A pharmaceutical product collection device, method, and pharmaceutical manufacturing system

Abstract

Disclosed is a pharmaceutical product collection device connectable to an outlet of a pharmaceutical processing system, the pharmaceutical product collection device comprising an inlet for receiving pharmaceutical products from the outlet of the pharmaceutical processing system, a product storing device, a labelling device, a product diversion device connected to the inlet and to the product storing device, and a control unit operably connected to the labelling device. Further disclosed is a method of collecting pharmaceutical products from a pharmaceutical processing system and a pharmaceutical manufacturing system comprising a pharmaceutical processing system and the pharmaceutical product collection device.

Description

[0001] Title of Invention

[0002] A pharmaceutical product collection device, method, and pharmaceutical manufacturing system

[0003] Technical Field

[0004] The present invention relates to a pharmaceutical product collection device, a method of collecting pharmaceutical products, and a pharmaceutical manufacturing system.

[0005] Background Art

[0006] Manufacturing of pharmaceutical products, such as tablets, capsules, pellets or the like, are typically manufactured from one or more powders comprising active pharmaceutical ingredients and excipients. When manufacturing pharmaceutical products, a high degree of containment is generally required to ensure the quality of the output pharmaceutical products as well as reduce the risk of health hazards for workers and operators of the pharmaceutical processing systems. As a consequence, pharmaceutical processing systems are generally high containment systems.

[0007] Often, the manufactured pharmaceutical products are output from a pharmaceutical processing system for packaging or further processing, e.g. coating in case of a tablet. Such manufactured products are typically output into larger bins to be transported to the next processing step or for packaging. Such bins may contain one or more production batches of manufactured pharmaceutical products and are generally not within the containment of the pharmaceutical processing system.

[0008] To ensure quality of the manufactured pharmaceutical products, samples are occasionally collected from an output of the pharmaceutical processing system and subsequently investigated further and / or used to monitor that the pharmaceutical processing system is operating according to intention. In some pharmaceutical processing systems, a separate output is provided from the pharmaceutical processing system for samples, such that some of the manufactured pharmaceutical products are diverted to a sample outlet.

[0009] When manufacturing pharmaceutical products, there, thus, remain a need for an improved collection and identification of output pharmaceutical products.

[0010] Summary of the Invention

[0011] An object of the present invention is to address the above-mentioned drawbacks, in particular to provide a pharmaceutical product collection device, by which an improved collection and identification of output pharmaceutical products from a pharmaceutical processing system may be provided.

[0012] In a first aspect, this and further objects are achieved by a pharmaceutical product collection device connectable to an outlet of a pharmaceutical processing system, wherein the pharmaceutical product collection device comprises: an inlet for receiving pharmaceutical products from the outlet of the pharmaceutical processing system, a product storing device configured to arrange one or more pharmaceutical products in a product container and to seal the product container, a labelling device configured to label the product container, a product diversion device connected to the inlet and to the product storing device, wherein the product diversion device is configured to divert pharmaceutical products from the inlet to the product storing device, and a control unit operably connected to the labelling device, wherein the control unit is configured to provide to the labelling device at least one data value indicating a production parameter of said pharmaceutical products and configured to control the labelling device to label the product container, wherein the label of the product container comprises information indicative of the production parameter.

[0013] It has been realized that by providing a system which allows for diverting pharmaceutical products from an outlet of a pharmaceutical processing system to a product storing device and sealing and labelling the pharmaceutical products in a product container, an improved collection of pharmaceutical products may be achieved, since the pharmaceutical products are diverted to the product storing device, arranged in the product container and sealed, in turn allowing for the output pharmaceutical products to remain within containment.

[0014] By the arrangement of the pharmaceutical products in containers and subsequent sealing of the containers, exposure to operators is furthermore reduced as this may be performed during production and within containment of the system so that the sealed containers are the items to be handled by the operators.

[0015] By the system moreover labelling the product container, an easy identification of the pharmaceutical products may be provided as the label indicates the production parameter.

[0016] In an example, where the pharmaceutical product collection device is used to collect samples of pharmaceutical product from a production, i.e. a certain subset of a production batch and / or stream of output pharmaceutical products, an improved sampling may moreover be achieved as the sealing of the product containers with the products in them and labelling with production parameter allows an easy monitoring of the production and, by the sealing, reduce the risk of contamination of the output pharmaceutical product by allowing the output pharmaceutical product(s) to remain within containment. However, similar advantages occur during production where all or substantially all output pharmaceutical products are diverted to the product storing device, arranged in the product container, sealed and labelled with a label comprising data indicative of a production parameter.

[0017] It will be appreciated throughout this disclosure that the product storing device may be configured to seal the product container subsequently to arranging the one or more pharmaceutical products in the product container.

