APPARATUS AND METHOD FOR THE AUTOMATED MANAGEMENT OF A PROCESSING CHAMBER WITH A CONTROLLED ATMOSPHERE

Abstract

An apparatus and a method for the automated management of the assembly of a machine for processing and/or packaging pharmaceutical products inside an insulated processing chamber, with controlled atmosphere and delimited by walls, at least one of which is provided with at least one access aperture which can be selectively closed by a primary closing unit. The apparatus includes a transport container able to contain one or more assemblable elements which are introduced into or removed from the processing chamber, and which is associated with the access aperture from the outside of the chamber provided with a secondary closing unit able to cooperate with the primary closing unit so that they can be opened to put the inside of the transport container in communication with the inside of the chamber. The apparatus also includes a handling device and a work tool configured to alternately grip or release the assemblable elements.

Claims

1. An apparatus for the automated management of the assembly of a machine for processing and/or packaging pharmaceutical products inside a clean room (12), comprising: a chamber (12) delimited by walls (14), at least one of said walls (14) being provided with at least one access aperture (15) which can be selectively closed by means of a primary closing unit (19′); a processing system (26) for processing the pharmaceutical products comprising at least one modular assemblable element (11), which can be removably coupled to other elements to obtain said processing system, said processing system (26) being housed in said chamber (12); a transport container (20) configured to be associated with said access aperture (15) from the outside of said chamber (12) and provided with a secondary closing unit (20′) able to cooperate with the primary closing unit (19′) of said chamber (12) so that they can be opened in order to put the inside of the transport container (20) in communication with the inside of the chamber (12), said transport container (20) being configured to contain said at least one modular assemblable element (11) that has to be coupled to other elements to obtain said processing system (26), said apparatus being wherein it comprises a handling device (13) housed in said chamber (12) and comprising a mobile work tool (25) configured to alternately grip or release said assemblable element (11) to respectively remove it from said transport container (20) and assemble it in a predeterminate position in order to couple it to other elements so as to obtain said processing system (26) and/or de-couple it from said other elements with which it forms said processing system (26) and return it into said transport container (20).

2. The apparatus as in claim 1, wherein it also comprises a recognition device (41) configured to recognize said at least one assemblable element (11) and send a corresponding recognition signal to said handling device (13).

3. The apparatus as in claim 2, wherein said recognition signal contains information relating to at least one of either the assembly position and/or the direction of assembly of said at least one modular assemblable element (11) on said processing system (26), or the gripping position of said at least one modular assemblable element (11) by said handling device (13).

4. The apparatus as in claim 2, wherein said recognition device (41) comprises at least one sensor configured to acquire images for recognizing said assemblable element (11).

5. The apparatus as in claim 2, wherein said assemblable element (11) comprises an identification code for its recognition by said recognition device (41).

6. The apparatus as in claim 1, wherein said work tool (25) comprises a gripper formed by a first gripping element (25a) and a second gripping element (25b) cooperating with each other and mobile with respect to each other to move reciprocally toward/away from each other in order to respectively grip and release said modular assemblable element (11).

7. The apparatus as in claim 1, wherein said handling device (13) comprises a robotic automatic handler, preferably configured as an anthropomorphic robot with at least six work axes, which is controlled by a control and command unit (40).

8. The apparatus as in claim 1, wherein said processing system (26) is configured as a transport system to transport the pharmaceutical products inside said clean room.

9. The apparatus as in claim 6, wherein said at least one modular assemblable element (11) is formed by a transport element (31, 32) on which the pharmaceutical products advance to obtain said transport system.

10. The apparatus as in claim 1, wherein said assemblable elements (11) comprise a hopper (28) and/or a collection container (29) which can be associated with said processing system (26).

