HANDLING SYSTEM FOR A CLEANROOM, A CLEANROOM AND A METHOD FOR LIFTING OFF COVER LAYERS

20240253844 ยท 2024-08-01

    Inventors

    Cpc classification

    International classification

    Abstract

    A handling system (10) for a cleanroom (64), a cleanroom (64) having such a handling system (10), and a method for lifting off cover layers (16).

    Claims

    1. A handling system (10) for a cleanroom (64), comprising: at least one dish-shaped transport container (12) with pharmaceutical primary packaging elements (14) arranged therein, the primary packaging elements (14) being covered by a cover layer (16), and a device (22) for lifting off the cover layer (16) from the primary packaging elements (14), the device (22) comprising a gripping unit (24) for gripping the cover layer (16), wherein the gripping unit (24) comprises an adhesive arrangement (25) that includes at least one adhesive element (26), the adhesive element (26) including an adhesive structure for gripping the cover layer (16) adhesively, the adhesive arrangement (25) can be brought into physical surface contact with a first side (36) of the cover layer (16) that faces away from the primary packaging elements (14), and a diameter of a smallest circle that lies in a holding plane of the adhesive arrangement (25) and surrounds the adhesive arrangement (25) is at least 50 mm.

    2. The handling system (10) according to claim 1, wherein the cover layer (16) has a plurality of corners, and the adhesive arrangement (25) can be brought into physical contact with the first side (36) of the cover layer (16) in such a way that a distance between the corners of the cover layer (16) and the adhesive arrangement (25) is less than 40 mm.

    3. The handling system (10) according to claim 1, wherein the cover layer (16) has a plurality of edges, and the adhesive arrangement (25) can be brought into physical contact with the first side (36) of the cover layer (16) in such a way that a distance between edge centers of the edges and the adhesive arrangement (25) is less than 40 mm.

    4. The handling system (10) according to claim 1, wherein the adhesive element (26) includes an adhesive film (26).

    5. The handling system (10) according to claim 1, wherein the adhesive arrangement (25) has an adhesive element (26) that is X-shaped, C-shaped, U-shaped or in the shape of a ring.

    6. The handling system (10) according to claim 1, wherein the adhesive arrangement (25) comprises a plurality of adhesive elements (26) that are each arranged at a different corner of a notional parallelogram.

    7. The handling system (10) according to claim 6, wherein the primary packaging elements (14) comprise a first end (17) that faces toward the cover layer (16), and the plurality of adhesive elements (26) can be brought into physical contact with the first side (36) of the cover layer (16) in such a way that each of the adhesive elements (26), in a direction of view (38) perpendicular to the holding plane, is brought into at least partial congruence with respectively at least one first end (17) of a primary packaging element (14) arranged directly beneath the cover layer (16).

    8. The handling system (10) according to claim 6, wherein the gripping unit (24) comprises a plurality of receiving structures (32), and the adhesive elements (26) are arranged on ends (34) of the receiving structures (32).

    9. The handling system (10) according to claim 8, wherein the receiving structures (32) are each arranged on a different side arm (30) of the gripping unit (24) that extends parallel or at an angle to the holding plane.

    10. The handling system (10) according to claim 8, wherein there is a different spring unit (74) held between the receiving structures (32) and the gripping unit (24), a restoring force being applied to each of the receiving structures (32) by the spring units (74), and the receiving structures (32) being displaceable, against the respective restoring force, in a first direction (76) that is perpendicular to the holding plane.

    11. The handling system (10) according to claim 10, wherein the receiving structures (32) are each held so as to be displaceable in a different recess (78) of the gripping unit (24), the gripping unit (24) comprises an actuator means (80) having at least one actuator (82), and that the actuator means (80) is designed to displace the receiving structures (32) in the first direction (76), for the purpose of detaching a gripped cover layer (16), so that the adhesive elements (26) are arranged in the recesses (78).

    12. A handling system (10) according to claim 11, wherein a respectively different actuator (82) is assigned to each receiving structure (32).

    13. The handling system (10) according to claim 1, further comprising a handling means (40) configured to move the gripping unit (24) toward the cover layer (16) and to press the adhesive arrangement (25) against the first side (36) of the cover layer (16), and/or a handling means configured to move the transport container (12) with the cover layer (16) toward the adhesive arrangement (25) and to press the first side (36) of the cover layer (16) against the adhesive arrangement (15).

    14. The handling system (10) according to claim 1, wherein the gripping unit (24) comprises at least one press-off punch (60), which can be pressed against the first side (36) of the cover layer (16) for the purpose of detaching a gripped cover layer (16).