[0018] By one or more pharmaceutical products may herein be understood one or more processed pharmaceutical products, such as tablets, pellets, capsules, or the like, comprising an active pharmaceutical ingredient and optionally excipients. The one or more pharmaceutical products may be end products, such as tablets or capsules to be packaged and distributed, or may be intermediate products, such as uncoated tablets, for further processing.

[0019] The labelling device may be configured to label the product container subsequent to the storing of pharmaceutical products in the product container and sealing of the product container.

[0020] The control unit may be further configured to determine, from the pharmaceutical processing system, a production parameter, or data indicative of a production parameter. Alternatively or additionally, the control unit may be configured to generate a production parameter, such as a time stamp.

[0021] The production parameter may be and / or comprise a time stamp, indicating a time of the production, such as a clock or a timer time stamp. Alternatively, the production parameter may be and / or comprise any production related information pertaining to the pharmaceutical product, such as a batch number, a product name or name code, an identifier of the pharmaceutical processing system or parts thereof, one or more ingredients of the pharmaceutical product, such as an active pharmaceutical ingredient, an ingredient composition, a product type, such as a tablet, capsule, pellet, granulate, final product or intermediate product to be further processed, or the like.

[0022] The product diversion device may be configured to repeatedly and / or frequently, such as by a frequency corresponding to time intervals, divert a respective subset of pharmaceutical products to the product storing device.

[0023] The labelling device may alternatively be a printing device or the like. The labelling / printing device may be configured to generate a label, such as print on a label, to be applied to the product container. In some examples, the labelling / printing device may be configured to apply the label to the product container. Alternatively or additionally, the labelling / printing device may be configured to print and / or apply a label on the product container, such as print and / or apply the label directly on the product container.

[0024] The control unit or labelling device may be configured to generate the label based on at least one data value. Alternatively or additionally, the labelling device may be configured to generate the label in response to receiving the at least one data value from the control unit. The label may be and / or comprise any one of a bar code, a QR code, a text, a time stamp, or the like.

[0025] The product diversion device may be configured to transport the one or more pharmaceutical products to the product storing device. Such transportation may be provided in any well-known manner, such as by means of a conveyor belt, by means of applying a vacuum, by gravity, or the like. In some examples, the product diversion device may be configured to divert the subset of pharmaceutical products to the product storing device by means of a transportation system, such as a conveyor belt, an Archimedes screw, a vibrator tray, and / or a vacuum transport.

[0026] Any transportation device may be encompassed or comprised by the product diversion device. The product diversion device may be configured to transport the pharmaceutical products in a contained manner and / or without breaking containment. For instance, the product diversion device may fulfil or substantially fulfil the same containment requirements as the pharmaceutical processing system, to which the pharmaceutical product collection device is connected.

[0027] In other embodiments, the product diversion device may be dispersed with, e.g. if a similar device is present in the pharmaceutical processing system. In such embodiments, the inlet may be connected, such as directly connected, to the product storing device so that pharmaceutical products entering through the inlet of the pharmaceutical product collection device, enters the product storing device. In some embodiments, the product diversion device may alternatively be denoted a product transportation device.

[0028] Alternatively or additionally, the inlet may be configured to provide a contained connection to the outlet of the pharmaceutical processing system, for instance so that the pharmaceutical product collection device in a connected state with the outlet of the pharmaceutical processing system, is a contained system and / or is part of a contained system.

[0029] The inlet may be connected to the product diversion device to allow pharmaceutical products entering via the inlet to proceed to the product diversion device and thereby to the product storing device. The product storing device may be operably connected to the labelling device so that the product storing device at least subsequent to sealing the product container, comprising at least one pharmaceutical product, provides the sealed product container to the labelling device. A transportation device, such as a conveyor, transportation belt, or any other transportation device may be present, e.g. forming part of the operable connection, to allow for transport from the product storing device to the labelling device.

[0030] The labelling device may be configured to output a labelled, sealed product container, comprising at least one pharmaceutical product.

[0031] In some embodiments, the pharmaceutical product collection device may be a contained system. Alternatively or additionally, elements of the pharmaceutical product collection device, such as the inlet, the product storing device, the labelling device, the product diversion device, and / or any transportation devices (where present) may be and / or form part of a contained system.

[0032] By the term "contained system" is herein to be understood that a system is to fulfil certain requirements to containment, i.e. that the system when functioning is at least dust tight. Equally, any part denoted herein as "contained" may be configured so that the part, at least during use, fulfils certain requirements to containment, i.e. that the system when functioning is at least dust tight. Correspondingly, a contained system may be a system which when functioning is configured to prevent that extensive amounts, such as detectable amounts and / or amounts over a certain threshold, of pharmaceutical components are emitted from the contained system into the surroundings, such as into a room in which it is arranged. By "contained" may herein be understood that a respective system and / or part is to have a containment capability of dust containment of up to 10 pg per m3, preferably, up to 1 pg per m3. Correspondingly, a contained system or part may be a system or part, which when functioning is configured to have a dust containment of up to 10 pg per m3, preferably, up to 1 pg per m3.