11. A method for the automated assembly of a machine for processing and/or packaging pharmaceutical products inside a clean room (12), delimited by walls, at least one of said walls (14) being provided with at least one access aperture (15) which can be selectively closed by a primary closing unit (19′), said method comprising the steps of: associating a transport container (20) outside of said chamber (12), in correspondence with said access aperture (15), said transport container (20) being provided with a secondary closing unit (20′) able to cooperate with said primary closing unit (19′) so that they can be opened in order to put the inside of the transport container (20) in communication with the inside of the chamber (12); opening said primary (19′) and secondary (20′) closing unit, to put the inside of said chamber (12) in communication with the inside of said transport container (20); removing at least one modular assemblable element (11) from said transport container (20) and assembling it in a predeterminate position on said system (26) for processing pharmaceutical products, wherein said steps of opening, extracting and removing are carried out by means of a handling device (13) housed in said chamber (12), said handling device (13) grips said at least one modular assemblable element (11) with a mobile work tool (25) and provides to assemble the pharmaceutical products in a predeterminate position of the processing system (26).

12. The method as in claim 11, wherein comprises a step of recognizing said at least one modular assemblable element (11) by a recognition device (41) in which a corresponding recognition signal is sent to said handling device (13).

13. The method as in claim 12, wherein said recognition signal contains information relating to the position and/or direction of assembly of said at least one modular assemblable element (11) on said processing system (26), and/or to the gripping position of said at least one modular assemblable element (11) by said handling device (13).

14. The method as in claim 11, wherein the step of removing the at least one assemblable element (11) is carried out by means of a step of extracting a support slider (23) from said transport container (20), said at least one modular assemblable element (11) being housed in said support slider (23), and subsequently by means of a step of extracting said at least one modular assemblable element (11) from said support slider (23).

15. The method as in claim 14, wherein after said step of removing and assembling said at least one modular assemblable element (11) it is provided to reintroduce said support slider (23) into said transport container (20) by means of said handling device (13), and close said primary closing unit (19′) by means of said handling device (13).

Description

DESCRIPTION OF THE DRAWINGS

[0042] These and other aspects, characteristics and advantages of the present invention will become apparent from the following description of some embodiments, given as a non-restrictive example with reference to the attached drawings wherein:

[0043] FIG. 1 is a schematic three-dimensional view of an articulated handling device comprised in the apparatus for the automated management of a processing chamber with a controlled atmosphere according to the embodiments described here; -

[0044] FIGS. 2 to 6 are schematic three-dimensional views that show an operating sequence of the apparatus for the automated management of a processing chamber with a controlled atmosphere in accordance with the present invention.

[0045] To facilitate comprehension, the same reference numbers have been used, where possible, to identify identical common elements in the drawings. It is understood that elements and characteristics of one embodiment can conveniently be incorporated into other embodiments without further clarifications.

DESCRIPTION OF EMBODIMENTS

[0046] We will now refer in detail to the various embodiments of the present invention, of which one or more examples are shown in the attached drawings. Each example is supplied by way of illustration of the invention and shall not be understood as a limitation thereof. For example, the characteristics shown or described insomuch as they are part of one embodiment can be adopted on, or in association with, other embodiments to produce another embodiment. It is understood that the present invention shall include all such modifications and variants.

[0047] Before describing these embodiments, we must also clarify that the present description is not limited in its application to details of the construction and disposition of the components as described in the following description using the attached drawings. The present description can provide other embodiments and can be obtained or executed in various other ways. We must also clarify that the phraseology and terminology used here is for the purposes of description only, and cannot be considered as limitative.

[0048] Embodiments described using the attached drawings concern an apparatus 10 for the automated management of the assembly of a machine for processing and/or packaging pharmaceutical products inside a processing chamber 12, in the sector also called “isolator” or “clean room”, of a machine for processing and/or packaging pharmaceutical products. The processing chamber 12 is a closed chamber, separate from the external environment and with a controlled atmosphere.

[0049] The apparatus 10 is suitable to be used in particular in the pharmaceutical sector to insert and position in the processing chamber 12 those assemblable elements 11 intended to come into contact with the products to be processed, and subsequently to remove such components from the processing chamber 12.

