Manipulation system for a clean room, clean room and method for uncovering a cover

Abstract

A handling system (10) for a clean room (64), a clean room (64) comprising such a handling system (10) and a method for uncovering a cover layer (16) are disclosed.

Description

Technical Field

[0001] This invention relates to an operating system for a cleanroom. Furthermore, it relates to a cleanroom incorporating such an operating system. Additionally, it relates to a method for lifting a covering layer. Background Technology

[0002] In the pharmaceutical manufacturing process, drugs or active pharmaceutical ingredients are typically filled into primary pharmaceutical containers. Before filling with the drug or active ingredient, the primary container itself, or a primary packaging portion of the primary container, is usually stored in a tray-shaped transport container. Examples of such tray-shaped transport containers include basins or pallets.

[0003] Before sterilizing the primary container or primary packaging component, a cover layer is typically applied. The transport container is then sealed with a sealing layer, for example, by attaching the sealing layer to the suspended portion of the transport container. Sterilization is then performed using a gas such as ethylene oxide. Before processing the sterilized primary container or primary packaging component, both the sealing and cover layers must be removed again. When the outer sealing layer is removed, the inner cover layer prevents particles from entering the primary container or primary packaging component. Removing the cover layer is a challenging operation because it is located in a recessed area of ​​the transport container. When removing the cover layer, it is also essential to prevent particles on the cover layer from entering the primary container or primary packaging component.

[0004] The practice of lifting caps using vacuum gripping units is well-known. These units adhere to the caps using suction, applying the necessary holding force to allow the caps to be lifted. However, vacuum gripping units have several drawbacks, particularly when processing toxic / highly potent surfactants. When a pharmaceutical machine is equipped with a vacuum gripping unit, a special decontamination cycle using H2O2 (hydrogen peroxide) is necessary to ensure sufficient H2O2 flow through the vacuum channels of the gripping unit. However, ensuring sufficient H2O2 flow through the vacuum channels is not easy, especially with complex gripping unit designs. In cases involving toxic and / or highly potent surfactants, filters must also be installed to prevent the surfactants from reaching external areas as aerosols via the vacuum. Furthermore, disassembling the production equipment is challenging because toxic surfactants may be present between the vacuum lines and the filters, and are not easily accessible to water during rinsing. Therefore, the entire assembly must be manually placed into a sealed bag through a glove opening and then washed separately, or automatically discharged via an RTP port by a robot or similar device. Vacuum gripping units also have a drawback: they require a negative pressure device to create a vacuum. This consumes energy and increases operating costs. Summary of the Invention

[0005] The object of this invention is to provide a method for peeling off a cover layer from a primary container or primary packaging component, wherein the gripping unit used for this purpose is easy to operate. Furthermore, when peeling off the cover layer, it is necessary to prevent particles on the cover layer from entering the primary container or primary packaging component.

[0006] This objective of the present invention can be achieved according to the operating system, cleanroom, and method of this application.

[0007] Advantageous variations and embodiments are indicated in the description.

[0008] Therefore, the present invention provides an operating system for cleanrooms. This operating system includes at least one disc-shaped transport container in which a primary pharmaceutical packaging element is arranged. The disc-shaped transport container is preferably a basin. However, it can also be a tray, etc. The term "primary pharmaceutical packaging element" refers both to the primary pharmaceutical container itself and to the primary packaging components of the primary pharmaceutical container. For example, a primary pharmaceutical container refers to an injectable vial, syringe, or box. Primary pharmaceutical container components refer to the reservoir or sealing element of the primary pharmaceutical container, particularly injectable vials, syringes, or boxes.

[0009] Primary packaging elements are preferably arranged in a nested manner within the transport container. This means that the primary packaging elements are placed within a plastic support plate called a nest. The nest is placed together with the primary packaging elements within the transport container. The primary packaging elements are preferably arranged in a nested manner. However, the primary packaging elements can also be arranged loosely among themselves within the transport container. The primary packaging elements can be arranged in a single layer or multiple layers within the transport container. For example, in the case of a multi-layer arrangement, nests of multiple primary packaging elements are stacked on top of each other within the transport container.

[0010] According to the invention, the primary packaging element is covered by a covering layer. The covering layer covers the primary packaging element and is therefore positioned above it. In the case of multiple primary packaging elements, the covering layer is positioned above the uppermost primary packaging element. The covering layer is preferably arranged within a transport container such that the sidewalls of the transport container surround the covering layer. The covering layer is preferably placed directly on the primary packaging element. However, the covering layer may also be arranged above the primary packaging element and maintained at a certain distance. The covering layer then rests against the opening of the transport container. The covering layer is preferably breathable. This has the advantage that gaseous ethylene oxide can permeate through the covering layer to sterilize the primary packaging element. The covering layer is preferably a covering film. This film is a thin and uniform fabric. Particularly preferred is that the covering layer or covering film is made of polyethylene nonwoven fabric.

[0011] The manipulation system according to the invention also includes a device for removing a cover layer from a primary packaging element, the device including a gripping unit for gripping the cover layer.

[0012] The gripping unit includes an adhesion device consisting of at least one adhesion element having an adhesion structure for adhesively gripping the cover layer. The adhesion device is capable of physical surface contact with a first side of the cover layer away from the primary packaging element. The diameter of the minimum circle located in the holding plane of the adhesion device and surrounding the adhesion device is at least 50 mm.