    15. The handling system (10) according to claim 1, wherein the gripping unit (24) comprises at least two portions (54, 55) that are displaceable relative to each other, the portions (54, 55) each carrying a different adhesive element (26) or a different group of adhesive elements (26), an actuator (58) being provided for displacing the portions (54, 55) relative to each other, and a gripped cover layer (16) being detachable from the gripping unit (24) by displacement of the portions (54, 55) relative to each other.

    16. The handling system (10) according to claim 1, further comprising at least one stationary retainer (44) configured and arranged to be brought to bear against the first side (36) of a gripped cover layer (16), and the gripped cover layer (16) being detachable from the gripping unit (24) as a result of the gripping unit (24) being moved in a direction away from the cover layer (16) when the at least one stationary retainer (44) is brought to bear against the first side (36).

    17. The handling system (10) according to claim 16, wherein arranged beneath the at least one stationary retainer (44) there is a slide unit (46) that has a slide surface (48), the slide surface (48), or a notional extension of the slide surface (48), extending in a sliding direction through a collecting opening (52) of a collecting container (50) for cover layers (16).

    18. The handling system (10) according to claim 1, further comprising at least one sensor unit configured to recognize a cover layer (16) gripped by the gripping unit (24).

    19. A cleanroom (64), in which a handling system (10) according to claim 1 is arranged.

    20. A method for lifting off cover layers (16), comprising: a. providing a dish-shaped transport container (12) with pharmaceutical primary packaging elements (14) arranged therein, the primary packaging elements (14) being covered by a cover layer (16), b. providing a device (22) that has a gripping unit (24) comprising an adhesive arrangement (25) that includes at least one adhesive element (26), the adhesive element (26) including an adhesive structure for gripping the cover layer (16) adhesively, and a diameter of a smallest circle that lies in a holding plane of the adhesive arrangement (25) and surrounds the adhesive arrangement (25) being at least 50 mm, c. pressing together the adhesive arrangement (25) and the cover layer (16), the adhesive arrangement (25) being brought into physical surface contact with a first side (36) of the cover layer (16) that faces away from the primary packaging elements (14), and the cover layer (16) being gripped adhesively by the adhesive arrangement (25), d. lifting off the gripped cover layer (16) from the primary packaging elements (14), and e. detaching the lifted-off cover layer (16) from the gripping unit (24).

    21. The method according to claim 20, wherein the cover layer (16) is detached from the gripping unit (24) by a jerking movement of the gripping unit (24), by a stationary retainer (44), by a displacing of adhesive elements (26) relative to each other, by a displacing of adhesive elements (26) into recesses (78) in the gripping unit (24), or by at least one press-off punch (60) held displaceably on the gripping unit (24).

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0047] The invention is described in greater detail below with reference to the figures, with identical or functionally identical elements being denoted only once by reference designations where appropriate. The figures serve as examples and are not to be understood as being restrictive. In the figures

    [0048] FIG. 1 shows a perspective representation of a handling system, which comprises a transport container with pharmaceutical primary packaging elements arranged therein, and a device having a gripping unit;

    [0049] FIG. 2 shows a sectional representation of the transport container and of the gripping unit when a cover layer, arranged in the transport container, is being lifted off by the gripping unit;

    [0050] FIG. 3 shows a perspective representation of the handling system following the lifting-off of the cover layer;

    [0051] FIG. 4 shows a side view of a detaching unit for detaching a gripped cover layer from the gripping unit;

    [0052] FIG. 5 shows a perspective representation of the detaching unit shown in FIG. 4;

    [0053] FIG. 6 shows a representation of a further exemplary embodiment of the gripping unit,

    [0054] FIG. 7 shows a sectional representation of a further exemplary embodiment of the gripping unit,

    [0055] FIG. 8 shows a sectional representation of a further exemplary embodiment of the gripping unit,

    [0056] FIG. 9 shows a further sectional representation of the gripping unit shown in FIG. 8, and

    [0057] FIG. 10 shows a perspective representation of the handling system having a further gripping unit.

    DETAILED DESCRIPTION

    [0058] FIGS. 1 to 3 show a handling system 10 that is arranged, as part of a pharmaceutical production machine, in a cleanroom 64.

    [0059] The system 10 comprises at least one dish-shaped transport container 12. In each of FIGS. 1 to 3, only a single dish-shaped transport container 12 is represented. Typically, however, there is a multiplicity of dish-shaped transport containers 12.

    [0060] In the present case, the transport container 12 is realized as a tub 12. Pharmaceutical primary packaging elements 14 are arranged, or stored, in the transport container 12. In the case of the exemplary embodiment represented, the primary packaging elements 14 are receptacles 14 for syringes.

