Particle counter and method for counting particles in a sterilization tunnel of a pharmaceutical filling system - Patents.com

Abstract

A particle counter (120) is proposed for counting particles in a sterilization tunnel (110) of a pharmaceutical filling system (112). The sterilization tunnel (110) comprises at least one conveyor belt (114). The particle counter (120) comprises at least one probe (122) connectable to the particle counter (174) for receiving particles in the sterilization tunnel (110), and at least one scanner (176) having at least one probe holder (178) for fixing the probe (122), the scanner (176) comprising at least one transverse runner (180) having at least one linear guide (182) for traversing the probe holder (178) with respect to the conveying direction (116) of the conveyor belt (114) of the sterilization tunnel (110). and at least one lateral runner (180), in particular configured for substantially vertical guiding, at least one carriage (184), to which the lateral runner (180) is fixed, the carriage (184) configured for moving the linear guide (182) in the conveying direction (116) of the conveyor belt (114), and at least one controller (186), in particular connected to the carriage (184), configured for controlling the movement of the scanner (176). A sterilization tunnel (110) of a medicament filling system (112), a method for counting particles in the sterilization tunnel (110) of the medicament filling system (112) by a particle counter (120), as well as a computer program and a computer program product are also proposed.

Description

[Technical field]

[0001] The present invention relates to a particle counting device for particle counting in a sterilization tunnel of a pharmaceutical filling system, a sterilization tunnel of a pharmaceutical filling system, use of the particle counting device and a method for particle counting in a sterilization tunnel of a pharmaceutical filling system. The device and method according to the present invention can be used, for example, in medical and / or pharmaceutical systems where special requirements are placed on the air purity, for example in clean rooms where pharmaceutical filling systems are located and therefore the filter systems used to keep the system clean need to be checked. However, alternatively and / or additionally, other possible uses are also conceivable, such as clean rooms for semiconductor manufacturing and / or food manufacturing. [Background technology]

[0002] In pharmaceutical plants for the production and / or filling of drugs, the production and / or filling of liquid drugs is generally carried out in a room kept sterile, in particular a clean room. Filling containers for liquid drugs may include, for example, glass injection bottles, vials and / or glass syringes. When drugs are filled into containers, these generally need to be free of particles and microorganisms. The cleaning and sterilization processes may be the same for different containers and may include, among others, sterilization in a sterilization tunnel.

[0003] For example, hot air sterilization tunnels can be used to depyrogenate the containers before filling them with the drug. Depyrogenation includes, inter alia, sterilization of the containers by dry heat at 160 to 400°C. Generally, a substantially particle-free laminar air flow is required. The particle-free nature of the air flow can be achieved using filters, e.g. HEPA filters, installed in the hot air sterilization tunnel. The quality of the installed filters can be checked periodically using a so-called leakage penetration test, so that excessive amounts of particles in the air flow can be recorded. For example, the filter surface can be scanned in a serpentine manner using a measuring probe.

[0004] Such leakage penetration tests can be part of the regular maintenance of the sterilization tunnel, for example, as part of the "standard operating procedure" (SOP), and can include the so-called DEHS test, where DEHS (diethyl-hexyl sebacate) denotes the aerosol used for the test. In the leakage penetration test, an aerosol is generally applied in front of the filter to be inspected, and the particle concentration is determined in front of the filter, in particular on the untreated air side. Then, on the other side of the filter, in particular on the clean air side, the filter surface can be probed for any increased particle flow paths using a probe. Generally, the probe is guided manually in the leakage penetration test. A funnel-shaped probe can be inserted into the sterilization tunnel on an extensible pipeline. With the help of the pipeline, the inspector can manually guide the probe along a conveyor belt below the air outlet of the filter, at a predetermined path and at a predetermined speed, within a predetermined time. The test process and the associated parameters are generally defined in the SOP.

[0005] Via the funnel probe and the pipeline, the air flowing out of the filter can be fed by a particle counter capable of determining the concentration of particles contained in the air. If the particle concentration is found to be above the threshold value specified in the SOP, the filter can be assumed to be permeable and / or leaking. If the particle concentration is determined again at this location, the filter can be classified as functional if the particle concentration has not increased, and the filter can be classified as non-functional if the particle concentration has increased. A non-functional filter generally requires a complex replacement of the filter.

[0006] However, known devices and methods for performing leakage penetration tests have many technical challenges. In particular, current manual measurement methods are generally poorly reproducible, since the results of the manual method are highly dependent on the inspector performing the test. Difficulties arise, for example, with respect to maintaining a specified test speed. Furthermore, depending on the depth of the sterilization tunnel, longer tube lengths may be required for the measurement probe. For example, in some sterilization tunnels, the filter surface needs to be inspected at a distance of up to 5 m, which represents a particular challenge with hand-held probes. Furthermore, when determining an increased particle concentration at a specific point, it may be difficult to determine the exact position and find it again. This may, in particular, involve increased time consumption. A more time-consuming inspection of the filter system in the filling system also generally reduces the availability of the filling system for the actual filling of the drug.

[0007] In his bachelor's thesis "Concept development for a semi-automatic scanning robot for particle counting in the sterilisation tunnel" Patrick Juelly from the Faculty of Economics, Technology and Management at Wilhelm Buechner University Darmstadt describes a scanning robot for particle counting in the sterilisation tunnel.

[0008] Object of the invention It would therefore be desirable to provide a particle counting device for particle counting in a sterilization tunnel of a pharmaceutical filling system, a sterilization tunnel of a pharmaceutical filling system, a use of the particle counting device, and a method for particle counting in a sterilization tunnel of a pharmaceutical filling system, which at least largely avoids the disadvantages of known devices, uses and methods. In particular, a reproducible inspection of filters in the sterilization tunnel should be possible, which is also economical in terms of time and costs. Summary of the Invention

[0009] This problem is addressed by a particle counting device for particle counting in a sterilization tunnel of a pharmaceutical filling system, a sterilization tunnel of a pharmaceutical filling system, use of the particle counting device and a method for particle counting in a sterilization tunnel of a pharmaceutical filling system with the features of the independent patent claims. Advantageous developments which can be implemented individually or in any combination are presented in the dependent claims.

[0010] In the following, the terms "having", "consisting of", "comprising" or "including" or any grammatical variants thereof are used non-exclusively. Thus, these terms can refer both to the situation where, in addition to the features introduced by these terms, no further features are present, or to the situation where one or more further features are present. For example, the expressions "A has B", "A consists of B", "A comprises B", or "A includes B" can refer to the situation where, apart from B, no other elements are present in A (i.e., as opposed to the situation where A consists only of B), as well as the situation where, in addition to B, one or more other elements are present in A, such as element C, elements C and D, or further elements.

[0011] Furthermore, it should be noted that the terms "at least one" and "one or more," as well as grammatical variations of these terms, when used in connection with one or more elements or features, and intended to express that the element or feature may be provided singly or in plural, are generally used only once, e.g., when the feature or element is first introduced. If the feature or element is referred to again at a later time, the corresponding term "at least one" or "one or more" is generally no longer used and does not limit the possibility that the feature or element may be provided singly or in plural.

[0012] Furthermore, the terms "preferably", "particularly", "for example" or similar terms are used below in connection with optional features without this limiting alternative embodiment. Features introduced by these terms are therefore optional features, which are not intended to limit the scope of protection of the claims, in particular the independent claims. Thus, as a person skilled in the art will recognize, the present invention can also be implemented using other embodiments. Similarly, features introduced with "in an embodiment of the present invention" or "in an exemplary embodiment of the present invention" are understood to be optional features, which are not intended to limit the scope of protection of alternative embodiments or the independent claims. Furthermore, these introductory expressions should not affect the possibility of combining the features introduced by them with other features, regardless of whether they are optional or non-optional features.

[0013] In a first aspect of the invention, a particle counting device for counting particles in a sterilization tunnel of a pharmaceutical filling system is proposed. The sterilization tunnel comprises at least one conveyor belt. The particle counting device comprises at least one probe for receiving particles in the sterilization tunnel, which can be connected to a particle counter. Furthermore, the particle counting device comprises at least one scanner having at least one probe holder for mounting the probe. The scanner comprises at least one lateral runner with at least one linear guide. The linear guide is configured to guide the probe holder transversely, in particular essentially perpendicularly, to the conveying direction of the conveyor belt of the sterilization tunnel. Furthermore, the scanner comprises at least one carriage. The lateral runner is attached to the carriage. The carriage is configured to move the linear guide in the conveying direction of the conveyor belt. Furthermore, the scanner comprises at least one controller, in particular a controller connected to the carriage, the controller configured to control the movement of the scanner.

[0014] The carriage may be configured to move itself and the lateral runners, in particular the lateral runners with the probes, in two-dimensional space. The particle counting device may in particular comprise a drive for guiding the probe holder transversely, in particular essentially perpendicularly, in each case to the conveying direction of the conveyor belt of the sterilization tunnel and for moving the carriage along the conveying direction of the conveyor belt. As will be explained in more detail below, both drives may each be moved with the help of a motor. In particular, the particle counting device may be designed such that the movement of the carriage is independent of the guidance of the probe holder.

[0015] The term "drug filling system" as used herein is a broad term to be given its ordinary and current meaning as understood by those skilled in the art. The term is not limited to a particular or adapted meaning. The term may refer, but is not limited to, any system configured to fill a container with one or more drugs. The container may be, for example, a vial, particularly an injection bottle, or a syringe, particularly a glass syringe. The drug filling system may be, in particular, set up and operated in a clean room. The drug filling system may include, in particular, a sterilization tunnel, which is described in more detail below. The sterilization tunnel may be configured to ensure that the container is free of particles and / or bacteria. Furthermore, the drug filling system may include at least one washer, at least one filling system, and / or at least one inspection machine. The washer may be configured to wash the container with water for injection (WFI). The drug filling system may be configured to transport the container from the washer to a conveyor belt of the sterilization tunnel. Optionally, the drug filling system may include at least one freeze-drying system. The lyophilization system may be configured to lyophilize the loaded drug after loading, particularly to ensure the shelf life of the loaded drug.

[0016] The term "sterilization tunnel" as used herein is a broad term to be given its ordinary and common meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term may refer, but is not limited to, in particular to an apparatus configured to free one or more objects passing through the sterilization tunnel, e.g., drug containers, from microscopic contamination or at least partially remove such contamination. The sterilization tunnel may be configured in particular to sterilize the objects. Sterilization may refer in particular to a process in which an object is completely or partially removed from attached bacteria and / or a bacterial reduction occurs on and / or within the object. This bacterial reduction may occur, for example, by heat treatment and / or by chemical treatment of the object, e.g., by treatment with disinfecting gas and / or superheated steam. Preferably, the bacterial reduction is performed by heat treatment in the sterilization tunnel.

[0017] The term "conveyor belt" as used herein is a broad term to be given its ordinary and common meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term may in particular, but not exclusively, refer to an apparatus configured to convey at least one other apparatus or at least one other element, for example one or more containers to be filled and / or drive the movement of other apparatus or elements. The conveyor belt may in particular comprise at least one drive element, for example at least one drive element running in a circuit through a sterilization tunnel. In particular, the conveyor belt may be at least partially permeable to air, for example so that at least a part of the air supply supplied to the conveyor belt can pass through the conveyor belt. For example, the conveyor belt comprises a wire mesh. The wire mesh may in particular ensure the necessary breathability, flexibility and heat resistance. The conveying may for example be continuous or discontinuous or in cycles, so that for example a continuously operating sterilization tunnel or a cyclic sterilization tunnel may be used. The conveying direction may for example be the main movement direction of the containers to be filled in the sterilization tunnel. The conveying direction can be fixed or can vary, for example locally or over time. For example, the conveying direction can be directed from the entrance to the exit of the sterilization tunnel. The conveying direction can be, for example, the main movement direction of the containers in the sterilization tunnel. The conveying direction can be fixed or can vary, for example locally or over time. For example, the conveying direction can be directed from the entrance to the exit of the sterilization tunnel. The conveying direction can therefore also be referred to as the transport direction.

[0018] The term "particulate filter" as used herein is a broad term to be given its ordinary and common meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term may refer, but is not limited to, in particular to a device configured to at least partially separate suspended matter, also called "particles", from at least one medium, in particular at least one gaseous medium, such as air, flowing through the particulate filter. The at least partial separation may in particular include completely removing suspended matter from the flowing medium or reducing the concentration of suspended matter in the flowing medium by at least 85%, preferably at least 95%, particularly preferably at least 99.95% of the concentration of suspended matter having a particle size in the range of, for example, 0.1 μm to 0.3 μm. The particulate filter may in particular separate one or more suspended matter from the medium, for example bacteria, viruses, pollen, dust, aerosols and / or smoke particles, flowing through the particulate filter. The particulate filter may include at least one filter selected from the group consisting of an Efficient Particulate Air (EPA) filter, a High Efficiency Particulate Air (HEPA) filter, and an Ultra Low Penetration Air (ULPA) filter. Particularly preferably, the particulate filter may comprise at least one HEPA filter.

[0019] The term "particle counting device" as used herein is a broad term to be given its ordinary and common meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term may refer in particular, but not exclusively, to a device that allows particle counting in a sterilization tunnel of a drug filling system. The particle counting device may be used in particular for a particle counting process. During the particle counting process, the particle counting device may have in particular the task of guiding a probe in a sterilization tunnel. The particle counting device may be configured for automated, in particular partially or fully automated, guidance of the probe in the sterilization tunnel. Alternatively and / or additionally, the particle counting device may be configured to supply the particle counter with a gaseous medium, e.g. air, in which the particles to be counted are included.

[0020] The particle counting device may be configured to use a probe to scan different sized areas below the particulate filter of the sterilization tunnel on a predetermined path at a predetermined speed. The probe may be configured to absorb air flowing through the particulate filter and direct it to a particle counter connected to the probe. The particle counter may be configured to count and / or measure particles present in the filtered air, as described in more detail below.

[0021] The particle counting device may further include at least one particle counter that may be connected to the probe. The term "particle counter" as used herein is a broad term to be given its ordinary and general meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term may refer, but is not limited to, in particular to a device configured to quantitatively and / or qualitatively record particles in a gaseous medium, in particular air. The particle counter may refer, in particular to a device configured to count particles in a gaseous medium. The particle counter may be configured to optically record particles in the gaseous medium. For example, the particle counter may comprise at least one light source, at least one measuring cell that includes at least a portion of the gaseous medium, and at least one photodetector that is capable of detecting light emitted by the light source and scattered and / or diffracted by particles contained in the gaseous medium. Based on the signal detected by the photodetector, the particles contained in the gaseous medium may be qualitatively and / or quantitatively recorded. The gaseous medium can flow continuously through the measuring cell of the particle counter or the measuring cell can be filled discontinuously by the gaseous medium to be examined. Thus, the particle counter can record the particles in the gaseous medium continuously or discontinuously. The particle counter can in particular record the number, size and / or concentration of particles in the gaseous medium. The particle counter can record particles having a size in the range of 10 nm to 1000 μm, preferably in the range of 100 nm to 100 μm, particularly preferably in the range of 0.3 μm to 10 μm. Thus, the term "particle counting", alternatively also called "particle counting", can in principle refer to any process for the quantitative and / or qualitative recording of particles in a gaseous medium, in particular in air.

[0022] In particular, the particle counter may be designed as a stationary particle counter, and the particle counter and the probe may be connected to each other by at least one pipeline, in particular a flexible pipeline. The pipeline may be part of the particle counter and / or part of the particle counting device. The probe and the pipeline may be configured to aspirate and supply air to the particle counter. The particle counter may be configured in particular to count and / or measure particles. If the measured particle count and / or the measured particle concentration exceeds a defined value, it may be concluded that there is a permeability, in particular a leak, in the particulate filter. Then, with the measured increased particle concentration or particle count, a more accurate measurement may be performed at the position of the particle counting device on the conveyor belt. If a new measurement does not show an increase in the particle concentration or number of particles, the particulate filter may be classified as functional. However, if an increase in the particle concentration or number of particles is repeatedly measured, the particulate filter must be replaced, which is a complicated process.

[0023] The term "probe" as used herein is a broad term to be given its ordinary and common meaning as understood by those skilled in the art. The term is not limited to a specific or adapted meaning. The term may refer, but is not limited to, a device configured to transmit information and / or objects, among other things. In particular, the probe may be configured for object transmission. For example, the probe may be configured to receive particles at a first location and deliver them to a second location different from the first location. Thus, in particular, the probe may allow for counting particles at a first location while the particles are recorded at the second location. Alternatively and / or additionally, direct recording of particles at the first location and information transmission of the particle counting results to the second location may also be possible. The probe may in particular be an isokinetic probe. The term "isokinetic probe" refers substantially to any probe configured to receive a sample, in particular particles, from a flowing fluid. In particular, the fluid flowing into the isokinetic probe may have a velocity corresponding to the velocity of the fluid in the immediate vicinity of the isokinetic probe. As a result, falsification of particle counts of fluid entering the isokinetic probe can be avoided or at least reduced during particle entrapment.

[0024] The term "scanner" as used herein is a broad term to be given its ordinary and common meaning as understood by those skilled in the art. The term is not limited to a specific or adapted meaning. The term may refer, but is not limited to, any device configured to systematically and / or regularly scan an area, in particular a two-dimensional area. In particular, the area may be an area in a sterilization tunnel, in particular an area below at least one particulate filter of the sterilization tunnel, in particular an area below at least one filter surface of the particulate filter. The scanner may preferably be configured to scan the area below at least one particulate filter in at least partially overlapping paths, as described in more detail below. Furthermore, the scanner may preferably be configured to scan a movement path with a serpentine pattern by alternating movements of the probe transversely and parallel to the conveying direction, as described in more detail below.

[0025] As mentioned above, the scanner includes at least one probe holder. The probe holder may be configured to mount a probe. The term "probe holder" as used herein is a broad term to be given its ordinary and general meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term may refer, in particular, but not exclusively, to any device configured to mount a probe of any design to a component of the scanner. In particular, the probe holder may be configured to fix the probe to a guide carriage of a linear guide. The probe holder itself may be mounted to a component of the scanner, in particular to a guide carriage. The probe holder may thus have at least one recess in which the probe holder can be at least partially received. Furthermore, the recess may be configured to at least partially receive a pipeline. In particular, the probe holder may have at least one groove for receiving the probe. Furthermore, the probe holder may have at least one clamp plate configured to fix the probe. Other configurations are of course also conceivable. Furthermore, the probe holder may be at least partially made of polyoxymethylene (POM). This can result in a reduced weight of the particle counter device. Other materials are of course contemplated.

[0026] As mentioned above, the scanner includes at least one lateral runner having at least one linear guide. The term "lateral runner" as used herein is a broad term to be given its ordinary and general meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term may refer, without being limited thereto, in particular to a component of a particle counting device configured to guide at least one component of the particle counting device transversely, in particular essentially perpendicularly, to the conveying direction of the conveyor belt. Thus, the lateral runner may also be referred to as a transverse shaft. The lateral runner has at least one linear guide, which will be described in more detail below.

[0027] The term "linear guide" as used herein is a broad term to be given its ordinary and common meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term may refer, in particular, to any device configured to allow linear guided movement of a component from one point to another, without being limited thereto. The linear guide may in particular be configured to move the probe at a constant speed in a straight line transverse to the conveying direction of the sterilization tunnel. The linear guide may be configured to limit the six degrees of freedom of the component, in particular three translational degrees of freedom and three rotational degrees of freedom, to one of the components, in particular a single translational degree of freedom. The linear guide may comprise at least one guide rail, in particular a contoured guide rail, in particular a T-shaped guide rail, or a round shaft. Furthermore, the linear guide may comprise at least one guide carriage, in particular at least one guide carriage attached to the guide rail or the round shaft. The probe may be mountable or mounted to the guide carriage, in particular by a probe holder. The linear guide may thus be configured to guide the probe. The linear guide can in particular have at least one plain bearing, in particular for the guide carriage. The plain bearing can be designed without lubricant. However, other bearings, such as ball or roller bearings, are naturally also conceivable.

[0028] The T-shaped guide rail makes it practically possible to design guide carriages with floating bearings in a direction transverse to, in particular perpendicular to, the conveying direction of the conveyor belt and / or in the conveying direction of the conveyor belt. The floating bearings allow the guide carriages to have some play in the selected direction. This makes it possible to compensate for manufacturing tolerances in the design. Without floating bearings, the system could be rigid, which means, for example, that the guide carriages could tilt. In particular, the guide rails can be configured as floating bearings, in particular as floating bearings in a direction transverse to, in particular perpendicular to, the conveying direction of the conveyor belt. This makes it possible for the guide carriages to compensate for small differences in height, in particular in the overall system. The length of the guide carriages can correspond to the flange width of the motor.