[0013] According to the present invention, the adhesion device comprises at least one adhesion element, that is, one or more adhesion elements. In this invention, when referring to the adhesion device, if the adhesion device has a single adhesion element, it refers to that single adhesion element; if the adhesion device has multiple adhesion elements, it refers to all of the multiple adhesion elements. For example, if the adhesion device is composed of a single adhesion element, that single adhesion element can make physical surface contact with the first side of the cover layer. On the other hand, if the adhesion device is composed of multiple adhesion elements, all adhesion elements can make physical surface contact with the first side of the cover layer. In particular, multiple adhesion elements can make physical contact with the first side simultaneously. However, in the case of movable adhesion elements, the adhesion elements can also make physical contact with the first side sequentially. The holding plane refers to the plane in which the single or multiple adhesion elements are located when the adhesion device makes physical surface contact with the first side of the cover layer. The single or multiple adhesion elements are preferably flat.

[0014] Adhesive gripping refers to gripping by adhesive forces. Adhesive forces are molecular attraction forces acting between mutually contacting surfaces. According to the invention, at least one adhesive element has an adhesive structure to enable the application of sufficiently large adhesive forces to lift the cover layer. In this respect, the adhesive element is distinguished from adhesive elements that have unstructured adhesive layers for gripping purposes, which are well known. In adhesive elements with adhesive structures, the adhesive forces are typically at least substantially composed of van der Waals forces. According to the invention, at least one adhesive element may have a microstructure and / or a mesostructure. At least one adhesive element is preferably made of a polymer. To grip the cover layer, an adhesive device, i.e., a single adhesive element or multiple adhesive elements, can be pressed together with the cover layer. This will generate the aforementioned adhesive forces between the adhesive device and the cover layer, thereby causing the cover layer to be adhesively gripped. Once the cover layer is gripped, it can be lifted from the primary packaging element, whereby the cover layer is held in place by the adhesive forces.

[0015] The gripping unit designed according to the present invention overcomes the aforementioned disadvantages associated with vacuum gripping units. The operating system of the present invention is easy to operate and clean, primarily due to the design of the gripping unit. Preferably, the gripping unit is designed to be treated and / or autoclaved using conventional pharmaceutical cleaning agents and disinfectants.

[0016] According to the invention, the diameter of the smallest circle located in the retaining plane and surrounding the adhesive device (i.e., a single adhesive element or multiple adhesive elements) is at least 50 mm. This design or size of the adhesive device ensures that even when using a flexible cover layer, the edge of the gripped cover layer will only droop slightly at most upon detachment. Therefore, the likelihood of particles entering the primary packaging element or the primary packaging element when the cover layer is lifted is very low. The diameter of the smallest circle is preferably at least 70 mm, and particularly preferably at least 100 mm.

[0017] According to a preferred embodiment, at least one adhesive element comprises a plurality of elastically deformable adhesive protrusions. The diameter of the adhesive protrusions is preferably less than 1 mm. These small-sized adhesive protrusions can effectively compensate for unevenness of the surface to be contacted through deformation, thereby providing an adhesive element capable of achieving high adhesion. The diameter of the protrusions is preferably less than 500 micrometers, and particularly preferably less than 200 micrometers.

[0018] Various designs are possible for the shape of the adhesive protrusion. The adhesive protrusion is preferably cylindrical. The cross-section of the cylindrical adhesive protrusion is at least substantially constant, and in particular circular. Alternatively, the adhesive protrusion is preferably mushroom-shaped. In the case of mushroom-shaped adhesive protrusions, the cross-sectional area of ​​the contact portion of the adhesive protrusion for contacting the capping layer is larger than the cross-sectional area of ​​the supporting portion of the same adhesive protrusion that carries the contact portion.

[0019] According to a preferred embodiment, the cover layer has multiple corners, and the adhesion device, i.e., a single adhesion element or multiple adhesion elements, can physically contact a first side of the cover layer, such that the distance between the corner of the cover layer and the adhesion device is less than 40 mm, preferably less than 30 mm. This matching of the adhesion device and the size of the cover layer is particularly effective in preventing the edges of the cover layer from sagging.

[0020] According to a preferred embodiment, the adhesion device, i.e., one or more adhesion elements, can physically contact the first side of the cover layer, such that the distance between the edge center of the cover layer edge and the adhesion device is less than 40 mm, preferably less than 30 mm. Similarly, this adaptation of the adhesion device to the cover layer size effectively prevents sagging of the cover layer edge.

[0021] At least one adhesive element is preferably an adhesive film. An advantage of using an adhesive element in the form of an adhesive film is that its size can be easily matched to the desired size. For example, the adhesive film can be cut to the required size. Preferably, the adhesive film is fixed to the gripping unit by an adhesive. If there are multiple adhesive elements, it is preferable that all adhesive elements are implemented as adhesive films.

[0022] According to a preferred embodiment, the adhesion device has an X-shaped, C-shaped, U-shaped, or annular adhesion element, particularly a circular or rectangular annular adhesion element. With this shape of adhesion element, the gripped cover layer can be separated from the gripping unit by simple design means, such as by at least one release punch or at least one fixed retainer. The adhesion element is preferably the only adhesion element in the adhesion device. However, the adhesion device may also have at least one additional adhesion element.