[0033] The pharmaceutical processing system may comprise or may be a tablet handling device, such as a tablet press, a tablet chute connected to a tablet press, or a tablet coating device connected to tablet press and / or to a tablet chute. Alternatively or additionally, the pharmaceutical processing system may comprise an extruder for generating pellets. Alternatively or additionally, the pharmaceutical processing system may be or comprise any one of a tablet coater, a tablet press, a tablet chute of a tablet press, a capsule manufacturing system, a pharmaceutical blender for powder, a pharmaceutical tester, a pharmaceutical product conveyor, a pharmaceutical product deduster, a pharmaceutical hopper, and / or an extruder for generating granulate. The output pharmaceutical product may be a tablet, a capsule, a coated tablet, a pellet, or the like.

[0034] The product collection device may be a bagging device. Alternatively or additionally, the product container may be a bag. The container may alternatively be any other type of container, such as a box, a canister, a cylinder with a plug / lid, or the like.

[0035] By sealing may herein be understood a heat sealing or any other type of sealing. In particular, the sealing may be a substantially air-tight sealing. Alternatively or additionally, the sealing may comprise mounting a lid to the container, plugging the container, or the like.

[0036] In some embodiments, the product diversion device is configured to selectively divert a subset of pharmaceutical products of a stream of pharmaceutical products from the inlet to the product storing device at predetermined intervals.

[0037] Thereby, an easy sampling allowing for an easy identification of the sampled pharmaceutical product afterwards may be allowed for by means of the sorting of the pharmaceutical products by the product diversion device and labelling of the product container.

[0038] Alternatively or additionally, the product diversion device may be configured to selectively divert a subset of pharmaceutical products of a stream of pharmaceutical products from the inlet to the product storing device, such as at predetermined intervals.

[0039] The subset may be any number of pharmaceutical products. In some examples, the subset comprises or consists of between 1 and 500 pharmaceutical products, such as between 1 and 200 pharmaceutical products.

[0040] The predetermined interval may be a predetermined time interval. For instance, a predetermined time interval may be between 2 seconds and 20 minutes, such as between 3 seconds and 15 minutes, such as between 5 seconds and 10 minutes. Alternatively or additionally, a predetermined time interval may be determined depending on the pharmaceutical product(s).

[0041] The predetermined interval may alternatively or additionally be a predetermined product interval. As an example, a certain number of pharmaceutical products may be diverted to the product storing device by the product diversion device with every given number of output pharmaceutical products from the output of the pharmaceutical processing system. As one example, the product diversion device may be configured to divert between 1 and 200 pharmaceutical products to the product storing device with every 1000 or 2000 output pharmaceutical products from the pharmaceutical processing system.

[0042] The product storing device may be configured to arrange the one or more pharmaceutical products in a respective product container at each predetermined interval and to seal it. Thus, at each predetermined interval, a sealed and labelled product container containing pharmaceutical product(s) may be provided.

[0043] The control unit may be configured to control the product diversion device to divert the subset of pharmaceutical products into the product storing device at the predetermined intervals.

[0044] The control unit may additionally be configured to be operably connected to a control system of the pharmaceutical processing system. The control system may be any well-known control system, such as a product data system and / or a Supervisory Control And Data Acquisition SCADA system configured controlling and / or obtaining data pertaining to the pharmaceutical product production (or processing) by the pharmaceutical processing system. Such data pertaining to the production may be production batch reports, time stamps, clocks, or the like. It will be appreciated that control systems, such as SCADA systems, are well-known in the art and that any such well-known system may be used.

[0045] The control unit may be configured to obtain at least one data value from and / or based on data from any potential control system, such as time stamps, clock values, batch IDs, batch reports, or the like from the control system of the pharmaceutical processing system.

[0046] The control unit may comprise a processing unit and a memory comprising instructions causing the processing unit to perform the functions, i.e. obtaining the data value and provide this to the labelling device. The processing unit may be and / or comprise any processing unit, such as one or more of a central processing unit (CPU), a microcontroller unit (MCU), a field-programmable gate array (FPGA), a programmable logic controller (PLC), or the like. Correspondingly, the memory may be and / or comprise any type of memory, such as random-access memory (RAM), read-only memory (ROM), or the like.

[0047] In some embodiments, the control unit provides the data value(s) to the labelling device. The labelling device may then use the latest provided data value(s) when generating the label and labelling the product container. As an example, the labelling device may label the product container upon determining that a product container, e.g. a sealed product container, is received, or in response to an operator requesting the labelling device to label the product container.