[0029] The linear guides can in particular be drylin® T small linear guides (Igus, Germany) made from hard anodized aluminum. The drylin® T small linear guides can have an overall height of 16 mm, a guide carriage length of 42 mm, a guide carriage width of 32 mm and a rail length that can be adjusted individually. Thus, the drylin® T small linear guides can have a low overall height and a sliding bearing. The length of the guide carriage can be equal to or less than the flange size of the stepper motor. The drylin® T small linear guides can be maintenance-free and lubricant-free. The drylin® T small linear guides can have polymer high-performance sliding elements with good wear and friction properties. Furthermore, the drylin® T small linear guides can have T-shaped guide rails. Contamination with oils and fats is strictly avoided since no lubricants are required. Dirt and dust particles cannot strictly adhere. According to the manufacturer, the system is insensitive to water, chemicals, heat and shocks. Thus, the requirements regarding the absence of lubricants and cleanability can be met. The length of the guide rails can be individually adapted to the different tunnel widths of the sterilization tunnel.

[0030] The linear guide may be configured to guide the probe transversely relative to the transport direction of the sterilization tunnel. The guide carriage of the linear guide may in particular be configured to mount all components necessary to generate and execute linear movements, as will be explained in more detail below, as well as the probe holder. In particular, the probe holder may be mounted on the guide carriage.

[0031] The linear guide, in particular the guide rail, can be attached to a base plate, in particular a base plate made of aluminum, in particular by at least one screw connection. The base plate can be designed to be replaceable. If the guide rail shows wear, it can be replaced at any time if necessary. The linear guide can be attached to the bogie using a base plate. In particular, the base plate can be attached to the bogie by at least one connection selected from the group consisting of at least one screw connection, at least one click connection, at least one tension lever connection. The screw connection can in particular comprise a knurled screw and / or a cylinder head screw. In particular, the base plate can be provided with a number of boreholes, in particular for attaching the lateral runners to the bogie. For a large number of lateral runners that need to be changed every year, in the order of six times per year, it can be advantageous to attach the lateral runners to the bogie by knurled screws. This makes it possible to form a compact construction by all means. This means that tool-free changes are reliably possible and the lateral runners can be connected to the bogie firmly, but releasably. The base plate can be adjusted by cutting out material that is not needed, in particular to save weight. Naturally, further embodiments for attaching the lateral runners to the carriage are also conceivable, such as a click system or tension levers.

[0032] The linear guide may have at least one drive, in particular a linear drive. The drive may be configured to move the guide carriage on the guide rail. The drive may be configured to scan the entire conveyor belt width of the conveyor belt of the sterilization tunnel. The drive may be selected from the group consisting of spindle drives, toothed belt drives, rack and pinion drives. Other embodiments are naturally also conceivable.

[0033] The toothed belt drive can in particular have at least one toothed belt and at least two toothed belt wheels. One of the toothed belt wheels can be configured to be driven by a motor. The toothed belt can be configured to guide on the toothed belt wheels. In this way, an object attached to the toothed belt, for example a carriage, can be moved. The toothed belt can have a plurality of teeth. Furthermore, the toothed belt wheels can each have a plurality of teeth. The shape of the teeth of the toothed belt can be adapted to the shape of the teeth of the toothed belt wheels. This results in a positive power transmission. With the correct tooth shape, a backlash-free drive can be substantially achieved. Changing the direction of rotation of the toothed belt wheels can achieve a linear movement in both directions of the toothed belt and thus of the carriage. The operation of the toothed belt drive is generally quiet. A slip-free and synchronous movement can be substantially transmitted in a shock-absorbing manner and with low preload. The running speed of the guide carriage can be controlled via the rotation speed of the motor. The toothed belt drive structure can be very small in height and is certainly suitable for the rapid positioning of smaller loads. No lubrication is required. It is certainly true that toothed belt drives are already available on the market as complete units. This certainly simplifies the structure.

[0034] The spindle drive can have at least one spindle. Furthermore, the guide carriage and the guide rail can be components of the spindle drive. The guide carriage can have in particular an internal thread that matches the thread of the spindle. The spindle can be configured to be driven by a motor, and the rotation of the spindle can be converted into a linear movement of the guide carriage by the interlocking of the thread. The guide rail can prevent the guide carriage from rotating about the axis of the spindle. The spindle can in particular be a ball screw or a trapezoidal spindle. The direction of movement of the guide carriage can be controlled by the direction of rotation of the motor. The pitch of the thread can indicate the advance of the guide carriage per spindle revolution. A larger pitch can result in a larger movement speed per revolution. The spindle drive can certainly generate significantly more running noise than a toothed belt drive and certainly may require lubrication.

[0035] Preferably, the linear guide can have at least one rack-and-pinion drive. The rack-and-pinion drive can have at least one rack and at least one spur gear. With the rack-and-pinion drive, the rotational movement of the spur gear is converted into a linear movement. In principle, there are two options here. On the one hand, the spur gear can be designed to be fixed with the motor as the drive unit and configured to drive the linearly mounted rack. The linearly mounted rack can be configured to move according to the direction of rotation of the gear. On the other hand, the rack can be fixed and configured to move the spur gear and the drive unit linearly, in particular along the rack. In particular, the drive unit with the spur gear can be mounted on the guide carriage of the linear guide. This flexibility is certainly the main advantage of the rack-and-pinion drive. The entire length of the rack can also be reliably used as a movement path. Due to the described features, the rack-and-pinion drive can be reliably constructed compactly and, if the materials are appropriately selected, can generally be operated without lubrication. Rack and pinion drives are substantially clear, have no slippage, and can achieve high efficiency when precisely manufactured. Like toothed belt drives, rack and pinion drives are generally quiet.

[0036] The rack may in particular have a circular cross section. The rack may in particular be configured to provide an additional guidance to the probe holder. The circular cross section may ensure simplified manufacturing for the additional guidance. The rack may in particular be shortened to the required length. The rack may in particular be made from austenitic stainless steel. In particular the rack may have a diameter of 10 mm, a delivery length of 1000 mm, a weight of 560 g and a strength of 200,000 N / mm 2 The gear may be made of austenitic stainless steel having a modulus of elasticity E of 1, as well as a module m of 1, the module m corresponding to the dimension of the gear teeth. The material has the material number 1.4305 according to EN 10027-2:1992-09.

[0037] Thus, depending on the tunnel type, the racks can be shortened to the required length. Starting from the maximum required length of the lateral runners, the deflection f of the rack can be calculated. This makes it possible to ascertain how the racks will deflect under their own weight. The knowledge thus gained can be taken into account when designing the lateral runners. A tunnel-type sterilization tunnel with a conveyor belt width of 800 mm can be used for the calculation. The maximum possible deflection of the racks is reliably anticipated here. To calculate the deflection f, the following formula can be used:

number

[0038] Thus, F corresponds to the weight of the rack, l corresponds to the length of the distributed load, and I corresponds to the moment of inertia.

[0039] The rack can be clamped on both sides with two rack holders each with a width of 10 mm. Thus, the length of the distributed load l is obtained as follows:

number

[0040] The weight m of the shortened rack can be determined in an additional calculation.

number

[0041] The rack weight force F can be calculated as follows:

number

[0042] The area moment of inertia I(TBB) may be determined as follows:

number

[0043] The determined value can be used in equation (1) to determine the deflection f of the rack.

number

[0044] The determined value of the deflection f is a maximum of 0.054 mm. Guide carriages with floating bearings in a direction transverse to the conveying direction of the conveyor belt can, in principle, easily compensate for this difference. The deflection of the rack due to its own weight is generally very small and does not generally have to be taken into account when designing the transverse runners. It can be assumed that a shorter length of the transverse runners generally results in less deflection of the rack.

[0045] The lateral runner may also have at least one, preferably at least two rack mounts. The rack mount may in particular be configured to fix the rack on the base plate of the lateral runner. The rack mount may in particular be made from aluminum. Other embodiments are naturally conceivable. The rack mount may in particular have an upper part and a lower part. The lower part may in particular be configured to be fixed on the base plate by at least one screw connection. In particular, as mentioned above, the lateral runner may have two rack mounts, the lower parts being respectively arranged at the ends of the guide rails. The upper part may be configured to be screwed into the lower part and may further be configured to fix the rack, in particular such that rotation and / or displacement of the rack is avoided or at least reduced.

[0046] As mentioned above, the rack and pinion drive can be configured to move the guide carriage on a rack, which can be fixed on the base plate of the transverse runner, in particular by the rotational movement of a spur gear. The spur gear can be made in particular from polyoxymethylene (POM). In comparison with metallic spur gears, running noise can generally be minimized and lubrication can certainly be omitted. Furthermore, spur gears made from polyoxymethylene (POM) can certainly be relatively light and have relatively low manufacturing costs.

[0047] The spur gear may in particular have 19 teeth. Furthermore, the spur gear may have a module m of 1, which corresponds to the size of the gear teeth. This means that the pitch diameter d for a complete revolution of the gear is z and the travel distance l z This gives the following values ​​for

number

[0048] Thus, a motor connected to a rack and pinion drive can perform one revolution per second to maintain the required particle counting velocity of 5.9 cm / s. This value can be used to program the motor.

[0049] The spur gear can be clamped as a non-positive connection with the set screw by means of a cut ring on the motor shaft of the motor of the rack-and-pinion drive. The motor shaft can have a flattening. The flattening of the motor shaft can provide the set screw with a relatively large surface area to generate a relatively high contact pressure. When the set screw is tightened, burrs can form on the surface of the motor shaft. The flattening of the motor shaft means that disassembling the spur gear is, in principle, not hindered by the formed burrs. Slipping of the motor shaft is also generally prevented.

[0050] By accurately positioning the spur gear relative to the rack, the teeth of the spur gear can, in principle, mesh with the teeth of the rack in the best possible way. This generally reduces any play between the interlocking teeth, at least as far as possible. The optimum centre distance a between the rack and the gear is calculated as follows, where d0 corresponds to the part circle line and d corresponds to the diameter of the rack:

number

[0051] The mounting bracket, especially made of aluminium, can be mounted, especially screwed, into a threaded hole in the guide carriage. The stepper motor can also be mounted, especially screwed, into the mounting bracket and configured to position the spur gear at a centre distance a from the rack. This allows the rack-and-pinion drive to function with great precision. By rotating the motor shaft and thus the spur gear, the guide carriage can move on the guide rail. A bore hole can be provided in the mounting bracket for mounting the probe holder.

[0052] By using a rack-and-pinion drive with the above mentioned characteristics, by means of a skilled selection and arrangement of the components, the guide carriage with the probe can in principle be moved over almost the entire length of the rack and thus over the entire conveyor belt width. Rack-and-pinion drives are generally particularly suitable here, since the rack length can be variably set independently of the majority of the components. With little effort, by adjusting the length of some components such as the rack, a suitable transverse runner can generally be designed for any type of tunnel.

[0053] The drive may include at least a first motor, the drive including at least a first motor selected from the group consisting of a servo motor, a stepper motor. Other types of motors are naturally conceivable. The terms "first motor" and "second motor" should be regarded as purely descriptive, without specifying an order or ranking, e.g. without excluding the possibility that multiple types of first motors or second motors or exactly one type may be provided. Furthermore, there may be additional motors, e.g. one or more third motors.

[0054] The term "motor" as used herein is a broad term to be given its ordinary and common meaning as understood by those skilled in the art. The term is not limited to any particular or applicable meaning. The term may refer to any engine configured to perform mechanical work by converting forms of energy, such as thermal, chemical, hydraulic, pneumatic or electrical energy, into kinetic energy, among others, without being limited thereto.

[0055] The servo motor may in particular be a synchronous servo motor. Together with the servo regulator, the servo motor may form a servo drive. The synchronous servo motor may in particular include a stator with copper wire windings and a rotor with permanent magnets. The permanent magnets may be configured to form a constant magnetic field around the rotor. The servo regulator may be configured to supply the stator with an alternating current that generates a second magnetic field, in particular a rotating magnetic field. The rotating magnetic field may exert a force on the magnetic field of the rotor, which rotates synchronously with the rotating magnetic field. A change in the current frequency may change the rotating magnetic field and therefore the speed of the rotor. The magnitude of the current may be used to determine the magnitude of the electromagnetic force and therefore the rotor torque. The upper control unit may pass the speed and the target position of the motor to the servo motor via the servo regulator. The motor may be configured to return the actual values ​​of the current, the speed and the position to the servo regulator. In case of deviations, the speed and the current may be readjusted via the control unit. The servo motor generally has high dynamics, high positioning accuracy and high overload capacity in a wide speed range. Further features of servo motors include high speed accuracy, short acceleration times, short torque response times, high stall torque and small mass moment of inertia. Furthermore, they generally have a compact design and are reliably lightweight in relation to their performance.

[0056] The stepping motor may in particular be selected from the group consisting of permanently excited stepping motors, reluctance stepping motors, hybrid stepping motors. The stepping motor may preferably be a hybrid stepping motor. A hybrid stepping motor may in principle combine the advantages of a permanently excited stepping motor and a reluctance stepping motor. A hybrid stepping motor may in particular be configured to achieve very small step angles. A stepping motor, in particular a hybrid stepping motor, may comprise at least one rotor, in particular at least one permanent magnet, in particular at least one cylindrical permanent magnet with an axial polarity alignment. Furthermore, a stepping motor, in particular a hybrid stepping motor, may have at least one stator field, in particular a fixed stator field, with multiple stator coils, for example eight stator coils. A stepping motor, in particular a hybrid stepping motor, may be configured to rotate a rotor by a defined angle or a defined step by means of alternatingly controlled stator coils.

[0057] At least two rotor shells with a number of teeth, e.g. 50 teeth each, twisted with respect to one another by one tooth width, may be arranged around the permanent magnet, one behind the other, and rigidly connected to the rotor. The rotor shells may be configured to receive the magnetization of the permanent magnets. The stator magnetic field may also have a number of teeth, e.g. 48 teeth. The stator coils of the stator magnetic field may be energized one after the other, shifted by 45 degrees per step, to form a changing electromagnetic field. The magnetized rotor shells may align their teeth with the electromagnetic field of the stator coils. Due to the different number of teeth in the stator magnetic field and the rotor shell, the rotor rotates, e.g. 1.8 degrees per step.

[0058] The first motor may in particular comprise a first motor drive. The terms "first motor drive" and "second motor drive" should be seen as purely descriptive, without specifying a sequence or ranking, for example excluding the possibility that several types of first motor drive or second motor drive, or exactly one type, can be provided. Furthermore, there may be additional motor drives, for example one or more third motor drives. The first motor drive may be configured to transmit signals, in particular signals from the controller, to the first motor and / or to supply a voltage to the first motor. For this purpose, the first motor drive may for example be connected to a main adapter. The main adapter may be configured to convert the voltage into the voltage required by the first motor.

[0059] In particular, the drive of the linear guide may include at least one NEMA 17 stepper motor (Stepperonline, China) and associated stepper motor drive. The NEMA 17 stepper motor may have manufacturer part number 17HS24-2104S, a holding torque M1 of 0.65 Nm, a step angle of 1.8°, a flange dimension of 42 mm, a length of 60 mm, and a weight of 500 g. NEMA 17 stepper motors are generally light for their size and have a large selection of different holding torques. If the selected holding torque is not sufficient to move the guide carriage together with the probe holder and the probe, it is certainly possible to replace the stepper motor with a more powerful stepper motor without having to change the design of the lateral runner. Despite its small size, the Nema 17 stepper motor may also be suitable to generate the power required to drive the linear guide of the lateral runner. Stepper motors with smaller holding torques may also certainly be used. This may certainly mean a lighter weight of the lateral runner. With a flange dimension of 42 mm, the NEMA 17 stepper motor is generally only slightly wider than the diameter of the probe, which may be, for example, 36 mm. This means that the probe is generally limited by the motor when it reaches the outer position, by a minimum of, for example, 3 mm each. The motor can also generally specify a maximum length of the guide carriage based on its flange dimension. The drive shaft of the motor can have a flattening by milling. The flattening can in principle facilitate the attachment of a spur gear to the motor shaft by a press-fit shaft-hub connection. Furthermore, the second motor can be a stepper motor of the OMC Stepperonline 17HS24-2104S type with a step generator of the OMC Stepperonline DM556N type.

[0060] Hybrid stepping motors generally have a high holding torque even when stationary, without overheating, and are generally small. For simple positioning tasks with hybrid stepping motors, a distance measurement system is generally not required, since the steps can be counted. However, there is generally no monitoring of the steps and therefore generally no position feedback. This open control circuit is also known as an open-loop system. This has the fundamental drawback that steps can be skipped, for example in case of external interference or overload. In the case of a probe's travel path, this certainly means that the accuracy of the travel path is reduced. One possibility for position feedback is to use a stepping motor equipped with an encoder. The encoder can be configured to count and monitor the number of steps. In such a closed control circuit, also known as a closed-loop system, generally also a suitable output stage is connected between the controller and the encoder, which processes the information coming from the encoder and transmits it to the controller. This means that the controller can reliably determine, store and adjust the current position as required. However, the encoder generally increases the overall length and weight of the stepping motor. Hybrid stepping motors can in principle only generate full torque up to a certain speed. As the speed increases, the torque generally decreases beyond a certain speed. The torque drop can be obtained from the motor's characteristic curve. If the torque is exceeded, the motor will, in principle, stall.

[0061] Stepper motors can have some advantages in accelerating drives, especially linear drives. The maximum speed of a stepper motor is certainly lower than that of a servo motor, and the torque transmitted certainly decreases with increasing speed of the stepper motor, but the expected required speed can be lower than perhaps 100 revolutions per minute. The short overall length and light weight of stepper motors are certainly advantages that help in the design of smaller and lighter lateral runners, especially the lateral shafts. Programming and controlling a stepper motor is certainly easier than programming and controlling a servo motor.

[0062] An increment of 1.8° can result in 200 steps for one complete revolution of the motor. The path can be measured and therefore very well programmed without the need for additional monitoring, for example by limit switches or encoders. Stepper motors certainly also have good conditions in terms of cost. This helps to keep the overall cost of the particle counting device low, since the cost of a stepper motor is certainly much lower than that of a servo motor.

[0063] Another distinct advantage of stepper motors is the standardized flange size. The connection dimensions of stepper motors are basically specified according to the National Electrical Manufacturers Association (NEMA) standard and are therefore the same depending on the size. The designation of stepper motors can generally be used to determine their flange size, for example, a stepper motor designated NEMA 17 has a flange size of 42 mm, or a NEMA 23 stepper motor has a flange size of 57 mm. This standardization has the fundamental advantage that motors from different manufacturers can usually be interchanged without design changes. Stepper motors with the same flange size but different torques can also be interchanged.

[0064] One task of the transverse runner can be to guide the probe for particle measurement transversely, in particular orthogonally, to the conveying direction of the conveyor belt. The probe can be mounted on a guide carriage or on a mounting bracket. The probe holder can be configured to be further guided through the rack. The probe holder can in particular be made from POM. The spur gear can also be made from POM, as mentioned above. This makes it possible to minimize the sliding friction between the rack and the probe holder. Furthermore, a weight reduction can be achieved. The probe holder and the mounting bracket can in particular be connected to each other by a screw connection. The probe holder can have a groove, in which the probe can be inserted and clamped by a clamping plate. The probe holder can be configured, in particular for safety reasons, such that it surrounds the spur gear in particular completely. This can avoid that other elements are trapped between the spur gear and the rack when the spur gear is moving.

[0065] For the design of the lateral runners, the tunnel-type sterilization tunnel can be analyzed and the important dimensions of the scanner, especially the lateral runners, can be incorporated. The most important dimensions are essentially the maximum height of the sterilization tunnel and the width of the conveyor belt. The sterilization tunnel can in particular have a conveyor belt width of 600 mm to 800 mm. Furthermore, the sterilization tunnel can have a maximum height of 160 mm to 230 mm. Furthermore, there can be one to five particulate filters in the sterilization tunnel. The particulate filters can have a filter length of 250 mm to 580 mm and a filter width of 600 mm to 720 mm. The listed dimensions can in particular be taken from existing technical drawings of the sterilization tunnel and / or the sterilization tunnel can be measured on site. The maximum height and the maximum width of the lateral runners of the scanner can be reliably derived from these dimensions. The maximum height of 160 mm, especially the passage height, basically sets a limit for the total height. Furthermore, the maximum total height can be limited by separating partitions between different zones in the sterilization tunnel. This can also require the particle counting device to be as flat as possible. However, it is a fundamental goal to make the height of the particle counting device as low as possible in order to facilitate handling on the sterilization tunnel and the introduction of the particle counting device on the conveyor belt. The lateral runners can be reliably adjusted to the width of the conveyor belt. Due to different widths of the particulate filters, the scanner can have a modular design. The lateral runners can be configured in such a way that they can be adapted to the tunnel width of the sterilization tunnel. In particular, the length of the racks, the length of the guide rails and the length of the base plate can be adjusted. The remaining components of the particle counting device can be independent of the tunnel type of the sterilization tunnel. For example, the height of the lateral runners can be 80 mm and the total weight of the lateral runners can be 1870 g. Furthermore, the connection of the components of the lateral runners can have Phoenix plug-in terminals. This can contribute to a further reduction of the overall height of the particle counting device, in particular up to 10 cm.