    [0061] In the present case, the primary packaging elements 14 are arranged nested in the transport container 12. This means that the primary packaging elements 14 are accommodated in a nest 15. The nest 15 is arranged together with the primary packaging elements 14 in the transport container 12.

    [0062] The primary packaging elements 14 are covered by a cover layer 16. In the present case, the cover layer 16 is placed directly onto the primary packaging elements 14. The primary packaging elements 14 each comprise an end 17 that faces toward the cover layer 16. In the present case, the ends 17 are constituted by opening edges of the primary packaging elements 14. The cover layer 16 is surrounded by a side wall 18 of the transport container 12 and is thus arranged in the transport container 12. In the case of the exemplary embodiment represented, the cover layer 16 is a flexible cover film 16.

    [0063] In the present case, the cover layer 16, or cover film 16, is gas-permeable, and for this purpose comprises a polyethylene-woven fabric. The gas-permeable design of the cover layer 16 has the advantage that, during sterilization with a gaseous sterilizing agent such as, for example, ethylene oxide, the sterilizing agent can pass through the cover layer 16.

    [0064] The transport container 12 comprises a lateral overhang 20. Typically, during the sterilization process the transport container 12 is closed by a closure layer stuck to the overhang 20. Preferably, the closure layer matches the cover layer 16 in respect of its design. In FIGS. 1 to 3, the said closure layer has already been removed from the transport container 12 and is therefore not visible.

    [0065] The handling system 10 also comprises a device 22 for lifting off the cover layer 16. The device 22 comprises a gripping unit 24 having an adhesive arrangement 25.

    [0066] In the case of the exemplary embodiment represented in FIGS. 1 to 3, the adhesive arrangement 25 is constituted by a plurality of adhesive elements 26 that are spaced apart from one another. However, the adhesive arrangement 25 may also be constituted by a single adhesive element 26, as shown, for example, in FIG. 10. Irrespective of the number of adhesive elements 26, the adhesive arrangement 25 in all the exemplary embodiments represented in the figures is dimensioned in such a way that the smallest circle that lies in a holding plane of the adhesive arrangement 25 and surrounds the adhesive arrangement 25, i.e. the plurality of adhesive elements 26 or the single adhesive element 26, has a diameter of at least 50 mm. Preferably, the circle has a diameter of at least 70 mm, particularly preferably a diameter of at least 100 mm. In the exemplary embodiments represented, the adhesive elements 26 are realized as adhesive films 26.

    [0067] The adhesive elements 26 are realized with an adhesive structure for gripping the cover layer 16 adhesively. The adhesive structure of the adhesive elements 26 is preferably constituted in each case by a multiplicity of elastically deformable adhesive projections. Preferably, a diameter of the adhesive projections is less than 1 mm. The adhesive structure is then accordingly realized as a microstructure. Due to their dimensions, the adhesive projections are not visible in the figures. For example, the adhesive projections are pin-shaped or mushroom-shaped.

    [0068] In the case of the exemplary embodiment represented in FIGS. 1 to 3, there are four adhesive elements 26. The adhesive elements 26 are each arranged at a different corner of a notional parallelogram. In the present case, the parallelogram is a square.

    [0069] The gripping unit 24 comprises a central main body 28. Arranged on the main body 28 in the present case are four side arms 30, which extend out from the main body 28, parallel to the holding plane. Arranged at the outer ends of the side arms 30 there is a respective receiving structure 32, which in the present case is columnar. The adhesive elements 26 are arranged on the ends 34 of the columnar receiving structures 32.

    [0070] The adhesive elements 26 are arranged in such a way that they can be brought together into physical surface contact with a first side 36 of the cover layer 16 that faces away from the primary packaging elements 14. In the exemplary embodiment represented, the adhesive elements 26 are arranged in such a way that they can be brought into physical contact with the first side 36 of the cover layer 16, adjacently to a respective other edge of the cover layer 16. The distance between the centers of the edges and the nearest adhesive element 26 is less than 40 mm.

    [0071] In the present case, the adhesive elements 26 are arranged so as to be complementary to the primary packaging elements 14. The adhesive elements 26 can therefore be brought into physical contact with the first side 36 of the cover layer 16 in such a way that each of the adhesive elements 26, in a direction of view 38 perpendicular to the holding plane, is brought into at least partial congruence with respectively at least one first end 17 of a primary packaging element 14 arranged directly beneath the cover layer 16. This is shown clearly in FIG. 2. The advantage of such a complementary arrangement of the adhesive elements 26 and the primary packaging elements 14 will be explained in greater detail below.