[0048] In some embodiments, the control unit is operably connected to the product diversion device. The control unit may additionally be configured to generate a data value, such as a respective data value, of the at least one data value at each predetermined interval. Correspondingly, the data value may be a data value corresponding to the specific samples, again allowing for an improved monitoring of the pharmaceutical processing system and / or the output pharmaceutical products.

[0049] In some embodiments, the data value(s), such as each data value, may be unique for each subset of pharmaceutical product.

[0050] The one or more data value(s), such as each data value, may comprise information about an active pharmaceutical ingredient in the output pharmaceutical product, a batch number, an identification of the pharmaceutical processing system, a time stamp of the manufacturing time of the pharmaceutical product(s), a production facility location, a manufacturing date of the pharmaceutical product(s), a type of pharmaceutical product, such as whether it is a tablet, a capsule, or the like.

[0051] Generating a data value at each time interval may alternatively be, refer to, and / or comprise updating the data value at each time interval. The control unit may be configured to provide the updated data value(s), such as each updated data value, to the labelling device, such as at each time interval. The updated data value may, for instance, comprise or be an updated time stamp.

[0052] In some embodiments, the control unit may be configured to be operatively connected to a control unit of the pharmaceutical processing system and / or may be configured to obtain information about the pharmaceutical processing system from a database, such as a central database, a server, or a central processing unit of a control system for controlling the pharmaceutical processing system.

[0053] In some embodiments, the product diversion device is configured to divert the subset of pharmaceutical products to the product storing device during a predetermined time period at each predetermined interval.

[0054] Thereby a certain number of pharmaceutical products may be stored at each predetermined interval, so that a similar or identical number of pharmaceutical products is collected in a product container at each interval. In some embodiments, the predetermined interval is a pre-set interval.

[0055] Alternatively or additionally, the predetermined interval is determined in response to input from an operator.

[0056] Thereby, a sampling of the pharmaceutical products may be performed upon request from an operator and / or automatically periodically.

[0057] Input from an operator may be an input to perform a sample, causing the product diversion device to divert the subset of the pharmaceutical products into the product storing device. The predetermined intervals may, thus, be a time interval between the operator input, e.g. samples being requested by the operator, and / or a number of tablets passing by without being diverted by the product diversion device in between the operator input, e.g. samples being requested by the operator.

[0058] The pharmaceutical product collection device may comprise a user interface allowing for an operator to provide an input to indicate that the product diversion device is to selectively divert pharmaceutical products, such as a subset of the pharmaceutical products, to the product storing device. The user interface may be or comprise any known user interface, such as a button, a switch or the like, implemented mechanically and / or electronically. In some embodiments, the pharmaceutical product collection device may comprise and / or be configured to be connected to a display device, such as a touch screen device, comprising the user interface. The control unit may be configured to, in response to receiving an operator input, e.g. from a user interface, indicating that one or more pharmaceutical products is to be diverted to the product storing device, cause the product diversion device to selectively divert one or more pharmaceutical products, such as the subset, to the product collection device.

[0059] Where the predetermined interval is a pre-set interval, the pre-set interval may be a pre-set time interval or a pre-set number of pharmaceutical products passing by without being diverted to the product storing device by the product diversion device. The pharmaceutical product collection device may, e.g., during a production or batch production of the pharmaceutical processing system, pharmaceutical product(s) is / are diverted to the product collection device by the product diversion device at the pre-set interval and / or with a pre-set periodicity corresponding to the pre-set interval. As an example, a pre-set time interval may, correspondingly, result in that every n seconds or minutes, a sampling is made, wherein a subset of products are selectively diverted to the product storing device. As another example, a pre-set interval may, correspondingly, result in that for every n pharmaceutical products in the stream of products, a sampling is made, wherein a subset of products are selectively diverted to the product storing device.

[0060] In some embodiments, the product diversion device is configured to selectively divert a subset of pharmaceutical products of a stream of pharmaceutical products from the inlet to the product storing device. The product diversion device may be configured to do so in response to an operator input as set out in the preceding.

[0061] In some embodiments of the pharmaceutical product collection device, the product diversion device is configured to: during a first time span, divert a first subset of pharmaceutical products to the product storing device, during a second time span, divert no pharmaceutical products to the product storing device, and during a third time span, divert a second subset of pharmaceutical products to product storing device.

[0062] Thereby samples may be obtained periodically.

[0063] The product storing device may be configured to arrange the first and second subsets of pharmaceutical products in individual containers, i.e. a first and a second container, and to seal the individual containers. The control unit may be configured to provide a first data value indicating a production parameter of the first subset of pharmaceutical products and to control the labelling device to label the product container of the first subset, i.e. the first container, so that the label of the product container of the first subset comprises information indicative of the production parameter of the first subset. The control unit may be configured to provide a second or updated data value indicating a production parameter of the second subset of pharmaceutical products and to control the labelling device to label the product container of the second subset, i.e. the second container, so that the label of the container of the second subset comprises information indicative of the production parameter of the second subset.