[0023] The adhesion device preferably includes multiple adhesion elements. Increasing the number of adhesion elements is particularly effective in preventing sagging of the cover layer edges. Preferably, the gripping unit includes at least three adhesion elements, more preferably at least four adhesion elements. Particularly preferred is a gripping unit with four adhesion elements, each arranged at a corner of the imaginary parallelogram. Typically, the cover layer is rectangular. The advantage of a gripping unit with four adhesion elements, each arranged at a corner of the imaginary parallelogram, is that the adhesion elements can be arranged at different corners of the cover layer, adjacent to different corners of the cover layer, adjacent to different edge centers of the cover layer, or adjacent to different edge centers of the cover layer. Particularly preferred is that the adhesion device includes at least four and at most ten adhesion elements.

[0024] According to a preferred embodiment, the primary packaging element includes a first end facing the cover layer, and a plurality of adhesive elements are physically contactable with the first side of the cover layer such that each adhesive element at least partially mates with at least one first end of the primary packaging element disposed directly beneath the cover layer in a line-of-sight direction perpendicular to the holding plane. If the above features are achieved, when the gripping unit is properly aligned and arranged relative to the transport container, the portions of the cover layer in contact with the adhesive elements will be supported on at least one first end. This can increase the pressure of the adhesive elements and the cover layer pressed together, especially in the case of a flexible cover layer. If one or more adhesive elements fail to mate with at least one first end during contact with the cover layer, the cover layer may bend in the corresponding adhesive element area, making it more difficult to grip the cover layer in any case. The first end of the primary packaging element is formed by a base of the primary packaging element or an open edge of the primary packaging element, etc.

[0025] According to a preferred embodiment, the gripping unit includes multiple receiving structures, with adhesive elements arranged at the ends of the receiving structures. Because they are arranged at the ends of the receiving structures, the adhesive elements can be axially spaced from the main structure of the gripping unit relative to an axis perpendicular to the holding plane. This makes it easier for the adhesive elements to contact the cover layer. Specifically, each end segment has only one adhesive element. However, multiple adhesive elements can also be arranged at the same end. The receiving structures are preferably cylindrical or punch-shaped. Cylindrical receiving structures can have various cross-sections. For example, the cross-section of a cylindrical receiving structure can be circular, rectangular, or elliptical. If the receiving structure is punch-shaped, its ends are widened.

[0026] According to a preferred embodiment, receiving structures are respectively arranged on different side arms of the gripping unit, which extend parallel to or at an angle to the holding plane. The side arms can achieve an ideal distance between the receiving structures or the adhesive elements arranged thereon.

[0027] According to a preferred embodiment, different spring units, particularly springs in the preloaded case, exist between the receiving structure and the gripping unit. These spring units apply a restoring force to each receiving structure, which can move against the corresponding restoring force in a first direction perpendicular to the holding plane. This design of the gripping unit limits the clamping force according to the spring unit design when the adhesive element and the cover layer are pressed together, thereby preventing excessive compression of the adhesive element. Over-compression refers to the adhesive element and the cover layer being pressed together with such great pressure that the adhesive protrusions of the adhesive element bend. The free ends of the adhesive protrusions then align with the cover layer at an angle, thus applying only a small adhesive force at most. This effect caused by over-compression is also known as "Euler buckling."

[0028] According to a preferred embodiment, each receiving structure is fixed in a different recess of a gripping unit, the gripping unit including an actuation device having at least one actuator designed to move the receiving structure along a first direction to arrange an adhesive element in the recess for separation of the gripped cover layer. Once the adhesive element is moved into the recess, the gripped cover layer can be safely separated. Specifically, when the adhesive element is moved into the recess, the cover layer is blocked by the bottom surface of the gripping unit extending from the recess.

[0029] According to a preferred embodiment, each receiving structure is assigned a different actuator to achieve movement of the receiving structure. This allows the gripped cover layer to be peeled off from the gripping unit in a particularly controllable manner. For example, the adhesive elements can be moved into the recess continuously or in pairs.

[0030] Preferably, the manipulation system includes a manipulation device, particularly a four-axis robot, a six-axis robot, or a manipulation device with two movable axes, for moving the gripping unit toward the covering layer and pressing the adhesion device against a first side of the covering layer. The gripping unit is preferably detachably connected to the manipulation device. However, the gripping unit can also be an integral part of the manipulation device. The manipulation system may further include a manipulation device, particularly a four-axis robot, a six-axis robot, or a manipulation device with two movable axes, for moving the transport container with the covering layer toward the adhesion device and pressing the first side of the covering layer against the adhesion device. Such a manipulation device can serve as a replacement or supplement to the aforementioned manipulation device.

[0031] According to a preferred embodiment, the gripping unit includes at least one release punch that can be pressed against a first side of the cover layer to separate the gripped cover layer. The gripped cover layer can also be securely separated by one or more release punches. Providing multiple release punches also offers the advantage of particularly precise control over the separation process. For example, for this purpose, the release punches can be continuously pressed against the first side of the cover layer. Preferably, at least one release punch is movable along an axis perpendicular to the holding plane.

[0032] According to a preferred embodiment, the gripping unit comprises at least two parts movable relative to each other, each part having a different adhesive element or a different group of adhesive elements. An actuator is provided for moving the two parts relative to each other, allowing the gripped cover layer to separate from the gripping unit through the relative movement of the two parts. This design of the gripping unit also allows the gripped cover layer to detach securely. The parts are preferably movable relative to each other along an axis parallel to the holding plane. For example, if the parts move relative to each other along this axis, the angle between the adhesive element and the gripped portion of the cover layer increases as the cover layer bends. Therefore, the cover layer detaches from the adhesive element.

