Device for removing a sterile object from an outer packaging, system comprising a corresponding device and method for removing a sterile object from an outer packaging

The device addresses the challenges of cutting and removing sterile objects by using a tensioning system with a gas supply channel to inflate the packaging, ensuring precise cutting and easy removal while maintaining sterility and reducing adherence issues.

EP4382441B1Active Publication Date: 2025-01-01SYNTEGON TECHNOLOGY GMBH
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Patent Information

Application Number
EP2023204430
Authority / Receiving Office
EP · EP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2022-11-03
Filing Date
2023-10-18
Publication Date
2025-01-01
Estimated Expiration
2043-10-18

AI Technical Summary

Technical Problem

Existing devices for removing sterile objects from outer packaging face challenges such as deformation during cutting, adherence of packaging to the object, and difficulty in maintaining sterility due to sudden gas influx and static friction.

Method used

A device with a rotatable tensioning roller and a further tensioning element, equipped with a piercing element having a gas supply channel to inflate the packaging before cutting, ensuring precise cutting and easy removal of the sterile object while minimizing static friction.

Benefits of technology

The solution allows for precise cutting and easy removal of sterile objects from their packaging, maintaining sterility and reducing the risk of packaging adherence, by controlling gas influx and static friction through inflation and design features like multiple piercing elements and a holding device.

✦ Generated by Eureka AI based on patent content.

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Abstract

A device (1) for removing a sterile item (2) from an outer packaging (3), a system with a corresponding device (1) and a method for removing a sterile item (2) from an outer packaging (3) are proposed.
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Description

[0001] The present invention relates to a device for removing a sterile object from an outer packaging. Furthermore, the present invention relates to a system comprising a corresponding device and a sterile object packaged in an outer packaging. Furthermore, the present invention relates to a method for removing a sterile object from an outer packaging.

[0002] Sterile items are used on a large scale, particularly in pharmaceutical production. Sterile items are often transported and stored in outer packaging. One example of sterile items is sterile tubes, which are conventionally packaged in outer packaging in the form of a foil bag. A tub is a plastic tray used to store nests or the like. A nest in the present sense is a plastic carrier plate and is typically used to hold primary packaging materials such as vials, syringes or cartridges, particularly for active medicinal substances, or other laboratory supplies such as plunger stoppers for syringes. The foil bag with the sterile tube arranged inside is often first evacuated and then welded.

[0003] Typically, sterile objects are handled automatically in a sterile environment. Removing a sterile object from its outer packaging represents a demanding handling step because the sterile nature of the object must be maintained. Furthermore, no residue of the outer packaging should adhere to the sterile object after removal. A conventional device for removing a sterile object from outer packaging is known, for example, from published patent application DE 10 2007 027 878 ​​A1. The device comprises a clamping device with two rotatable clamping rollers. During a removal process, a first section of the outer packaging is clamped between the clamping rollers. The outer packaging is then tensioned by rotating the clamping rollers.A cutting device is then used to create a cut in the tensioned outer packaging and the sterile article is removed from the outer packaging through the cut using a removal device.

[0004] With the device known from published patent application DE 10 2007 027 878 ​​A1, problems can arise during the removal process, affecting both the cutting process and the removal itself. For example, a negative pressure in the outer packaging can cause gas to suddenly flow into the outer packaging when the outer packaging is cut. This can lead to deformation of the outer packaging during cutting, which at the very least makes it difficult to create a precise cut. Furthermore, the outer packaging can adhere to the sterile object. This makes removal itself more difficult because the static friction between the outer packaging and the sterile object must be overcome.

[0005] DE 10 2014 201814 A1 discloses a similar device in which a needle with a gas supply channel is inserted into a foil bag in order to fill it with gas in order to inflate the foil and thus detach the foil from the object.

[0006] The invention is based on the object of providing a possibility of removing a sterile object from an outer packaging in a sterile environment, whereby a precise cutting open of the outer packaging and easy removal of the sterile object should be possible.

[0007] This object is achieved according to the invention by a device according to claim 1, by a system according to claim 14 and by a method according to claim 15.

