation unit can be configured to pulse or continuously transmit data to the first sensor to measure the number and / or concentration and / or type of particles of the production material in the air in the process room.

[0029] ,.. / 10. Pulsed measurements can be performed at different or regular time intervals. In particular, according to the invention, it is possible to measure the particle count and / or concentration and / or type multiple times consecutively or continuously before and / or during and / or after a production process. In this way, the evaluation unit can generate evaluable data series that allow conclusions to be drawn, for example, about changes during a production or cleaning process.

[0030] The evaluation unit can be further configured to direct the first sensor, after cleaning the process room, to measure the number and / or concentration and / or type of particles of the production material in the air in the process room.

[0031] The evaluation unit can also be configured to issue a warning message if the measured number, concentration, and / or type of particles from the production material in the air within the process chamber exceeds a setpoint, and / or to only allow access to the process chamber if the setpoint falls below a certain threshold, and / or to continue a cleaning process to clean the process chamber until the setpoint is no longer exceeded. The setpoint can be determined based on the production material processed in the production machine. Alternatively or additionally, the setpoint can be determined based on a reference measurement taken by the first sensor before the start of a production process in the production machine. For example, a reference measurement can be taken before the production machine is started up in a production process, which can then be compared to a measurement taken after a cleaning process.This allows for an assessment after a cleaning process of whether airborne particles have been sufficiently removed. If necessary, the evaluation unit can suggest and / or initiate another cleaning process. The reference measurement can therefore be a zero measurement.

[0032] ... / llBeginning of a production process within the housing of the production machine. As explained in more detail below, the reference measurement can also be a measurement taken outside the housing of the production machine, for example, outside a containment structure, provided it is a containment production machine. A reference measurement can be used to determine the level of acceptable particle contamination and, based on this, to define the target value. It is also conceivable that the evaluation unit, based on the production material and the measured values ​​of the first sensor and / or, if applicable, a second sensor (explained in more detail below), automatically adjusts a cleaning program for a cleaning process to achieve optimal cleaning results.

[0033] As explained, the evaluation unit can further grant permission to open the production machine, in particular the housing to the process chamber, depending on defined release limits, especially the setpoint. This permission, as well as a warning message if the setpoint is exceeded, can be indicated visually and / or audibly. The evaluation unit can also be configured to unlock and / or lock at least one access point of the housing to the process chamber, for example, at least one window flap of the housing, based on the measurement according to the invention. The setpoint is selected in such a way that any health hazard to an operator can be ruled out. The setpoint can be set depending on the production material being processed. It can also take into account permissible daily doses for an operator.

[0034] According to a further embodiment, the production machine can also include a second sensor that measures the number and / or concentration and / or type of particles of the production material in the air in the environment outside the housing, and thus outside any containment of a containment production machine, whereby the measured values ​​of the second sensor are also transmitted to the

[0035] ,.. / 12 Evaluation unit. As already explained, the setpoint can also be determined based on a reference measurement from the second sensor. The second sensor, located outside the housing and thus outside the process chamber, can be designed – apart from its different arrangement – ​​like the first sensor.

[0036] The evaluation unit can then be further configured to compare the readings of the first and second sensors during a production process within the production machine and to infer from this comparison whether particles are escaping from the process chamber. Further measurements with the second sensor outside the housing can be performed in temporal overlap, and in particular simultaneously, with the particle measurements inside the process chamber. By performing repeated measurements, the evaluation unit can generate a trend from the comparison, providing information about the tightness, for example, of any containment, of the production machine. If, for instance, the difference between the readings of the first and second sensors decreases over time, it can be concluded that particles of the production material are escaping from the production machine, and thus that the housing is leaking.Of course, several second sensors can also be provided, arranged, for example, at different locations in the vicinity of the production machine.

[0037] The evaluation unit can be further configured to activate the first sensor before and after cleaning the process chamber to measure the number, concentration, and / or type of particles of the production material in the air within the process chamber. By comparing the measured values ​​before and after cleaning, the evaluation unit can assess the cleaning process. Furthermore, the evaluation unit can be configured to detect when a minimum distance between the measurements before and after cleaning is not maintained.

[0038] The system can issue a warning message indicating the need for further cleaning based on the measured number, concentration, and / or type of particles from the production material in the air within the process chamber. As previously explained, the evaluation unit can also suggest adjustments to the cleaning process based on this information. By comparing measurements taken before and after cleaning, the effectiveness of the cleaning can be assessed, and appropriate measures can be taken. This allows the cleaning process to be advantageously adapted to individual cleaning requirements, particularly those specific to the production machine and the specific production materials being processed.