[0033] Preferably, the actuation system includes at least one fixed retainer designed and arranged to abut against a first side of the gripped cover layer. When the retainer abuts against the first side, the gripped cover layer can be separated from the gripping unit as the gripping unit moves away from the cover layer. Such a retainer also allows the gripped cover layer to be safely separated from the gripping unit. The retainer is preferably designed and arranged to contact the first side of the cover layer between two adhesive elements or between two legs of a single adhesive element. When the retainer is in this supported contact state, the cover layer can be separated particularly safely. Particularly preferred is that the retainer can be shaped like a shovel. Multiple different retainers may also be used, for example, retainers of different sizes.

[0034] According to a preferred embodiment, a sliding unit is arranged below the retainer. This sliding unit has a sliding surface, or a nominal extension dimension of the sliding surface, extending along the sliding direction through a collection opening in a collection container for the cover layer. The cover layer, separated from the gripping unit by the retainer, falls onto the sliding surface and slides into the collection container. Collecting the cover layer into the collection container facilitates processing.

[0035] Preferably, the manipulation system includes at least one sensor unit for identifying the cover layer grasped by the gripping unit. This allows for monitoring the correct execution of the peeling process. The sensor unit is preferably a radiation sensor, particularly a camera sensor or a laser sensor. Alternatively, the sensor unit is preferably implemented as a force sensor and integrated with the gripping unit, so that the weight of the gripped cover layer acts on the force sensor. The sensor unit as a force sensor also has the advantage of measuring the clamping force acting on the adhesion device during pressing. Therefore, such a force sensor can control the pressing, preventing the adhesion element from being excessively squeezed.

[0036] A cleanroom possessing the features described in this application can also achieve the above objectives. An operating system with the aforementioned features is arranged within the cleanroom. This operating system is preferably part of a pharmaceutical manufacturing machine.

[0037] For details regarding the advantages achievable with a cleanroom, please refer to the description of the operating system and / or methods. Features related to the operating system and / or methods can be used for further cleanroom design.

[0038] The desired result can also be achieved by lifting the covering layer, a method that includes: Provide disc-shaped transport containers, particularly basins, in which primary packaging elements of pharmaceuticals are arranged, particularly containers or sealing elements, the primary packaging elements being covered by a covering layer, particularly a covering film; A device with a gripping unit is provided, the gripping unit comprising an adhesion device consisting of at least one adhesion element having an adhesion structure for adhesively gripping a cover layer, the smallest circle located in the holding plane of the adhesion device and surrounding the adhesion device having a diameter of at least 50 mm. Press the adhesive device and the cover layer together so that the adhesive device makes physical surface contact with the first side of the cover layer away from the primary packaging element, and use the adhesive device to adhesively grip the cover layer. The cover layer to be grabbed is peeled off from the primary packaging element; The overlay to be captured is separated from the capture unit.

[0039] The advantages and development potential of a control system should also be understood as being related to the method; conversely, the advantages and development potential of a method should also be understood as being related to the control system.

[0040] There are several embodiments of this method regarding the pressing of the adhesion device and the cover layer. In a preferred first embodiment, the transport container with the cover layer is pressed against a fixed gripping unit. In a preferred second embodiment, the gripping unit with the adhesion device is pressed against the cover layer of the fixed transport container. In a third embodiment, the adhesion device and the cover layer move relative to each other, so that neither the gripping unit nor the transport container is stationary.

[0041] If multiple adhesive elements are provided, when the adhesive elements are pressed together, they each contact different portions of the cover layer. The adhesive elements and the cover layer are preferably pressed together in such a way that at least a portion of the cover layer portion contacted by the adhesive elements is supported on at least one primary packaging element disposed directly beneath the cover layer. The advantage of supporting the contact portions is that the required clamping force can be achieved even with a flexible cover layer.

[0042] Preferably, the cover layer is separated from the gripping unit by pulling the gripping unit. This utilizes the inertia and air resistance of the cover layer for separation. The advantage of this method is that it does not require sophisticated design of the gripping unit. Alternatively, the cover layer is preferably separated from the gripping unit by a fixed retainer. In this case, the first side of the gripped cover layer abuts against the retainer. Moving the gripping unit away from the cover layer separates the cover layer from the retainer. Alternatively, the cover layer is preferably separated from the gripping unit by the relative movement of the adhesive element. The relative movement of the adhesive element causes an increase in the angle between the adhesive element and the gripped portion of the cover layer. As a result, the cover layer detaches from the adhesive element. Alternatively, the cover layer is preferably separated from the gripping unit by the adhesive element moving into a recess of the gripping unit. If the adhesive element moves into the recess, the gripped cover layer is held by, for example, the bottom surface of the gripping unit (extending from the recess). Alternatively, the cover layer is preferably separated from the gripping unit by at least one release punch movably fixed to the gripping unit. The cover layer can also be safely separated from the gripping unit by one or more push-out punches. Attached Figure Description