[0050] The apparatus 10 comprises at least one handling device 13 positioned inside the processing chamber 12, and a transport container 20 configured to transport one or more assemblable elements 11 inside and outside the processing chamber 12, as will be explained in more detail below.

[0051] The processing chamber 12, a portion of which can be seen in FIGS. 2-6, is separated from the external environment by walls 14 and is also provided with access apertures 15 associated with respective closing devices structured in such a way as to allow a protected transfer of material inside or outside the chamber 12.

[0052] According to some embodiments, the closing devices can be rapid transfer ports (RTP), or “Alpha-Beta” ports, of a type known in the state of the art, provided with a primary closing unit 19′, also referred to as “Alpha unit”, suitable to be coupled with a mating secondary closing unit 20′, also referred to as a “Beta unit”, provided on a transfer device, for example the transport container 20, by means of suitable reciprocal coupling interfaces.

[0053] The primary closing unit 19′ can be installed on the access aperture 15 inside the processing chamber 12.

[0054] According to some embodiments, the primary closing unit 19′ comprises coupling means, comprising a flange 16 which surrounds the access aperture 15, and a hatch 19a which closes the access aperture, provided with suitable sealing elements.

[0055] According to some embodiments, the hatch 19a of the primary closing unit 19′ can be hinged on one side to the flange 16 so as to rotate with respect to it between a closed condition and an open condition (FIG. 1).

[0056] According to some embodiments, the primary 19′ and secondary closing unit 20′ can be conformed so that, once coupled to each other, the opening of the hatch 19a of the primary closing unit 19′ also determines the opening of the secondary closing unit 20′, so as to put the inside of the transport container 20 in communication with the inside of the processing chamber 12, maintaining the respective internal environments, now communicating with each other, separate and isolated from the external environment.

[0057] In one embodiment, the handling device 13 is configured to open and close the hatch 19a, thus determining the opening and closing of the primary 19′ and secondary closing unit 20′ respectively.

[0058] According to some embodiments, the mobile transport container 20 is configured to contain at least one assemblable element 11 inside it so that it can transport it in a closed and sealed condition.

[0059] With the term “assemblable element” here and hereafter in the description we mean an element comprised in equipment, devices, systems or apparatuses disposed inside the processing chamber 12 which can be used alone, or in connection with other components or objects or parts of the machine. In particular, the assemblable elements 11 in question are preferably modular elements, that is, they can be assembled and disassembled with respect to the equipment, device, system or apparatus of which they are a part. Furthermore, it should be noted the assemblable elements 11 in question are preferably components intended to come into contact with the objects to be processed in the processing chamber 12, that is, for example with the pharmaceutical products. By way of a non-limiting example, the assemblable elements 11, when coupled together, can form a system for processing the pharmaceutical products, housed inside the processing chamber 12.

[0060] According to some embodiments, the transport container 20 comprises a tubular body 22 closed at one end 22b and provided at the opposite end 22a with the secondary closing unit 20′ suitable to be hermetically coupled with the primary closing unit 19′ associated with the access aperture 15 provided on a wall 14 of the processing chamber 12.

[0061] According to some embodiments, the transport container 20 comprises a support slider 23 provided with one or more support planes 39 intended to receive the assemblable element 11 resting on them. In one embodiment, the slider 23 can provide at least two support planes 39, offset vertically, and that substantially have the shape of a parallelepiped.

[0062] The slider 23 is disposed sliding in the tubular body 22. In a preferred embodiment, the slider 23 is sliding on linear guides (not shown) which can have a certain inclination which allows the slider to partly protrude outside the tubular body 22 to project inside the processing chamber 12, as shown in figs. from 3 to 6. In one embodiment, the linear guides provide an end-of-travel, located in a suitable position, such as to block the advancement of the slider 23 and thus prevent its complete exit from the tubular body 22.

[0063] According to a variant embodiment, a drive unit is provided for moving the slider 23, of a type known in the state of the art and not shown, which can comprise, for example, an electric motor. In this variant, the movement of the slider 23 along the linear guides which alternately allows it to be extracted from the tubular body 22 (so as to be extracted at least in part outside the latter), and subsequently to be reintroduced inside it, is obtained by means of the drive unit as above.