[0039] The housing of the production machine is sealed from the environment. This prevents production materials from escaping the process chamber into the surroundings. The degree of sealing of the housing can vary. In particular, the housing can be dustproof. As explained, the production machine can be a containment production machine, especially a containment rotary press. In this case, the housing's sealing meets containment requirements. Such containment production machines process particularly hazardous production materials, and for operator safety, it is crucial that any airborne particles of the production material are reliably detected. The containment can, for example, have a containment level of OEB 3 or higher, measured, for instance, according to the SMEPAC test (Standardized Measurement of Equipment Particulate Airborne Concentration).As also explained, the production machine, for example the rotary press or capsule filling machine, can also be a production machine without containment.

[0040] The invention also solves the problem by means of a method for monitoring the number and / or concentration and / or type of particles of a

[0041]

[0042] Production material in the air located in a process chamber of a production machine, using a production machine according to the invention. In the process according to the invention, in particular the process steps for which the production machine according to the invention, in particular the first sensor and / or the second sensor and / or the evaluation device, is configured according to all the embodiments described above, can be carried out.

[0043] An embodiment of the invention is explained in more detail below with reference to the figures. These schematically show:

[0044] Fig. 1 shows a rotary press as a production machine in an unwound representation of the rotor, and

[0045] Fig. 2 shows a production machine according to the invention in a front view.

[0046] Unless otherwise stated, the same reference symbols in the figures denote the same objects.

[0047] The rotary press according to the invention shown in Figure 1 is a rotary press for tablet production in which powdered production material is compressed into tablets. The rotor of the rotary press is driven by a rotary drive and comprises a die disk 10 having a plurality of cavities 12. The cavities 12 can, for example, be formed by bores in the die disk 10. The rotor further comprises a plurality of upper press rams 14 and lower press rams 16, which rotate synchronously with the die disk 10. The upper press rams 14 are axially guided in an upper ram guide 18, and the lower press rams 16 are axially guided in a lower ram guide 20. The axial movement of the upper press rams 14 and lower press rams 16 is

[0048] The rotation of the rotor is controlled by upper control cam elements 22 and lower control cam elements 24. The control cam elements 22 and 24 are held on a cam carrier of the rotary press. Furthermore, a filling device 26, shown only very schematically in Figure 1, is provided. This device has a feed hopper 28, a first filling chamber 30, and a second filling chamber 31, the feed hopper 28 being connected to a filling tube 32. The second filling chamber 31 can form a metering chamber. In this example, powdered production material flows from the feed hopper 28, via the filling tube 32, for example by gravity, into the filling chambers 30 and 31, and from there, via an outlet provided on the underside of the filling chambers 30 and 31, again for example by gravity, into the cavities 12 of the die disk 10.

[0049] The rotary press also includes a pressure unit 34. The pressure unit 34 comprises a pre-pressure unit with an upper pre-pressure roller 36 held on an upper support 35 and a lower pre-pressure roller 38 held on a lower support 37, as well as a main pressure unit with an upper pressure roller 40 held on an upper support 39 and a lower pressure roller 42 held on a lower support 41. Furthermore, the rotary press includes an ejection unit 44 with an ejection element 46. The ejection element 46 strips tablets 48, which are conveyed by the lower press rams 16 onto the upper surface of the die 10, from the die 10 and conveys the tablets 48 to a first pellet discharge 50. The rotary press also includes a control unit 52 for controlling the operation of the rotary press.The rotary press also includes a second tablet discharge, not shown in detail in Figure 1, which is located upstream of the first tablet discharge 50 in the direction of rotation of the die disk 10 and can, for example, be arranged parallel to it. Tablets can be selectively discharged into the first discharge by means of a sorting device, comprising, for example, a sorting nozzle.

[0050] ,.. / 16 second tablet run. The first tablet run (50) can be for tablets identified as good, and the second tablet run can be for tablets identified as bad.

[0051] Figure 2 shows a production machine according to the invention, wherein the product search engine can, for example, be a rotary press as shown in Figure 1. However, the production machine shown in Figure 2 can also be a capsule filling machine.

[0052] The production machine has a housing 54 that tightly encloses a process chamber 56 from the environment. The production machine can be a containment production machine or a production machine without containment. The process chamber 56 contains the components 58 for processing a powdered production material into a product. For example, the rotor of a rotary press shown in Figure 1 can be arranged at position 58 within the process chamber 56. Several first sensors 64 are arranged on an inner surface of the housing 54 that delimits the process chamber 56, in particular on lateral columns 60 and a ceiling 62. These sensors, acting as particle sensors, measure the number, concentration, and / or type of particles of the production material processed in the production machine in the air within the process chamber 56.The measured values ​​from the first sensors 64 are available at an evaluation unit 66 of the production machine 54. The evaluation unit 66 can, for example, be combined with the control unit 52 to form a control and evaluation unit. The measuring heads of the first sensors 64 are oriented towards the process chamber 56. The first sensors 64 can, for example, be optical sensors 64 that measure the number and / or concentration and / or type of particles based on the scattering of optical radiation emitted by the first sensors 64 at the particles. The first sensors 64 can measure the number and / or concentration and / or type of particles with a...

