Particle measuring device, sterilization tunnel and system for processing pharmaceutical containers

Abstract

The invention relates to a particle measuring device (162, 206) for a gas-filled chamber (134) of a system (100) for processing pharmaceutical containers, in particular for a sterilization tunnel (104), wherein the containers are received in the chamber (134) and in particular can be moved through the chamber. The particle measuring device comprises a collecting body (164), which comprises an inlet opening (180) and can be positioned in the chamber (134), said collecting body (164) being exposed to a gas flow in the chamber (134), and an evaluation unit (166), which can be positioned in particular outside the chamber (134) and is fluidically connected to the collecting body (164). Particles contained in the gas flow enter the inlet opening (180) and are fed into the evaluation unit (166), and the collecting body (164) is designed, at least in some parts, as a tube (172) or comprises a tube (172) which comprises a casing (182) and forms an inner channel (184), a plurality of tube (172) inlet openings (180) being formed in the casing (182). The invention also relates to a sterilization tunnel (104) and to a system for processing pharmaceutical containers.

Description

[0001] PARTICLE MEASURING DEVICE, STERILIZATION TUNNEL AND PHARMACEUTICAL CONTAINER PROCESSING FACILITY

[0002] The present invention relates to a particle measuring device for a gas-charged chamber in a system for processing pharmaceutical containers, in particular for a sterilization tunnel, wherein the containers are received in the chamber and in particular are movable through it, comprising a collecting body which comprises an inlet opening and can be positioned in the chamber, wherein the collecting body is exposed to a gas flow in the chamber, and an evaluation unit which can be positioned in particular outside the chamber and is in flow connection with the collecting body, wherein particles contained in the gas flow enter the inlet opening and are fed to the evaluation unit.

[0003] Furthermore, the present invention relates to a sterilization tunnel for pharmaceutical containers, comprising a chamber with two side walls arranged at a distance from one another, a ceiling wall and a transport device opposite the ceiling wall, with which the containers can be transported through the chamber in a transport direction between the side walls, wherein a flow device is arranged or formed on or in the ceiling wall for providing a gas flow in the chamber.

[0004] Furthermore, the present invention relates to a system for processing pharmaceutical containers with a filling machine and a sterilization tunnel.

[0005] In such a system, the containers are processed, with sterilized containers from the sterilization tunnel being fed to the filling machine through aligned openings. In the filling machine, the containers are weighed empty (tare weighing), filled, weighed full (gross weighing), and then sealed. Upstream of the sterilization tunnel, the system can, for example, include a washing machine for internal and external cleaning, after which the containers are dried and transported to the sterilization tunnel chamber for sterilization.

[0006] However, the invention is not limited to the necessity of such a system and such a sterilization tunnel, but also relates to the particle measuring device of the type mentioned above. This particle measuring device is used, for example, in a sterilization tunnel, wherein the collecting body is positioned in the gas flow through the chamber, in particular in the sterilization tunnel. Particles can enter the collecting body via the inlet opening and are then fed, for example, through a channel to the evaluation unit. The particle measuring device thus serves for control and / or monitoring purposes to monitor the hygienic condition of, for example, the sterilization tunnel and the system. For example, it ensures that a predetermined number of particles is not exceeded when the containers are processed in the filling machine.Particles can enter the chamber, for example, if the incoming gas, especially air, is inadequately filtered. It is also conceivable that leaks in a chamber wall lead to a bypass flow path containing particles.

[0007] It is known to use a funnel as a collecting body. These funnels have a relatively large inlet opening, which is, however, spatially limited to a small area within the chamber. A further disadvantage is that the gas flow is usually directed from top to bottom through the chamber, and the funnel is therefore directed with the inlet opening upwards. This makes it necessary to connect the funnel to the evaluation unit, which is usually positioned outside the chamber, via an arc-shaped connecting part in order to ensure sufficient flow connection. However, due to the arc-shaped connecting part, the particle measuring device takes up a relatively large amount of space within the chamber.

[0008] In particular, the free height within the chamber is impaired, which is disadvantageous for the use of the particle measuring device with containers that exceed a certain height.

[0009] The object of the present invention is to provide a particle measuring device of the type mentioned above which allows a more advantageous monitoring of particles in the gas flow with preferably reduced restrictions due to the design.

[0010] This object is achieved according to the invention in a particle measuring device of the type mentioned at the outset in that the collecting body is designed at least in sections as a tube or comprises a tube which comprises a casing and forms an internal channel, wherein a plurality of inlet openings of the tube are formed in the casing.