[0064] In another alternative embodiment, the slider 23 is moved by the handling device 13, which extracts it from the tubular body 22 and reintroduces it therein. In this embodiment, the slider 23 can comprise suitable gripping means, for example conformed as a hook, a peg or a bracket, and intended to be grip by the handling device 13 during the extraction and the reintroduction of the slider 23.

[0065] According to some embodiments described here, the handling device is configured as an articulated robot 13, of a type known in the state of the art.

[0066] The articulated robot 13 comprises a plurality of articulated components 17 pivoted one to the other and is in particular suitable to be used in the sector of production and packaging of pharmaceutical products. That is to say, the articulated robot 10 can be used in isolated chambers which have to meet stringent sterility requirements to prevent possible contamination of the pharmaceutical products themselves, such as for example the processing chamber 12 of a so-called isolator.

[0067] To this end, the articulated robot 13 in question is suitable, in particular, to be subjected to appropriate decontamination and sterilization treatments, for example CIP and/or SIP treatments which provide the use Vapor Phase Hydrogen Peroxide (VPHP), which has a high oxidizing power with a bactericidal, sporicidal and fungicidal action, without oxidation of its external surface, or possible damage to the components themselves.

[0068] By way of example, the articulated robot 13, shown enlarged in FIG. 1a, has five articulated components 17, respectively indicated by the letters A, B, C, D, E, coupled in an articulated manner one after the other in correspondence with respective coupling interfaces 18.

[0069] According to some embodiments, in correspondence with the coupling interfaces 18, movement members, not shown, can be provided, configured to allow a relative rotation of the two respectively coupled articulated components 17 around a common axis of rotation.

[0070] It is not excluded, however, that the articulated robot 13 can have a smaller or greater number of articulated components 17, depending on requirements.

[0071] According to some embodiments, each articulated component 17 is at least partly hollow and is internally provided with a housing compartment (not shown) configured to house the drive members, the electrical and electronic circuitry and/or the ducts for fluids required to move the articulated component 17 itself and to transmit power and data signals between the respective articulated components 17.

[0072] In one embodiment, the succession of articulated components 17 comprises a base articulated component, indicated with the letter A in FIG. 1a, intended to be attached to a floor 21 of the processing chamber 12, an end articulated component, indicated with the letter E in FIG. 1a, and a plurality of other articulated components interposed between them to define the kinematic chain that governs the movement of the handling device 13, indicated with the letters B, C and D in FIG. 1a. The end articulated component E comprises an attachment portion 24 to which a work tool 25 is connected in a temporary and removable manner.

[0073] In the embodiment shown in FIG. 1a, the work tool 25 is conformed as a gripper comprising a first and a second gripping element 25a, 25b cooperating with each other to remove and release the assemblable element 11.

[0074] The first and second gripping elements 25a, 25b are mobile with respect to each other to move reciprocally toward/away from each other, as indicated by the arrow F in FIG. 1, in order to respectively grip and release the assemblable element 11, and they can also rotate around the axis of rotation R.

[0075] Thanks to the fact that the work tool 25 is supported at the end of an articulated robot 13 formed by a plurality of articulated components 17 (five in the example described and shown in the attached drawings), it is able to be moved in space at will, since it is able to reach a sufficiently wide maneuvering space.

[0076] It is evident that according to alternative embodiments, all included within the field of protection of the present invention, the work tool 25 can be conformed differently from what is shown by way of example in FIG. 1a, but in many ways technically equivalent to it.

[0077] In one embodiment, the apparatus 10 can comprise two or more handling devices 13, each for example being able to be configured as an articulated robot such as the one described above with reference to FIG. 1a and being placed in a suitable respective position inside the processing chamber 12.

[0078] Inside the processing chamber 12, there are provided a plurality of pieces of equipment, devices, systems or apparatuses configured to carry out respective processes on the pharmaceutical products.