[0043] The invention will now be described in more detail with reference to the accompanying drawings, in which identical or functionally identical elements are appropriately indicated only once by reference numerals. These drawings are illustrative only and should not be construed as limiting. In the drawings: Figure 1 A perspective view of the control system is shown, which includes a transport container in which primary packaging elements of the pharmaceutical are contained, and a device with a gripping unit. Figure 2 A cross-sectional view of the transport container and the gripping unit is shown, in which the gripping unit is lifting the cover layer inside the transport container; Figure 3A perspective view of the control system is shown after the cover has been lifted; Figure 4 A side view of a separation unit for separating a gripped overlay from a gripping unit is shown. Figure 5 yes Figure 4 Perspective view of the separated unit shown; Figure 6 Another exemplary embodiment of the grasping unit is shown; Figure 7 This is a cross-sectional view of another exemplary embodiment of the grasping unit; Figure 8 A cross-sectional view of another exemplary embodiment of the grasping unit is shown; Figure 9 yes Figure 8 Another cross-sectional view of the grasping unit shown; and Figure 10 A perspective view of a manipulation system with another gripping unit is shown. Detailed Implementation

[0044] Figures 1 to 3 An operating system 10 is shown, which is arranged in a clean room 64 as part of a pharmaceutical production machine.

[0045] The control system 10 includes at least one disc-shaped transport container 12. Figures 1 to 3 The image shows only one disc-shaped transport container 12. However, in practice, there are usually multiple disc-shaped transport containers 12.

[0046] In this example, the transport container 12 is implemented as a basin 12. The primary packaging element 14 of the pharmaceutical product is arranged or stored in the transport container 12. In the illustrated exemplary embodiment, the primary packaging element 14 is a receiver 14 for a syringe.

[0047] In this example, the primary packaging element 14 is arranged nested within the transport container 12. This means that the primary packaging element 14 is housed within a nest 15. The nest 15 is arranged together with the primary packaging element 14 within the transport container 12.

[0048] The primary packaging element 14 is covered by a cover layer 16. In this example, the cover layer 16 directly covers the primary packaging element 14. Each primary packaging element 14 has an end 17 facing the cover layer 16. In this example, the end 17 is formed by the open edge of the primary packaging element 14. The cover layer 16 is surrounded by the sidewalls 18 of the transport container 12 and is therefore disposed within the transport container 12. In the exemplary embodiment shown, the cover layer 16 is a flexible cover film 16.

[0049] In this example, the covering layer 16 or covering film 16 is breathable, for which a polyethylene woven fabric is used. The breathable design of the covering layer 16 has the advantage that when sterilizing with a gaseous sterilizing agent (such as ethylene oxide), the sterilizing agent can pass through the covering layer 16.

[0050] The transport container 12 includes side cantilever 20. Typically, during sterilization, the transport container 12 is sealed by a sealing layer attached to the cantilever 20. The sealing layer is preferably designed to match the covering layer 16. Figures 1 to 3 In this case, the sealing layer has been removed from the transport container 12 and is therefore not visible.

[0051] The manipulation system 10 also includes a device 22 for lifting the cover layer 16. The device 22 includes a gripping unit 24 with an adhesion device 25.

[0052] exist Figures 1 to 3 In the exemplary embodiment shown, the adhesion device 25 is composed of a plurality of mutually spaced adhesion elements 26. However, the adhesion device 25 may also be composed of a single adhesion element 26, for example... Figure 10 As shown. Regardless of the number of adhesive elements 26, in all exemplary embodiments illustrated in the figures, the adhesive device 25 is sized such that the diameter of the smallest circle located within the holding plane of the adhesive device 25 and surrounding the adhesive device 25 (i.e., a plurality of adhesive elements 26 or a single adhesive element 26) is at least 50 mm. Preferably, the diameter of the circle is at least 70 mm, and particularly preferably at least 100 mm. In the exemplary embodiments illustrated, the adhesive elements 26 are implemented as adhesive films 26.

[0053] The adhesive element 26 has an adhesive structure for adhesively gripping the cover layer 16. The adhesive structure of the adhesive element 26 preferably consists of multiple elastically deformable adhesive protrusions. The diameter of the adhesive protrusions is preferably less than 1 mm. Thus, the adhesive structure is implemented as a microstructure. Due to size constraints, the adhesive protrusions are not visible in the figures. For example, the adhesive protrusions are needle-shaped or mushroom-shaped.

[0054] exist Figures 1 to 3 In the exemplary embodiment shown, there are four adhesive elements 26. The adhesive elements 26 are respectively arranged at different corners of the nominal parallelogram. In this example, the parallelogram is a square.

[0055] The gripping unit 24 includes a central body 28. In this example, four side arms 30 are arranged on the body 28, extending from the body 28 and parallel to the holding plane. Each side arm 30 has a receiving structure 32 at its outer end; in this example, the receiving structure is columnar. An adhesive element 26 is arranged on the end 34 of the columnar receiving structure 32.

[0056] The adhesive elements 26 are arranged to make physical surface contact with a first side 36 of the cover layer 16 opposite to the primary packaging element 14. In the illustrated exemplary embodiment, the adhesive elements 26 are arranged to make physical contact with the first side 36 of the cover layer 16 adjacent to a corresponding other edge of the cover layer 16. The distance between the center of the edge and the nearest adhesive element 26 is less than 40 mm.

[0057] In this example, the arrangement of the adhesive elements 26 complements the primary packaging element 14. Thus, the adhesive elements 26 can be physically contacted with the first side 36 of the cover layer 16, such that each adhesive element 26 at least partially mates with at least one first end 17 of the primary packaging element 14 disposed directly below the cover layer 16 in a line-of-sight direction 38 perpendicular to the retaining plane. Figure 2 This is clearly illustrated. The advantages of this complementary fit arrangement of the adhesive element 26 and the primary packaging element 14 will be explained in detail below.