[0011] The present invention takes into account the consideration that particles can be spatially distributed within the gas flow. For this reason, it is advantageous if the collecting body has a plurality of distributed inlet openings. These can, for example, be spatially distributed over the collecting body and preferably arranged at positions where particles are expected within the gas flow. The plurality of inlet openings makes it possible to construct the collecting body compactly. This is achieved according to the invention in that the collecting body is designed as a tube or comprises a tube. The inlet openings are formed in the casing. This makes it possible to eliminate the need for an arc-shaped connecting part, as is required in conventional particle measuring devices with a funnel.This results in a compact design, which minimizes any interference with the containers transported through the chamber. At the same time, particles distributed spatially within the chamber can be better detected, making the particle measuring system more versatile than a conventional particle measuring system.

[0012] It is advantageous if the tube is designed to extend at least partially in a straight line. In particular, the tube can be designed to extend completely in a straight line. For example, when used in a sterilization tunnel, the tube runs within the chamber between two opposing side walls in a transverse direction that is oriented transversely and in particular perpendicularly to the transport direction of the containers.

[0013] It may be advantageous if the pipe is free of an inlet opening on an end face facing away from the evaluation unit. In this case, this can be understood in particular to mean that the pipe is closed at this end face. The absence of an inlet opening on the end face can, for example, be advantageous for creating a flow connection through the inlet openings to the evaluation unit.

[0014] It is advantageous if several inlet openings are provided along a particularly axial longitudinal extension of the tube, spaced apart from one another in the direction of extension. This advantageously makes it possible to capture particles over a larger cross-sectional area of ​​the gas flow.

[0015] The inlet openings can be arranged equidistant from each other.

[0016] In an advantageous embodiment of the invention, the inlet openings can be grouped into two or more groups of inlet openings in the direction of extension of the tube, wherein a distance between adjacent inlet openings along the direction of extension within a group is smaller than a distance between adjacent inlet openings of different groups. Inlet openings of the same group can be arranged equidistant from one another. For example, the inlet openings are concentrated by the groups in regions within the chamber and exposed to regions of the gas flow where an increased number of particles is to be expected. Regions between groups of inlet openings on the tube are located, for example, where fewer particles are to be expected in the gas flow.

[0017] However, it is conceivable that there are also entry openings between the groups.

[0018] Distances relative to the longitudinal extents of adjacent inlet openings may be identical for two or more groups.

[0019] For example, the distance between adjacent inlet openings within a group is significantly smaller than the distance between adjacent inlet openings in different groups. The factor in this regard can be, for example, at least 5, in particular at least 10, and for example at least 20.

[0020] When implementing the invention, it may prove advantageous if a group of inlet openings is arranged on or near a side of the pipe facing away from the evaluation unit.

[0021] Alternatively or additionally, a group of inlet openings can be arranged on or near a side of the pipe facing the evaluation unit.

[0022] When the particle measuring device is used as intended, the two sides mentioned above are positioned, for example, at or near the edge areas of the chamber that face opposite side walls.

[0023] It can be provided that at least one group of inlet openings is arranged within a tube half, based on its longitudinal extent, wherein the tube half is arranged centrally between a side facing away from the evaluation unit and a side facing the evaluation unit. In the present case, this can be understood, for example, to mean that the corresponding group of inlet openings is arranged in a central region of the tube. This central region can, for example, be positioned substantially centrally between the side walls of the chamber during the intended use of the particle measuring device. For example, two groups of inlet openings are arranged within the tube half as described above.

[0024] It can be provided that the at least one group of inlet openings is arranged within one third of the pipe, between a side facing away from the evaluation unit and a side facing the evaluation unit. It can prove advantageous if the inlet openings are aligned radially with respect to a pipe axis.

[0025] It can be advantageous if the inlet openings have a round, and especially circular, cross-section. The inlet openings can be created, for example, by drilling holes.

[0026] It can be advantageous if the inlet openings are designed identically.

[0027] In practice, it may be advantageous if, relative to a longitudinal extension of the pipe, two or more inlet openings are arranged at at least one position, wherein an angle between orientations of the inlet openings is approximately 10° to approximately 40°, preferably approximately 20° to approximately 30°. The angle is measured, for example, through the respective axes of the inlet openings, with the apex of the angle lying on the axis of the pipe.

[0028] In particular, three inlet openings can be formed at the position, wherein adjacent inlet openings can enclose the above-mentioned angle between them.

[0029] The particle measuring device can advantageously comprise a suction unit for applying negative pressure to the channel.

[0030] The tube can be constructed in one piece to ensure simple construction.

[0031] Alternatively, the pipe may, for example, be multi-segmented with two or more segments connected to each other longitudinally.

[0032] It is also an object of the present invention to provide a sterilization tunnel with a particle measuring device.