[0066] As mentioned above, the scanner comprises a dolly. The term "dolly" as used herein is a broad term to be given its ordinary and general meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term can refer, in particular, to any part of the device configured to carry further components of the device, but is not limited to it. Thus, the dolly can be configured as a support for the device. The dolly can have, in particular, elements that allow the dolly to move on a surface. The elements can include, in particular, one or more wheels, one or more wheel suspensions, at least one drive and / or at least one motor. Thus, the dolly can also be called a chassis.

[0067] The trolley can have a frame. The frame can also be called a base frame. The frame can in particular be made of a metal sheet, in particular a metal sheet made of austenitic stainless steel. The metal sheet can in particular have a thickness of 1 mm to 5 mm, preferably 1.5 mm to 2.5 mm, particularly preferably 2 mm. Due to its structure, austenitic stainless steel can generally be very well cold formed, so that the metal sheet can be bent. Thanks to the chromium content of >13.5%, austenitic stainless steel also has good corrosion resistance and is therefore well suited for use in the pharmaceutical field. Through well selected folds, a high level of sheet metal rigidity can be achieved. By welding the abutting edges, the rigidity of the sheet metal can be further increased. In this way, a torsion-resistant and lightweight frame can be produced, on which further components can be attached. Alternatively or additionally, the frame can be made at least partially from aluminum. This can contribute to the weight reduction of the particle counting device. As mentioned above, the lateral runners are attached to the trolley. In particular, the lateral runners, in particular the base plates of the lateral runners, can be mounted on the frame. In particular, the lateral runners can be mounted centrally on the trolley, in particular on the frame. Furthermore, the lateral runners can be mounted flush with the trolley, in particular with the frame. In particular, the lateral runners can be mounted flush with the rear side of the trolley, in particular with the rear side of the frame. Due to the small outflow surfaces in front and behind the sterilization tunnel, the size can be minimized and particle counting can be performed even without an outflow zone.

[0068] The controller can in particular be attached and in particular be located in the center of the dolly. The controller can in particular be attached in a free area of ​​the dolly. The length of the free area can in particular be selected so that the controller and in particular cable ducts for wiring can be attached.

[0069] As mentioned above, the carriage is configured to move the linear guide in the conveying direction of the conveyor belt. For example, the carriage may have a crawler chassis configured to move the linear guide in the conveying direction of the conveyor belt. However, the carriage may preferably have at least two wheels, in particular at least two drive wheels, configured to move the linear guide in the conveying direction of the conveyor belt. The drive wheels may in particular be any wheels configured for an independent movement of the device to which they are attached. The drive wheels may in particular be driven by a motor, as will be explained in more detail below.

[0070] As mentioned above, the conveyor belt of the sterilization tunnel can have a wire mesh. As explained in more detail below, the wheels can be configured to, among other things, increase the contact area between the wheels and the wire mesh of the conveyor belt. In particular, by appropriate selection of materials and the self-weight of the particle counter, sufficient rolling friction can be applied to achieve non-slip motion.

[0071] Since the wire mesh is usually made of at least one metal, metal-to-metal contact can be fundamentally avoided in the design and material selection of the wheel, otherwise, since the contact area on the wire mesh is generally small, sufficient rolling friction generally cannot be generated between the wheel and the conveyor belt, and basically slip-free movement cannot be guaranteed. If the wheel is made of a thermoplastic or thermosetting material, a similar behavior is assumed. Here too, there may not be enough rolling friction between the wheel material and the conveyor belt to ensure reliable slip-free movement.

[0072] In particular, the wheels may be at least partially made of an elastomer. The elastomer may be selected from the group consisting of silicone, ethylene propylene diene (monomer) rubber (EPDM). These materials are approved for use in the pharmaceutical sector. However, other elastomers are naturally also conceivable. In particular, the wheels may each have one or more O-rings made of an elastomer. The elastomer may be configured to generate rolling friction between the wheel and the conveyor belt. Due to the elastic deformability and high coefficient of friction of the elastomer, the contact area between the O-ring and the conveyor belt may be increased. This means that a slip-free operation is possible.

[0073] The wheels may in particular be designed such that an elastomeric O-ring can be mounted thereon. The wheels, in particular the drive wheels, may in particular be made from polyoxymethylene (POM). In particular the wheels may have one or more grooves configured to receive an O-ring. The diameter of the wheels may be selected such that a low ground clearance is achieved between the frame and the conveyor belt. This means that the overall height of the subsequent scanner can be kept to a minimum. The wheels, in particular the drive wheels, may each have a plurality of O-rings, in particular at least two, preferably at least three, preferably at least four O-rings, in particular to increase the contact area between the wheels and the conveyor belt. The O-rings may be arranged spaced apart from one another on at least one circumferential surface of the drive wheels. The O-rings may each be received in a groove in the circumferential surface of the drive wheels.

[0074] The drive wheels may each be attached to an axle. The rotational motion of the axle may be positively transferred to the drive wheels using a feather key. This may prevent the wheels from spinning. Additionally, the drive wheels may be secured by a set screw, specifically to prevent them from moving on the axle.

[0075] The particle counting device may further comprise at least a second motor selected from the group consisting of a stepper motor, a servo motor. However, other types of motors are naturally conceivable. The second motor may be configured to drive at least one of the drive wheels. For further details regarding the design of the stepper motor and the servo motor, reference may be made to the above description.

[0076] Preferably, the second motor can be a stepper motor. In particular, the second motor can be a motor having a size corresponding to that of the first motor. In particular, the second motor can be a motor structurally identical to the first motor. This minimizes the number of different components of the particle counting device. Furthermore, only one type of stepper motor can be kept in stock as a spare part, which generally ensures interchangeability.

[0077] The second motor may in particular comprise a second motor drive. The second motor drive may be configured to transmit signals to the second motor and / or to supply a voltage to the second motor. For this purpose, the second motor drive may for example be connected to a main adapter. The main adapter may be configured to convert the voltage to a voltage required by the second motor, for example the main adapter may be configured to convert the voltage from 230V to 24V. In particular, the particle counter may comprise a main adapter configured to supply the first motor, the second motor, the first motor drive and the second motor drive. Alternatively, two main adapters may be provided, each supplying the first motor and the first motor drive or the second motor and the second motor drive.

[0078] In particular, the second motor can be a NEMA 17 stepper motor (Stepperonline, China) with an associated stepper motor drive. The Nema 17 stepper motor can be suitable to generate the power required to drive the movement of the carriage, despite its small size. For further details, see the above description. Furthermore, the second motor can be a stepper motor of the OMC Stepperonline 17HS24-2104S type with a step generator of the OMC Stepperonline DM556N type. The carriage can in particular have a drive shaft. The stepper motor can be mounted on the base frame so as to be offset transversely from the drive shaft, in particular by 90°. The carriage can also have several bevel gears. To transmit the rotary motion of the stepper motor to the drive shaft, a bevel gear with a transmission ratio of 2:1 can be selected. The first bevel gear can have, for example, a number z of teeth of 15 and the second bevel gear can have a number z of teeth of 30. The first bevel gear and the second bevel gear may each be made of POM and have a module m of 1.

[0079] The first bevel gear can be configured to be driven by the second motor and transmit rotary motion to the drive shaft via the second bevel gear. The transmission ratio allows the speed n1 of the second motor on the drive shaft to be halved and the transmitted torque M1 to be doubled. As a result, a stepper motor with a generally low holding torque can be used. z1 corresponds to the number of teeth of the first bevel gear and z2 corresponds to the number of teeth of the second bevel gear.

number

[0080] A torsionally rigid but angularly and transversely flexible compensating coupling may be used to transmit torque and speed from the second motor to the shaft of the first bevel gear. This can, in principle, compensate for design tolerances or misalignments. The compensating couplings used are generally backlash-free and can be torsionally rigid, compensating for both radial and axial angular misalignments. The gear shaft can be held in place by a holder. Grooved ball bearings can be pressed into the holder, which supports the shaft and axle of the first bevel gear and ensures a smooth running. Grooved ball bearings have the fundamental advantage that friction torque does not increase during warm-up. They also generally show little wear at low speeds and are maintenance-free. The first bevel gear can be frictionally locked to the shaft using a set screw. The second bevel gear can also be attached to the shaft by a set screw and fixed by an adjusting ring to prevent accidental displacement on the shaft.

[0081] Furthermore, the wheels can include one or more, in particular two, rear wheels. The rear wheels can be designed to be drive-free. The rear wheels can run particularly smoothly. For further details of the design of the rear wheels, see the description above. The rear wheels can be made of POM. Furthermore, the rear wheels can have a groove configured to receive an O-ring. The O-ring can be made of at least one elastomer. The diameter of the rear wheels can be selected such that the rear wheels do not impede the movement of the lateral runners. For a particularly smooth run, ball bearings can be pressed into the rear wheels. The rear wheels can have a locking ring configured to secure the ball bearings against unintentional loosening. The rear wheels can each be pressed on a shaft and attached by a self-locking nut. The self-locking nut can be configured to prevent the self-locking nut from loosening when the rear wheels rotate. The shaft of the rear wheels can also be attached to the carriage by means of a self-locking nut, in particular screwed.

[0082] The trolley may be designed to be used in any type of sterilization tunnel. Thanks to its compact size, the trolley is easy to handle. The frame may have welded studs, in particular arranged at the rear end, which may be configured in particular for mounting lateral runners. The lateral runners may be detachably connected to the trolley using knurled nuts. It may be possible to easily replace the lateral runners. The height of the trolley may in particular be selected not to exceed the total height of the particle counting device, which is 160 mm. Furthermore, the total height of the trolley may be kept as low as possible. A trolley with the above components may have, for example, a total height of 79 mm and a total weight of 3000 g. The trolley may have, for example, a width of 300 mm. This may make it easier to handle and introduce the particle counting device into the sterilization tunnel.

[0083] As mentioned above, the scanner further comprises at least one controller configured to control the movement of the scanner. The movement can in particular be a movement of the carriage in the conveying direction of the conveyor belt. Furthermore, the movement can include guiding the probe holder transversely to the conveying direction of the conveyor belt. The term "controller" as used herein is a broad term to be given its ordinary and general meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term can in particular, but not exclusively, refer to a one-part or multi-part device of a particle counting device configured to fully or partially control and / or regulate the operation of the particle counting device. In particular, the controller can include a programmable logic controller (PLC). In the context of the present invention, a "programmable logic controller (PLC)" basically means any device that is used to control or regulate a machine or a system and is programmed on a digital basis. In particular, the controller can be configured to control and / or regulate a motor of a drive device for guiding the probe holder transversely, in particular essentially perpendicularly, to the conveying direction of the conveyor belt and / or a motor of a drive device for moving the carriage along the conveying direction of the conveyor belt. The controller may in particular comprise at least one data processing device, for example at least one processor. The controller may therefore be implemented partly by hardware and / or alternatively or additionally, fully or partly by software. Furthermore, the controller may include at least one volatile and / or non-volatile data memory. The controller may in particular be configured to control at least one of the drives. In the context of the present invention, "controlling the drives" should essentially be understood as the type of operation of the drives, in particular the start and / or stop of one or more movements or steps, in particular the change in the speed of the movements.The controller may in particular be configured to control the drive during operation of the particle counting device, whereby a repeated, predetermined movement of the carriage or the guide of the probe holder is performed with the linear guide. The controller may in particular be configured to send a signal to a first motor drive of a first motor or to send a signal to a second motor drive of a second motor. The controller may in particular be configured, for example by programming, to control a particle counting method, which will be described in more detail below. The controller may also be configured to log data from the drive. Logging may in particular include storing or recording data. In particular, the controller may include a TIA PLC S7-1200. The TIA PLC S7-1200 may provide the controller with sufficiently high performance, despite its small size and limited number of channels. Furthermore, the controller may comprise a Siemens PLC S7-1211C DC / DC / DC, in particular an 8" touch panel for operation. The Siemens PLC S7-1211C DC / DC / DC may have a particularly compact design. Furthermore, the controller may comprise a board with a microcontroller (Arduino), which may be connected to a computer in particular via an interface, in particular via a USB interface. A program for controlling the movement of the carriage and / or for guiding the probe holder may be loaded onto the board. The program may in particular specify the steps, speed and / or direction of rotation of a motor, in particular a stepper motor.

[0084] Furthermore, the particle counting device may have at least one y position sensor for determining the position of the probe in one dimension of the conveying direction on the conveyor belt. Furthermore, the particle counting device may have at least one x position sensor for determining the position of the probe in a dimension transverse to the conveying direction on the conveyor belt, in particular a dimension essentially perpendicular to the conveying direction. The term "position sensor" generally refers to any sensor configured to measure the change in distance and / or length between an object and a reference point. The position sensor may in particular be configured to convert the change in path into a standard signal or to transmit it to a control device. The y position sensor may be connected to the carriage, in particular to the drive of the carriage. As mentioned above, the carriage may have a stepper motor, and the y position sensor may include an incremental encoder of the stepper motor. The x position sensor may be connected to the linear guide, in particular to the drive of the linear guide. As mentioned above, the linear guide may have a stepper motor, and the x position sensor may include an incremental encoder of the stepper motor. The particle counting device, in particular the controller, may be configured to count the pulses of the stepper motor, in particular the stepper motor drive, in particular by means of a forward and reverse counter. The forward and reverse counters may in particular be part of the controller. This means that any position that may be significant in the measurement may be cached in a Cartesian manner during the measurement and may be approached in manual mode in a subsequent more precise check, as will be explained in more detail below.

[0085] In particular, the particle counting device, in particular the controller, may be configured to count first pulses of a first motor, in particular a first stepping motor drive, by at least one first forward and reverse counter. Furthermore, the particle counting device, in particular the controller, may be configured to count second pulses of a second motor, in particular a second stepping motor drive, by at least one second forward and reverse counter. In particular, the particle counting device, in particular the controller, may be configured to determine the position of the probe on the linear guide using the first pulses of the first motor and to determine the position of the carriage on the conveyor belt using the second pulses of the second motor. Furthermore, the particle counting device, in particular the controller, may comprise at least one further forward and reverse counter configured to count pulses of a second motor, in particular a second stepping motor drive. Thus, the further forward and reverse counter may be configured to determine the path distance during the movement in the conveying direction, in particular. The particle counting device, in particular the controller, may be configured to reset the further forward and reverse counters to zero after a stepwise movement of the carriage, in particular after reaching a next measurement path. Furthermore, the linear guide may have a first end stop and a second end stop, and the controller may be configured to reset the first forward and reverse counters to zero when the probe is at the first end stop. In particular, the first end stop may be the left end stop.

[0086] In particular, the first forward and reverse counter, the second further forward and reverse counter, and the further forward and reverse counter are configured to count pulses of the first stepper motor drive and the second stepper motor drive, respectively, so that the controller may be configured to calculate metric data for the representation of coordinates using the pulses of the first stepper motor drive or the second stepper motor drive.

[0087] To determine the position of the probe holder transverse to the transport direction the following basically applies:

number

[0088] Thus, a ratio between pulse and Cartesian position can be specified.

number

[0089] Now the Cartesian position can be determined by rearranging:

number

[0090] The pulses per revolution can depend on the speed as well as the minimum possible adjustable time delay in the pulse programming. When using a minimum time delay of 1 ms and a speed of 5 cm / s, the geometry of the drive gear results in the following:

number

[0091] For Cartesian positions, the following results are obtained:

number

[0092] As explained above, a bevel gear transmission, in particular a single stage bevel gear transmission, may be installed for propulsion, so that the transmission ratio can be taken into consideration.

number

[0093] With a pinion diameter of 11.96 mm this may result in the following:

number

[0094] To determine the position of the scanner in the transport direction, the following results are obtained:

number

[0095] Furthermore, the scanner may have one or several limit switches. The term "limit switch" generally refers to any device configured to record when a moving object reaches a defined position. In particular, the lateral runner may have at least two limit switches, in particular at least two roller limit switches, configured to determine the position of the limit of the probe transverse to the conveying direction of the conveyor belt. In particular, the lateral runner may have at least two snap switches, for example at least two Marquardt 1006.1501 snap switches. Furthermore, the carriage may have at least one limit switch, in particular at least one spring rod limit switch, for determining at least one position of at least one limit of the particle counting device in the conveying direction.

[0096] Furthermore, the particle counting device may comprise at least one stationary user interface. The user interface may be connected to the scanner. The movement of the scanner may be controllable using the user interface. The term "interface" as used herein is a broad term to be given its ordinary and general meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term may refer, in particular, to a device of essentially any design configured to receive at least one piece of information and then, optionally, process and / or transfer it, fully or partially, for example, to at least one controller. The term "user interface" as used herein is a broad term to be given its ordinary and general meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term may refer, in particular, to any interface for inputting commands and / or outputting information, and / or to a wireless or wired interface for unidirectional or bidirectional exchange of data and / or commands between the device and at least one operator of the device. The user interface may be a communication interface, in particular a data interface, configured to receive data from another device and / or from a user and / or to transmit data from the user interface to an external device. The user interface may have at least one electronic interface and / or human-machine interface, such as a display, in particular a touch display, in particular an 8" touch display, and / or an input / output device such as a keyboard. The interface may have at least one data connection, for example a Bluetooth connection, an NFC connection or another connection. The user interface may have at least one network or be part of a network.The user interface may have at least one internet port, at least one USB port, at least one drive, or a web interface.

[0097] In particular, the user interface may comprise a graphical user interface, in particular a graphical user interface having at least one touch screen. The term "graphical user interface" as used herein is a broad term to be given its ordinary and general meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term may refer in particular, but not exclusively, to a form of computer user interface having the task of enabling application software on a computer to operate using graphic symbols or control elements. This may be done, for example, using a mouse as a control device to operate or select the graphic elements. Alternatively or additionally, the operation may be performed by touching a sensor screen, in particular a touch screen.

[0098] In particular, the at least one movement path and / or the at least one measurement position for particle counting can be predeterminable using a user interface. Furthermore, the at least one movement path and / or the at least one measurement position can be predeterminable in manual or automatic operation. Furthermore, the at least one speed can be predeterminable for the at least one movement path, in particular in manual mode, as described in more detail below. Furthermore, the user interface can be connected to the particle counter.

[0099] The graphical user interface may in particular comprise at least three operator interfaces, in particular at least three individual operator interfaces. The operator interfaces may each be accessed via a main menu. The main menu may also be called a basic screen. The graphical user interface may be configured in such a way that the three operator interfaces, which may also be called submenu items, may be reached from the main menu, in particular via a TIA internal function, which may in particular be called "ActivateScreen". The first operator interface may correspond to an automatic, in particular partially or fully automatic operation. The first operator interface may in particular include starting and stopping a defined automatic run of the carriage and / or the probe. Furthermore, the first operator interface may include a coordinate display and / or a coordinate storage device. The partially or fully automatic operation may also be called a partial measurement operation. The second operator interface may correspond to a manual operation, in particular manual operation. The second operator interface may in particular provide separate control options for the direction of movement, in particular the direction of movement of the carriage and / or the probe holder. Furthermore, the second user interface may provide an execution in the start position. Furthermore, the second operator interface may provide one or more service functions that may include, for example, an incremental reset or a display of a digital output. The third operator interface may correspond to an interface for system settings. The at least three operator interfaces may each include a display of date and time, which may in particular be obtained from the control internal system time. Furthermore, the at least three operator interfaces may each be configured to display an occurring fault via a message text line. In particular, the third operator interface may be configured to terminate runtime and in particular then move to a settings area of ​​the user interface.Furthermore, the third operator interface may include a user management, in particular a user account management. The user interface may be particularly configured to create groups, in particular for operators and administrators with respective users and their initial passwords, in particular via TIA internal functions, in particular prior to particle counting. The one or more functions that may be controlled or activated only by a limited user group may comprise a safety function, in particular a security function, with a corresponding restriction of authorization for the pre-defined groups.