[0064] The predetermined interval may be a predetermined time interval. The time difference between first time span and third time span may be and / or correspond to the predetermined time interval. Alternatively, the predetermined interval may be a predetermined pharmaceutical product interval. The first subset and the second subset may comprise an identical or different number of pharmaceutical products.

[0065] In some embodiments, the pharmaceutical product collection device further comprises a sensor configured to determine a number of pharmaceutical products in a stream of pharmaceutical products.

[0066] The sensor may be any known sensor, such as infrared (I R) sensor, a nearinfrared (NIR) sensor, or the like.

[0067] The sensor may be configured to count a number of pharmaceutical products in the stream of pharmaceutical products. The stream of pharmaceutical products may be a stream of pharmaceutical products present in the pharmaceutical processing system, such as at the outlet of the pharmaceutical processing system. Correspondingly, the sensor may be arranged to determine a number of pharmaceutical products in the pharmaceutical processing system, such as at the outlet of the pharmaceutical processing system. Alternatively or additionally, the stream may be a stream of pharmaceutical products present at the inlet of the pharmaceutical product collection device. The sensor may reset the counter upon with each time interval, i.e., after a subset of pharmaceutical products have been diverted to the product collection device by the pharmaceutical product diversion device.

[0068] In some embodiments, the product diversion device is configured to divert a respective subset of pharmaceutical products to the product storing device in response to the sensor determining that the number of pharmaceutical products in the stream of pharmaceutical products has reached a predetermined product interval.

[0069] Thereby a sample based on the number of output pharmaceutical products may be obtained, thereby allowing for an efficient sampling.

[0070] Alternatively or additionally, the predetermined interval is a predetermined product interval.

[0071] Alternatively or additionally, the pharmaceutical product collection device may further comprise a sensor configured to determine a number of pharmaceutical products delivered to the product storing device and / or to the container, such as to each container. The sensor may be any known sensor, such as infrared (IR) sensor, a near-infrared (NIR) sensor, or the like. The sensor may count a number of pharmaceutical products.

[0072] In some embodiments, the information indicative of the production parameter comprises one or more of a production time of the pharmaceutical product, a sample number, or a name of at least a pharmaceutical component of the pharmaceutical product.

[0073] Thereby, the pharmaceutical product(s) in the container(s) may easily be identified by means of the label provided on the product container.

[0074] In some embodiments, the pharmaceutical product collection device further comprises a storage rack, configured to store the product container after it has been sealed.

[0075] Thereby, for instance where samples of a production are collected and arranged in product containers, the pharmaceutical product(s) in the containers may be arranged for an easier collection and inspection. The storage rack may be any storage device configured to arrange and store the product containers.

[0076] In some embodiments, the inlet of the pharmaceutical product collection device is configured to be connected to a sample outlet of a tablet chute of a pharmaceutical processing system.

[0077] According to a second aspect of the present invention, there is provided a method of collecting pharmaceutical products from a pharmaceutical processing system, the method comprising the steps of, a) providing a pharmaceutical product collection device according to the first aspect of the present invention and connecting the inlet of the pharmaceutical product collection device to an outlet of the pharmaceutical processing system, b) during operation of the pharmaceutical processing system, diverting, by the product diversion device, pharmaceutical products from a stream of pharmaceutical products in the pharmaceutical processing system to the product storing device, c) collecting, by the product storing device, the pharmaceutical products in a product container, d) sealing, by the product storing device, the product container, e) providing, by the control unit to the labelling device, at least one data value indicating a production parameter of said pharmaceutical products, and f) labelling, by the labelling device, the product container, wherein the label of the product container comprises information indicative of the production parameter.

[0078] The method according to the second aspect may provide the same or identical advantages and benefits described in relation to the pharmaceutical product collection device according to the first aspect. It will be appreciated that any embodiment disclosed in relation to the product collection device according to the first aspect may equally apply to the method according to the second aspect of the invention.

[0079] The steps of the method may occur in various orders, such as a), b), c), d), e), f), or a), b), c), e), d), f), or a), e), b), c), d), f), or the like.

[0080] In particular, it will be appreciated that step e) may occur prior to, subsequent to, or simultaneously with any one of steps b), c), d).

[0081] In some embodiments, the method comprises repeating, during operation of the pharmaceutical processing system, steps b)-f).

[0082] In some embodiment, the diversion of the subset of pharmaceutical products to the product storing device occurs during a predetermined time period at each predetermined interval.

[0083] Alternatively or additionally, in some embodiments, step b) comprises diverting a subset of pharmaceutical products from the stream of pharmaceutical products of the pharmaceutical processing system to the product storing device at predetermined intervals.