[0008] The respective subclaims and the description specify advantageous variants and embodiments. According to the invention, a device is provided for removing a sterile object, in particular a tub, from an outer packaging, in particular a film bag. The device comprises a clamping device with a rotatable clamping roller and a further clamping element. A first section of the outer packaging, in particular a tab-shaped section, can be clamped between the clamping roller and the further clamping element. When the first section is clamped, the outer packaging can be clamped by rotating the clamping roller. Preferably, the clamping roller is displaceable relative to the further clamping element. As a result, the first section can be clamped between the clamping roller and the further clamping element, for example, by lowering or raising the clamping roller. Preferably, the clamping roller is assigned a controllable actuator for displacing the clamping roller relative to the further clamping element.The additional tensioning element is preferably a rotatable additional tensioning roller. However, the additional tensioning element can also be a stationary, bent tensioning plate or the like. A controllable actuator for rotating the tensioning roller is preferably assigned to the tensioning roller.

[0009] The device further comprises a cutting device for cutting open the stretched outer packaging. The cutting device is preferably designed to cut open the outer packaging in such a way that the outer packaging remains intact as a continuous piece. Cutting the outer packaging into two separate parts is then avoided. This facilitates handling of the cut outer packaging during the subsequent removal of the sterile article.

[0010] The device further comprises a removal device for removing the sterile object from the outer packaging. The removal device preferably comprises at least one suction device for sucking the sterile object during removal. Such a removal device is particularly suitable for removing tubs. Tubs generally comprise at least substantially flat side walls that are easily suctioned.

[0011] It is now provided that at least one piercing element is arranged on the tensioning roller, which comprises a gas supply channel with at least one inlet opening for supplying gas into the gas supply channel, and at least one outlet opening. The piercing element can be pierced into the outer packaging, in particular by rotating the tensioning roller. Once the piercing element has been pierced into the outer packaging, gas can be blown into the outer packaging via the outlet opening of the piercing element in order to fill the outer packaging with gas. By blowing in gas, a sudden influx of gas into the outer packaging when the outer packaging is later cut. In addition, the outer packaging can be detached from the sterile object by blowing in gas. This facilitates the removal of the sterile object because at most only slight static friction between the sterile object and the outer packaging needs to be overcome.Preferably, the piercing element is hollow, so that the gas supply channel extends through the piercing element. However, the gas supply channel can also extend, at least in sections, along an outer contour of the piercing element.

[0012] The device preferably comprises a gas supply device with a compressed gas source, wherein the compressed gas source is fluidly connected to the inlet opening of the gas supply channel. The compressed gas source is designed to supply gas at a pressure above atmospheric pressure. Nitrogen, sterile compressed air, protective gas, etc. are preferably used or provided. The gas supply device preferably comprises a valve unit with a pressure control valve, by which the gas pressure of the supplied gas can be regulated to a desired pressure value. This can prevent excessive or uncontrolled inflation of the outer packaging.

[0013] According to a preferred embodiment, the tensioning roller is tubular with a hollow space extending along its length, and the hollow space is fluidly connected to the inlet opening of the gas supply channel. In this embodiment, the gas is supplied to the gas supply channel through the hollow space of the tensioning roller. Such a supply of gas is structurally simple to implement. In particular, the hollow space of the tensioning roller can also be used to fluidically connect a plurality of piercing elements. Separate fluid lines for the individual piercing elements are not necessary. Preferably, the aforementioned compressed gas source is fluidly connected to the hollow space of the tensioning roller, such that the inlet opening of the gas supply channel is fluidly connected to the compressed gas source through the hollow space.

[0014] According to a preferred embodiment, the piercing element is arranged in a through-opening, in particular a through-bore, in a casing wall of the tensioning roller. The arrangement in the through-opening reliably ensures the fluidic connection of the cavity of the tensioning roller with the inlet opening of the gas supply channel. Furthermore, the arrangement in the through-opening creates a mechanically robust assembly of the tensioning roller and the piercing element(s). Preferably, the piercing element is pressed into the through-opening, so that the piercing element is held in the through-opening by a press fit. Preferably, a particularly circumferential projection of the piercing element bears against a stop step of the through-opening. The through-opening is thus stepped.By engaging the projection against the stop step, radial displacement of the piercing element is blocked. Preferably, a stop surface of the stop step is directed radially outward, so that the stop step blocks radial inward displacement of the piercing element. Preferably, a sealing ring is provided, which acts as a seal between the through-opening and the outer contour of the piercing element.