[0100] As mentioned above, the second operator interface may provide separate control options, in particular for the direction of movement, in particular for the direction of movement of the carriage and / or the probe holder. The second operator interface may be configured for manual driving of the scanner, in particular for manual guiding of the probe holder transversely to the conveying direction of the conveyor belt and / or for manual driving of the carriage in the conveying direction of the conveyor belt. The second operator interface may have several buttons, in particular several separate buttons, configured in particular for controlling the first motor of the linear guide and / or the second motor of the carriage, in particular in the direction of movement. In particular, the buttons may comprise at least a first button for controlling the forward movement of the carriage in the conveying direction. Furthermore, the buttons may comprise at least a second button for controlling the backward movement of the carriage opposite to the conveying direction. Furthermore, the buttons may comprise at least a third button for controlling the probe holder transversely to the conveying direction, in particular from the first end of the guide rail to the second end of the guide rail. Furthermore, the buttons may include at least a fourth button for controlling the probe holder transversely to the conveying direction, in particular from the second end of the guide rail to the first end of the guide rail. Guiding the probe holder from the first end of the guide rail to the second end of the guide rail may also be referred to as moving or guiding the probe holder to the left. Furthermore, guiding the probe holder from the second end of the guide rail to the first end of the guide rail may also be referred to as moving or guiding the probe holder to the right, or vice versa. The first button, the second button, and the fourth button may be particularly arranged as a D-pad. Furthermore, the second operator interface may include a home button, in particular, which may be arranged in the center of the D-pad. The home button may be used to guide the probe holder to the first end of the guide rail or the second end of the guide rail.

[0101] In particular, the second operator interface may be configured to return the scanner to the starting position after the particle counting method has been performed, in particular to return the carriage to the starting position. In particular, returning the carriage to the starting position may comprise retracting the carriage to the starting position. To this end, in particular, the second operator interface may comprise at least one, in particular at least two input fields for speed. In particular, the second operator interface may comprise a first input field for the speed of the carriage in the conveying direction and a second input field for the speed of the probe holder transverse to the conveying direction. This means that, if necessary, the scanner may be returned to the starting position more quickly than if the particle counting method had been performed. The input speed value may be configured to manipulate the holding time of the on-switch delay or the off-switch delay, which may be used for the pulse generator, as will be explained in more detail later. Furthermore, the second operator interface may have at least one "back" button, by which the second operator interface, in particular the manual mode, switches to the main menu with a screen change and in particular to exit the manual mode. Furthermore, the second operator interface may have one or more information windows, in particular when one or more test runs for example for troubleshooting may be performed via the second operator interface. The information window may have in particular one or more texts, displays and buttons. The second operator interface may have in particular a service button by which the information window is activated. The activation may be realized in programming, in particular by a visibility function of the screen element. In particular, the service button may be configured to activate a bit used for the visibility query of the element. The information window may have in particular a close button, which may in particular be configured to deactivate the bit, whereby the elements lose their visibility. The information window may also include one or more buttons for resetting the increments for the movement of the carriage and / or for guiding the probe holder.Additionally, the information window may have one or more buttons for simulating end stops. Additionally, the information window may have one or more displays for the binary output of the step generator controller. Other configurations are of course possible.

[0102] As mentioned above, the first operator interface may in particular include starting and stopping a defined automatic travel of the carriage and / or the probe. In particular, the first operator interface may include a method for a predefined serpentine path of the scanner. In particular, the movement path may include a serpentine pattern with alternating movements of the probe parallel to transverse to the conveying direction. In particular, the user interface may be configured to move the linear guide stepwise in the conveying direction of the conveyor belt by the carriage. Furthermore, the user interface may be configured to guide the probe holder transversely, in particular essentially perpendicularly, to the conveying direction by means of a transverse runner. The stepwise movement of the linear guide in the conveying direction and the guiding of the probe holder transverse to the conveying direction are alternated, in particular from the first end of the guide rail to the second end of the guide rail or from the second end of the guide rail to the first end of the guide rail, to form a serpentine pattern. The first operator interface may in particular include a start button used to start a programmed sequence of steps. Furthermore, the first operator interface may be configured to make visible a stop button that appears in particular at a position of the first operator interface corresponding to the position of the start button. Furthermore, the first operator interface may be configured to stop the sequence of steps programmed via a stop button, in particular deactivating the visibility of the stop button. Furthermore, the first operator interface may have two output fields displaying the current Cartesian position of the probe. Furthermore, the first operator interface may have a "save position" button. The first operator interface may be configured to temporarily store the coordinates recorded by pressing the "save position" button, in particular the coordinates recorded at the time of pressing, in particular in a data block. This allows a counter, in particular a leak counter, to increase the number of possible leaks. The representation of the position of the possible leak may have several, in particular five, variables for each of the positions in the conveying direction and the positions transverse to the conveying direction.This position can also be referred to as the x and y position. The values ​​of these variables can be zero by default, especially if the leak counter has a value of zero. As soon as the leak counter increases to a value of one, the current position value is displayed in the first pair of variables, especially the first pair of xy variables. However, this certainly leads to the problem that the position value of the first leak continues to advance simultaneously to the current measurement position, rather than taking a snapshot of the position. This problem can be solved by using a side. Now, as soon as the leak counter increases to the value one, a pulse, especially a pulse with a time span of 100 ms, can be initiated, which is configured such that the current position value is written only during the time span of the pulse. The representation of the position of the possible leak can in particular have a "clear" button, in particular configured to reset the variables to the value zero by resetting the leak counter. As already mentioned, a storage of up to five leaks in particular can be provided, since this number of anomalies indicates a critical state of the filter element being checked. The user interface can in particular be configured to move the probe to at least one predeterminable probe position, in particular a storage position, and to perform a particle counting there. In this way, the saved locations of possible leaks can be checked again.

[0103] As mentioned above, the probe may include a probe opening, in particular a probe funnel. The user interface may be configured, in particular via the first operator interface, to perform a stepwise movement of the linear guide in the conveying direction of the carriage of the conveyor belt, such that the increment of the particle counting device in the conveying direction of the carriage of the conveyor belt is smaller than the outer diameter of the probe opening. Further details can be found in FIG. 16 and the associated description given below. Furthermore, the user interface may be configured to record and in particular display the particle count as a function of the probe position.

[0104] Furthermore, the particle counting device may comprise at least one temperature sensor. The temperature sensor may be configured to record the temperature in the sterilization tunnel. In particular, the temperature sensor may be configured to record the temperature of the air in the sterilization tunnel. The temperature sensor may be an electric or electronic component that may in particular be configured to provide an electric signal as a measurement of the temperature.

[0105] The temperature sensor can in particular be mounted on the carriage. The particle counting device, in particular the user interface, can be configured to issue an alarm, in particular at the first operator interface and / or the second operator interface, when at least one temperature threshold, in particular a defined temperature threshold, is exceeded. Furthermore, the particle counting device, in particular the user interface, can be configured to interrupt the movement of the linear guide in the conveying direction of the conveyor belt by the carriage when at least one temperature threshold is exceeded.

[0106] In a further aspect of the invention, a sterilization tunnel of a pharmaceutical filling system is proposed. The sterilization tunnel comprises at least one conveyor belt. The conveyor belt is configured to guide at least one container along a conveying direction of the conveyor belt. Furthermore, the sterilization tunnel comprises at least one particulate filter. Furthermore, the sterilization tunnel comprises at least one particle counting device arranged between the particulate filter and the conveyor belt as described above or below. In particular, the particle counting device may be arranged at least partially on the conveyor belt. The probe of the particle counting device has a probe opening, in particular a probe funnel, facing the particulate filter.

[0107] The sterilization tunnel may also include at least one supply air duct. The term "supply air duct" as used herein is a broad term to be given its ordinary and general meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term may refer, but is not limited to, in particular to a device configured to direct a supply air, including a gaseous medium, in particular air, in such a direction that it may be supplied to another device. The supply air duct may be configured to supply the supply air to the sterilization tunnel, in particular to a particulate filter. The supply air duct may in particular supply air surrounding a drug filling system to the sterilization tunnel. The supply air duct may be configured to supply the supply air to another device in a laminar flow.

[0108] The supply air duct may include at least one fan for drawing in ambient air. The term "fan" as used herein is a broad term to be given its ordinary and common meaning as understood by those skilled in the art. The term is not limited to a specific or adapted meaning. The term may refer, but is not limited to, a device configured to transport a gaseous medium, in particular by increasing the pressure in the gaseous medium. The fan may, for example, comprise a propeller rotating axially or radially, which increases the pressure of the gaseous medium by this very rotation. The fan may have a suction side and a pressure side, and the pressure in the gaseous medium on the pressure side may be greater than on the suction side. The gaseous medium may be transported in particular from the suction side to the pressure side of the fan. The gaseous medium transported by the fan may include air, in particular the air surrounding the drug loading system. The fan may be selected from the group consisting of an axial fan, an oblique fan, a radial fan, a centrifugal fan, a tangential fan, and a cross-flow fan.

[0109] The sterilization tunnel may further comprise at least one suction device. The suction device may be configured to suction air below the conveyor belt. The term "suction device" as used herein is a broad term to be given its ordinary and general meaning as understood by a person skilled in the art. The term is not limited to a specific or adapted meaning. The term may in particular, but is not limited to, refer to a device configured to partially remove a gaseous medium, in particular air, from a removal area and to supply it to an output area. Partial removal may in particular include removal of only a partial volume of the gaseous medium in the removal area, the partial volume removed depending on the extraction speed of the suction device. The removal area may be at least partially surrounded by another device or may at least partially coincide with this other device. The suction device may thus transport a gaseous medium, for example air, from this other device, in particular by removing the gaseous medium from the removal area and supplying it to the output area. For example, the removal area of ​​the suction device may at least partially coincide with the sterilization tunnel and the output area may be located outside the sterilization tunnel so that the suction device can transport air from the sterilization tunnel.

[0110] The sterilization tunnel may in particular comprise at least three zones. The first zone may be a warm-up zone. The warm-up zone may also be referred to as an entrance. The second zone may be a sterilization zone. The sterilization zone may also be referred to as a hot section. The third zone may be a cooling zone. The third zone may also be referred to as a cooling zone. The conveyor belt may be configured to move through the sterilization tunnel in particular at a constant speed.

[0111] The warm-up zone may be configured to slowly bring the container up to the temperature of the sterilization zone. In particular, the warm-up zone may be configured to heat, in particular slowly, the glass of the container, in particular to reduce tensions that build up in the glass and avoid possible glass breakage. The sterilization zone may be configured to vaporize water on and in the container. Furthermore, the sterilization zone may be configured to sterilize the container, in particular at a temperature above 300° C., preferably 330° C. The cooling zone may be configured to cool, in particular slowly, the container, in particular to a temperature below 60° C., in particular to reduce tensions that build up in the glass in a controlled manner. The drug system may be configured to transport the container from the cooling zone to a filling system. The filling system may be configured to fill the container with one or more drugs. Furthermore, the filling system may be configured to seal the container after filling. The inspection machine may be configured to inspect the filled drug, in particular for particle contamination. The inspection machine may be configured in particular for visual inspection of the drug. If no contamination is found, the drug is released for packaging.

[0112] The warm-up zone may have at least a first supply air duct, at least a first fan, and a first particulate filter. The first fan and the first particulate filter may be disposed in the supply air duct. The first particulate filter may also be referred to as a pre-filter. The first fan may be configured to draw ambient air, in particular ambient air from a clean room, through the first particulate filter. The first fan may also be configured to supply the drawn-in ambient air to the first particulate filter. The supply air duct may be configured to supply the filtered ambient air as a laminar flow. The filtered air may flow through a conveyor belt area of ​​the sterilization tunnel.

[0113] The suction device may include at least one further fan, which may in particular be arranged below the conveyor belt, which may be configured to suck out air, in particular moist air, below the conveyor belt.

[0114] The sterilization zone can function in a circulation procedure. The sterilization zone can have at least one second fan and at least one second particulate filter. The second fan can be configured to suck air from below the conveyor belt and direct it to the area above the conveyor belt. The sterilization zone can also have at least one heating unit configured to heat the air. The second fan can also be configured to supply heated air, in particular hot air, to the second particulate filter. The hot air can emerge above the conveyor belt area, in particular in a stratified manner.

[0115] The further fan may be configured to suck out air within the sterile zone, particularly air saturated with water vapour, to prevent air saturated with water vapour from accumulating within the sterile zone. The sterile zone may also have at least a third particulate filter. Ambient air may flow in through the third particulate filter, if required.

[0116] The cooling zone can have at least a third fan and at least a fourth particulate filter. The third fan can be configured to draw in ambient air, particularly cold ambient air, particularly cold clean room air, and force it through the fourth particulate filter. The emerging laminar flow can be configured to cool the vessel.

[0117] The sterilization tunnel may also have at least a fourth fan and at least one drain channel. The fourth fan may in particular be a cooling zone fan. The fourth fan may be configured to suck air below the conveyor belt, in particular heated air, in particular air in the cooling zone, and to supply it to an exhaust duct.

[0118] The laminar air flow in the individual zones, especially the warm-up zone, the sterilization zone and the cooling zone, can flow from top to bottom, which ensures that any particles present in the sterilization tunnel are pushed downwards and that they do not enter the container. In the sterilization tunnel, especially the entire sterilization tunnel, there can also be an overpressure, especially a slight overpressure, so that particles cannot enter the sterilization tunnel.

[0119] In a further aspect of the invention, the use of a particle counting device as described above or below is proposed for particle counting within the sterilization tunnel of a pharmaceutical filling system.

[0120] In a further aspect of the invention, a method is proposed for particle counting in a sterilization tunnel of a pharmaceutical filling system using a particle counting device as previously described or as described below. The particle counting method may also be referred to as leak testing.

[0121] There is a fundamental difference between two different operating states of the sterilization tunnel. The first operating state can be described as "at rest". In the case of "at rest", the entire sterilization tunnel can be brought to a cold state while performing the particle counting method. In particular, the fan can be operated to supply air to the sterilization tunnel. However, the heater can be switched off and in particular no containers can be present on the conveyor belt. The second operating state can be described as "operating". In the case of "operating", the class determination of the clean room can be performed in production conditions. The sterilization tunnel can be brought to a hot state. The fan for supplying air to the sterilization tunnel can be operated, the heater can be switched on and also no containers can be present on the conveyor belt.

[0122] The particle counting method is strictly performed in the "quiet" state of the system. Particulate filters, especially HEPA filters, can be acted upon with a nominal volumetric flow rate on the untreated air side. The nominal volumetric flow rate basically means the amount of air that the particulate filter can use in the sterilization tunnel under operating conditions. The air in the intake air duct in front of the particulate filter can be defined as untreated air. The air after flowing through the particulate filter can be defined as clean air.

[0123] When carrying out the particle counting method, the aerosol generator can generate a constant test aerosol with defined characteristics. The particle concentration can be adjusted using an adjustable flowmeter with a needle valve. As a particle material, di-2-ethylhexyl sebacate (DEHS) can be used. This test aerosol can be introduced through a test socket, on the raw air side, before the particulate filter. The particle concentration on the raw air side can be monitored by a particle counter with a dilution stage connected upstream of it. The dilution stage can reduce the aspirated particles with a dilution factor of 1:1000. The particle counter can suck air with particles, measure their size and amount and evaluate them. The sensor of the particle counter can measure and count particles with a size of 0.3 μm to 10 μm. The dilution stage can be necessary so that the particle counter can strictly measure the maximum concentration of particles, which can be exceeded without the dilution stage.

[0124] On the clean air side, the number of particles can be measured using a defined isokinetic probe, the tube of which is connected to another particle counter using a suitable hose. During the measurement, the entire filter surface can be moved stepwise, as explained in more detail below. A further particle counter can suck in the clean air emerging through the probe and evaluate the measured particle number.

[0125] As part of the particle counting method, the defined number of particles on the clean air side per measurement process can depend on the number of particles on the raw air side. The exact ratio between the number of particles on the raw air side and the acceptable number of particles on the clean air side can be accounted for and determined in-house. By checking the functioning of the particulate filter, it can be ensured that a defined increase in the number of particles on the raw air side does not contaminate the clean room area in the sterilization tunnel, in particular not at a specific point. As part of the particle counting method, the scanner can carry out the steps listed below simultaneously with the start of the particle count, in particular while independently scanning the area below the particulate filter.

[0126] The method includes the steps listed below. The method may include further steps not mentioned.

[0127] The particle counting method includes the following steps: a) the movement of the lateral runners by the carriage in the conveying direction of the conveyor belt, especially in stages; and b) Guiding the probe holder transversely, in particular essentially perpendicularly, to the conveying direction by means of linear guides, preferably at a constant speed.

[0128] Steps a) and b) are repeatedly performed one after the other.

[0129] During step a), the carriage may be moved a defined distance in the conveying direction of the conveyor belt. This distance may be called an increment. Before performing step a), the probe holder may be placed at a first end of the linear guide. During step b), the probe holder may be guided from the first end to the second end of the linear guide. This may result in a serpentine track of the probe holder. Furthermore, the probe may comprise a probe opening, in particular a probe funnel, having an outer diameter, and step a) is performed such that the increment of the particle counter in the conveying direction of the conveyor belt by the carriage is smaller than the outer diameter of the probe opening. This means that the area below the particulate filter may be scanned in overlapping paths. Further details may be found in FIG. 16 and the associated description given below. Steps a) and / or b) may in particular be performed manually or automatically. For further details, reference is made to the description above. In particular, the method may comprise particle counting by a particle counter. In particular, particle counting may be performed during step b) or between steps a) and b).

[0130] The method can be, in particular, a computer-implemented method. The term "computer-implemented" used herein is a broad term that should be given its ordinary and common meaning as understood by those skilled in the art. The term is not limited to a specific or adapted meaning. The term can, in particular, but not limited to, refer to a process that is fully or partially implemented using data processing means, in particular using at least one processor. Programmed movement speed and movement path can ensure reproducibility of particle counting even at the rearmost filter surface.

[0131] As mentioned above, the particle counting device may comprise at least one temperature sensor. During the method, the temperature in the sterilization tunnel may be recorded using the at least one temperature sensor, and if the temperature exceeds a predetermined limit value, step a) may be stopped.

[0132] As described above, the linear guide may include at least one drive device. The drive device may include at least one first motor. Furthermore, the particle counter may include at least one second motor configured to drive the carriage.

[0133] The controller may have at least one digital output for releasing the motor drives and at least one digital output for the direction of movement of the first motor and the second motor, respectively. When performing step a) and / or step b), the following sequence of steps may be performed: i. Activation of a digital output for motor drive release; and ii. Generation of a pulse signal.

[0134] In particular, when performing step a), a digital output for a motor drive release of the second motor drive of the second motor may be activated, and in particular, when performing step b), a digital output for a motor drive release of the first motor drive of the first motor may be activated.

[0135] Steps i. and ii. may be performed at different times from each other. In particular, steps i. and ii. may be performed at a time interval of 100 ms or 200 ms. Other time intervals are of course also conceivable.

[0136] In particular, after performing step i., the digital output for the movement direction is activated. In particular, the digital output for the movement direction may be activated in step a) when the carriage moves in the conveying direction, in particular forwards. If the carriage moves relative to the conveying direction, in particular in a backwards movement, the digital output for the movement direction may be deactivated. In particular, the digital output for the movement direction in step b) may be activated when the probe holder is guided from the first end of the guide rail to the second end of the guide rail and the digital output for the movement direction may be deactivated when guiding the probe holder from the second end of the guide rail to the first end of the guide rail, or vice versa.

[0137] As mentioned above, the particle counting device, in particular the controller, can comprise at least one first forward and reverse counter, at least one second forward and reverse counter, and at least one further forward and reverse counter. The first pulses of the first motor can be counted using at least one first forward and reverse counter, and the second pulses of the second motor can be counted using at least one second forward and reverse counter. The position of the probe on the linear guide can be determined by the first pulses of the first motor, and the position of the carriage on the conveyor belt can be determined by the second pulses of the second motor. After performing step a), the further forward and reverse counters of the second motor can be reset to zero. After performing step b), the first forward and reverse counters of the first motor can be reset to zero when the probe is at the first end stop. If the particle count exceeds a predetermined limit, the position of the probe on the conveyor belt may be recorded, and in particular stored, as explained in more detail above.

[0138] In a further aspect of the invention, a computer program is proposed which, when executed on a controller of a particle counting device as described above or below, carries out a method as described above or below.

[0139] In a further aspect of the invention, a computer program product is proposed comprising program code means stored on a machine readable medium for performing the methods described above or below when the program is executed on a controller of a particle counting device as described above or below.

[0140] A computer program product is understood to mean a program as a tradeable product. It can be in essentially any form, for example on paper or a computer-readable data carrier, and can in particular be distributed via a data transmission network. In particular, the program code means can be stored in a computer-readable data carrier and / or a computer-readable storage medium. The terms "computer-readable data carrier" and "computer-readable storage medium" as used herein may in particular refer to a non-transitory data storage, for example a hardware data storage medium on which computer-executable instructions are stored. The computer-readable data carrier or computer-readable storage medium may in particular be or include a storage medium, such as a random access memory (RAM) and / or a read-only memory (ROM).

[0141] Furthermore, within the scope of the present invention, a data carrier is proposed on which a data structure is stored which, after being loaded into the working memory and / or main memory of a computer or computer network, is capable of carrying out the method as described above or below.

[0142] Finally, within the scope of the present invention, a modulated data signal is proposed which includes instructions which can be executed by a computer system or computer network to carry out the methods described above or below.