[0053] ,.. / 17 Size between 1 nm and 200 pm, preferably between 1 nm and 100 pm. Furthermore, a second sensor 68 is provided outside the housing 54, which measures the number and / or concentration and / or type of particles of the production material in the air in the environment outside the housing 54. The measured values ​​of the second sensor 68 are also available at the evaluation unit 66. The second sensor 68 can be configured like the first sensors 64.

[0054] The evaluation unit 66 can control the first sensors 64 and / or the second sensor 68 before, during, and / or after cleaning the process chamber 56 to measure the particles in the air. Based on this, a completed cleaning process—as explained above—can be evaluated. For example, the evaluation unit 66 can assess whether and when a cleaning process can be terminated, or whether, for instance, a further cleaning process needs to be carried out. Furthermore, the evaluation unit 66 can suggest adjustments to the cleaning process for optimal cleaning. In doing so, the evaluation unit 66 can also take into account the production material being processed in the production machine.

[0055] The evaluation unit 66 can control the first sensors 64 and / or the second sensor 68 in a pulsed or continuous manner to measure the particles in the air, for example during a production process in the production machine and / or before and / or during and / or after a cleaning process.

[0056] In principle, if the first sensors 64 detect that a setpoint is exceeded by the measured number, concentration, and / or type of particles of the production material in the air in process chamber 56, the evaluation unit 66 can issue a warning message to an operator. The evaluation unit 66 can also prevent access to process chamber 56 until the setpoint is undershot, in order to avoid a health hazard.

[0057] ,.. / 18 operator to avoid. The production material to be processed in the production machine can be taken into account when determining the setpoint. The setpoint can also be determined based on a reference measurement of the first sensors 64 before the start of a production process or a reference measurement of the second sensor 68 outside the housing 54.

[0058] The evaluation unit 66 can further compare the measured values ​​obtained during a production process from the first sensor 64 and the second sensor 68. If the measured values ​​recorded inside and outside the process chamber 56 approach each other over time, for example during a production process, a leak in the housing 54 and thus an escape of particles from the process chamber 56 can be inferred. The evaluation unit 66 can then issue a corresponding warning message and / or interrupt a production process.

[0059]

[0060] Reference symbol list

[0061] 10 die disc

[0062] 12 cavities

[0063] 14 upper press ram

[0064] 16 lower press die

[0065] 18 upper die guide

[0066] 20 lower stamp guide

[0067] 22 upper control curve element

[0068] 24 lower control cam element

[0069] 26 Filling device

[0070] 28 feed funnels

[0071] 30 first filling chamber

[0072] 31 second filling chamber

[0073] 32 Filling tube

[0074] 34 Printing device

[0075] 35 upper bracket

[0076] 36 upper pre-print roller

[0077] 37 lower bracket

[0078] 38 lower pre-print roller

[0079] 39 upper bracket

[0080] 40 upper pressure roller

[0081] 41 lower bracket

[0082] 42 lower pressure roller

[0083] 44 Ejection device

[0084] 46 Ejection element

[0085] 48 tablets

[0086] 50 pellets

[0087] 52 Control unit

[0088] 54 cases

[0089] 56 Process room

[0090] 58 components

[0091] 60 pillar

[0092] 62 Ceiling

[0093] 64 first sensor

[0094] 66 Evaluation unit

[0095] 68 second sensor

[0096] ,.. / 20

Claims

Claims:

1. Production machine, in particular a rotary tablet press or capsule filling machine, in which a powdered production material is processed into a product, in particular tablets (48) or capsules, wherein the production machine comprises a housing (54) closed to the environment, which surrounds a process chamber (56) in which components (58) of the production machine are arranged that process the production material into the product, characterized in that the production machine comprises a first sensor (64) arranged inside the housing (54), which measures a number and / or concentration and / or type of particles of the production material in the air in the process chamber (56), and that the production machine comprises an evaluation device (66) which receives measured values ​​from the first sensor (64) regarding the number and / or concentration and / or type of particles of the production material in the air in the process chamber (56).

2. Production machine according to claim 1, characterized in that the production machine is a rotary press comprising a rotor arranged in the housing (54) and rotatable by means of a rotary drive, wherein the rotor has an upper punch guide (18) for upper press punches (14) and a lower punch guide (20) for lower press punches (16) as well as a die disk (10) arranged between the punch guides (18, 20), wherein the press punches (14, 16) interact with cavities (12) of the die disk (10), wherein the rotary press further comprises a filling device (26) by which powdered production material to be pressed is filled into the cavities (12) of the die disk (10), wherein the rotary press comprises a pressure device (34) with an upper pressure unit (40) and a lower pressure unit (42) which, in operation, press punches (14) and the lower press punches (16) cooperate to compress the production material in the cavities (12) of the die disk (10) to form pellets (48), and wherein the rotary press has an ejection device (44) for ejecting pellets (48) produced in the rotary press.