[0033] This object is achieved according to the invention by a sterilization tunnel for pharmaceutical containers, comprising a chamber with two side walls arranged at a distance from one another, a ceiling wall and a transport device opposite the ceiling wall, with which the containers can be transported through the chamber in a transport direction between the side walls, wherein a flow device is arranged or formed in the ceiling wall for providing a gas flow in the chamber, wherein the sterilization tunnel comprises at least one particle measuring device of the type described above and the collecting body is positioned in the gas flow in the chamber.

[0034] The advantages already mentioned in connection with the explanation of the particle measuring device according to the invention can also be achieved with the sterilization tunnel according to the invention. Advantageous embodiments of the sterilization tunnel according to the invention result from advantageous embodiments of the particle measuring device according to the invention. Reference is made to the above explanations in each case.

[0035] The containers are transported through the chamber by the transport device and are exposed to the gas flow of the flow device. The gas flow acts on the containers from above. The collecting body is arranged above the containers and positioned in the gas flow so that any particles can enter the inlet openings. Accordingly, the inlet openings are directed upwards.

[0036] Position and orientation specifications such as “top”, “above” or the like are based on the intended use of the particle measuring device and the sterilization tunnel.

[0037] The sterilization tunnel comprises, for example, a cooling zone where the particle measuring device is arranged, with the collecting body being arranged in a cooling gas stream. The collecting body can preferably be arranged on the outlet side of the cooling zone.

[0038] The sterilization tunnel may further comprise, for example, a warming zone and a sterilization zone upstream of the cooling zone.

[0039] To achieve a structurally simple design, the collecting body can be held, for example, on at least one side wall. The holding can be direct or indirect. For example, a holding element, e.g., in the form of a sleeve, is fixed to the side wall, through which the collecting body is guided or against which the collecting body engages. The collecting body can have a free end on its side facing away from the evaluation unit, which is arranged at a distance from the side wall. Alternatively, it can be provided that the end is not free and is held on the side wall.

[0040] Preferably, the tube is aligned in a transverse direction of the sterilization tunnel, which is aligned transversely and in particular perpendicularly to the transport direction.

[0041] The collecting body is advantageously arranged at a distance from the ceiling wall, wherein the distance to the ceiling wall is less than approximately one-third of the height of the chamber, measured as the distance of the transport device from the ceiling wall. For example, the distance is approximately one-quarter of the height of the chamber.

[0042] It can be provided that the collecting body extends over at least 75% of the width of the chamber, relative to a direction perpendicular to the transport direction.

[0043] The flow device can comprise at least one filter element arranged in the ceiling wall or forming the ceiling wall (at least in sections) for filtering the gas flowing into the chamber, wherein the collecting body is arranged below the at least one filter element.

[0044] It can be provided that inlet openings of the tube are arranged below a border of the at least one filter element and / or below an edge of an opening in the ceiling wall into which the at least one filter element is inserted. This embodiment takes into account the consideration that the at least one filter element can effectively retain particles in the gas flow. In contrast, the probability may be higher that particles can enter the chamber past the at least one filter element in the region of the border or the edge of the opening. By positioning the inlet openings below these locations, the probability that any particles will be captured can be increased.

[0045] With respect to the longitudinal extension of the pipe, for example, a respective group of inlet openings can be positioned below a respective edge area of ​​the ceiling wall.

[0046] With respect to the longitudinal extent of the tube, for example, a section of the tube may be free of a group of inlet openings, which is located below a central region of the at least one filter element, which occupies approximately one-third or more of the filter's extension. Here, too, the consideration that a smaller number of particles can be expected below a filter medium is taken into account. Accordingly, it may be expedient to arrange the groups of inlet openings below a frame of the filter element.

[0047] The enclosure can, for example, be a housing of the filter element in which the filter medium is arranged.

[0048] In relation to a transverse direction, transversely and in particular perpendicular to the transport direction, for example, two filters can be positioned next to each other.

[0049] It can be provided that two particle measuring devices are provided, the collecting bodies of which are preferably aligned along a transverse direction, transversely and in particular perpendicular to the transport direction, and with each other. For example, the collecting bodies protrude into the chamber from opposite side walls. Particles collected by a respective tube are fed to the respective evaluation unit. The evaluation units are positioned, for example, outside the chamber. The particle measuring devices are designed identically, for example.

[0050] The transport device can, for example, comprise a conveyor belt on which the containers can be transported upright.

[0051] As mentioned above, the present invention also relates to a system. A system according to the invention for processing pharmaceutical containers comprises a filling machine, which has a filling station for filling the containers, and an inlet opening through which the containers can be fed to the filling machine. It also comprises a sterilization tunnel of the type described above, which is arranged upstream of the filling machine in a feed direction, wherein a discharge opening of the sterilization tunnel is aligned with the inlet opening.