[0143] With respect to computer-implemented aspects of the present invention, one, some, or even all of the method steps of the method according to one or more of the embodiments proposed herein may be performed using a computer or a computer network. Thus, in general, any of the method steps that include providing and / or manipulating data may be performed using a computer or a computer network. In general, these steps may include any of the method steps except for steps that require manual work, such as providing a sample and / or certain aspects of performing the actual measurement.

[0144] The proposed device and method have many advantages over known devices and methods.

[0145] Particle measurements in the sterilization tunnel generally ensure that the particulate filters used in the sterilization tunnel are functioning properly. Manual guidance of a probe known from the prior art allows an inspector to record the entire filter surface of the particulate filter.

[0146] However, the speed of the probe movement and the path of movement are subject to larger or smaller variations with each test. The current manual guidance of the probe by the inspector can lead to errors, which means that possible leaks are not recorded. When measuring an increased particle concentration at a specific point, the inspector also has difficulty finding the exact position where the deviation was first measured. This can entail increased time consumption.

[0147] The proposed device and method can be used to achieve partially automated particle measurements. In particular, the scanner can be used to semi-automatically guide the probe to scan filter surfaces of different sizes, in particular as part of particle measurements of particulate filters in various sterilization tunnels. The particle counting device can be flexibly used in sterilization tunnels of different dimensions.

[0148] Partial automation of leak testing of particulate filters can save time and costs. Partial automation of the process basically ensures that the probe for particle measurement can move at least approximately consistently over the filter surface, in particular the entire filter surface, at a constant speed in an optimal path. On the one hand, this can result in a high-quality filling agent. Furthermore, emissions can be substantially reduced, since any leaks in the particulate filter can be found and localized. On the other hand, the burden on the inspector can be reduced, since he no longer has to use long and cumbersome rods, in particular pipelines.

[0149] Process automation can further result in improvements in the measurement process since it can be carried out in less time and under reproducible conditions, which can also increase the availability of the drug filling system.

[0150] The probe can be guided over the filter surface of the particulate filter to be measured in a defined path and at a defined speed without slipping. The trajectories of the specified paths can overlap by a certain value, but do not exceed this value. The semi-automatic guidance of the probe can still be flexibly adapted to the different types of sterilization tunnels operated in-house. This allows the probe to be guided over the entire area. The movement path can be optimally adjusted to be able to reproducibly cover the entire filter surface of the particulate filter in the sterilization tunnel, while minimizing the test time and thus increasing the availability of the system.

[0151] The particle counting device is easy to handle and can be flexibly adapted to the different dimensions of the different sterilization tunnel types. The size and weight of the particle counting device can be kept as low as possible. The total height of the particle counting device can be less than the minimum passage height in the sterilization tunnel, but as low as is structurally feasible. The probe can represent the highest point of the particle counting device. The components can be selected such that programming and visualization of the movement path is possible. Furthermore, operator safety can be respected in order to avoid injuries by proper use.

[0152] In order to make the handling of the particle counting device easier for the inspector, the total weight of the particle counting device can be as low as possible. To reduce the weight, lightweight materials such as aluminum or plastics, e.g. polytetrafluoroethylene (PTFE) or polyoxymethylene (POM), can be preferably used. Stainless steel, austenitic steels can also be used, which are only used to a limited extent due to their higher weight. Since the particle counting device can be used in a production plant in the pharmaceutical sector, the materials used can be cleaned by a surface disinfectant, which can for example include isopropanol. The requirements set out in Regulation (EC) No. 1935 / 2004 can be met. The particle counting method can be carried out at room temperature. The heat resistance of the materials is therefore essentially of less importance. Standard components can be used, at least to a large extent, in order to make it possible to quickly and easily procure and replace the necessary parts if necessary. This also makes it possible to minimize production costs.

[0153] The conveyor belt of the sterilization tunnel may be made of wire mesh made from stainless steel. The wire mesh may provide the necessary breathability, flexibility, and heat resistance for the conveyor belt to function reliably under typical conditions such as high temperatures. However, due to the coarse mesh structure of the conveyor belt, the resulting contact area between the scanner and the wire mesh may be very small. Therefore, a small amount of friction may occur here. Friction may be increased by attaching O-rings to the wheels, especially the drive and / or rear wheels.

[0154] Furthermore, the scanner can be moved in a slip-free manner, so that there is no or only little deviation in the path of movement between the two measurements. Furthermore, abrasive wear of the scanner components and between the sterilization tunnel and the scanner is avoided or at least reduced. This can prevent particles from being introduced into the sterilization tunnel. Components that do not require lubrication with oils or fats can also be used. In this way, contamination in the sterilization tunnel can be strictly avoided.

[0155] The scanner may have at least two modules: a lateral runner and a trolley. The particle counting device may have a maximum height of 160 mm and a maximum width of 600 mm. In particular, the particle counting device may have a height of 116 mm. This facilitates handling when the inspector inserts and places the particle counting device in the sterilization tunnel before the measurement process.

[0156] The lateral runners can be interchangeable. This allows for a flexible adaptation and use of the particle counting device to different tunnel widths of the sterilization tunnel. The lateral runners can be attached to the trolley without tools. The length of the lateral runners can be smaller than the conveyor belt width. The distance between the probe and the lateral borders of the conveyor belt can be as small as possible. A movement speed of the probe of 5.9 cm / s when guided transversely to the conveying direction of the conveyor belt can be achieved. A slip-free movement can be achieved. The particle counting device can have a very high repeatability.

[0157] A total weight of the particle counting device of 5090g can be achieved. This makes it possible to realize a compact particle counting device that is easy for the inspector to handle. The lateral runners can be easily exchanged by the inspector without additional tools, and thus the particle counting device can be adapted to the respective tunnel width of the different sterilization tunnel types.

[0158] With the aid of a particle counting device, particle counting methods can be performed precisely at a given speed at a given time on a given path. Virtually perfect reproducibility of the measurements is also possible.

[0159] Furthermore, by programming and visualization of the particle counting device, particularly the scanner, the position of the probe on the conveyor belt can be determined and monitored essentially at any time.

[0160] In summary, without limiting further possible configurations, the following embodiments are proposed: Embodiment 1: A particle counting device for counting particles in a sterilization tunnel of a pharmaceutical filling system, the sterilization tunnel comprising at least one conveyor belt, the particle counting device comprising: at least one probe for receiving particles within the sterilization tunnel, the probe being connectable to a particle counter; at least one scanner having at least one probe holder for mounting a probe; The scanner includes: at least one transverse runner having at least one linear guide, which is configured to guide the probe holder transversely, in particular essentially perpendicularly, to a conveying direction of the conveyor belt of the sterilization tunnel; at least one carriage, the lateral runners being attached to the carriage, the carriage being configured to move the linear guide in a conveying direction of the conveyor belt; at least one controller, in particular a controller connected to the carriage, configured to control the movement of the scanner; A particle counting device comprising:

[0161] Embodiment 2: A particle counting device as described in the preceding embodiment, wherein the controller comprises a programmable logic controller.

[0162] Embodiment 3: A particle counting device according to any one of the preceding embodiments, wherein the probe holder is mounted on a linear guide.

[0163] Embodiment 4: A particle counting device according to any of the preceding embodiments, wherein the particle counting device further comprises at least one particle counter that can be connected to the probe.

[0164] Embodiment 5: A particle counting device according to the preceding embodiment, wherein the particle counter is designed as a stationary particle counter and the particle counter and the probe are connected to each other by at least one pipeline, in particular a flexible pipeline.

[0165] Embodiment 6: A particle counting device according to any one of the preceding embodiments, further comprising at least one stationary user interface, the user interface being connected to the scanner, and the movement of the scanner being controllable by the user interface.

[0166] Embodiment 7: A particle counting device according to the preceding embodiment, wherein the user interface comprises a graphical user interface, in particular a graphical user interface having at least one touch screen.

[0167] Embodiment 8: A particle counting device according to one of the previous two embodiments, wherein at least one movement path and / or measurement position for particle counting is predeterminable by a user interface.

[0168] Embodiment 9: A particle counting device as described in the preceding embodiment, wherein the movement path comprises a serpentine pattern with alternating movement of the probe transversely and parallel to the conveying direction.

[0169] Embodiment 10: A particle counting device according to one of the previous two embodiments, wherein at least one of the movement path and / or the measurement position is predeterminable in manual or automatic operation.

[0170] Embodiment 11: Furthermore, the particle counting device according to the preceding embodiment, wherein at least one speed can be predetermined for at least one movement path, particularly in manual operation.

[0171] Embodiment 12: A particle counting device described in one of the preceding six embodiments, wherein the user interface is further configured to specifically move the probe to at least one predeterminable probe position and perform particle counting thereat.

[0172] Embodiment 13: A particle counting device described in one of the preceding seven embodiments, wherein the user interface is configured to record and particularly display the particle count depending on the probe position, and in particular, the user interface is further connected to the particle counter.

[0173] Embodiment 14: A particle counting device described in one of the preceding eight embodiments, wherein the user interface is configured to move the linear guide stepwise in the conveying direction of the conveyor belt by a carriage, and the user interface is further configured to move the probe holder transversely, in particular essentially perpendicularly, to the conveying direction by a lateral runner.

[0174] Embodiment 15: A particle counting device as described in the preceding embodiment, wherein the probe comprises a probe opening, in particular a probe funnel, and the user interface is configured to perform a stepwise movement of the linear guide in the conveying direction of the conveyor belt by the carriage, such that the increment of the particle counting device in the conveying direction of the conveyor belt by the carriage is smaller than the outer diameter of the probe opening.

[0175] Embodiment 16: A particle counting device according to any one of the preceding embodiments, wherein the particle counting device has at least one y position sensor for determining the position of the probe in a conveying dimension on the conveyor belt.

[0176] Embodiment 17: A particle counting device according to the preceding embodiment, wherein the y-position sensor is connected to the carriage, in particular to the drive of the carriage.

[0177] Embodiment 18: A particle counting device as described in the preceding embodiment, wherein the carriage has a stepper motor and the y position sensor comprises an incremental encoder of the stepper motor.

[0178] Embodiment 19: A particle counting device as described in any of the preceding embodiments, wherein the particle counting device has at least one x-position sensor for determining the position of the probe in a dimension transverse to the conveying direction on the conveyor belt, in particular in a dimension essentially perpendicular to the conveying direction.

[0179] Embodiment 20: A particle counting device according to the preceding embodiment, wherein the x-position sensor is connected to the linear guide, in particular to a drive device of the linear guide.

[0180] Embodiment 21: A particle counting device as described in the preceding embodiment, wherein the linear guide has a stepper motor and the x-position sensor comprises an incremental encoder of the stepper motor.

[0181] Embodiment 22: A particle counting device according to one of the preceding embodiments, wherein the lateral runner comprises at least two limit switches, in particular at least two roller limit switches, for determining the limit positions of the probe transverse to the conveying direction of the conveyor belt.

[0182] Embodiment 23: A particle counting device described in one of the preceding embodiments, wherein the carriage has at least one limit switch, in particular at least one spring rod limit switch, for determining at least one position of at least one limit of the particle counting device in the conveying direction.

[0183] Embodiment 24: A particle counting device according to any one of the preceding embodiments, wherein the particle counting device further comprises at least one temperature sensor, the temperature sensor being configured to record the temperature within the sterilization tunnel.

[0184] Embodiment 25: A particle counting device as described in the preceding embodiment, wherein the particle counting device is configured to issue an alarm when at least one temperature threshold is exceeded.

[0185] Embodiment 26: A particle counting device as described in the preceding embodiment, wherein the particle counting device is configured to interrupt the movement of the linear guide in the conveying direction of the conveyor belt by the carriage when at least one temperature threshold is exceeded.

[0186] Embodiment 27: A particle counting device described in any one of the preceding embodiments, wherein the linear guide is attached to a base plate, and the linear guide is attached to the carriage by the base plate.

[0187] Embodiment 28: A particle counting device as described in the preceding embodiment, wherein the base plate is made of aluminum.

[0188] Embodiment 29: A particle counting device as described in the preceding embodiment, wherein the base plate is attached to the carriage by at least one connection selected from the group consisting of at least one screw connection, at least one click connection, and at least one tension lever connection.

[0189] Embodiment 30: A particle counting device according to any one of the preceding embodiments, wherein the linear guide has a sliding bearing.

[0190] Embodiment 31: A particle counting device according to one of the preceding embodiments, wherein the linear guide has a guide rail, in particular a T-shaped guide rail, and a guide carriage attached to the guide rail, and the probe can be attached to the guide carriage.

[0191] Embodiment 32: A particle counting device according to the preceding embodiment, wherein the guide rail is configured as a floating bearing, in particular a floating bearing transverse to the conveying direction of the conveyor belt.

[0192] Embodiment 33: A particle counting device described in any one of the preceding embodiments, wherein the linear guide has at least one drive selected from the group consisting of a spindle drive, a toothed belt drive, and a rack-and-pinion drive, the linear guide has at least one rack-and-pinion drive, and the rack-and-pinion drive has at least one rack and at least one spur gear.

[0193] Embodiment 34: A particle counting device as described in the preceding embodiment, wherein the rack has a circular cross-section.

[0194] Embodiment 35: A particle counting device according to one of the previous two embodiments, wherein the rack is made of austenitic stainless steel.

[0195] Embodiment 36: A particle counting device described in one of the preceding three embodiments, wherein the rack is centrally positioned above the linear guide.

[0196] Embodiment 37: A particle counting device according to one of the preceding four embodiments, wherein the spur gear is made of polyoxymethylene (POM).

[0197] Embodiment 38: A particle counting device described in one of the preceding five embodiments, wherein the drive device comprises at least a first motor selected from the group consisting of a servo motor and a stepping motor.

[0198] Embodiment 39: A particle counting device as described in the preceding embodiment, wherein the drive comprises a rack and pinion drive comprising a rack and a spur gear, the spur gear being clamped to the shaft of the first motor, and the first motor being attached to the guide carriage using a mounting bracket.

[0199] Embodiment 40: A particle counting device described in one of the preceding nine embodiments, wherein the probe holder is attached to the guide carriage.

[0200] Embodiment 41: A particle counting device according to one of the preceding embodiments, wherein the probe holder is made of polyoxymethylene (POM).

[0201] Embodiment 42: A particle counting device described in one of the preceding embodiments, wherein the probe holder has at least one groove for receiving a probe, and the probe holder further has at least one clamp plate, the clamp plate being configured to fix the probe.

[0202] Embodiment 43: A particle counting device according to any one of the preceding embodiments, wherein the lateral runner is mounted in the center of the carriage.

[0203] Embodiment 44: A particle counting device according to any one of the preceding embodiments, wherein the carriage is made from at least one austenitic stainless steel.

[0204] Embodiment 45: A particle counting device described in any one of the preceding embodiments, wherein the cart has at least two drive wheels.

[0205] Embodiment 46: A particle counting device as described in the preceding embodiment, wherein the drive wheel is made of polyoxymethylene (POM).

[0206] Embodiment 47: A particle counting device described in one of the previous two embodiments, wherein the drive wheels each have several O-rings arranged spaced apart from each other on at least one circumferential surface of the drive wheel.

[0207] Embodiment 48: A particle counting device as described in the preceding embodiment, wherein the O-rings are each received in a groove in the circumferential surface of the drive wheel.

[0208] Embodiment 49: A particle counting device described in one of the preceding four embodiments, wherein the drive wheels are each mounted on an axle.

[0209] Embodiment 50: A particle counting device described in one of the preceding five embodiments, wherein the particle counting device comprises at least a second motor selected from the group consisting of a stepping motor and a servo motor, and the second motor is configured to drive at least one of the drive wheels.

[0210] Embodiment 51: A sterilization tunnel of a drug filling system, comprising: at least one conveyor belt, the conveyor belt configured to guide the at least one container along a conveying direction of the conveyor belt; at least one particulate filter; At least one particle counting device according to any one of the preceding embodiments, disposed between the particle filter and the conveyor belt; wherein the probe of the particle counter has a probe opening, in particular a probe funnel, facing the particulate filter.

[0211] Embodiment 52: A sterilization tunnel according to the preceding embodiment, wherein the sterilization tunnel further comprises at least one intake air duct, the intake air duct comprising at least one fan for drawing in ambient air.

[0212] Embodiment 53: A sterilization tunnel according to one of the previous two embodiments, wherein the sterilization tunnel further comprises at least one suction device, the suction device being configured to suck out air from beneath the conveyor belt.

[0213] Embodiment 54: Use of a particle counting device according to any one of the preceding embodiments for particle counting in a sterilization tunnel of a pharmaceutical filling system.

[0214] Embodiment 55: A method for counting particles in a sterilization tunnel of a drug filling system using a particle counting device according to any one of the preceding embodiments, comprising the following steps: a) a step of movement of the linear guide in the conveying direction of the conveyor belt by the carriage, in particular a stepwise movement step; b) guiding the probe holder transversely, in particular essentially perpendicularly, to the conveying direction by means of linear guides; Including, A method, wherein steps a) and b) are alternately and repeatedly performed.

[0215] Embodiment 56: A method according to the preceding embodiment, wherein before performing step a), the probe holder is positioned at a first end of the linear guide, and in step b), the probe holder is guided from the first end to the second end of the linear guide.

[0216] Embodiment 57: A method according to one of the preceding two embodiments, wherein the temperature in the sterilization tunnel is further recorded during the execution of the method by at least one temperature sensor, and step a) is aborted if the temperature exceeds a predetermined limit value.

[0217] Embodiment 58: A method according to one of the preceding three embodiments, wherein step a) and / or step b) are performed manually.

[0218] Embodiment 59: The method according to one of the preceding four embodiments, wherein step a) and / or step b) are performed automatically.

[0219] Embodiment 60: The linear guide has at least one drive, the drive has at least one first motor, the particle counting device further has at least one second motor, the second motor is configured to drive the carriage, and the controllers for the first motor and the second motor respectively have at least one digital output for a direction of movement and at least one digital output for a motor drive release, and when step a) and / or step b) are performed, the following sequence of steps is performed, namely: i. Activation of a digital output for motor drive release; and ii. Pulse signal generation The method of any one of the preceding five embodiments, wherein:

[0220] Embodiment 61: The method described in the preceding embodiment, wherein step i. and step ii. are performed at different times from each other.

[0221] Embodiment 62: The method according to one of the preceding two embodiments, wherein after performing step i., a digital output for the movement direction is activated.

[0222] Embodiment 63: A method according to one of the preceding four embodiments, wherein a first pulse of a first motor is counted by at least a first forward and reverse counter, a second pulse of a second motor is counted by at least a second forward and reverse counter, a position of a probe on a linear guide is determined by the first pulse of the first motor, and a position of a carriage on a conveyor belt is determined by the second pulse of the second motor.

[0223] Embodiment 64: The method according to the preceding embodiment, wherein the linear guide has a first end stop and a second end stop, and after performing step b), the first forward and reverse counters of the first motor are reset to zero when the probe is at the first end stop.

[0224] Embodiment 65: A method according to one of the preceding ten embodiments, wherein if the particle count exceeds a predetermined limit, the position of the probe on the conveyor belt is recorded.

[0225] Embodiment 66: A method according to one of the preceding eleven embodiments, wherein the probe comprises a probe opening, in particular a probe funnel, having an outer diameter, and step a) is performed such that the increment of the particle counting device in the conveying direction of the conveyor belt by the cart is smaller than the outer diameter of the probe opening.

[0226] Embodiment 67: A computer program, which, when executed on a controller of a particle counting device as described in one of the preceding embodiments relating to a particle counting device, performs a method as described in one of the preceding embodiments relating to a method.

[0227] Embodiment 68: A computer program product having program code means stored on a machine-readable carrier for performing a method relating to a method according to one of the preceding embodiments relating to a particle counting device, when the program is executed on a controller of a particle counting device according to one of the preceding embodiments relating to a particle counting device. [Brief description of the drawings]

[0228] Further details and features emerge from the following description of exemplary embodiments, in particular in conjunction with the dependent claims. The respective features can be implemented individually or in combination with one another. The invention is not limited to the exemplary embodiments. The exemplary embodiments are illustrated diagrammatically in the drawings. The same reference signs in the individual figures denote the same or functionally identical elements or elements that correspond in terms of their function.