[0058] The device 22 also includes a manipulation device 40. For example, the manipulation device 40 is implemented as a six-axis robot 40. In the exemplary embodiment shown, the manipulation device 40 is designed to move the gripping unit 24 toward the cover layer 16 and press the adhesive element 26 against the cover layer 16. Alternatively, the manipulation device 40 may also be designed to move the transport container 12 with the cover layer 16 toward the adhesive element 26 and press the cover layer 16 against the adhesive element 26 by moving the transport container 12. In this case, the gripping unit 24 is preferably arranged in a fixed manner.

[0059] The method of peeling the cover layer 16 off the primary packaging element 14 will now be described in more detail. The gripping unit 24 moves toward the cover layer 16 via the manipulating device 40, and the adhesive device 25 is pressed against the first side 36 of the cover layer 16. Pressing the adhesive device 25 against the cover layer 16 causes the cover layer 16 to be adhesively gripped by the adhesive device 25 (i.e., the plurality of adhesive elements 26).

[0060] When pressed together, the gripping unit 24 and the transport container 12 are preferably aligned relative to each other, such that each adhesive element 26 is at least partially aligned in the line of sight 38 direction with at least one first end 17 of the primary packaging element 14 disposed directly below the cover layer 16. Therefore, the portion of the cover layer 16 in contact with the adhesive element 26 is supported by the primary packaging element 14 disposed directly below. Particularly in the case of a flexible cover layer 16, the non-complementary mating arrangement of the adhesive element 26 and the primary packaging element 14 may cause the cover layer 16 to bend upon contact. This at least increases the difficulty of adhering the cover layer 16.

[0061] The adhesion device 25 preferably presses against the cover layer 16 with a predetermined clamping force. The clamping force is preferably selected to avoid excessive pressure on the adhesion element 26.

[0062] After the cover layer 16 is grasped, it is lifted off the primary packaging element 14 by the manipulating device 40. Due to the size of the aforementioned adhesive device 25, the edges and boundaries of the cover layer 16 will only sag slightly at most when it is lifted. Therefore, under any circumstances, the possibility of particles on the cover layer 16 entering the primary packaging element 14 is extremely low.

[0063] Once opened, the cover layer 16 separates from the gripping unit 24, allowing the gripping unit 24 to be used for the subsequent opening of another transport container 12. Various advantageous methods can be employed for separating the cover layer 16, which will be referred to below. Figures 4 to 10 The manipulation system 10 or the gripping unit 24 shown will be described in more detail.

[0064] exist Figure 4 and Figure 5 In the exemplary embodiment shown, the manipulation system 10 includes a separation unit 42 having a fixed retainer 44, which in this example is shovel-shaped. The retainer 44 abuts against a first side 36 of the gripped cover layer 16. Once the retainer 44 abuts against the first side 36, the cover layer 16 separates from the gripping unit 24 as the gripping unit 24 moves away from the cover layer 16. Because of the shovel-shaped design of the retainer 44, the narrow retainer 44 can be positioned between the two adhesive elements 26, abutting against the first side 36 of the cover layer 16. This contact between the retainer 44 and the first side 36 of the cover layer 16 allows the cover layer to separate from the gripping unit 24 in a particularly secure manner.

[0065] In the exemplary embodiment shown, the separating unit 42 further includes a sliding unit 46 having a sliding surface 48. The sliding unit 46 is located below the retainer 44, so that the separated cover layer 16 falls onto the sliding surface 48 of the sliding unit 46.

[0066] The control system 10 also includes a collection container 50 for the cover layer 16. The collection container 50 is arranged such that the nominal extension dimension of the sliding surface 48 passes through the collection opening 52 of the collection container 50 in the sliding direction. The cover layer 16 that falls onto the sliding surface 48 is accordingly conveyed into the collection container 50.

[0067] Figure 6Another exemplary embodiment of the gripping unit 24 is shown, in which only two adhesive elements 26 are visible. The gripping unit 24 includes a first portion 54 and a second portion 55, each portion carrying a different adhesive element 26. In particular, the adhesive device 25 includes four adhesive elements 26, with each portion 54, 55 carrying two adhesive elements 26. However, one of the portions 54 and 55 may also carry three adhesive elements 26, while the other portion carries only one adhesive element 26. The portions 54 and 55 can move relative to each other. In this example, the portions 54 and 55 can move relative to each other along an axis 56 parallel to the retaining plane. An actuator 58 is used for the relative movement of the portions 54 and 55. The actuator 58 is arranged within the housing 57 of the gripping unit 24 and is therefore not visible.

[0068] exist Figure 6 In the case of the gripping unit 24 shown, in order to separate the cover layer 16, it is preferable to move portions 54 and 55 by means of the actuator 58, thereby reducing the distance between the adhesive elements 26. This increases the angle between the adhesive elements 26 and the gripped cover layer 16. Therefore, as Figure 6 As shown, the overlay layer 16 is separated from the gripping unit 24.

[0069] Figure 7 A cross-sectional view of another exemplary embodiment of the gripping unit 24 is shown. Figure 7 In the gripping unit 24 shown, only two adhesive elements 26 are visible. The gripping unit 24 includes a release punch 60 movably held on the gripping unit 24. In this example, the release punch 60 is movable along an axis 62 perpendicular to the holding plane. Figure 7 The examples in the text are different, and there may also be multiple push-out punches 60.