[0052] The advantages already mentioned in connection with the particle measuring device according to the invention can also be achieved with the system according to the invention. Advantageous embodiments of the system according to the invention result from advantageous embodiments of the particle measuring device according to the invention and the sterilization tunnel according to the invention. Reference is made to the above explanations in each case. In the system, the containers are transported through the sterilization tunnel, whose discharge opening is aligned with the inlet opening of the filling machine. At least one partition wall can be provided in the aligned openings, for example in the form of a bulkhead.

[0053] Typically, the cleanliness level inside the filling machine is higher than outside. The particle measuring device on the sterilization tunnel can be used to ensure that the cleanliness level at the exit of the sterilization tunnel is sufficiently high, for example, if the cooling zone can be considered a clean room. If the number of detected particles exceeds a specified limit, appropriate countermeasures can be initiated.

[0054] Preferably, the plant according to the invention meets the requirements of Good Manufacturing Practice, Annex 1 (GMP).

[0055] The following description of preferred embodiments of the invention, taken in conjunction with the drawings, serves to explain the invention in more detail. They show:

[0056] Figure 1: a schematic representation of a system according to the invention for

[0057] Processing containers in a preferred embodiment comprising a sterilization tunnel according to the invention with a particle measuring device according to the invention, each in a preferred embodiment;

[0058] Figure 2: a perspective partial view of the sterilization tunnel according to the invention;

[0059] Figure 3: a side view of the sterilization tunnel from Figure 2;

[0060] Figure 4: an enlarged perspective partial view of the sterilization tunnel from

[0061] Figure 2;

[0062] Figure 5: a perspective view of the particle measuring device according to the invention;

[0063] Figure 6: an enlarged view of detail A in Figure 5;

[0064] Figure 7: a sectional view taken along line 7-7 in Figure 6; Figure 8: an enlarged view of detail B in Figure 4;

[0065] Figure 9: two further particle measuring devices according to the invention in preferred

[0066] Embodiment.

[0067] Figure 1 shows a schematic representation of an advantageous embodiment of the system according to the invention for processing pharmaceutical containers, designated overall by the reference numeral 100. The containers, which are not shown in the drawing, can be, for example, vials, syringes, cartridges, or ampoules. The containers can be stable or non-stable. Non-stable containers, such as syringes, as primary packaging, can be accommodated, for example, in a secondary packaging such as a tub or tray for processing purposes.

[0068] In the system, for example, the containers are first washed with a washing machine 102 and then sterilized in a sterilization tunnel 104.

[0069] The sterilization tunnel 104 is arranged downstream of the washing machine 102, with respect to a feed direction 106 of the containers, and comprises in particular a heating and sterilization zone 108 and an adjoining cooling zone 110. The heating and sterilization zone 108 may, for example, comprise a warming zone 112 and a sterilization zone 114.

[0070] On the output side, the sterilization tunnel 104 has a discharge opening 116.

[0071] Downstream of the feed direction 106, the system 100 comprises a filling machine 118, which in particular comprises a plurality of processing stations 120 for the containers.

[0072] The filling machine 118 comprises a chamber 122 in which an insertion opening 124 is formed, aligned with the discharge opening 116. A partition wall 126 can optionally be arranged at the aligned openings 116, 124. In an open position of the partition wall 126, which can effectively form a bulkhead, the containers can be transported from the cooling zone 110 into the filling machine 118 in a manner not described in detail. In a closed position, the partition wall 126 closes the chamber 122.

[0073] The processing stations 120 comprise, for example, at least one weighing station 128, a filling station 130, and a closing station 132. The stations 128, 130, and 132 can be configured in a manner known to those skilled in the art. As can be seen in particular from Figures 2 to 4, which show a partial view of the sterilization tunnel 104, the latter comprises a chamber 134 with two opposing side walls 136, 138, a ceiling wall 140, and a bottom wall 142. Arranged above the bottom wall 142 is a transport device 144 for the containers, which in this case has a conveyor belt 146 for transporting the containers in a transport direction 148. The transport direction 148 coincides with the feed direction 106.

[0074] A flow device 150 is provided on the ceiling wall 140. A gas is supplied to the chamber 134 via the flow device 150. A gas flow is provided in the chamber 134, preferably in a defined manner with a laminar flow. The gas flow runs from the top, from the ceiling wall 140, downwards to the containers positioned on the conveyor belt 146.