[0229] In detail, the figure shows:

[0230] [Figure 1] FIG. 1 illustrates a side view of an embodiment of a sterilization tunnel of a drug filling system. [Diagram 2] 1 shows a schematic configuration of a leak test in a sterilization tunnel. [Diagram 3] 1A-1D show different views of an embodiment of a particle counting device or a part thereof; [Figure 4] 1A-1D show different views of an embodiment of a particle counting device or a part thereof; [Diagram 5] 1A-1D show different views of an embodiment of a particle counting device or a part thereof; [Figure 6] 1A-1D show different views of an embodiment of a particle counting device or a part thereof; [Figure 7] 1A-1D show different views of an embodiment of a particle counting device or a part thereof; [Figure 8] 1A-1D show different views of an embodiment of a particle counting device or a part thereof; [Figure 9] 1A-1D show different views of an embodiment of a particle counting device or a part thereof; [Figure 10] 1A-1D show different views of an embodiment of a particle counting device or a part thereof; [Figure 11] 1A-1D show different views of an embodiment of a particle counting device or a part thereof; [Figure 12] 1A-1D show different views of an embodiment of a particle counting device or a part thereof; [Figure 13]1A-1D show different views of an embodiment of a particle counting device or a part thereof; [Figure 14] 1A-1D show different views of an embodiment of a particle counting device or a part thereof; [Figure 15] FIG. 1 shows a schematic plan view of a particle counting device within a sterilization tunnel. [Figure 16] 1 shows the geometric dimensions of a particle counting device within a sterilization tunnel. [Figure 17A] 2 illustrates an exemplary sequence of steps for a particle counting method according to the present invention. [Figure 17B] 4 shows an exemplary time diagram of a control signal. [Figure 17C] 2 illustrates an exemplary sequence of steps for a particle counting method according to the present invention. [Figure 18A] 1 shows a user interface operator interface. [Figure 18B] 1 shows a user interface operator interface. [Figure 18C] 1 shows a pulse representation. [Figure 18D] 1 shows a user interface operator interface. [Figure 18E] 1 shows a user interface operator interface. [Figure 18F] 1 shows a user interface operator interface. [Figure 19] 1 illustrates an exemplary embodiment of the programming of a controller. [Figure 20] 1 illustrates an exemplary embodiment of the programming of a controller. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0231] Description of exemplary embodiments Figure 1 shows a side view of an embodiment of a sterilization tunnel 110 of a pharmaceutical filling system 112. The sterilization tunnel 110 includes at least one conveyor belt 114. The conveyor belt 114 is configured to guide at least one container (not shown in Figure 1) along a conveying direction 116 of the conveyor belt 114. The conveying direction 116 of the conveyor belt 114 is indicated by an arrow 116 in Figure 1.

[0232] Furthermore, the sterilization tunnel 110 includes at least one particulate filter 118 and at least one particle counter 120 arranged between the particulate filter 118 and the conveyor belt 114, as will be explained in more detail below. In Fig. 1, the particle counter 120 is only shown diagrammatically. For a detailed description of the particle counter 120, please refer to the description of Figs. 3 to 14. As shown in Fig. 1, the particle counter 120 may in particular be arranged at least partially on the conveyor belt 114. The probe 122 of the particle counter 120 has a probe opening 124, in particular a probe funnel 126, facing the particulate filter 118.

[0233] The sterilization tunnel 110 may also include at least one supply air duct 128. The supply air duct 128 may include at least one fan 130 for drawing in ambient air. The sterilization tunnel 110 may further include at least one suction device 132. The suction device 132 may be configured to draw in air below the conveyor belt 114.

[0234] As shown in FIG. 1, the sterilization tunnel 110 may specifically comprise at least three zones. The first zone may be a warm-up zone 134. The warm-up zone 134 may also be referred to as an entrance. The second zone may be a sterilization zone 136. The sterilization zone 136 may also be referred to as a hot section. The third zone may be a cooling zone 138. The third zone may also be referred to as a cooling zone 138. The conveyor belt 114 may be configured to move through the sterilization tunnel 110, specifically through one or more zones of the sterilization tunnel 110, specifically at a constant speed.

[0235] The warm-up zone 134 may be configured to slowly bring the container up to the temperature of the sterilization zone 136. In particular, the warm-up zone 134 may be configured to heat, in particular slowly, the glass of the container, in particular to reduce tensions that build up in the glass and avoid possible glass breakage. The sterilization zone 136 may be configured to vaporize water on and in the container. Furthermore, the sterilization zone 136 may be configured to sterilize the container, in particular at a temperature above 300° C., preferably 330° C. The cooling zone 138 may be configured to cool, in particular slowly, the container, in particular to a temperature below 60° C., in particular to reduce tensions that build up in the glass in a controlled manner. The drug filling system 112 may be configured to transport the container from the cooling zone 138 to a filling system, not shown in FIG. 1.

[0236] The warm-up zone 134 may have at least a first supply air duct 140, at least a first fan 142, and a first particulate filter 144. The first fan 142 and the first particulate filter 144 may be disposed in the supply air ducts 128, 140. The first particulate filter 144 may also be referred to as a pre-filter. The first fan 142 may be configured to draw in ambient air, in particular ambient air from a clean room, through the first particulate filter 144. The first fan 142 may also be configured to supply the drawn in ambient air to the first particulate filter 144. The supply air ducts 128, 140 may be configured to supply the filtered ambient air as a laminar flow. The filtered air may flow through a conveyor belt area of ​​the sterilization tunnel 110.

[0237] The suction device 132 may include at least one further fan 146. The further fan 146 may in particular be arranged below the conveyor belt 114. The further fan 146 may be configured to suck out air, in particular moist air, below the conveyor belt 114.

[0238] The sterilization zone 136 can function in a circulation procedure. The sterilization zone 136 can have at least one second fan 148 and at least one second particulate filter 150. The second fan 148 can be configured to suck air from below the conveyor belt 114 and direct it to the area above the conveyor belt 114. The sterilization zone 136 can also have at least one heating unit (not shown in FIG. 1 ) configured to heat the air. The second fan 148 can also be configured to supply heated air, in particular hot air, to the second particulate filter 150. The hot air can emerge above the conveyor belt area, in particular in a laminar flow.

[0239] A further fan 146 may be configured to suck out air within the sterile zone 136, particularly air saturated with water vapour, to prevent air saturated with water vapour from accumulating within the sterile zone 136. The sterile zone 136 may also have at least a third particulate filter, which is not shown in Figure 1. Ambient air may flow through the third particulate filter, if required.

[0240] The cooling zone 138 can have at least a third fan 152 and at least a fourth particulate filter 154. The third fan 152 can be configured to draw in ambient air, particularly cold ambient air, particularly cold clean room air, and push it through the fourth particulate filter 154. The emerging laminar flow can be configured to cool the vessel.

[0241] The sterilization tunnel 110 may further comprise at least a fourth fan 156 and at least one drain channel 158. The fourth fan 156 may in particular be a fan of the cooling zone 138. The fourth fan 156 may be configured to suck out air below the conveyor belt 114, in particular heated air, in particular the air of the cooling zone 138, and supply it to the exhaust duct 158.

[0242] The laminar air flow in the individual zones, particularly the warm-up zone 134, the sterilization zone 136 and the cooling zone 138, can flow from top to bottom, which ensures that any particles present in the sterilization tunnel 110 are pushed downwards and do not enter the container. There can also be an overpressure, particularly a slight overpressure, in the sterilization tunnel 110, particularly throughout the sterilization tunnel 110, such that particles cannot enter the sterilization tunnel 110.

[0243] FIG. 2 shows a schematic structure of a leak test in the sterilization tunnel 110. The setup can be performed in particular in a method for particle counting in the sterilization tunnel 110, as described in more detail below, for example in FIGS. 17A to 17C. The leak test can be performed in a first and / or second operating state of the sterilization tunnel 110. The first operating state can be described in particular as "stationary". When "stationary", the entire sterilization tunnel 110 can be brought to a low temperature state while performing the particle counting method. In particular, the fan 130 can be operated to supply air to the sterilization tunnel 110. However, the heater can be turned off and in particular no containers can be present on the conveyor belt 114. The second operating state can be described as "operating". When "operating", a class determination of the clean room can be performed in production conditions. The sterilization tunnel 110 can be brought to a high temperature state. The fan 130 for supplying air to the sterilization tunnel 110 can be operated, the heater can be turned on and no containers can be present on the conveyor belt 114.

[0244] The particle counting method is strictly performed in the "quiescent" state of the system. The particulate filter 118, especially the HEPA filter, may be operated at a nominal volumetric flow rate on the raw air side 160. The nominal volumetric flow rate basically means the amount of air that the particulate filter 118 can use in the sterilization tunnel 110 under operating conditions. The air in the air supply duct 128 in front of the particulate filter 118 may be defined as raw air. The air after flowing through the particulate filter 118 may be defined as clean air.

[0245] When carrying out the particle counting method, the aerosol generator 162 can generate a certain test aerosol with defined characteristics. The particle concentration can be adjusted using an adjustable flowmeter with a needle valve. As a particle material, di-2-ethylhexyl sebacate (DEHS) can be used. This test aerosol can be introduced through a test socket 164 on the raw air side 160, before the particulate filter 118. The particle concentration on the raw air side 160 can be monitored by a particle counter 166 having a dilution stage 168 connected upstream of it. The dilution stage 168 can reduce the aspirated particles with a dilution factor of 1:1000. The particle counter 166 can suck air with particles, measure their size and amount and evaluate them. The sensor of the particle counter 166 can measure and count particles with a size of 0.3 μm to 10 μm. The dilution stage 168 may be necessary because the particle counter 166 can measure exactly the maximum concentration of particles, which may be exceeded without the dilution stage.

[0246] On the clean air side 170, the number of particles can be measured using a defined isokinetic probe 172, which can be, for example, the probe 122 of the particle counter 120, the tube of which is connected by means of a suitable hose to a further particle counter 174. During the measurement, the entire filter surface can be moved stepwise, as will be explained in more detail below. The further particle counter 174 can suck in the clean air emerging through the probe and evaluate the measured particle number.

[0247] As part of the particle counting method, the defined number of particles on the clean air side per measurement process can depend on the number of particles on the raw air side 160. The exact ratio between the number of particles on the raw air side 160 and the acceptable number of particles on the clean air side 170 can be accounted for and determined in-house. By checking the functioning of the particulate filter 118, it can be ensured that a defined increase in the number of particles on the raw air side 160 does not contaminate the clean room area in the sterilization tunnel 110, especially not at a specific point.

[0248] 3 to 14 show different views of an embodiment of a particle counting device 120 or a part thereof. FIG. 3 shows a perspective view of the particle counting device 120. The particle counting device 120 for counting particles in a sterilization tunnel 110 of a drug filling system 112, as illustrated in FIG. 1, comprises at least one conveyor belt 114 and at least one probe 122 for receiving particles in the sterilization tunnel 110, which may be connected to a particle counter 174. Furthermore, the particle counting device 120 comprises at least one scanner 176 having at least one probe holder 178 for mounting the probe 122. The scanner 176 includes at least one transverse runner 180 having at least one linear guide 182. The linear guide 182 is configured to guide the probe holder 178 transversely, in particular essentially perpendicularly, to the conveying direction 116 of the conveyor belt 114 of the sterilization tunnel 110. Furthermore, the scanner 176 includes at least one carriage 184. The lateral runners 180 are attached to the carriage 184. The carriage 184 is configured to move the linear guide 182 in the conveying direction 116 of the conveyor belt 114. Furthermore, the scanner 176 includes at least one controller 186, in particular the controller 186 connected to the carriage 184, the controller 186 being configured to control the movement of the scanner 176.

[0249] The carriage 184 may be configured to move itself and the lateral runner 180, in particular the lateral runner 180 with the probe 122, in two-dimensional space. The particle counting device 120 may in particular comprise a drive for guiding the probe holder 178 in each case transversely (indicated by reference sign 188), in particular essentially perpendicularly, to the conveying direction 116 of the conveyor belt 114 of the sterilization tunnel 110, and for moving the carriage 184 along the conveying direction 116 of the conveyor belt 114 (indicated by reference sign 190). Both drives 188, 190 may be moved by means of motors, for example a first motor 191 and a second motor 192, respectively, as will be explained in more detail below. In particular, the particle counting device 120 may be designed such that the movement of the carriage 184 is independent of any guidance of the probe holder 178.

[0250] FIG. 4 shows a perspective detail view of the lateral runner 180. As can be seen in FIG. 4, the linear guide 182 of the lateral runner 180 can comprise at least one guide rail 194, in particular a contoured guide rail 196, in particular a T-shaped guide rail 198. Alternatively and / or additionally, the linear guide 182 can also comprise a round shaft. Furthermore, the linear guide 182 can comprise at least one guide carriage 200, in particular at least one guide carriage 200 mounted on the guide rail 194 or on the round shaft. The probe 122 can be mountable or can be mounted on the guide carriage 200, in particular by means of a probe holder 178. The linear guide 182 can thus be configured to guide the probe 122. The linear guide 182, in particular the guide rail 194, can be mounted on a base plate 202, in particular a base plate 202 made of aluminum, in particular by means of a screw connection. The base plate 202 can be designed to be exchangeable. If the guide rails 194 show wear, they may be replaced whenever necessary. The linear guide 182 may be attached to the carriage 184 using a base plate 202.

[0251] The linear guide 182 may have at least one sliding bearing, in particular for the guide carriage 200. The sliding bearing may be designed without lubricant. However, other bearings, such as ball or roller bearings, are naturally also conceivable. The T-shaped guide rail 198 makes it entirely possible for the guide carriage 200 with floating bearings 204 to be designed in a direction transverse to, in particular perpendicular to, and / or to the conveying direction 116 of the conveyor belt 114. Possible embodiments of the floating bearings 204 are shown in FIG. 5. The floating bearings 206, the floating bearings 208 in the z direction, the floating bearings 210 in the y direction and the floating bearings 212 in the yz direction are not shown.

[0252] In this exemplary embodiment, the linear guide 182 is equipped with a floating bearing 210 in the y-direction. However, other floating bearings 204 as shown are also possible. The floating bearing 204 allows the guide carriage 200 to have some play in the selected direction. This makes it possible to compensate for manufacturing tolerances in the design. Without the floating bearing 204, the system could be rigid, which means, for example, that the guide carriage 200 could tilt. In particular, the guide rail 194 can be configured as a floating bearing 204, in particular a floating bearing 204, in a direction transverse to, in particular perpendicular to, the conveying direction 116 of the conveyor belt 114 (indicated by reference number 210). This makes it possible for the guide carriage 200 to compensate for small differences in height, in particular in the entire system. The length of the guide carriage 200 can correspond to the flange width of the motor 192.

[0253] FIG. 6 shows a further perspective detail of the lateral runner 180. As mentioned above, the particle counter 120 may include a drive 188 for guiding the probe holder 178. For example, the linear guide 182 may have at least one drive 188, in particular a linear drive. The drive 188 may be configured to move the guide carriage 200 on the guide rail 194. The drive 188 may be configured to scan the entire conveyor belt width of the conveyor belt 114 of the sterilization tunnel 110. As can be seen in FIG. 6, the drive 188 may include a rack and pinion drive 214. However, other embodiments, such as spindle drives and / or toothed belt drives, are naturally also conceivable. The drive 188 may in particular comprise a stepper motor 215.

[0254] The rack and pinion drive 214 may have at least one rack 216 and at least one spur gear 218. The lateral runner 180 may also have at least one, preferably at least two, rack mounts 220. The rack mounts 220 may be configured to fix the rack 216, in particular on the base plate 202 of the lateral runner 180. The rack mounts 220 may be made, in particular, from aluminum. The rack and pinion drive 214 may be configured to move the guide carriage 200, in particular on the rack 216, which may be fixed, in particular on the base plate 202 of the lateral runner 180, by the rotational movement of the spur gear 218. The spur gear 218 may be made, in particular, from polyoxymethylene (POM). A mounting bracket 222, in particular made of aluminum, may be attached, in particular screwed, to a threaded hole of the guide carriage 200. The stepper motor 215 may also be attached, in particular screwed, to the mounting bracket 222.

[0255] Another perspective detail view of the lateral runner 180 is shown in Figure 7. As can be seen in Figure 7, the base plate 202 can be attached to the carriage 184 by at least one screw connection 224. However, other types of connections are possible, such as click connections and / or tension lever connections.

[0256] The screw connection 224 may in particular comprise a knurled thread and / or a cylinder head thread. In particular, the base plate 202 may comprise a number of bore holes 226, in particular for attaching the lateral runners 180 to the carriage 184. Due to the large number of lateral runners 180 that need to be changed every year, about six times a year, it may be advantageous to attach the lateral runners 180 to the carriage 184 by means of knurled screws. This allows a compact construction to be formed. This means that tool-free changes are certainly possible and that the lateral runners 180 may be connected to the carriage 184 in a rigid but releasable manner. As shown in FIG. 7, the base plate 202 may be adjusted by cutting out material that is not needed, in particular to save weight. Naturally, other embodiments for attaching the lateral runners 180 to the carriage 184 are also conceivable, such as a click system or a tension lever.

[0257] 8, the lateral runner 180 is shown in a side cross-sectional view. As can be seen in this view, the probe holder 178 can have at least one groove 228 for receiving the probe 122. Furthermore, the probe holder 178 can have at least one clamp plate 230 configured to secure the probe 122. Alternatively and / or additionally, the probe holder 178 can be attached to the guide carriage 200.

[0258] 8, it can be seen that the rack 216 can in particular have a circular cross section. The rack 216 can be centrally located above the linear guide 182.

[0259] 8, the particle counting device 120 may further comprise at least one particle counter 174, which may be connected to the probe 122. In particular, the particle counter 174 may be designed as a stationary particle counter, and the particle counter 174 and the probe 122 may be connected to each other by at least one pipeline 232, in particular a flexible pipeline. The pipeline 232 may be part of the particle counter 174 and / or part of the particle counting device 120.

[0260] In FIG. 9, the carriage 184 of the particle counter 120 is shown in a perspective view. The carriage 184 may in particular have a frame 234. The frame 234 may also be called a base frame. The frame 234 may in particular be made of a metal sheet, in particular a metal sheet made of austenitic stainless steel. The metal sheet may in particular have a thickness of 1 mm to 5 mm, preferably 1.5 mm to 2.5 mm, particularly preferably 2 mm. As mentioned above, the lateral runner 180 is attached to the carriage 184. In particular, the lateral runner 180, in particular the base plate 202 of the lateral runner 180, may be attached to the frame 234. In particular, the lateral runner 180 may be attached to the carriage 184, in particular the center of the frame 134. Furthermore, the lateral runner 180 may be attached flush with the carriage, in particular with the frame 234. In particular, the lateral runners 180 can be mounted flush with the carriage 184, in particular the rear side 236 of the frame 234. Due to the small outflow surfaces at the front and rear of the sterilization tunnel 110, the size can be minimized and particle counting can be performed even without an outflow zone.

[0261] FIG. 10 shows another perspective view of the carriage 184. The second motor 192 of the particle counting device 120 can, for example, comprise at least one stepper motor. However, other types of motors, such as, for example, servo motors, are naturally conceivable. In particular, the second motor 192 can be a NEMA 17 stepper motor (Stepperonline, China) with an associated stepper motor drive. Despite its small size, the Nema 17 stepper motor can be suitable for generating the power required to drive the movement of the carriage 184. For further details, please refer to the above description.

[0262] The carriage 184 may in particular have a drive axle, also referred to as axle 238. The stepper motor may be mounted on the base frame so as to be offset transversely from the drive axle, in particular by 90°. The carriage 184 may also have several bevel gears. To transmit the rotary motion of the stepper motor to the drive axle, a bevel gear with a transmission ratio of 2:1 may be selected. The first bevel gear 240 may have, for example, a number of teeth z of 15, and the second bevel gear 242 may have a number of teeth z of 30. The first bevel gear 240 and the second bevel gear 242 may each be made of POM and have a module m of 1.

[0263] The first bevel gear 240 may be configured to be driven by the second motor 192 and transmit rotary motion to the drive shaft via the second bevel gear 242. The transmission ratio allows the speed n1 of the second motor 192 on the drive shaft to be halved and the transmitted torque M1 to be doubled. As a result, a stepper motor with a generally low holding torque may be used.

[0264] A torsionally stiff but angularly and transversely flexible compensating coupling 246 may be used to transmit torque and speed from the second motor 192 to the shaft 244 of the first bevel gear 240. This can in principle compensate for design tolerances or misalignments. The compensating coupling 246 used can generally be backlash-free and torsionally stiff, and can compensate for both radial and axial angular misalignments. The gear shaft can be held in place by a holder 248. Grooved ball bearings can be pressed into the holder 248, which supports the shaft 244 of the first bevel gear 240 and the axle 238, ensuring a smooth running. Grooved ball bearings have the fundamental advantage that friction torque does not increase during warm-up. They also generally show little wear at low speeds and are maintenance-free. The first bevel gear 240 can be frictionally locked to the shaft 244 using a set screw. The second bevel gear 242 may also be attached to the axle 238 by a set screw and secured by an adjustment ring 250 to prevent accidental displacement on the axle 238 .