[0079] By way of example, we refer to a processing system 26 of pharmaceutical products configured as a transport system for transporting the pharmaceutical products inside the processing chamber 12. One portion of this processing system 26 can be seen in FIGS. 2-6, for the sole purpose of better clarifying the subsequent description of the functioning of the apparatus according to the present invention. Hereafter in the description, with reference number 26 we will refer specifically to the transport system, described purely by way of example with reference to the embodiments shown in FIGS. 2-6.

[0080] It is clear that the person of skill in the art will understand that the transport system 26, which is not comprised in the apparatus 10 according to the present invention, can be made according to many other embodiments, all equivalent to the one described below with reference to FIGS. 2-6.

[0081] The transport system 26 can comprise a base 27 attached to the floor 21 of the processing chamber 12.

[0082] According to some embodiments, the transport system 26 can be of the vibrating type. In this case, the transport system 26 can comprise one or more vibrator devices (not shown) suitable to properly make one or more elements of the transport system 26 vibrate, according to determinate frequencies, so as to determine the feed of the objects being transported. In some embodiment versions, such vibrator devices can be disposed inside the base 27, or in any case associated with, and supported by, the latter.

[0083] The transport system 26 comprises a hopper 28 intended to receive a multitude of objects haphazardly, such objects possibly being pharmaceutical products such as for example pills, tablets or capsules. The transport system 26 also comprises a collection container 29, into which the objects leaving the hopper 28 arrive. In one embodiment, the collection container 29 is disposed below the hopper 28, in communication with an exit thereof, so that the objects contained in the hopper 28 can gradually fall by gravity into the collection container 29. According to a version provided here, the collection container 29 has an inclined bottom 30 so as to allow the objects to advance by sliding.

[0084] The transport system 26 comprises a first transport element 31 and a second transport element 32 on which a plurality of tracks 33 are made, inside which the objects as above are fed. In one embodiment, the transport elements 31, 32 are adjacent to each other so that the tracks 33 made in one are the direct continuation of the ones made in the other.

[0085] The transport system 26 comprises a support bench 34 intended to receive the transport elements 31, 32 resting on it, in a stable and removable manner. The support bench 34 is supported by spacer elements 35, for example configured as columns, to distance it from the base 27.

[0086] According to some embodiments provided here, the transport elements 31, 32 are supported by the support bench 34 by means of a mechanical coupling, for example by means of a same-shape coupling which can provide both a connection with play, and also with interference.

[0087] In the version shown by way of example in the drawings, the transport elements 31, 32 comprise the plane on which the objects advance, in which the tracks 33 are made, and a base plane 36 which supports the advance plane, that is, the tracks 33, by means of support columns 37. In this version, the support bench 34 comprises one or more seatings 38, in particular made as hollows on a lateral wall of the support bench 34, for example on the wall facing the handling device 13. In some embodiments, the seatings 38 are shaped as holes with a substantially cylindrical shape, sized so as to each house a respective support column 37. In other words, since the seatings 38 are intended to each receive a support column 37, the sizes and shape of the seatings 38 are correlated to those of the support columns 37.

[0088] It should be noted that the first transport element 31 and the second transport element 32 constitute only some non-limiting example embodiments of the assemblable elements 11. Other examples of assemblable components 11, modular, are, with reference to the embodiment that can be seen in FIGS. 1-6, the hopper 28 and the collection container 29.

[0089] According to some embodiments, the automated management apparatus 10 comprises a control and command unit 40 (FIG. 1) configured to control and command the functioning of the automated management apparatus 10, in particular to control and command the handling device or articulated robot 13.

[0090] In accordance with embodiments provided here, the apparatus 10 comprises a recognition device which is configured to recognize the assemblable element 11 and send a corresponding recognition signal to the handling device 13, in particular through the control and command unit 40. In possible embodiments, the recognition device comprises at least one sensor configured to acquire images to recognize the assemblable element 11. In the example shown in FIG. 1, the recognition device is configured as a video camera, in particular of the high-resolution type commonly used in industrial automation applications, indicated with reference number 41. The video camera 41 can for example be attached to one of the walls 14 of the chamber 12, in a suitable position that allows it to have a field of vision over the entire processing system 26.