[0075] The flow device 150 comprises at least one filter element 152 on the ceiling wall. In the present example, several filter elements 152 are provided, namely six. However, this number is non-limiting to the present invention.

[0076] With respect to a transverse direction 154, which is oriented transversely and in particular perpendicularly to the transport direction 148, two filter elements 152 are positioned laterally next to one another. In the transport direction 148, three filter elements 152 are positioned one behind the other.

[0077] The flow device 150 may include a unit (e.g., a blower) for generating an overpressure, which generates the flow through the filter elements 152 into the chamber 134. Reference numeral 153 schematically shows such a unit (Figure 3). The unit 153 may, for example, be comprised by the filter element 152 or integrated into it. Alternatively, the unit may be formed separately from the filter element 152, for example, on or in a conveying line that supplies the filter elements 152.

[0078] It is understood that the filter element 152 comprises an active filter medium by which particles within the supplied gas can be effectively retained.

[0079] In this case, gas can also be understood to mean a gas mixture. This is, in particular, air. The filter elements 152 do not each extend over half the width of the chamber 134 in the transverse direction 154. As can be seen, for example, from Figure 4 and can be seen from the side wall 136, the filter element 152 is spaced from the side wall 136 via an edge region 156 on the ceiling wall 140. The same applies on the opposite side for the side wall 138 and the filter element 152 closest to it. A gap 158 is arranged between the filter elements 152 in the transverse direction 154.

[0080] An intermediate element 160 with passage openings for the gas (not shown in the drawing) can be arranged below the ceiling wall 140 (see in particular Figures 4 and 8). The intermediate element 160 is, for example, a perforated sheet.

[0081] The particle measuring device 162 according to the invention, in a preferred embodiment, is arranged on the outlet side of the cooling zone 110 and is shown in detail in particular in Figures 5 to 8. The purpose of the particle measuring device 162 is to detect particles entrained in the gas flow. The number of particles—for example, absolute and / or per unit of time—can be determined to determine the degree of purity in the chamber 134.

[0082] In the present case, chamber 122 of filling machine 118 has a high degree of cleanliness, for example, according to cleanliness class A. It may be desirable for a high degree of cleanliness to also be present within cooling zone 110, especially when partition wall 126 is open. Therefore, it is advisable to monitor chamber 134 for the presence of any unwanted particles. Preferably, the requirements of Annex 1 (GMP) for Good Manufacturing Practice can be met with the aid of the invention.

[0083] The particle measuring device 162 comprises a collecting body 164 and an evaluation unit 166. The evaluation unit 166 is arranged outside the chamber 134 and, for example, is fixed to the side wall 136. Advantageously, the evaluation unit 166 is operatively connected to a control device 168 of the system 100 in order to transmit information about the number of particles detected.

[0084] The evaluation unit 166 comprises a suction unit 170. The suction unit 170 is designed to apply negative pressure to the collecting body 164, described in more detail below, in order to suck out incoming particles. In the present embodiment, the collecting body 164 is designed as a tube 172. The tube 172 is longitudinally extended and extends in a straight line and defines an axis 174. In the present case, the tube 172 is aligned along the transverse direction 154.

[0085] It may be advantageous if the collecting body 164 extends in the transverse direction 154 over at least 75% of the width of the chamber 134. In the present example, the collecting body 164 extends over the entire or substantially entire width of the chamber 134 in the transverse direction.

[0086] The collecting body 164 is fixed to the side wall 136 by means of a sleeve-shaped holding element 176 in the present example.

[0087] A connecting part 178 engages the holding element 176 and is in fluid communication with the tube 172. The connecting part 178 is connected to the evaluation unit 166. This creates a fluid connection from the tube 172 through the connecting part 178 to the evaluation unit 166.

[0088] On the side facing away from the evaluation unit 166, the collecting body 164 can be held on the side wall 138. For example, the side wall 138 can include a receptacle into which the collecting body 164 engages.

[0089] Alternatively, it can be provided that the collecting body 164 has a free end on the side facing away from the evaluation unit 166, which is arranged at a distance from the side wall 138.

[0090] Relative to a height of the chamber 134, the collecting body 164 is arranged at a distance from the ceiling wall 140, wherein the distance in the present case is approximately 25% of the height of the chamber 134 and the height is measured from the transport device 144 to the ceiling wall 140.

[0091] As can be seen particularly from Figures 5 to 7, inlet openings 180 are formed on the tube 172. The tube comprises a casing 182 and forms a channel 184 inside. The inlet openings 180 are formed in the casing 182.

[0092] At the end facing away from the evaluation unit 166, the tube 172 is preferably closed and thus free of an inlet opening. The particles enter the channel through the inlet openings 180, which is subjected to negative pressure. As a result of the negative pressure, they are sucked away and fed to the evaluation unit 166 for analysis.