    [0072] The device 22 also comprises a handling means 40. The handling means 40 is realized, by way of example, as a six-axis robot 40. In the case of the exemplary embodiment represented, the handling means 40 is designed to move the gripping unit 24 toward the cover layer 16 and to press the adhesive elements 26 against the cover layer 16. Alternatively, the handling means 40 may also be designed to move the transport container 12, with the cover layer 16 located therein, toward the adhesive elements 26 and to press the cover layer 16 against the adhesive elements 26 by moving the transport container 12. In such an embodiment, the gripping unit 24 is preferably arranged in a stationary manner.

    [0073] In the following, a method for lifting off the cover layer 16 from the primary packaging elements 14 is explained in greater detail. The gripping unit 24 is moved toward the cover layer 16 by the handling means 40, and the adhesive arrangement 25 is pressed against the first side 36 of the cover layer 16. The pressing of the adhesive arrangement 25 against the cover layer 16 causes the cover layer 16 to be gripped adhesively by the adhesive arrangement 25, i.e. the plurality of adhesive elements 26.

    [0074] Upon being pressed together, the gripping unit 24 and the transport container 12 are preferably aligned relative to each other in such a way that each of the adhesive elements 26, in the direction of view 38, is brought into at least partial congruence with respectively at least one first end 17 of a primary packaging element 14 arranged directly beneath the cover layer 16. As a result, the portions of the cover layer 16 contacted by the adhesive elements 26 are supported by the primary packaging elements 14 arranged directly underneath. In particular, in the case of a flexible cover layer 16, a non-complementary arrangement of the adhesive elements 26 and the primary packaging elements 14 could result in bending of the cover layer 16 when the cover layer 16 is contacted. This would at least make it more difficult to grip the cover layer 16 adhesively.

    [0075] The adhesive arrangement 25 is preferably pressed against the cover layer 16 with a predefined pressing force. The pressing force is preferably selected such that over-pressing of the adhesive elements 26 is avoided.

    [0076] After being gripped, the cover layer 16 is lifted off from the primary packaging elements 14 by the handling means 40. Due to the dimensions of the adhesive arrangement 25, described above, the edges and the borders of the cover layer 16 hang down only slightly at most when it is lifted off. Accordingly, the likelihood of particles from the cover layer 16 getting onto or into the primary packaging elements 14 when it is being lifted off is in any case extremely low.

    [0077] After being lifted off, the cover layer 16 is detached from the gripping unit 24, such that the gripping unit 24 can be used for a subsequent lifting-off process on another transport container 12. With regard to detaching the cover layer 16, various advantageous procedures are possible, these being explained in greater detail below with reference to the handling system 10, or gripping units 24, represented in FIGS. 4 to 10.

    [0078] In the case of the exemplary embodiment represented in FIGS. 4 and 5, the handling system 10 comprises a detaching unit 42 having a stationary retainer 44, which in the present case has the shape of a spatula. The retainer 44 is brought to bear against the first side 36 of a gripped cover layer 16. Once the retainer 44 has been brought to bear against the first side 36, the cover layer 16 is detached from the gripping unit 24 as a result of the gripping unit 24 moving in a direction away from the cover layer 16. Due to the spatula-shaped design of the retainer 44, the narrow retainer 44 can be brought between two adhesive elements 26 to bear against the first side 36 of the cover layer 16. Such bearing of the retainer 44 against the first side 36 of the cover layer 16 allows the cover layer to be detached from the gripping unit 24 in a particularly safe manner.

    [0079] In the case of the exemplary embodiment represented, the detaching unit 42 also comprises a slide unit 46 that has a slide surface 48. The slide unit 46 is arranged beneath the retaining means 44, such that detached cover layers 16 fall onto the slide surface 48 of the slide unit 46.

    [0080] The handling system 10 also comprises a collecting container 50 for cover layers 16. The collecting container 50 is arranged in such a way that a notional extension of the slide surface 48 extends in the sliding direction through a collecting opening 52 of the collecting container 50. Cover layers 16 falling onto the slide surface 48 are accordingly delivered to the collecting container 50.