3. Production machine according to claim 1, characterized in that the production machine is a capsule filling machine for filling capsules composed of a capsule top and a capsule bottom, comprising a machine table arranged in the housing (54) and a conveyor wheel, on the circumference of which a plurality of capsule holders are provided, each having a plurality of capsule receptacles for one capsule, further comprising a conveyor wheel drive also arranged in the housing (54), with which the conveyor wheel can be rotated intermittently so that the capsule holders move intermittently along a conveyor path, and comprising a plurality of process stations arranged along the conveyor path on or at the machine table and also arranged in the housing (54), wherein the process stations include at least one feed station for feeding capsules to be filled into the capsule receptacles,The system shall include at least one opening station for opening the capsules to be filled by separating the capsule tops from the capsule bottoms, at least one filling station for filling the capsule bottoms with powdered production material, at least one closing station for closing the filled capsules by connecting the capsule tops to the capsule bottoms, and at least one ejection station for ejecting the filled capsules.

4. Production machine according to one of the preceding claims, characterized in that a measuring head of the first sensor (64) is aligned in the process space (56).

5. Production machine according to one of the preceding claims, characterized in that the first sensor (64) is arranged on an inside of the housing (54), in particular on a column (60), a window, a middle part, or a ceiling (62) of the housing (54).

6. Production machine according to one of the preceding claims, characterized in that the first sensor (64) comprises an optical sensor (64) which measures the number and / or concentration and / or type of particles due to scattering of optical radiation at the particles.

7. Production machine according to one of the preceding claims, characterized in that the first sensor (64) is arranged in or on an extraction line connected to the process chamber (56) for extracting air from the process chamber (56).

8. Production machine according to one of the preceding claims, characterized in that the first sensor (64) comprises a flow sensor, in particular a triboelectric sensor.

9. Production machine according to claims 7 and 8, characterized in that the flow sensor is arranged in the extraction line.

10. Production machine according to one of the preceding claims, characterized in that the first sensor (64) detects the number and / or concentration and / or type of particles with a size between 1 nm and 200 pm, preferably between 1 nm and 100 pm.

11. Production machine according to one of the preceding claims, characterized in that the evaluation device (66) is configured to control the first sensor (64) pulsedly or continuously for measuring the number and / or concentration and / or type of particles of the production material in the air located in the process chamber (56).

12. Production machine according to one of the preceding claims, characterized in that the evaluation device (66) is configured to direct the first sensor (64) after cleaning of the process chamber (56) to measure the number and / or concentration and / or type of particles of the production material in the air in the process chamber (56).

13. Production machine according to one of the preceding claims, characterized in that the evaluation device (66) is configured to issue a warning message if the measured number and / or concentration and / or type of particles of the production material in the air in the process chamber (56) exceeds a setpoint value and / or to allow access to the process chamber (56) to be opened only if a setpoint value is undershot and / or to continue a cleaning process to clean the process chamber (56) until a setpoint value is undershot.

14. Production machine according to claim 13, characterized in that the setpoint is determined depending on the production material processed in the production machine and / or that the setpoint is based on a reference measurement of the first sensor (64) before the start of a production process in the production machine is defined.

15. Production machine according to one of the preceding claims, characterized in that it further comprises a second sensor (68) which measures a number and / or concentration and / or type of particles of the production material in the air in the environment outside the housing (54), wherein the measured values ​​of the second sensor (68) are also available at the evaluation device (66).

16. Production machine according to claim 15 and one of claims 13 or 14, characterized in that the setpoint is determined on the basis of a reference measurement of the second sensor (68).

17. Production machine according to one of claims 15 or 16, characterized in that the evaluation device (66) is designed to compare measured values ​​of the first sensor (64) and the second sensor (68) during a production process in the production machine and to conclude from a comparison that particles have escaped from the process chamber (56).

18. Production machine according to one of the preceding claims, characterized in that the evaluation device (66) is configured to direct the first sensor (64) before and after cleaning the process chamber (56) to measure the number and / or concentration and / or type of particles of the production material in the air in the process chamber (56).

19. Production machine according to claim 18, characterized in that the evaluation device (66) is designed to issue a warning message for renewed cleaning if a minimum distance is not reached between the number and / or concentration and / or type of particles of the production material measured before and after cleaning in the air in the process chamber (56).

20. Production machine according to one of the preceding claims, characterized in that the production machine is a containment production machine, in particular a containment rotary press.

21. Method for monitoring the number and / or concentration and / or type of particles of a production material in the air located in a process chamber (56) of a production machine, using a production machine according to one of the preceding claims.

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