[0015] According to a preferred embodiment, the piercing element comprises a conical end section, and the outlet opening is formed in the end section at a distance from the tip of the end section. The conical end section makes it possible to realize a mechanically robust piercing element, in particular compared to a piercing element that has a needle-shaped end section. By arranging the outlet opening at a distance from the tip in the conical end section, it is also achieved that the gas flow flowing out of the outlet opening has a tangential direction component with respect to the rotation axis of the tensioning roller. This makes it possible to achieve particularly effective detachment of the outer packaging from the sterile object. Preferably, several outlet openings are provided, which are formed in the end section at a distance from the circumferential direction of the end section.This further improves the detachment of the outer packaging from the sterile article. Preferably, the outlet openings are formed axially at the same height in the end section relative to the longitudinal center axis of the piercing element.

[0016] Preferably, the additional clamping element has a circumferential groove radially opposite the piercing element. The circumferential groove ensures that the piercing element does not come into contact with the additional clamping element when the clamping roller rotates. Instead, the piercing element protrudes radially into the circumferential groove, depending on the rotational position of the clamping roller. Contact between the piercing element and the additional clamping element could result in damage to the piercing element and / or the additional clamping element.

[0017] According to a preferred embodiment, it is provided that a plurality of piercing elements are arranged on the tensioning roller, in particular wherein at least two piercing elements are arranged one behind the other in the circumferential direction of the tensioning roller, in particular wherein at least two piercing elements are arranged one behind the other with respect to a longitudinal center axis of the tensioning roller. Preferred features disclosed above and below in connection with a piercing element are preferably implemented in all piercing elements when a plurality of piercing elements are present. Various advantages can be realized by the presence of a plurality of piercing elements, as explained below. If only a single piercing element is present, piercing of the piercing element into the outer packaging is only possible within a limited rotational position range of the tensioning roller.However, if at least two piercing elements are arranged one behind the other in the circumferential direction of the tension roller, the rotational range of the tension roller can be increased, allowing at least one of the piercing elements to penetrate the outer packaging. If at least two piercing elements are arranged one behind the other relative to the longitudinal center axis of the tension roller, gas can be introduced into the outer packaging at various points relative to the longitudinal extent of the tension roller. This allows the outer packaging to be detached from the sterile object particularly effectively.

[0018] Preferably, at least one elastically deformable ring element is arranged on the tensioning roller. The elastically deformable ring element can increase the static friction between the tensioning roller and the clamped first section of the outer packaging. Accordingly, the ring element ensures that rotation of the tensioning roller, when the first section is clamped, is reliably converted into tensioning of the outer packaging. Preferably, several elastically deformable ring elements are provided, which are arranged one behind the other on the tensioning roller relative to the longitudinal extent of the tensioning roller.

[0019] The device preferably comprises a holding device for holding a flat section of the outer packaging, in particular a horizontally extending section. The holding device can improve the handling of the outer packaging, for example, during tensioning of the outer packaging and / or during removal of the sterile article from the cut-open outer packaging. Depending on the design of the holding device, the holding device can interact with the flat section of the outer packaging in various ways, as explained in more detail below.

[0020] According to a preferred embodiment, the holding device comprises at least one suction element for sucking the flat section of the outer packaging, in particular wherein the suction element is arranged on a support structure of the holding device. The suction element is designed to suck the flat section using negative pressure. This allows the position of the flat section to be securely fixed when the outer packaging is cut open. In addition, the cut created in the outer packaging can be kept open, thereby facilitating the removal of the sterile object from the cut-open outer packaging. The holding device preferably comprises a plurality of distributed suction elements for sucking the flat section.