[0091] According to possible embodiments, the recognition signal as above contains information relating to at least one of either the assembly position and/or assembly direction of the assemblable element 11, modular, on the processing system 26, and/or the gripping position of the assemblable element 11, modular, by the handling device 13.

[0092] In some embodiments, it is provided that the assemblable element 11 comprises an identification code for its recognition by the recognition device, of a known type and not shown. By way of a non-limiting example, such identification code can be configured as an RFID tag, a barcode, or any other alphanumeric code whatsoever.

[0093] With reference to the drawings, the functioning of the apparatus for the automated management of the processing chamber 12 is now described. Initially, it is provided to attach the secondary closing unit 20′ made on a transport container 20 to a primary closing unit 19′ of the processing chamber 12 (FIG. 2). The transport container 20 contains inside it an assemblable element 11 positioned resting on the support slider 23. It should be noted that the disposition of the assemblable element 11 on the support slider 23 can be previously carried out by an operator, for example in an environment with a controlled atmosphere.

[0094] The transport container 20 is positioned in a closed condition, so that its secondary closing unit 20′ couples to the primary closing unit 19′. Subsequently, it is provided to open the hatch 19a toward the inside of the processing chamber 12, so as to open both the primary and secondary closing unit 19′, 20′ and put the inside of the transport container 20 in communication with the inside of the processing chamber 12, as shown in FIG. 2.

[0095] At this point the slider 23 is extracted in the manner described above, so that the handling device 13 can remove the assemblable element 11.

[0096] It should be noted that, in the embodiments in which the apparatus provides the recognition device 41, before the steps that will be described below, there is provided a step of recognition of the assemblable element 11, modular, by the recognition device 41. Such step provides to send a corresponding recognition signal to the handling device 13, in particular by means of the control and command unit 40. According to some embodiments of the method according to the present invention, the recognition signal as above contains information relating to the position and/or direction of assembly of the modular assemblable element 11 on the processing system 26, and/or to the gripping position of the modular assemblable element 11 by the handling device 13.

[0097] For this purpose, the handling device 13 is disposed so as to take the work tool 25 in the proximity of the assemblable element 11, and the gripping elements 25, 25b are brought close to each other so as to grasp the assemblable element 11 (FIGS. 3 and 4).

[0098] Subsequently, the handling device 13 is disposed so as to place the assemblable element 11 in the expected position, which—in the example shown—is on the support bench 34. In the particular embodiment described above, the handling device 13 disposes the assemblable element 11 on the support bench 34 causing the support columns 37 to be inserted into the respective seatings 38 (FIGS. 5 and 6).

[0099] Subsequently, the gripping elements 25a, 25b are moved away from each other and the handling device 13 can thus release the assemblable element 11.

[0100] When it is necessary to disassemble the assemblable element 11, the handling device 13 can of course be commanded to carry out the sequence described above with reference to FIGS. 1-6 in a reverse order, so as to remove the assemblable element 11 from its operating position (for example from the support bench 34) and rest it on the support slider 23 so that it is closed within the transport container 20.

[0101] It should be noted that the functioning of the automated management apparatus 10 has been described with reference to the example in which the handling device 13 removes the first transport element 31 from the transport container 20 to deposit it on the support bench 34. It is evident that the functioning of the apparatus 10 would be the same also in those cases in which the articulated robot 13 handles assemblable elements 11 different from the first transport element 31, such as for example the second transport element 32, the hopper 28 or the collection container 29.

[0102] It is clear that modifications and/or additions of parts or steps may be made to the apparatus 10 and method for the automated management of a processing chamber 12 as described heretofore, without departing from the field and scope of the present invention.

[0103] It is also clear that, although the present invention has been described with reference to some specific examples, a person of skill in the art shall certainly be able to achieve many other equivalent forms of apparatus 10 and method for the automated management of a processing chamber 12, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.