    [0081] FIG. 6 shows a representation of a further exemplary embodiment of the gripping unit 24, with only two of the adhesive elements 26 being visible. The gripping unit 24 comprises a first portion 54 and a second portion 55, each of the portions 54 and 55 carrying a different one of the represented adhesive elements 26. In particular, the adhesive arrangement 25 comprises four adhesive elements 26, each of the portions 54 and 55 carrying two of the adhesive elements 26. However, one of the portions 54 and 55 may also carry three adhesive elements 26 and the other of the portions 54 and 55 only one adhesive element 26. The portions 54 and 55 are displaceable relative to each other. In the present case, the portions 54 and 55 are displaceable relative to each other along an axis 56 that is parallel to the holding plane. An actuator 58 is provided for displacing the portions 54 and 55 relative to each other. The actuator 58 is arranged in a housing 57 of the gripping unit 24 and is therefore not visible.

    [0082] In order to detach the cover layer 16 in the case of the gripping unit 24 represented in FIG. 6, the portions 54 and 55 are preferably displaced by the actuator 58 in such a way that the distance between the adhesive elements 26 represented is reduced. This causes the angle between the adhesive elements 26 and the gripped cover layer 16 to increase. As a result, the cover layer 16 is detached from the gripping unit 24, as shown in FIG. 6.

    [0083] FIG. 7 shows a sectional representation of a further exemplary embodiment of the gripping unit 24. In the case of the gripping unit 24 shown in FIG. 7, also, only two of the adhesive elements 26 are visible. The gripping unit 24 comprises a press-off punch 60, which is held displaceably on the gripping unit 24. In the present case, the press-off punch 60 is displaceable along an axis 62 that is perpendicular to the holding plane. In departure from the example shown in FIG. 7, there may also be a plurality of press-off punches 60.

    [0084] In order to detach a gripped cover layer 16 in the case of the gripping unit 24 represented in FIG. 7, the press-off punch 60 is displaced along the axis 62 and pressed against the first side 36 of the cover layer 16.

    [0085] FIGS. 8 and 9 show sectional representations of a further exemplary embodiment of the gripping unit 24. In this case, only a detail of the gripping unit 24 is represented in each case. In this exemplary embodiment, the receiving structures 32, which in this case have the shape of a punch, are each held displaceably in a different recess 78 of the gripping unit 24. In the present case, the gripping unit 24 comprises a main body 86 with cavities realized therein. A plurality of pneumatic cylinders 88 are fastened to the main body 86. The cavities and the pneumatic cylinders 88 together form the recesses 78.

    [0086] In each case, there is a different spring unit 74 held under preload between the receiving structures 32 and the gripping unit 24. In the present case, the spring units 74 are realized as coil springs 74. The receiving structures 32 is displaceable, against the restoring forces provided by the spring units 74, in a first direction 76 that is perpendicular to the holding plane.

    [0087] When the adhesive arrangement 25 and the cover layer 16 are pressed together, the pressing force is limited by the spring units 74. As a result, over-pressing of the adhesive elements 26 is avoided.

    [0088] In the present case, the gripping unit 24 comprises an actuator means 80 having a plurality of actuators 82 that, in the case of exemplary embodiment represented, are realized as pneumatic actuators 82. The actuators 82 are designed to displace the receiving structures 32 in the first direction 76 to such an extent that the adhesive elements 26 are arranged in the recesses 78. Such an arrangement of the adhesive elements 26 is shown in FIG. 9. When the adhesive elements 26 are displaced into the recesses 78, the cover layer 16 is retained by a bottom surface 84 of the gripping unit 24, or of the main body 86, from which the recesses 78 extend. Preferably, the adhesive elements 26 are displaced into the recesses 78 in succession or in pairs by the actuators 82.

    [0089] In the case of the exemplary embodiment of the gripping unit 24 represented in FIG. 10, the adhesive arrangement 25 is constituted by a single adhesive element 26. In the case of the exemplary embodiment represented, the adhesive element 26 is U-shaped.

    [0090] The adhesive arrangement 25 is brought into physical contact with the cover layer 16 in such a way that the distance between the corners of the cover layer 16 and the adhesive arrangement 25 is less than 40 mm. Such an arrangement of the adhesive arrangement 25 on the cover layer 16 can also reliably prevent the edges of the cover layer 16 from hanging down when it is being lifted off.

    [0091] In the case of the exemplary embodiment of the gripping unit 24 represented in FIG. 10, a gripped cover layer is detached, for example, by the retainer 44 shown in FIGS. 4 and 5. In addition, one or more displaceable press-off punches 60 may also be provided as part of the gripping unit 24.

    [0092] In the case of a further exemplary embodiment of the method, the gripped cover layer 16 is detached from the gripping unit 24 by a jerking movement of the gripping unit 24. The inertia and the air resistance of the cover layer 16 are thus utilized for detaching. This has the advantage that neither a stationary retainer nor a special design of the gripping unit is required for detaching.