[0021] According to a preferred embodiment, the holding device comprises a vertically displaceable hold-down device, in particular a hold-down plate, for applying a compressive force to the flat section of the outer packaging. The hold-down device can be used to control the inflation of the outer packaging. When the outer packaging is inflated, the flat section comes into contact with the hold-down device. The displaceable hold-down device then applies the compressive force acting in the direction of the sterile article or vertically downwards to the flat section. This compressive force must be overcome for further bulging of the flat section. The design of the hold-down device as a hold-down plate has the advantage that the compressive force acts on the flat section in a horizontally distributed manner. The hold-down device is preferably mounted displaceably on the support structure.This makes it easy to handle the components of the holding device together as an assembly.

[0022] Preferably, the device comprises a spring device that applies a spring force to the hold-down device in the direction of the flat portion of the outer packaging. The aforementioned compressive force is thus defined not only by the weight of the hold-down device, but also by the spring force of the spring device. This has the advantage that a comparatively lightweight hold-down device can be used to achieve a compressive force of a desired magnitude.

[0023] According to a preferred embodiment, at least one of the suction elements protrudes through an opening or a recess in the hold-down device. In particular, when the hold-down device is designed as a flat hold-down plate, a large part of the flat section of the outer packaging is occupied by the hold-down plate. With a closed hold-down plate, only those areas of the flat section that lie laterally outside the outer contour of the hold-down device would be suitable for the arrangement of the suction elements. However, if at least one of the suction elements protrudes through an opening or a recess in the hold-down device, a tensile force can also be applied to those areas of the flat section of the outer packaging that do not lie laterally outside the outer contour of the hold-down device.

[0024] According to a preferred embodiment, the device comprises at least one, in particular solid, piercing unit for piercing the flat section, in particular wherein the piercing unit is arranged on the support structure or on the hold-down device. By piercing the at least one piercing unit into the flat section, an opening is created in the flat section through which gas can escape from the outer packaging. This results in the outer packaging being able to be inflated in a controlled and uniform manner via the at least one piercing element. The piercing unit is preferably arranged on the support structure in such a way that an end face of the hold-down device facing the flat section is arranged vertically below the tip of the piercing unit, at least in a vertically lower end position of the hold-down device.In the vertically lower end position, the hold-down device prevents the piercing unit from penetrating the flat section of the outer packaging. The piercing unit therefore only penetrates the flat section of the outer packaging once the hold-down device has already been displaced vertically upwards due to inflation of the outer packaging.

[0025] The problem to be solved is also solved by a system having the features of claim 14. The system comprises a sterile object, in particular a tub, which is packaged in an outer packaging, in particular a film bag, and a device having the features described above for removing the sterile object from the outer packaging. Preferably, the first section of the outer packaging is tab-shaped. This makes it easy to clamp the first end section using the tensioning device of the device. Preferably, the aforementioned support structure of the holding device of the device is complementary to the sterile object in terms of its shape. If the sterile object is square, for example, the support structure is also square and has approximately the same dimensions as the sterile object.

[0026] With regard to the advantages achievable with the system, reference is made to the relevant explanations of the device and method. The features described in connection with the device and method can be used to further refine the system.

[0027] The object to be achieved is also achieved by a method for removing a sterile object, in particular a tub, from an outer packaging, in particular a film bag, wherein the method comprises at least the following steps: clamping a first section, in particular a tab-shaped section, of the outer packaging between a rotatable tensioning roller and a further tensioning element, wherein at least one piercing element is arranged on the tensioning roller, which comprises a gas supply channel with at least one inlet opening and at least one outlet opening. Preferably, the first section is clamped between the tensioning roller and the further tensioning element by lowering or raising the tensioning roller.

[0028] Tensioning of the outer packaging by rotating the tensioning roller. Preferably, the first section is first clamped between the tensioning roller and the additional tensioning element. Only then is the tensioning roller rotated to tension the outer packaging while the first section is clamped. Alternatively, the tensioning roller is rotated during clamping, so that the process steps "clamping the first section" and "tensioning the outer packaging" overlap in time.