[0093] As can be seen particularly from Figures 6 and 7, the inlet openings 180 have a round and, in particular, circular cross-section. The inlet openings are aligned radially with respect to the axis 174. Reference numeral 186 indicates an axis of the respective inlet opening 180.

[0094] The drawing also shows that, relative to the longitudinal extent of the tube 172, inlet openings 180 are arranged at different positions on the tube 172. Accordingly, relative to the direction of extension, several spaced-apart inlet openings 180 are provided.

[0095] As further shown in particular in Figures 5 and 6, more than one inlet opening 180 is formed at at least one position, and preferably at all positions, where inlet openings 180 are arranged along the longitudinal extent. In the present example, there are three inlet openings 180. The inlet openings 180 are formed on the casing 182 in the circumferential direction of the tube 172. Adjacent inlet openings 180 are spaced apart by an angular distance of approximately 20° to approximately 30° relative to the axis 174.

[0096] As can further be seen in particular from Figure 5, the tube 172 comprises a plurality of groups 188 of inlet openings 180. Within a group 188 of inlet openings, the distance between adjacent inlet openings 180 relative to the longitudinal extent of the tube 172 is smaller than the distance between adjacent inlet openings 180 of adjacent groups.

[0097] The first-mentioned distance within group 188 is designated in the drawing by reference numeral 190. The second-mentioned distance from adjacent groups 188 is designated in the drawing by reference numeral 192.

[0098] Within each group 188, the spacing 190 is preferably identical, so that equidistant positioning exists within the group 188. Furthermore, the spacing 190 is preferably identical in each of the groups 188. As can be seen from Figures 5 and 8, a group 188 of inlet openings 180 is arranged on the side of the tube 172 facing away from the evaluation unit 166. This side is adjacent to the side wall 138.

[0099] In addition, another group 188 of inlet openings 180 is arranged on the side of the tube 172 facing the evaluation unit 166. This side is adjacent to the side wall 136.

[0100] The groups 188 mentioned in the last two paragraphs are arranged below the surrounds 194 of the filter elements 152 and also below the edge regions 156 of the ceiling wall 140.

[0101] The tube 172 comprises at least one further group 188, and in this case two further groups 188, of inlet openings. These groups are arranged within a tube half 196, relative to the longitudinal extent of the tube 172, with the tube half being arranged centrally between the side facing the evaluation unit 166 and the side facing away from the evaluation unit 166 (Figures 5 and 8). In particular, these two groups 188 of inlet openings 180 are arranged within a tube third 198 in the region of this center.

[0102] These two groups 188 are arranged below the borders 194 of the adjacent filter elements 152 and below the intermediate space 158.

[0103] Between the groups 188 arranged at the ends of the tube 172 and the centrally arranged groups 188 of inlet openings, the tube 172 has a respective section 200, which may be completely or largely free of inlet openings. In the present example, the sections 200 each have a group of three inlet openings 180 arranged in the circumferential direction, essentially centrally between the opposite groups 188 of inlet openings 180.

[0104] Within each group, the number of positions along the longitudinal extent of the tube 172 at which inlet openings 180 are formed is, for example, approximately 5 to approximately 15. In the present example, there are eleven positions, with each position having a group of three circumferentially arranged inlet openings 180.

[0105] The above-described positioning of the inlet openings 180 relative to the longitudinal extent of the tube 172 is based on the consideration that a smaller number of particles entering the chamber 134 can be expected below the filter element 152, since the particles can be effectively retained by the filter medium of the filter element 152. In contrast, the probability may be higher that a larger number of particles can be expected below the surrounds 194 and / or the edge regions 156 and / or the intermediate space 158. This is due, for example, to the fact that there may be small through-openings at the edge regions 156 and in the intermediate space 158, for example due to imperfect weld seams, through which particles can pass.

[0106] The tube 172 can be made in one piece. In the present example, the tube 172 comprises two segments 202 connected to each other in the axial direction. Reference numeral 204 indicates the connection point between the two segments 202. The connection can be made in various ways, for example by welding or screwing.

[0107] In practice, computer-aided modeling shows that the above configuration of the particle measuring device 162 enables reliable detection of particles and determination of the particle count. For example, it has proven advantageous for the cross-sections of the inlet openings 180 to be round, in particular circular. An arrangement of a plurality of inlet openings 180 in the circumferential direction of the tube 172 was considered more advantageous than an alternative design with an elongated hole.