[0084] In some embodiments, step b) comprises the diverting the subset of pharmaceutical products to the product storing device during a predetermined time period at each predetermined interval.

[0085] In some embodiments, the method further comprises repeating steps b)-f) at each predetermined interval.

[0086] The production parameter may be a first production parameter. The subset in steps b)-f) may be a first subset. Step b) may comprise, during a first time period, diverting a first subset of pharmaceutical products to the product collection device.

[0087] Alternatively or additionally, the method may further comprise: g) diverting, by the product diversion device, a second subset of pharmaceutical products to the product storing device during a second time period. h) performing steps c)-f) for second subset

[0088] The time difference between first and second time spans may be a time interval, such as the pre-determined time interval.

[0089] According to a third aspect of the invention, there is provided a pharmaceutical manufacturing system comprising, a pharmaceutical processing system for processing pharmaceutical components to generate pharmaceutical products comprising an outlet for pharmaceutical products, and a pharmaceutical product collection device according to the first aspect of the present invention, wherein the inlet of the pharmaceutical product collection device is connected to the outlet of the pharmaceutical processing system.

[0090] The pharmaceutical manufacturing system according to the third aspect of the present invention may provide the same or identical advantages and benefits described in relation to the pharmaceutical product collection device according to the first aspect and / or to the method according to the second aspect. It will be appreciated that any embodiment disclosed in relation to the product collection device according to the first aspect and / or to the method according to the second aspect of the invention may equally apply to the pharmaceutical manufacturing system according to the third aspect of the present invention.

[0091] In some embodiments of the pharmaceutical manufacturing system, the pharmaceutical processing system is one or more of a tablet coater, a tablet press, a tablet chute of a tablet press, a capsule manufacturing system, a blender for powder, and / or an extruder for generating granulate.

[0092] Where the pharmaceutical processing system is a tablet chute of a tablet press, the outlet thereof may be a sample outlet of the tablet chute.

[0093] The different aspects of the present invention can be implemented in different ways including a pharmaceutical product collection device connectable to an outlet of a pharmaceutical processing system, a method of collecting pharmaceutical products from a pharmaceutical processing system, and a pharmaceutical manufacturing system comprising a pharmaceutical processing system and a pharmaceutical product collection device as described above and in the following, each yielding one or more of the benefits and advantages described in connection with at least one of the aspects described above, and each having one or more preferred embodiments corresponding to the preferred embodiments described in connection with at least one of the aspects described above and / or disclosed in the dependent claims. Furthermore, it will be appreciated that embodiments described in connection with one of the aspects described herein may equally be applied to the other aspects.

[0094] Brief Description of Drawings

[0095] In the following description embodiments of the invention will be described with reference to the drawings, in which

[0096] FIG. 1 is a schematic block diagram of an embodiment of a pharmaceutical manufacturing system comprising a pharmaceutical product collection device according to the present invention,

[0097] FIG. 2 is a schematic flow diagram of an embodiment of a method of collecting pharmaceutical products according to an aspect of the present invention, and

[0098] FIG. 3 is a schematic block diagram of an embodiment of a pharmaceutical manufacturing system comprising a pharmaceutical product collection device according to the present invention.

[0099] Detailed description

[0100] The present invention will now be described in more detail hereinafter with reference to the accompanying drawings, in which embodiments of the invention is shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided for thoroughness and completeness.

[0101] FIG. 1 shows a schematic illustration of an embodiment of a pharmaceutical manufacturing system 1 comprising a pharmaceutical product collection device 3 according to the present invention. The pharmaceutical product collection device 3 is connectable to an outlet 20 of the pharmaceutical processing system 2.

[0102] The pharmaceutical product collection device 3 comprises an inlet 30 for receiving pharmaceutical products from the outlet 20 of the pharmaceutical processing system 2. The inlet 30 of the pharmaceutical product collection device 30 is connected so that pharmaceutical products output at the outlet 20 of the pharmaceutical processing system 2 can be received at the inlet 30 of the pharmaceutical product collection device 3.

[0103] The pharmaceutical product collection device 3 further comprises a product storing device 32 configured to arrange one or more pharmaceutical products in a product container and to seal the product container.

[0104] The pharmaceutical product collection device 3 further comprises a labelling device 33 configured to label the product container. The labelling device 33 is illustrated as connected to the product storing device 32 to illustrate that the labelling device receives the sealed product container(s) from the product storing device 32 and labels these.

[0105] The pharmaceutical product collection device 3 further comprises a product diversion 31 device connected to the inlet 30 and to the product storing device 32. The product diversion device 31 is configured to divert pharmaceutical products from the inlet 30 to the product storing device 32.

[0106] The pharmaceutical product collection device 3 further comprises a control unit 34 operably connected to the labelling device 33. The control unit 34 is configured to provide to the labelling device 33 at least one data value indicating a production parameter of said pharmaceutical products and configured to control the labelling device 33 to label the product container, wherein the label of the product container comprises information indicative of the production parameter.