[0070] exist Figure 7 In the case of the gripping unit 24 shown, in order to separate the gripped cover layer 16, the push-off punch 60 moves along the axis 62 and presses against the first side 36 of the cover layer 16.

[0071] Figure 8 and Figure 9 A cross-sectional view of another exemplary embodiment of the gripping unit 24 is shown. In this example, only details of the gripping unit 24 are shown. In this exemplary embodiment, the receiving structure 32 (in this example, a punch shape) is movably held in different recesses 78 of the gripping unit 24. In this example, the gripping unit 24 includes a body 86 with cavities provided therein. A plurality of cylinders 88 are fastened to the body 86. The cavities and the cylinders 88 together form the recesses 78.

[0072] Both the receiving structure 32 and the gripping unit 24 have different spring units 74, which maintain a preload force. In this example, the spring unit 74 is implemented as a helical spring 74. Under the restoring force provided by the spring unit 74, the receiving structure 32 can move along a first direction 76 perpendicular to the holding plane.

[0073] When the adhesive device 25 and the cover layer 16 are pressed together, the clamping force is limited by the spring unit 74. Therefore, excessive pressure on the adhesive element 26 can be avoided.

[0074] In this embodiment, the gripping unit 24 includes an actuation device 80 having a plurality of actuators 82, which, in the illustrated exemplary embodiment, are implemented as pneumatic actuators 82. The actuators 82 are designed to move the receiving structure 32 along a first direction 76 such that the adhesive element 26 is arranged in the recess 78. This arrangement of the adhesive element 26 is as follows: Figure 9 As shown. When the adhesive element 26 is moved into the recessed fabric 78, the cover layer 16 is held by the gripping unit 24 or the bottom surface 84 of the body 86, and the recessed fabric 78 extends in the body 86. The adhesive element 26 is preferably moved into the recessed portion 78 continuously or in pairs by the actuator 82.

[0075] exist Figure 10 In the exemplary embodiment of the gripping unit 24 shown, the adhesion device 25 is composed of a single adhesion element 26. Figure 10 In the exemplary embodiment shown, the adhesive element 26 is U-shaped.

[0076] The physical contact between the adhesive device 25 and the cover layer 16 ensures that the distance between the corner of the cover layer 16 and the adhesive device 25 is less than 40 mm. This arrangement of the adhesive device 25 on the cover layer 16 also reliably prevents the edges of the cover layer 16 from sagging when it is lifted off.

[0077] exist Figure 10 In the exemplary embodiment of the grasping unit 24 shown, the grasped overlay is, for example, through... Figure 4 and Figure 5 The retainer 44 shown is detached. Additionally, one or more movable push-out punches 60 may be provided as part of the gripping unit 24.

[0078] In another exemplary embodiment of this method, the gripped cover layer 16 is separated from the gripping unit 24 by the pulling motion of the gripping unit 24. This utilizes the inertia and air resistance of the cover layer 16 for separation. The advantage of this is that neither a fixed retainer nor a specially designed gripping unit is required.

Claims

1. An operating system (10) for a cleanroom (64), comprising: At least one disc-shaped transport container (12) in which a primary packaging element (14) of the pharmaceutical product is arranged, the primary packaging element (14) being covered by a cover layer (16); and Device (22) for lifting the cover (16) from the primary packaging element (14), the device (22) including gripping unit (24) for gripping the cover (16). Its features are, The gripping unit (24) includes an adhesion device (25) consisting of at least one adhesion element (26), the adhesion element (26) being configured to have an adhesion structure for adhesively gripping the cover layer (16). The adhesion device (25) is capable of physical surface contact with a first side (36) of the cover layer (16), the first side being opposite to the primary packaging element (14), and The diameter of the smallest circle located in the retaining plane of the adhesive device (25) and surrounding the adhesive device (25) is at least 50 mm.

2. The operating system (10) according to claim 1, characterized in that, The at least one disc-shaped transport container (12) is a basin, the primary packaging element (14) is a receiver or closure element, and the covering layer (16) is a covering film.

3. The operating system (10) according to claim 1 or 2, characterized in that, The cover layer (16) has multiple corners, and the adhesive device (25) is able to make physical contact with the first side (36) of the cover layer (16) such that the distance between the corner of the cover layer (16) and the adhesive device (25) is less than 40 mm.

4. The operating system (10) according to claim 1 or 2, characterized in that, The cover layer (16) has multiple edges, and the adhesive device (25) is able to make physical contact with a first side (36) of the cover layer (16) such that the distance between the edge center and the adhesive device (25) is less than 40 mm.

5. The operating system (10) according to claim 1 or 2, characterized in that, The adhesive element (26) is implemented as an adhesive film (26).

6. The operating system (10) according to claim 1 or 2, characterized in that, The adhesive element (26) of the adhesive device (25) is X-shaped, C-shaped, U-shaped or ring-shaped.

7. The operating system (10) according to claim 1 or 2, characterized in that, The adhesive element (26) of the adhesive device (25) is circular or rectangular.

8. The operating system (10) according to claim 1 or 2, characterized in that, The adhesion device (25) includes a plurality of adhesion elements (26).

9. The operating system (10) according to claim 1 or 2, characterized in that, The adhesive device (25) includes four adhesive elements (26), each of which is arranged at a different corner of a nominal parallelogram.