[0029] Inserting the piercing element into the outer packaging. The piercing element is preferably inserted into the outer packaging by rotating the tensioning roller. This is structurally simple to implement. Furthermore, the piercing element can then be easily integrated into the process flow because the tensioning roller is rotated anyway to tension the outer packaging. However, a controllable actuator can also be assigned to the piercing element, which moves the piercing element relative to the tensioning roller to insert the piercing element into the outer packaging.

[0030] Blowing gas through the outlet opening of the pierced piercing element into the outer packaging.

[0031] Cutting open the stretched and inflated outer packaging and removing the sterile item from the outer packaging.

[0032] Advantages and further development possibilities of the device are to be understood as being described in relation to the method and, conversely, advantages and further development possibilities of the method are to be understood as being described in relation to the device.

[0033] According to a preferred embodiment of the method, a flat section of the outer packaging, in particular one extending horizontally, is held by a holding device. This facilitates handling of the outer packaging.

[0034] Preferably, the flat section of the outer packaging is suctioned by at least one suction element of the holding device. The suction element preferably suctions the flat section before the outer packaging is cut open, during the cutting of the outer packaging, and during the removal of the sterile object from the cut-open outer packaging. Depending on the process step, various advantages are achieved by suctioning the flat section. By suctioning before and during the cutting, the precise creation of a desired cut can be ensured. By suctioning during removal, the created cut can be kept open, thereby facilitating the removal of the sterile object through the cut.

[0035] Preferably, the flat section is subjected to a vertically downward pressure force by a vertically movable hold-down device, in particular a hold-down plate. The hold-down device can be used to control the inflation of the outer packaging.

[0036] According to a preferred embodiment of the method, at least one, particularly solid, piercing unit is inserted into the flat section for pressure regulation. This allows the outer packaging to be inflated in a controlled and uniform manner. Specifically, by piercing the piercing unit into the flat section, an opening is created in the flat section through which the injected gas can slowly escape from the outer packaging. Preferably, the piercing unit is inserted into the flat section while the gas is being injected. For example, the piercing unit is arranged such that it only pierces the flat section after the outer packaging has been at least partially inflated.

[0037] The invention is described in more detail below with reference to the figures, wherein identical or functionally identical elements may be provided with reference numerals only once. The description serves as an example and is not to be understood as limiting. Fig. 1 shows a schematic, perspective view of a device for removing a sterile article from an outer packaging; Fig. 2 shows a further perspective view of the device; Fig. 3 shows a sectional view of the device; Fig. 4 shows a sectional view of a clamping device of the device; Fig. 5 shows a holding device of the device; and Fig. 6 shows a compressed gas supply device of the device.

[0038] The following is based on the Figures 1 to 6A device 1 for removing a sterile object 2 from an outer packaging 3 is described. The outer packaging 3 is a foil bag 3 in the present case. The foil bag 3 comprises a tab-shaped first section 11. The sterile object 2 is a sterile tub 2 in the present case. A tub refers to a plastic tub. Tubs are used, for example, in pharmaceutical production for storing nests or the like. In the present case, the tub 2 is sealed into the evacuated foil bag 3.

[0039] Figure 1shows a schematic, perspective view of the device 1. The device 1 comprises a clamping device 4, a cutting device 5, a holding device 6, and a removal device 7. The design of the devices 4, 5, 6, and 7 will be explained in more detail below. The device 1 also comprises a transport device 8 with two conveyor belts 8a, 8b. The transport device 8 serves to transport the outer packaging 3 with the sterile object 2 packaged therein into a removal area in which the sterile object 2 is removed from the outer packaging 3.