[0265] As mentioned above, the carriage 184 is configured to move the linear guide 182 in the conveying direction 116 of the conveyor belt 114. As seen in the perspective view of FIG. 11 , the carriage 184 may have at least two wheels 252, in particular at least two drive wheels 254, configured to move the linear guide 182 in the conveying direction 116 of the conveyor belt 114. In this exemplary embodiment, the second motor 192 may be configured to drive at least one of the drive wheels 254, in particular via the axle 238.

[0266] In particular, the wheels 252 may be at least partially made of an elastomer. The elastomer may be selected from the group consisting of silicone, ethylene propylene diene (monomer) rubber (EPDM). However, other elastomers are of course also conceivable. In particular, the wheels 252 may each have one or more O-rings 256 made of an elastomer. The elastomer may be configured to generate rolling friction between the wheels 252 and the conveyor belt 114. Due to the elastic deformability and high coefficient of friction of the elastomer, the contact area between the O-rings 256 and the conveyor belt 114 may be increased. This means that a slip-free operation is possible.

[0267] The wheels 252 may be designed in particular such that an elastomeric O-ring 256 can be mounted thereon. The wheels 252, in particular the drive wheels 254, may in particular be made of polyoxymethylene (POM). In particular, the wheels 252 may have one or more grooves configured to receive an O-ring. The diameter of the wheels 252 may be selected such that a low ground clearance is achieved between the frame 234 and the conveyor belt 114. This means that the overall height of the rear scanner 176 can be kept to a minimum. The wheels 252, in particular the drive wheels 254, may each have several O-rings 256. In this exemplary embodiment, in particular to increase the contact area between the wheels 252 and the conveyor belt 114, it is preferred that the wheels 252 have at least four O-rings 256. The O-rings 256 may be arranged spaced apart from one another on the circumferential surface of at least one of the drive wheels 254. The O-rings 256 may each be received in a groove in the circumferential surface of the drive wheels 254.

[0268] The drive wheels 254 may each be attached to an axle 238. The rotational motion of the axle 238 may be positively transferred to the drive wheels 254 using a feather key. This may prevent the wheels 252 from spinning. Additionally, the drive wheels 254 may be secured by a set screw to prevent movement, particularly on the axle 238.

[0269] The wheels 252 may further include one or more, particularly two, rear wheels 258. A cross-sectional view of one of the rear wheels 258 is shown in Figure 12. A perspective view of the rear wheel 258 is shown in Figure 13. The dolly 184, including the wheels 252, particularly including the drive wheel 254 and the rear wheel 258, can be seen in the perspective view of Figure 14.

[0270] The rear wheels 258 may be designed to be drive-free. The rear wheels 258 may run particularly smoothly. For further details of the design of the rear wheels 258, please refer to the above description, especially the description of the drive wheels 254. The rear wheels 258 may be made of POM. Furthermore, the rear wheels 258 may have a groove that may be configured to receive an O-ring 256. The O-ring 256 may be made of at least one elastomer. The diameter of the rear wheels 258 may be selected so that the rear wheels 258 do not impede the movement of the lateral runners 180. The ball bearings 260, especially the grooved ball bearings 262, may be pressed into the rear wheels 258 for a particularly smooth run. The rear wheels 258 may have a locking ring 264 configured to secure the ball bearings 260, especially the grooved ball bearings 262, against unintentional loosening. The rear wheels 258 may be pressed onto the shafts 266 and attached by self-locking nuts 268, respectively. The self-locking nut 268 may be configured to prevent the self-locking nut 268 from loosening when the rear wheel 258 rotates. The shaft 266 of the rear wheel 258 may also be attached, particularly screwed, to the dolly 184 with the self-locking nut 268.

[0271] FIG. 15 shows a schematic plan view of the particle counting device 120 in the sterilization tunnel 110. A basic requirement of the leakage test is that the filter surface of the particulate filter 118 should be scanned in partially overlapping paths. To achieve the required movement path of the probe 122, at least two movement directions may be necessary. The particle counting device 120 may be configured to move the probe 122 along the conveyor belt width (indicated by arrow 270) of the conveyor belt 114, preferably at a constant speed. Furthermore, the particle counting device 120 may be configured to perform stepwise movements in the conveying direction 116 of the conveyor belt 114. These steps may be adjusted in particular so that the required overlap is maintained. After the particle counting is finished, the particle counting device 120 may return to the starting point.

[0272] The drive 190 of the carriage 184 can drive the movement of the entire particle counter 120 in the conveying direction 116 of the conveyor belt 114. The carriage 184 can scan the conveyor belt 114 and thus the particulate filter 118 located above it along its length and can therefore be used for any type and size of sterilization tunnel 110. In order to be able to properly align the particle counter 120, especially with the carriage 184 and the lateral runners 180, even for sterilization tunnels 110 with smaller conveyor belt widths, for example up to 600 mm, the width of the carriage 184 cannot exceed this width.

[0273] The width of the particulate filter 118 can be scanned along the conveyor belt width by moving the probe 122 transversely, in particular perpendicularly, to the conveying direction 116 of the conveyor belt 114. This can be made possible in particular by the transverse runners 180. The width of the particulate filter 118 corresponds essentially to or less than the width of the conveyor belt 114. The width of the conveyor belt 114, and therefore also the dimensions of the particulate filter 118, can vary depending on the type of sterilization tunnel 110. The length of the transverse runners 180 can therefore be smaller than the width of the conveyor belt 114, in particular because the distance from the lateral borders of the conveyor belt 114 to the side walls of the sterilization tunnel 110 can sometimes be only a few millimeters. The different widths of the different sterilization tunnels 110 can be accommodated by the exchangeable transverse runners 180 so that the entire width in each sterilization tunnel 110 can be scanned. The particle counter 120 can therefore be flexibly adapted to different widths of the particulate filter 118. The transverse runners 180 can be changed without the use of tools. The components of the lateral runners 180 may be selected in particular such that the probe 122 can reach and remain constant at a predetermined travel speed of 5.9 cm / s. The probe 122 may also be moved as close as structurally possible to the outer boundaries on both sides of the conveyor belt 114 to ensure that the largest possible area can be scanned. The maximum path height within the sterilization tunnel 110 may also vary. The maximum overall height of the particle counter 120 does not exceed a minimum maximum path height of 160 mm, making the particle counter 120 suitable for use in all sterilization tunnels 110.

[0274] FIG. 16 illustrates the geometric dimensions of the particle counter 120 within the sterilization tunnel 110, and in particular the serpentine movement path 272 of the particle counter 120.

[0275] Thus, the filter surface of the particulate filter 118 can be scanned with a circular constant velocity probe 122 with a diameter D of 36 mm in partially overlapping paths. The path overlap is generally set to 6 mm in standard guidelines and should be taken into account as the path distance when moving the probe 122 to the next path. To simplify the calculation, consider an imaginary rectangular probe with edge lengths Wp and Dp. The edge lengths Wp and Dp are needed to calculate the number of paths scanned per particulate filter 118 and to calculate the measurement period. The edge length Wp can correspond to the path distance that the particle counter 120 should advance in steps. The edge length Dp is the distance from the intersection of the 6 mm overlapping probe paths.

[0276] The edge length Wp can be determined as follows:

number

[0277] The edge length Dp can be determined as follows:

number

[0278] Furthermore, a measurement period t can be calculated for each particulate filter 118, in particular for each filter element. The maximum allowable lateral distance a of the probe 122 from the outer edge of the conveyor belt 114 can be defined as 20 mm on each side. This value can be maintained by an appropriate design of the transverse runners 180. To calculate the measurement period t for each filter element, the filter width B and the filter length L of the filter element can also be used. As mentioned above, the particulate filter 118 can have a filter length L of 250 mm to 580 mm and a filter width B of 600 mm to 720 mm. A fixed, in particular defined, scanning speed v of 59 mm / s results in the following formula:

number

[0279] This results in a measurement time t for a particulate filter 118 of width 700 mm and length 570 mm.

number

[0280] The calculated values ​​of the total measurement time per filter element are listed below. Only the total lateral movement of the probe was taken into account. For a particulate filter 118 with a width of 700 mm, this results in t=167 s for a length of 450 mm and t=212 s for a length of 570 mm. For a particulate filter 118 with a width of 600 mm, this results in t=126 s for a length of 400 mm and t=183 s for a length of 580 mm. For a particulate filter 118 with a width of 720 mm, this results in t=100 s for a length of 260 mm, t=153 s for a length of 400 mm and t=215 s for a length of 560 mm. Furthermore, the duration of the particle counter 120 step of advancing in the conveying direction 116 of the conveyor belt 114 can be taken into account.

[0281] Considering the diameter of the drive wheel 254 with the O-ring 256, the necessary steps taken by the stepper motor for the movement, particularly the forward movement, of the scanner 176 can essentially be determined. For example, the drive wheel 254 with the O-ring 256 can have an outer diameter of 79 mm. The drive wheel can therefore have a circumference U of 248.2 mm. With a step angle of 1.8°, the motor, particularly the stepper motor, may require 200 steps for one revolution.

number

[0282] Therefore, the stepper motor must move 24 steps to move the carriage 184 the required path distance of 30 mm.

[0283] The particle counter 120, in particular the scanner 176, can be programmed and the user interface configured via the TIA Portal software, in particular in version 13. Here, primarily the programming language SCL (Structured Control Language) can be used. In individual cases, the function blocks can be programmed in FBD (Function Block Diagram in STEP-7, a graphic programming language).

[0284] The program may include at least one operating part, which contains the individual functions necessary in particular for operation, and at least one document part, which contains system messages. This subdivision may increase clarity, which may be particularly useful when troubleshooting. The operating block OB1, which may in particular be responsible for the control of the scanner 176, may be divided into further function blocks, which may be called FB or FC in the following. The controller of the scanner 176 may be modular. Four possible movement types, which may be called left, right, forward and backward, may be programmed as separate functions of OB1. Depending on the requirements, these functions may be activated or may remain deactivated, for example when guiding the probe holder 178 transversely to the conveying direction 116, which may also be called lateral movement, in manual operation or in propulsion in automatic measurement mode. The operating method of the motor drive may also reliably prevent the activation of the opposite movement direction for technical reasons. Furthermore, quadratic functions for step counters, conversion and temperature monitoring may be stored in OB1.

[0285] The programming of the movement direction may in particular be implemented using a series of steps.

[0286] The controller 186 may in each case have at least one digital output for releasing the motor drives and at least one digital output for the movement direction of the first motor 191 and the second motor 192. The digital output for the motor drive release may be called ENA. The digital output for the movement direction may in particular be a digital output for the movement direction and may be called DIR. Furthermore, the controllers 186 for the first motor 191 and for the second motor 192 may each have at least one digital output for the generation of a pulse signal, which may also be called PUL.

[0287] FIG. 17A shows an exemplary sequence of steps of a particle counting method according to the invention. After controlling the movement direction, which is indicated diagrammatically by an arrow 510, the digital output ENA for releasing the motor drive can be activated. This corresponds to field 512 of the sequence of steps. Then, the digital output of the movement direction DIR can be activated. This corresponds to field 512 of the sequence of steps. This step can be optional. To select the opposite movement direction, DIR can remain deactivated. Then, a pulse signal can be generated. The pulse signal can be required for the actual movement. This corresponds to field 514 of the sequence of steps. The sequence of steps can be performed with a time lag. For example, the activation of the digital output ENA for releasing the motor drive and the activation of the digital output for the movement direction DIR can be performed at intervals of 100 ms. Furthermore, the activation of the digital output for the movement direction DIR and the generation of the pulse signal can be performed at intervals of 100 ms.

[0288] Programming the direction of movement may be implemented using the sequence of steps shown in Figure 17A, in particular according to the timing diagram of the control signals shown in Figure 17B. Thus, t1 corresponds to the required time delay between the binary signals for ENA and DIR, t2 corresponds to the required time delay between the binary signals for DIR and PUL, t3 corresponds to the period when the binary PUL signal is present, and t4 corresponds to the period when the binary PUL signal is absent. A "high level" corresponds to a voltage greater than 3.5V DC such that this is deterministically identified as a (binary) 1 signal, and a "low level" corresponds to a voltage less than 0.5V DC such that this is deterministically identified as a (binary) 0 signal.

[0289] The following binary states, shown in Tables 1 and 2, arise for the transfer functions: [Table 1] [Table 2]

[0290] The obtained movement direction function can be used to control the movement. In manual mode, it is possible to activate the movement direction selection of the corresponding stored function. In particular, the "left" movement function can be shown with a button showing an arrow pointing in the left direction. In particular, the "right" movement function can be shown with a button showing an arrow pointing in the right direction. In particular, the "forward" movement function can be shown with a button showing an arrow pointing up. In particular, the "backward" movement function can be shown with a button showing an arrow pointing down.

[0291] In the measurement mode, which may also be referred to as the “partial measurement mode”, the alternatively required movement direction function may be activated by a programmed loop function of the serpentine track, also referred to as the serpentine movement path 272 .

[0292] Fig. 17C shows a further exemplary sequence of steps of a method according to the invention for counting particles in an automated operation. In particular, after starting a measurement, indicated by arrow 518, a transfer function can be triggered. In particular, the probe holder 178 can have a left-most position first, and a transfer function can be started first to the right, which is indicated diagrammatically by field 520. When the probe holder 178 is in the right-most position, a transfer function can be started in the forward direction, which is indicated diagrammatically by field 522. When the probe holder 178 is in the right-most position, and in particular considering the 30-counter, a transfer function to the left can be started, which is indicated diagrammatically by field 524. Thereafter, when the probe holder 178 is in the left-most position, a transfer function can be started again in the forward direction, which is indicated diagrammatically by arrow 526. After starting a transfer function in the forward direction, with the probe holder 178 in the left-most position, and in particular considering the 30-counter, a transfer function can be started to the right, which is indicated diagrammatically by arrow 528.

[0293] The pulses from the motor drive can be used to represent the Cartesian position and the distance from the measurement path transverse to the conveying direction 116. In principle, the position determination can be performed without further use of incremental encoders. The pulses can be counted using forward and reverse counters in the conveying direction 116 and transverse to the conveying direction 116.

[0294] To determine the path distance when moving in the conveying direction 116 further, in particular additional forward and reverse counters may be used, which are reset to a value of zero by the controller 186 after reaching the next measurement path. To prevent carryover of increments in the long term, the forward and reverse counters transverse to the conveying direction 116 are zeroed at the left end stop, at which point the forward and reverse counters should have the value zero in any case.

[0295] The forward and reverse counters are essentially configured to count pulses from the motor drive so that the pulses can be converted into separate function blocks to display coordinates.

[0296] 18A-18F show various operator interfaces (FIGS. 18A, 18B, 18D, 18E and 18F) and pulse representations (FIG. 18C) of the user interface 530, and in particular the graphical user interface 532.

[0297] 18A shows a main menu 534, which may also be called a basic screen 536. From the main menu 534, three operator interfaces, which may also be called submenu items, may be accessed, in particular via a TIA internal function, which may be called "ActivateScreen". In particular, the main menu 534 may have a name "Parameter measurement operation" and a first button 538, which may be used to access a first operator interface corresponding to an automatic, in particular a partially or fully automatic operation. Furthermore, the main menu 534 may have a name "Manual operation" and a second button 540, which may be used to access a second operator interface corresponding to a manual operation, in particular a manual operation. Furthermore, the main menu 534 may have a third button 542, which may have a name "Service" and which may be used to access a third operator interface corresponding to an interface for system settings.

[0298] 18B shows an exemplary embodiment of the second operator interface 544. The second operator interface 544 may in particular have a position 546 where the label "Manual Operation" is displayed. The second operator interface 544 may in particular provide separate control options for the direction of movement, in particular for the direction of movement of the carriage 184 and / or the probe holder 178. The second operator interface 544 may be configured to manually drive the scanner 176, in particular for manually guiding the probe holder 178 transversely to the conveying direction 116 of the conveyor belt 114 and / or for manually driving the carriage 184 in the conveying direction 116 of the conveyor belt 114. The second operator interface 544 may in particular have several buttons 548 configured to control the first motor 191 of the linear guide 182 and / or the second motor 192 of the carriage 184, in particular in the direction of movement 116. In particular, the buttons 548 may include at least a first button 550 for controlling the forward movement of the carriage 184 in the conveying direction 116. Furthermore, the buttons 548 may include at least a second button 552 for controlling the backward movement of the carriage 184 relative to the conveying direction 116. Furthermore, the buttons 548 may include at least a third button 554 for controlling the probe holder 178 transversely relative to the conveying direction 116, in particular from the first end of the guide rail 194 to the second end of the guide rail 194. Furthermore, the buttons 548 may include at least a fourth button 556 for controlling the probe holder 178 transversely relative to the conveying direction 116, in particular from the second end of the guide rail 194 to the first end of the guide rail 194. Guiding the probe holder 178 from the first end of the guide rail 194 to the second end of the guide rail 194 may also be referred to as moving or guiding the probe holder 178 to the left. Furthermore, guiding the probe holder 178 from the second end of the guide rail 194 to the first end of the guide rail 194 can also refer to moving or guiding the probe holder 178 to the right, or vice versa.The first button 550, the second button 552, the third button 554 and the fourth button 556 may be specifically arranged as a D-pad. Furthermore, the second operator interface 544 may include a home button 558, which may be specifically arranged in the center of the D-pad.

[0299] In particular, the second operator interface 544 may be configured to return the scanner 176 to the starting position after the particle counting method has been performed, and in particular to return the carriage 184 to the starting position. In particular, returning the carriage 184 to the starting position may comprise retracting the carriage 184 to the starting position. For this reason, in particular, the second operator interface 544 may comprise at least one, in particular at least two input fields 560 for speed. In particular, the second operator interface 455 may comprise a first input field 562 for the speed of the carriage 184 in the conveying direction 116 and a second input field 564 for the speed of the probe holder 178 transverse to the conveying direction 116. Before the first input field 560, in particular at position 566, the second operator interface 544 may comprise the label "Longitudinal speed". Before the second input field 564, in particular at position 568, the second operator interface 544 may comprise the label "Transverse speed". The input speed value may be configured to manipulate the hold time of an on switch delay or an off switch delay that may be used in the pulse generator.

[0300] Since the input field can be of data type REAL and a holding time of data type TIME, the input value may first be converted or translated to a TIME data type. Real In this case, the following applies strictly:

number

[0301] Now assuming one revolution for the speed calculation, the circumference of the drive gear can be taken for the distance.

number

[0302] Depending on the parameter settings, one revolution can include a defined number of pulses, each of which can be programmed as a time delay element with the same delay time. This is shown diagrammatically in the pulse representation of FIG. 18C. Arrow 570 indicates a complete revolution, and arrow 572 indicates the individual time delay elements. Thus, in the basic formula for calculating the speed, the product of the individual time delays can be used for the time.

number

[0303] This means that the basic formula for calculating the velocity can be:

number

[0304] Since the pulse length is always the same, it can be written as:

number

[0305] The input speed value Real Since a pulse length is required to program from, the following applies:

number

[0306] After conversion, the data types can be converted specifically in two steps. Thus, values ​​can be converted using the following statements:

number

[0307] It may be linked to a corresponding timer.

[0308] Furthermore, the second operator interface 544 may have at least one "back" button 574, by which the second operator interface 544 switches to the main menu 534 by screen change, in particular to exit the manual mode. Furthermore, the second operator interface 544 may have one or more information windows 576, in particular when one or more test runs for example for troubleshooting may be performed via the second operator interface 544. An exemplary information window is shown in FIG. 18D. The second operator interface 544 may have, in particular, a service button 578 by which the information window 576 is activated. The activation may be realized in programming, in particular by a visibility function of the screen element. In particular, the service button 578 may be configured to activate a bit used for the visibility query of the element. The information window 576 may have, in particular, a close button, which may be particularly configured to deactivate the bit, by which the elements lose their visibility. The information window 576 may have several fields 580, each corresponding to a digital output of the motor drive, and may be labeled by "x-ENA", "x-DIR", "x-PUL", "y-ENA", "y-DIR" and "y-PUL", respectively. The information window 576 may also include one or more buttons 582 for resetting the increments of travel of the carriage 184 and / or for guiding the probe holder 178. Additionally, the information window may have one or more buttons 584 for simulating end stops. The information window 576 may be closed using a close button 586.