10. The operating system (10) according to claim 8, characterized in that, The primary packaging element (14) includes a first end (17) facing the cover layer (16), and the plurality of adhesive elements (26) are capable of physical contact with a first side (36) of the cover layer (16) such that each adhesive element (26) at least partially matches at least one first end (17) of the primary packaging element (14) disposed directly below the cover layer (16) in a line-of-sight direction (38) perpendicular to the retaining plane.

11. The operating system (10) according to claim 8, characterized in that, The gripping unit (24) includes multiple cylindrical or punch-shaped receiving structures (32), and the adhesive element (26) is arranged on the end (34) of the receiving structure (32).

12. The operating system (10) according to claim 11, characterized in that, The receiving structure (32) is arranged on different side arms (30) of the gripping unit (24), which extend parallel to the holding plane or at an angle to the holding plane.

13. The operating system (10) according to claim 11 or 12, characterized in that, Each receiving structure (32) and the grasping unit (24) is maintained by a different spring unit (74), which applies a restoring force to each receiving structure (32), and the receiving structure (32) is able to move against the corresponding restoring force in a first direction (76) perpendicular to the holding plane.

14. The operating system (10) according to claim 13, characterized in that, Each receiving structure (32) is held movable in different recesses (78) of the gripping unit (24), which includes an actuation device (80) having at least one actuator (82) designed to move the receiving structure (32) along the first direction (76) such that the adhesive element (26) is arranged in the recess (78) to separate the gripped cover layer (16).

15. The operating system (10) according to claim 14, characterized in that, Each receiving structure (32) is assigned a different actuator (82).

16. The operating system (10) according to any one of claims 1, 2, 10-12, 14, and 15, characterized in that, The control system includes: A manipulator (40) is designed to move the gripping unit (24) toward the cover layer (16) and press the adhesive device (25) against a first side (36) of the cover layer (16); and / or A manipulator is designed to move a transport container (12) with the cover (16) toward the adhesive device (25) and press the first side (36) of the cover (16) against the adhesive device (25).

17. The operating system (10) according to any one of claims 1, 2, 10-12, 14, and 15, characterized in that, The gripping unit (24) includes at least one push-off punch (60) which is capable of pressing against a first side (36) of the cover layer (16) to separate the gripped cover layer (16).

18. The operating system (10) according to any one of claims 1, 2, 10-12, 14, and 15, characterized in that, The gripping unit (24) includes at least two parts (54, 55) that are movable relative to each other, each part (54, 55) carrying a different adhesive element (26) or a different set of adhesive elements (26), and an actuator (58) is provided for the movement of the parts (54, 55) relative to each other, through which the gripped cover layer (16) can be separated from the gripping unit (24).

19. The operating system (10) according to any one of claims 1, 2, 10-12, 14, and 15, characterized in that, The manipulation system has at least one fixed retainer (44) designed and arranged to abut against a first side (36) of the gripped cover layer (16), such that when the retainer (44) abuts against the first side (36), the gripping unit (24) moves toward a direction away from the cover layer (16), allowing the gripped cover layer (16) to be separated from the gripping unit (24).

20. The operating system (10) according to claim 19, characterized in that, The retainer (44) is implemented in the shape of a shovel.

21. The operating system (10) according to claim 19, characterized in that, Below the retainer (44) is a sliding unit (46) having a sliding surface (48) the nominal extension dimension of which extends along the sliding direction through the collection port (52) of the collection container (50) for the cover layer (16).

22. The operating system (10) according to any one of claims 1, 2, 10-12, 14, 15, 20, and 21, characterized in that, The manipulation system has at least one sensor unit designed to identify the cover layer (16) being grasped by the grasping unit (24).

23. The operating system (10) according to claim 22, characterized in that, The at least one sensor unit is a radiation sensor or a force sensor.

24. A cleanroom (64), wherein the operating system (10) according to any one of claims 1 to 23 is arranged in the cleanroom as part of a pharmaceutical production machine.

25. A method for removing a covering layer (16), comprising: a. Provide a disc-shaped transport container (12) in which a primary packaging element (14) of a pharmaceutical product is arranged, the primary packaging element (14) being covered by a cover layer (16); b. Provides a device (22) having a gripping unit (24), the gripping unit comprising an adhesive device (25) consisting of at least one adhesive element (26), the adhesive element (26) being configured to have an adhesive structure for adhesively gripping the cover layer (16), the smallest circle located in the holding plane of the adhesive device (25) and surrounding the adhesive device (25) having a diameter of at least 50 mm; c. Press the adhesive device (25) and the cover layer (16) together so that the adhesive device (25) makes physical surface contact with the first side (36) of the cover layer (16) away from the primary packaging element (14), and the cover layer (16) is adhesively gripped by the adhesive device (25). d. Peel off the gripped cover (16) from the primary packaging element (14); e. Separate the uncovered cover layer (16) from the gripping unit (24).

26. The method according to claim 25, characterized in that, The disc-shaped transport container (12) is a basin, the primary packaging element (14) is a receiver or sealing element, and the covering layer (16) is a covering film.

27. The method according to claim 25 or 26, characterized in that, The cover layer (16) is separated from the gripping unit (24) by the pulling motion of the gripping unit (24), by the fixed retainer (44), by the movement of the adhesive elements (26) relative to each other, by the movement of the adhesive elements (26) into the recess (78) in the gripping unit (24), or by at least one push-off punch (60) movably held on the gripping unit (24).

Images