[0108] The particle measuring device 162 according to the invention has the advantage that the collecting body 164, with its compact design and numerous inlet openings 180 arranged thereon, allows for the collection of particles across a large cross-section of the gas flow. Furthermore, only a small amount of space is required within the chamber 134, which is advantageous for uninterrupted transport of the containers.

[0109] Figure 9 shows two particle measuring devices 206 according to the invention, each in a preferred embodiment. Identical reference numerals are used for identical or equivalent features or components of the particle measuring device 162, 206. Reference is made to the above explanations regarding the technical design and advantages.

[0110] The preferably identically designed particle measuring devices 206 can be used in the sterilization tunnel 104 and the system 100 instead of the particle measuring device 162 or in combination with it. The key difference is that the collecting bodies 164 differ from one another. It is provided that the collecting body 164 in the particle measuring device 206 has approximately half the extension of the collecting body 164 of the particle measuring device 162. Consequently, each collecting body 164 extends over substantially half or almost half of the chamber 134 in the transverse direction 154.

[0111] Both particle measuring devices 206 are preferably arranged at the identical position relative to the transport direction 148 and positioned relative to each other such that the two collecting bodies 164 are aligned with each other, as shown in Figure 9.

[0112] List of reference symbols

[0113] System Washing machine Sterilization tunnel Feed direction Heating zone Cooling zone Warming zone Sterilization zone Discharge opening Filling machine Processing station Chamber Inlet opening Partition wall Weighing station Filling station Closing station Chamber , 138 Side wall Ceiling wall Floor wall

[0114] T ransport device Conveyor belt Transport direction Flow device Filter element Unit Transverse direction Edge area Intermediate space Intermediate element Particle measuring device Collecting body Evaluation unit Control device Suction unit

[0115] Pipe

[0116] axis

[0117] Holding element

[0118] connecting part

[0119] Entrance opening

[0120] Coat

[0121] channel

[0122] axis

[0123] Group , 192 distance

[0124] frame

[0125] Pipe half

[0126] Pipe third

[0127] Section

[0128] segment

[0129] liaison office

[0130] Particle measuring device

Claims

PATENT CLAIMS 1. Particle measuring device (162, 206) for a gas-charged chamber (134) of a system (100) for processing pharmaceutical containers, in particular for a sterilization tunnel (104), wherein the containers are accommodated in the chamber (134) and in particular are movable through it, comprising a collecting body (164) which comprises an inlet opening (180) and is positionable in the chamber (134), wherein the collecting body (164) is exposed to a gas flow in the chamber (134), and an evaluation unit (166) which is positionable in particular outside the chamber (134) and is in flow connection with the collecting body (164), wherein particles contained in the gas flow enter the inlet opening (180) and are fed to the evaluation unit (166), characterized in that the collecting body (164) is designed at least in sections as a tube (172) or a tube (172) comprising a jacket (182) and forming an internal channel (184),wherein a plurality of inlet openings (180) of the tube (172) are formed in the jacket (182).

2. Particle measuring device (162, 206) according to claim 1, characterized in that the tube (172) is designed to extend in a straight line.

3. Particle measuring device (162, 206) according to claim 1 or 2, characterized in that the tube (172) is free of an inlet opening (180) on an end side facing away from the evaluation unit (166) and / or that a plurality of inlet openings (180) spaced apart from one another in the direction of extension are provided along a particularly axial longitudinal extension of the tube (172).

4. Particle measuring device (162, 206) according to one of the preceding claims, characterized in that the inlet openings (180) are grouped in the direction of extension of the tube (172) into two or more groups (188) of inlet openings (180), wherein a distance between adjacent inlet openings (180) within a group (188) is smaller than a distance between adjacent inlet openings (180) of different groups (188) from each other, in particular that inlet openings (180) of the same group (188) are arranged equidistant from each other.

5. Particle measuring device (162, 206) according to claim 4, characterized in that at least one of the following applies: a group (188) of inlet openings (180) is arranged on or near a side of the tube (172) facing away from the evaluation unit (166); a group (188) of inlet openings (180) is arranged on or near a side of the tube (172) facing the evaluation unit (166); at least one group (188) of inlet openings (180) is arranged within a pipe half (196), based on its longitudinal extent, wherein the pipe half (196) is arranged centrally between a side facing away from the evaluation unit (166) and a side facing the evaluation unit (166), preferably wherein the at least one group (188) of inlet openings (180) is arranged within a pipe third (198) centrally between a side facing away from the evaluation unit (166) and a side facing the evaluation unit (166).

6. Particle measuring device (162, 206) according to one of the preceding claims, characterized in that at least one of the following applies: the inlet openings (180) are aligned radially with respect to an axis (174) of the tube (172); the inlet openings (180) have a round and in particular circular cross-section; the inlet openings (180) are configured identically.