[0309] FIG. 18E shows an exemplary embodiment of the first operator interface 588. The first operator interface 588 may have, among other things, a position 590 where the label "Parameter measurement operation" is displayed. The first operator interface 588 may include, among other things, starting and stopping a defined automatic run of the carriage 184 and / or the probe 122. The first operator interface 588 may include, among other things, a start button 592 used to start a programmed sequence of steps. Furthermore, the first operator interface 592 may be configured to make visible (not shown in FIG. 18E) a stop button that appears in a position of the first operator interface 588 that corresponds in particular to the position of the start button 592. Furthermore, the first operator interface 588 may be configured to stop the programmed sequence of steps via the stop button and in particular to deactivate the visibility of the stop button. Furthermore, the first operator interface 588 may have two output fields 594 that display the current Cartesian position of the probe 122. The label "position in x direction" may be shown in a position 596 before one of the output fields 594. The label "position in y direction" may be shown in another position 598 before one of the output fields 594. Furthermore, the first operator interface 588 may have a "save position" button 600. The first operator interface 588 may be configured to temporarily store the coordinates recorded by pressing the "save position" button, in particular the coordinates recorded at the time of pressing, in a data block in particular. This allows a counter, in particular a leak counter, to increase the number of possible leaks. The representation of the position of the possible leak 602 may have several, in particular five, variables for each of the position in the conveying direction 116 and the position transverse to the conveying direction 116. This position may also be referred to as the x and y position. The values ​​of these variables may default to zero, in particular when the leak counter has a value of zero. As soon as the leak counter is increased to a value of one, the current position value is displayed in the first pair of variables, in particular the first pair of xy variables.The representation of the possible leak locations may in particular have a "clear" button 604 configured to reset the variable to a value of 0, in particular by resetting a leak counter. As already mentioned, a storage of up to 5 leaks may in particular be provided, since the number of anomalies indicates a critical state of the filter element being checked. Figure 18F shows a detailed view of the location of the possible leak 602.

[0310] 19 and 20 show various exemplary embodiments of programming of the controller 186, particularly a programmable logic controller (PLC). In these exemplary embodiments, programming is performed via version 13 of the TIA Portal software using the SCL programming language. In particular, FIG. 19 shows an exemplary embodiment of programming of the controller 186 with at least one forward and reverse counter 610. The controller 186 may include a first forward and reverse counter 612, a second forward and reverse counter 614, and a third forward and reverse counter 616. As shown in FIG. 19, the second forward and reverse counter 614 may be included in a first network 618, a first forward and reverse counter 612 in a second network 620, and a third forward and reverse counter 616 in a third network 622 of the controller 186.

[0311] The particle counter 120, in particular the controller 186, may be configured to count second pulses of the second motor 192, in particular the second stepper motor drive, by at least one second forward and reverse counter 614. The second forward and reverse counter 614 may therefore in particular be a counter on the x-axis. The second count input 624 for counting up may be assigned the "x-PUL_V" signal. The second count input 626 for counting down may be assigned the "x-PUL_R" signal. The second reset input 628 may be assigned the "Reset_x-axis" signal. The second charge input 630 may be assigned the "false" signal. The second load value 632 may be assigned a value of 0. Furthermore, the second forward and backward counter 614 may have a second output 634 for counter reading and a further second output 636 for querying the counter state. In particular, the "x position" may be obtained from the second output 634 for counter reading.

[0312] The particle counter 120, in particular the controller 186, may be configured to count the first pulses of the first motor 191, in particular the first stepper motor drive, by at least the first forward and reverse counter 612. The first forward and reverse counter 614 may therefore in particular be a counter on the y-axis. The first counting input 638 for counting up may be assigned the "y-PUL_R" signal. The first counting input 640 for counting down may be assigned the "y-PUL_L" signal. The first reset input 642 may be assigned a signal from an OR element 652, to which the input signals "Reset_y-axis" 654 and "Limit_Left" 656 are in contact. The first charge input 644 may be assigned the "false" signal. The first load value 646 may be assigned the value of 0. Furthermore, the first forward and backward counter 612 may have a first output 648 for counter reading and a further first output 650 for querying the counter state. In particular, the "y position" may be obtained from the first output 648 for counter reading.

[0313] Thus, the particle counting device 120, and in particular the controller 186, may be configured to use a first pulse of the first motor 191 to determine the position of the probe 122 on the linear guide 182, and to use a second pulse of the second motor 192 to determine the position of the carriage 184 on the conveyor belt 114.

[0314] Thus, the third forward and reverse counter 616 may in particular be an "x-axis_temp" counter. The third counting input 658 for counting up may be assigned the "x-PUL_V" signal. The third counting input 660 for counting down may be assigned the "x-PUL_R" signal. The third reset input 662 may be assigned a signal from an OR element 664 with an upstream AND element 666. The input signals 668 "Limit_Left" 670 and "Limit_Right" 670 are in contact with the AND element 666. The OR element 664 is supplied with the output signal 672 of the AND element 666 and with an input signal "Reset_x-axis" 674. The third charging input 676 may be assigned the "right drive" signal. The third load value 678 may be assigned a value of 0. Furthermore, the third forward and reverse counter 616 may have a third output 680 for counter reading and a further third output 682 for querying the counter state. In particular, "x-Position_Temp" may be obtained from the third output 680 for counter reading.

[0315] Furthermore, the particle counter 120, in particular the controller 186, may comprise at least one further forward and reverse counter (not shown) configured to count pulses of the second motor 192, in particular the second stepper motor drive. The further forward and reverse counter may therefore be configured in particular to determine the path distance during the movement in the conveying direction 116. The particle counter 120, in particular the controller 186, may be configured to reset the further forward and reverse counter to zero after the stepwise movement of the carriage 184, in particular after reaching the next measurement path. Furthermore, the linear guide 182 may have a first end stop and a second end stop, and the controller 186 may be configured to reset the first forward and reverse counter 612 to zero when the probe 122 is at the first end stop. In particular, the first end stop may be the left end stop.

[0316] FIG. 20 shows an exemplary embodiment of the programming of the controller 186, including a sequence of steps for controlling the movement of the particle device 120. The sequence of steps shown in FIG. 20 starts with an OR element 684, which is contacted by an input signal "Start_L" 686 or "Initial Movement" 688. An output signal 690 of the OR element 684 can be contacted as a start condition of a function block 692 with a "Left_ENA" function. A switch-on delay with a time specification 694 of, for example, 100 ms can be present in the function block 692. A memory element "y-ENA" 696 can pass the output signal 698 of the function block 692 as an input signal 700 for a start condition of a further function block 702 with a "Left_DIR" function. A switch-on delay with a time specification 704 of, for example, 100 ms can be present in the function block 702. An output signal 706 of the function block 702 can be passed as an input signal 710 of an AND element 712 via a memory element "y-DIR" 708. A further input signal "Pulse_Restart" 714 can be present at the AND element 712. An output signal 716 of the AND element 712 can be contacted as a start condition of a further function block 718 with the function "Left_PUL". In the function block 718 there can be a switch-off delay with time specification 720 "Time_PUL". An output signal 722 of the function block 718 can serve as a start condition of another function block 724 with the function "Waiting_time_for_restart_L". A switch-on delay with time specification "Time_PUL" 726 can be present at the function block 724. An output signal 728 of the function block 724 can be present as an input signal from the memory elements "Pulse_Restart" 730 and "y-PUL" 732 connected in series. EXAMPLES

[0317] The following examples serve to illustrate the invention and should not be construed as limiting the scope of protection.

[0318] The stepper motors were controlled using a board with a microcontroller (Arduino) to check their functionality. The board was connected to a computer via a USB interface. With the associated software, a program was written and loaded onto the board to control the movement of the linear guide or the movement of the carriage. The program specified, among other things, the steps, the speed and the direction of rotation of the stepper motor. The board sent a signal to the motor drive via the experimental circuit board. The motor drive passed the signal to the stepper motor and supplied it with the required voltage. A main adapter, also connected to the motor drive, converted the 230V voltage to the 24V required by the motor drive. The main adapter was chosen to supply the two motor drives of the particle counter 120 and therefore both stepper motors. This setup made it possible to perform realistic functional tests.

[0319] Example 1: Checking the repeatability of a linear guide stepping motor To check the repeatability of the stepping motor of the linear guide, the movement sequence of the probe holder or the rack-and-pinion drive was tested for several consecutive paths. It was checked whether steps were skipped when the stepping motor rotated. This could essentially lead to the path of movement not being completely scanned. This could result in subsequent errors such as collisions with the rack mount. For a tunnel-type particulate filter 118 with a length L of 570 mm, especially a HEPA filter, many paths are required to essentially scan the entire filter surface. It should be strictly guaranteed that the forward movement of the carriage follows each guide of the probe holder transverse to the conveying direction. The number of paths scanned n B was determined and programmed. A path distance W of 30 mm was P was used.

number

[0320] The guide carriage was positioned at an initial distance of 5 mm from the rack mount. The starting position was measured by a digital caliper and the program was started. The guide carriage was moved continuously at a speed of 5.9 cm / s for n calculated paths. B The rack mount was scanned along the length of the rack and then stopped at the end position, which was the same as the start position. Again, the distance between the rack mount and the end position was measured with a digital caliper.

[0321] To obtain meaningful results for the average repeatability and to be able to obtain an average value, this process was repeated five times in succession and the difference between the start and end positions was determined, as summarized in Table 3 below. [Table 3]

[0322] The arithmetic mean x1 of the measured deviations was calculated.

number

[0323] To prove that no steps were skipped, the deviation x1 must be strictly less than the distance traveled by the spur gear per step S1.

number

[0324] Therefore, l z corresponds to the distance traveled during one revolution of the gear. See above for further details.

[0325] Since the deviation x1 is smaller than the distance traveled by the spur gear per step S1, it was possible to demonstrate the perfect functionality and exact repeatability of the stepper motor and thus of the rack-and-pinion drive of the linear guide. It was shown that the stepper motor does not skip a step. The deviation determined between the start and end positions was less than 0.299 mm in all runs, with an average of 0.108 mm.

[0326] Example 2: Checking the repeatability of the stepping motor for the trolley Next, the functionality of the trolley was tested. A new program for controlling the trolley was created to move the trolley along a path distance of 30 mm. P A program was loaded onto the board using a microcontroller that advances the carriage in sequential steps, pausing between each advance. This program was used to simulate the movement of the carriage in the sterilization tunnel. During the pauses in the carriage movement, the probe holder can be guided on a lateral runner. Again, the repeatability of the travel distance was checked.

[0327] The repeatability of the carriage was tested on a flat surface. During the tests, which were performed on a flat surface, the drive wheels moved at a speed of 30 revolutions per minute. The carriage, fitted with lateral runners, was scanned over a number of paths, n B The path distance Wp was advanced in steps of 30 mm for 19 repetitions depending on the robot. The distance traveled by the robot had to be 570 mm for 19 repetitions. The end position of the robot was measured using a tape measure with 0.50 mm pitch from the starting position. This process was also repeated five times consecutively. [Table 4]

[0328] The arithmetic mean of the deviation x2 of the trolley's travel path was determined.

number

[0329] To show that no motor steps are skipped and the carriage moves forward without error, the deviation x2 must be substantially less than the distance traveled by the drive wheels, and therefore the carriage, per step S2.

number

[0330] Thus, U corresponds to the circumference of the driving wheel, see explanation above.

[0331] The deviation of the travel path x2 is smaller than the distance traveled by the drive wheel per step S2, thus demonstrating the perfect functionality and precise repeatability of the trolley. It was also shown here that the stepper motor does not skip steps. The deviation determined between the start and end positions was less than 1.241 mm for all runs, with an average of 0.3 mm.

[0332] Example 3: Parameter setting for motor drive device The scanner can be driven by two separate stepper motors with associated motor drives. For a functioning drive, the current consumption and the number of pulses per revolution of the connected motors can be set in the motor drives.

[0333] A 17HS24-2104S type stepper motor may be used, with a current consumption of up to 2.1 A. The determination of the number of pulses depends essentially on the speed as well as the minimum adjustable time delay for pulse programming.

[0334] Now, if a minimum time delay of 1 ms, a speed of 5 cm / s and a drive gear geometry are used, this results in 596.90 pulses per revolution. For the calculation, see equations 22 and 23 above. Since no value can be chosen for a delay time less than 1 ms, the calculated 596.9 pulses per revolution corresponds to a maximum value so that a speed of 5 cm / s can be guaranteed.

[0335] According to the parameter table of the stepper drive DM556N (see Tables 5 and 6), a maximum current consumption of 2.3 A and a speed of 400 pulses per revolution can be set. [Table 5] [Table 6]

[0336] This results in the following parameter settings for the two motor drives according to Table 7: [Table 7] [Explanation of symbols]

[0337] 110 Sterilization tunnel 112 Drug Filling System 114 Conveyor Belt 116 Transport direction 118 Particulate Filter 120 Particle Counter 122 Probe 124 Probe opening 126 Probe Funnel 128 Air Supply Duct 130 Fans 132 Suction device 134 Warm Zone 136 Sterilization Zone 138 Cooling Zone 140 First Air Supply Duct 142 The First Fan 144 First Particulate Filter 146 More Fans 148 Second Fan 150 Secondary Particulate Filter 152 The Third Fan 154 4th Particulate Filter 156 The Fourth Fan 158 Drain Channel 160 Untreated air side 162 Aerosol Generator 164 Test Socket 166 Particle Counter 168 dilution stage 170 Clean air side 172 Constant Velocity Probe 174 Particle Counter 176 Scanner 178 Probe holder 180 lateral runner 182 Linear guide 184 Trolley 186 Controller 188 Driving device for guiding the probe holder 190 Driving device for moving the cart 191 First Motor 192 Second Motor 194 Guide rail 196 Contoured guide rail 198 T-shaped guide rail 200 Guide Carriage 202 Base Plate 204 Floating Bearing 206 without floating bearing 208 Floating bearing in z direction 210 Floating bearing in the y direction 212 Floating bearing in yz direction 214 Rack and pinion drive 215 Stepping motor 216 LACK 218 Spur Gear 220 Rack Mount 222 Mounting bracket 224 Screw connection 226 Borehole 228 Groove 230 Clamp Plate 232 Pipeline 234 frames 236 Rear of the dolly 238 Axle 240 First bevel gear 242 Second bevel gear 244 First bevel gear shaft 246 Compensation Coupling 248 Holder 250 Adjustment Ring 252 Wheels 254 Drive Wheel 256 O-ring 258 Rear wheel 260 ball bearing 262 Grooved ball bearing 264 Lock Ring 266 Shaft 268 Self-locking nut 270 conveyor belt width 272 Meandering migration route 510 Arrow 512 Field 514 Field 516 Field 518 Arrow 520 Field 522 Field 524 Field 526 Arrow 528 Arrow 530 User Interface 532 Graphical User Interface 534 Main Menu 536 Basic screen 538 First Button 540 Second Button 542 Third Button 544 Secondary Operator Interface 546 position 548 Button 550 First Button 552 Second Button 554 Third Button 556 Fourth Button 558 Home button 560 Input Field 562 First input field 564 Second input field 566 position 568 position 570 Arrow 572 Arrow 574 "Back" button 576 Information Window 578 Service Button 580 Field 582 Buttons 584 Buttons 586 Close button 588 First Operator Interface 590 position 592 Start button 594 Output Fields 596 position 598 Further Locations 600 Buttons 602 Representation of possible leak locations 604 Clear button 610 Forward and Backward Counters 612 First forward and backward counter 614 Second forward and reverse counter 616 Third forward and backward counter 618 First Network 620 Second Network 622 The Third Network 624 Second count input for count up 626 Second count input for counting down 628 Second Reset Input 630 Second Charging Input 632 Second Load Value 634 Second output for counter reading 636 Second output for requesting counter status 638 First count input for count up 640 First count input for counting down 642 First Reset Input 644 1st charging input 646 First Load Value 648 First output for counter reading 650 First output for requesting counter status 652 OR element 654 Input Signal 656 Input Signal 658 Third count input for count up 660 Third count input for counting down 662 3rd Reset Input 664 OR element 666 AND element 668 Input Signal 670 Input Signal 672 Output Signal 674 Input Signal 676 3rd Charging Input 678 Third Load Value 680 Third Output for Counter Reading 682 Third output to request counter status 684 OR element 686 Input Signal 688 Input Signal 690 Output Signal 692 Function Blocks 694 Timing 696 Memory Elements 698 Output Signal 700 Input Signal 702 Function Block 704 Timing 706 Output Signal 708 Memory Element 710 Input Signal 712 AND element 714 Input Signal 716 Output Signal 718 Function Blocks 720 Timing 722 Output Signal 724 Function Blocks 726 Timing 728 Output Signal 730 Memory Element 732 Memory Element

Claims

1. A particle counting device (120) for counting particles in a sterilization tunnel (110) of a drug filling system (112), wherein the sterilization tunnel (110) comprises at least one conveyor belt (114), and the particle counting device (120) comprises at least one probe (122) connectable to a particle counter (174) for receiving particles within the sterilization tunnel (110); at least one scanner (176) having at least one probe holder (178) for mounting the probe (122); and the scanner (176) comprises at least one lateral runner (180) having at least one linear guide (182), wherein the linear guide (182) is configured to guide the probe holder (178) transversely to the conveying direction (116) of the conveyor belt (114) in the sterilization tunnel (110); at least one lateral runner (180); at least one carriage (184), wherein the lateral runner (180) is attached to the carriage (184), and the carriage (184) is configured to move the linear guide (182) in the conveying direction (116) of the conveyor belt (114); at least one carriage (184); at least one controller (186) configured to control the movement of the scanner (176); at least one controller (186) A particle counting device (120) comprising.

2. The particle counting device (120) according to claim 1, wherein the controller (186) includes a programmable logic controller.

3. The particle counting device (120) according to claim 1, further comprising at least one particle counter (174) connectable to the probe (122).

4. The particle counting device (120) according to claim 1, further comprising at least one stationary user interface connected to the scanner (176), wherein the movement of the scanner (176) is controllable by the user interface.

5. The particle counting device (120) according to claim 4, wherein at least one movement path and / or measurement position for particle counting is predeterminable by the user interface.

6. The particle counting device (120) according to claim 4, wherein the user interface is further configured to move the probe (122) to at least one predetermined probe position and perform particle counting there.

7. The particle counting device (120) according to claim 4, wherein the user interface is configured to record and display particle counting as a function of the probe position, and the user interface is further connected to a particle counter (174).

8. A sterilization tunnel (110) of a drug filling system (112), At least one conveyor belt (114), wherein the conveyor belt (114) is configured to guide at least one container along a conveying direction (116) of the conveyor belt (114), at least one conveyor belt; At least one particulate filter (118); At least one particle counting device (120) according to any one of claims 1 to 7 disposed between the particulate filter (118) and the conveyor belt (114); A sterilization tunnel (110) comprising a probe (122) of the particle counting device (120) having a probe opening (124) facing the particulate filter (118).

9. A method for counting particles in a sterilization tunnel (110) of a drug filling system (112) by a particle counting device (120) according to any one of claims 1 to 7, the following steps: a) a step of moving the lateral runner (180) in the conveying direction (116) of the conveyor belt (114) by the carriage (184); b) a step of guiding the probe holder (178) transversely to the conveying direction (116) by the linear guide (182); Including, A method in which steps a) and b) are alternately and repeatedly executed.

10. Before performing step a), the probe holder (178) is disposed at a first end of the linear guide (182), and in step b), the probe holder (178) is guided from the first end to a second end of the linear guide (182). The method according to claim 9.

11. The temperature inside the sterilization tunnel (110) is further recorded during the execution of the method by at least one temperature sensor, and if the temperature exceeds a predetermined limit value, step a) is aborted, according to the method of claim 9.

12. The method according to claim 9, wherein step a) and / or step b) are performed manually.

13. The method according to claim 9, wherein step a) and / or step b) are performed automatically.

14. The linear guide (182) has at least one drive device (188), the drive device (188) has at least a first motor (191), the particle counting device (120) further has at least one second motor (192), the second motor (192) is configured to drive the carriage (184), and the controller (186) for the first motor (191) and the second motor (192) each has at least one digital output for the direction of movement and at least one digital output for motor drive release. When step a) and / or step b) are executed, the following series of steps, namely, i. activation of the digital output for motor drive release, and ii. generation of a pulse signal are executed, according to the method of claim 9.

15. The method according to claim 14, wherein step i. and step ii. are executed at different times.

16. The method according to claim 14, wherein the digital output for the direction of movement is activated after step i. is executed.

17. The first pulse of the first motor (191) is counted by at least one first forward and reverse counter, the second pulse of the second motor (192) is counted by at least one second forward and reverse counter, the position of the probe (122) on the linear guide (182) is determined by the first pulse of the first motor (191), and the position of the carriage (184) on the conveyor belt (114) is determined by the second pulse of the second motor (192), according to the method of claim 14.

18. The linear guide (182) has a first end stop and a second end stop, and the first forward and reverse counters of the first motor (191) are reset to zero after step b) is executed when the probe (122) is at the first end stop. The method according to claim 17.

19. The method according to claim 9, wherein the position of the probe (122) on the conveyor belt (114) is recorded when the particle count exceeds a predetermined limit value.

20. The probe (122) comprises a probe opening (124) having an outer diameter, and step a) is performed such that the increment of the particle counting device (120) in the conveying direction (116) of the conveyor belt (114) by the carriage (184) is smaller than the outer diameter of the probe opening (124). The method according to claim 9.

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