[0107] The pharmaceutical processing system 2 is a tablet press and the outlet is an outlet of a tablet chute of the pharmaceutical processing system 2. In other embodiments, the outlet 20 may be an outlet for connecting a tablet chute and the product diversion device 31 may be and / or may comprise a tablet chute. In these and other embodiments, the product diversion device 31 may be and / or may comprise a transportation system for transporting the pharmaceutical products to the product storing device 32. It will be appreciated that in other embodiments, the pharmaceutical processing system 2 may be an extruder configured to extrude granulates or pellets as pharmaceutical products and output them via outlet 20. In yet other embodiments, the pharmaceutical processing system 2 may be configured to produce and output capsules via outlet 20 and / or may be configured to receive and coat tablets and output coated tablets via outlet 20.

[0108] Fig. 2 shows a schematic flow diagram of an embodiment of a method 4 of collecting pharmaceutical products according to an aspect of the present invention. The method 4 is a method of collecting pharmaceutical products from a pharmaceutical processing system. The method 4 comprises the steps of: providing 40 a pharmaceutical product collection device according to the first aspect of the present invention and connecting the inlet of the pharmaceutical product collection device to an outlet of the pharmaceutical processing system, during operation of the pharmaceutical processing system, diverting 41, by the product diversion device, pharmaceutical products from a stream of pharmaceutical products in the pharmaceutical processing system to the product storing device, collecting 42, by the product storing device, the pharmaceutical products in a product container, sealing 43, by the product storing device, the product container, providing 44, by the control unit to the labelling device, at least one data value indicating a production parameter of said pharmaceutical products, and labelling 45, by the labelling device, the product container, wherein the label of the product container comprises information indicative of the production parameter.

[0109] The pharmaceutical product collection device may be the pharmaceutical product collection device 3 illustrated in Fig. 1. Alternatively or additionally, the pharmaceutical processing system may be the pharmaceutical processing system 2.

[0110] FIG. 3 shows a block diagram of an embodiment of a pharmaceutical manufacturing system 1' comprising a pharmaceutical product collection device 3 according to the present invention.

[0111] The pharmaceutical manufacturing system 1' comprises the pharmaceutical product collection device as described in the preceding with respect to the system 1 illustrated in FIG. 1.

[0112] The pharmaceutical manufacturing system 1' furthermore comprises a pharmaceutical processing system 2' comprising a plurality of outlets 20'. Any one or more of these outlets 20' may be connected to the inlet of the pharmaceutical product collection device 3. One or more pharmaceutical product ingredients, such as one or more active pharmaceutical ingredients and optionally one or more excipients, and / or a blend of pharmaceutical product ingredients is input into the pharmaceutical processing system 2'.

[0113] The pharmaceutical processing system 2' may be a tablet press, a tablet coater, a pharmaceutical tester, a pharmaceutical product conveyor, a pharmaceutical product deduster, a pharmaceutical hopper, a pharmaceutical blender, or the like.

[0114] The pharmaceutical processing system 2' furthermore comprises a control system 21. The control system 21 is a SCADA control system and / or a production data system configured obtain production data, such as production batch reports, and configured to track / trace output pharmaceutical products and generate clock and / or time stamps.

[0115] The control system 21 is in operative connection with the pharmaceutical product collection device 3, i.e. the control unit of the pharmaceutical product collection device 3. The control unit of the pharmaceutical product collection device 3 is configured to obtain data about the production parameter of the pharmaceutical products from the control system 21.

[0116] The pharmaceutical product collection device 3 arranges the pharmaceutical products output at outlet(s) 20' in product containers, seals the product containers and outputs the sealed product container(s) 5 comprising the pharmaceutical products.

[0117] Although some embodiments have been described and shown in detail, the invention is not restricted to them, but may also be embodied in other ways within the scope of the subject matter defined in the following claims. In particular, it is to be understood that other embodiments may be utilized, and structural and functional modifications may be made without departing from the scope of the present invention.

[0118] In device claims enumerating several means, several of these means can be embodied by one and the same item of hardware. The mere fact that certain measures are recited in mutually different dependent claims or described in different embodiments does not indicate that a combination of these measures cannot be used to advantage.