7. Particle measuring device (162, 206) according to one of the preceding claims, characterized in that, based on a longitudinal extent of the tube (172), two or more inlet openings (180) are arranged at at least one position, in particular three inlet openings (180), wherein an angle between orientations of the inlet openings (180) is approximately 10° to 40°, preferably approximately 20° to 30°.

8. Particle measuring device (162, 206) according to one of the preceding claims, characterized in that the particle measuring device (162, 206) comprises a suction unit (170) for applying negative pressure to the channel (184).

9. Particle measuring device (162, 206) according to one of the preceding claims, characterized in that the tube (172) is formed in one piece or that the tube (172) is multi-segmented with two or more segments (202) connected to one another in the longitudinal direction.

10. Sterilization tunnel (104) for pharmaceutical containers, comprising a chamber (134) with two side walls (136, 138) arranged at a distance from one another, a ceiling wall (140) and a transport device (144) opposite the ceiling wall (140), with which the containers can be transported in a transport direction (148) between the side walls (136, 138) through the chamber (134), wherein a flow device (150) is arranged or formed on or in the ceiling wall (140) for providing a gas flow in the chamber (134), wherein the sterilization tunnel (104) comprises at least one particle measuring device (162, 206) according to one of the preceding claims and the collecting body (164) is positioned in the gas flow in the chamber (134).

11. Sterilization tunnel (104) according to claim 10, characterized in that the sterilization tunnel (104) comprises a cooling zone (110) at which the particle measuring device (162, 206) is arranged, wherein the collecting body (164) is arranged in a cooling gas stream, wherein the collecting body (164) is preferably arranged on the outlet side of the cooling zone (110).

12. Sterilization tunnel (104) according to claim 10 or 11, characterized in that at least one of the following applies: the collecting body (164) is held on at least one side wall (136, 138); the evaluation unit (166) is arranged outside the chamber (134); the collecting body (164) has, on its side facing away from the evaluation unit (166), a free end which is arranged at a distance from the side wall (136, 138).

13. Sterilization tunnel (104) according to one of claims 10 to 12, characterized in that at least one of the following applies: the tube (172) is oriented in a transverse direction (154) of the sterilization tunnel (104), which is oriented transversely and in particular perpendicular to the transport direction (148); the collecting body (164) is arranged at a distance from the ceiling wall (140), wherein the distance from the ceiling wall (140) is less than approximately one-third of the height of the chamber (134), measured as the distance of the transport device (144) from the ceiling wall (140); the collecting body (164) extends over at least 75% of the width of the chamber (134), based on a direction perpendicular to the transport direction (148).

14. Sterilization tunnel (104) according to one of claims 10 to 13, characterized in that the flow device (150) comprises at least one filter element (152) arranged in the ceiling wall (140) or forming the ceiling wall (140) for filtering the gas flowing into the chamber (134), wherein the collecting body (164) is arranged below the at least one filter element (152).

15. Sterilization tunnel (104) according to claim 14, characterized in that at least one of the following applies: Inlet openings (180) are arranged below a border (194) of the at least one filter element (152) and / or an edge of an opening in the ceiling wall (140) into which the at least one filter element (152) is inserted; with respect to the longitudinal extent of the tube (172), a respective group (188) of inlet openings (180) is positioned below a respective edge region (156) of the ceiling wall (140); with respect to the longitudinal extent of the tube (172), a section (200) of the tube (172) free of a group (188) of inlet openings (180) is arranged below a central region of the at least one filter element (152), which takes up approximately one-third or more of the extent of the filter element (152).

16. Sterilization tunnel (104) according to claim 14 or 15, characterized in that two filters are positioned next to one another with respect to a transverse direction (154) transversely and in particular perpendicularly to the transport direction (148).

17. Sterilization tunnel (104) according to one of claims 10 to 16, characterized by two particle measuring devices (162, 206), the collecting bodies (164) of which are preferably aligned along a transverse direction (154) transversely and in particular perpendicularly to the transport direction (148) and are aligned with one another.

18. Sterilization tunnel (104) according to one of claims 10 to 17, characterized in that the transport device (144) comprises at least one conveyor belt (146) on which the containers can be transported in an upright position.

19. Plant (100) for processing pharmaceutical containers, comprising a filling machine (118) which has a filling station (130) for filling the containers and an insertion opening (124) through which the containers can be fed to the filling machine (118), and a sterilization tunnel (104) according to one of claims 10 to 18, which is arranged upstream of the filling machine (118) in a feed direction (106), wherein a discharge opening (116) of the sterilization tunnel (104) is aligned with the insertion opening (124).

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