[0119] It should be emphasized that the term "comprises / comprising" when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

[0120] List of reference numerals

[0121] 1 pharmaceutical manufacturing system

[0122] 2 pharmaceutical processing system

[0123] 2' pharmaceutical processing system

[0124] 3 pharmaceutical product collection device

[0125] 4 method

[0126] 5 sealed, labelled product container

[0127] 20 outlet

[0128] 21 control system

[0129] 30 inlet

[0130] 31 product diversion device

[0131] 32 product storing device

[0132] 33 labelling device

[0133] 34 control unit

[0134] 40 method step

[0135] 41 method step

[0136] 42 method step

[0137] 43 method step

[0138] 44 method step

[0139] 45 method step

Claims

Claims1. A pharmaceutical product collection device connectable to an outlet of a pharmaceutical processing system, wherein the pharmaceutical product collection device comprises: an inlet for receiving pharmaceutical products from the outlet of the pharmaceutical processing system, a product storing device configured to arrange one or more pharmaceutical products in a product container and to seal the product container, a labelling device configured to label the product container, a product diversion device connected to the inlet and to the product storing device, wherein the product diversion device is configured to divert pharmaceutical products from the inlet to the product storing device, and a control unit operably connected to the labelling device, wherein the control unit is configured to provide to the labelling device at least one data value indicating a production parameter of said pharmaceutical products and configured to control the labelling device to label the product container, wherein the label of the product container comprises information indicative of the production parameter.

2. The pharmaceutical product collection device according to claim 1, wherein the product diversion device is configured to selectively divert a subset of pharmaceutical products of a stream of pharmaceutical products from the inlet to the product storing device at predetermined intervals.

3. The pharmaceutical product collection device according to claim 2, wherein the control unit is operably connected to the product diversion device, wherein the control unit is configured to generate a data value of the at least one data value at each predetermined interval.

4. The pharmaceutical product collection device according to any one ofthe claims 2-3, wherein the product diversion device is configured to divert the subset of pharmaceutical products to the product storing device during a predetermined time period at each predetermined interval.

5. The pharmaceutical product collection device according to any one of claims 2-4, wherein the predetermined interval is a pre-set interval or wherein the predetermined interval is determined in response to input from an operator.

6. The pharmaceutical product collection device according to any one of claims 2-5, wherein the product diversion device is configured to: during a first time span, divert a first subset of pharmaceutical products to the product storing device, during a second time span, divert no pharmaceutical products to the product storing device, and during a third time span, divert a second subset of pharmaceutical products to the product storing device.

7. The pharmaceutical product collection device according to any one of the preceding claims, wherein the pharmaceutical product collection device further comprises a sensor configured to determine a number of pharmaceutical products in a stream of pharmaceutical products.

8. The pharmaceutical product collection device according to claim 7, wherein the product diversion device is configured to divert a subset of pharmaceutical products to the product storing device in response to the sensor determining that the number of pharmaceutical products in the stream of pharmaceutical products has reached a predetermined product interval.

9. The pharmaceutical product storing device according to any one of thepreceding claims, wherein the information indicative of the production parameter comprises one or more of a production time of the pharmaceutical product, a sample number, or a name of at least a pharmaceutical component of the pharmaceutical product.

10. The pharmaceutical product collection device according to any one of the preceding claims further comprising a storage rack, configured to store the product container after it has been sealed.

11. The pharmaceutical product collection device according to any one of the preceding claims, wherein the inlet of the pharmaceutical product collection device is configured to be connected to a sample outlet of a tablet chute of a pharmaceutical processing system.

12. A method of collecting pharmaceutical products from a pharmaceutical processing system, the method comprising the steps of, a) providing a pharmaceutical product collection device according to any one of claims 1-11 and connecting the inlet of the pharmaceutical product collection device to an outlet of the pharmaceutical processing system, b) during operation of the pharmaceutical processing system, diverting, by the product diversion device, pharmaceutical products from a stream of pharmaceutical products in the pharmaceutical processing system to the product storing device, c) collecting, by the product storing device, the pharmaceutical products in a product container, d) sealing, by the product storing device, the product container, e) providing, by the control unit to the labelling device, at least one data value indicating a production parameter of said pharmaceutical products, and f) labelling, by the labelling device, the product container, wherein thelabel of the product container comprises information indicative of the production parameter.

13. The method according to claim 12 wherein step b) comprises diverting a subset of pharmaceutical products from the stream of pharmaceutical products of the pharmaceutical processing system to the product storing device at predetermined intervals.

14. The method according to claim 13, wherein the diversion the subset of pharmaceutical products to the product storing device occurs during a predetermined time period at each predetermined interval.

15. The method according to any one of claims claim 13-14 further comprising repeating steps b)-f) at each predetermined interval.

16. A pharmaceutical manufacturing system comprising, a pharmaceutical processing system for processing pharmaceutical components to generate pharmaceutical products comprising an outlet for pharmaceutical products, and a pharmaceutical product collection device according to any one of claims 1-11, wherein the inlet of the pharmaceutical product collection device is connected to the outlet of the pharmaceutical processing system.

17. The pharmaceutical manufacturing system according to claim 16, wherein the pharmaceutical processing system is one or more of a tablet coater, a tablet press, a tablet chute of a tablet press, a capsule manufacturing system, a blender for powder, and / or an extruder for generating granulate.

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