[0040] In the following, with additional reference to the Figures 2 , 3 and 4 First, the design of the clamping device 4 is explained in more detail. Figure 2 a further perspective view of the device 1, whereby the illustration of the holding device 6 has been omitted. It should be noted that in Figure 2the outer packaging 3 is shown in dashed lines for the sake of better traceability. Figure 3 shows a sectional view of device 1. Figure 4shows a sectional view of the tensioning device 4. The tensioning device 4 has a tensioning roller 9 which is mounted so as to be rotatable about its longitudinal central axis. The tensioning roller 9 is assigned a controllable actuator (not shown in detail) for rotating the tensioning roller 9. The tensioning device 4 also has a further tensioning element 10. In the present case, the further tensioning element 10 is a further tensioning roller 10. The further tensioning roller 10 is also mounted so as to be rotatable about its longitudinal central axis. The tensioning roller 9 can be displaced vertically upwards and vertically downwards. For this purpose, the tensioning roller 9 is assigned a controllable actuator (not shown in detail) for displacing the tensioning roller 9. By displacing the tensioning roller 9, the distance between the tensioning roller 9 and the further tensioning element 10 can be increased or decreased.If the tensioning roller 9 is spaced apart from the further tensioning element 10, the tab-shaped first section 11 of the outer packaging 3 can be arranged between the tensioning roller 9 and the further tensioning element 10. By lowering the tensioning roller 9, the first section 11 can then be clamped between the tensioning roller 9 and the further tensioning element 10.

[0041] If the first section 11 is clamped between the tensioning roller 9 and the further tensioning element 10, the outer packaging 3 can be tensioned by rotating the tensioning roller 9. In the exemplary embodiment shown in the figures, a plurality of elastically deformable ring elements 13 are arranged on the tensioning roller 9. The ring elements 13 are distributed along the longitudinal center axis of the tensioning roller 9. The ring elements 13 increase the static friction between the tensioning roller 9 and the clamped first section 11. This ensures that the rotation of the tensioning roller 9 is reliably converted into tensioning of the outer packaging 3. In order to prevent the outer packaging 3 with the sterile object 2 packaged therein from being pulled in the direction of the tensioning roller 9 and the further tensioning element 10 by the rotation of the tensioning roller 9, a rail-shaped locking element 12 is provided.The blocking element 12 rests by means of the outer packaging 3 on a side of the sterile object 3 facing the clamping device 4 and thereby blocks a displacement of the sterile object 3 in the direction of the clamping device 4.

[0042] Several piercing elements 14 are arranged on the tensioning roller 9. The structural design and the function of the piercing elements 14 are explained in more detail below, with particular reference to the Figure 4 shown sectional view.

[0043] As from Figure 4As can be seen, the piercing elements 14 each have a gas supply channel 15. In the present case, the piercing elements 14 are hollow, so that the gas supply channel 15 extends through the piercing elements 14. The gas supply channels 15 each have an inlet opening 16 and a plurality of outlet openings 17. The piercing elements 14 are arranged such that they can be pierced into the outer packaging 3 by rotating the tensioning roller 9 with the first section 11 clamped. Once a piercing element 14 has been pierced into the outer packaging 3, gas can be blown into the outer packaging 3 through the outlet openings 17 of the pierced piercing element 14 in order to fill the outer packaging 3 with gas.

[0044] The piercing elements 14 each have a conical end section 19. The outlet openings 17 are formed in the end sections 19 at a distance from the tips 20 of the end sections 19. In the present case, the outlet openings 17 of a piercing element 14 are arranged axially at the same height relative to the longitudinal center axis of the piercing element 14 and are evenly distributed in the circumferential direction of the respective end section 19. In view of the previously described arrangement of the outlet openings 17, the gas streams flowing out of the piercing elements 14 have a tangential direction component relative to the rotational axis of the tensioning roller 9.

[0045] In the embodiment illustrated in the figures, the tensioning roller 9 is tubular with a cavity 22 extending along its length. A circumferential jacket wall 24 of the tensioning roller 9 radially encloses the cavity 22. The cavity 22 is fluidly connected to the inlet openings 16 of the gas supply channels 15. Gas can thus be returned to the gas supply channels 15 through the cavity 22.

[0046] In the exemplary embodiment illustrated in the figures, the piercing elements 14 are arranged in a respective different through-opening 23 in the casing wall 24. The tips 20 of the piercing elements 14 protrude radially from the through-openings 23. In the present case, the piercing elements 14 are pressed into the through-openings 23. The through-openings 23 have a first stop step 25 and a second stop step 26. The stop surfaces of the stop steps 25 and 26 are each oriented radially outward relative to the longitudinal center axis of the tensioning roller 9. The first stop step 25 is arranged radially outside the second stop step 26 relative to the longitudinal center axis of the tensioning roller 9 and has a larger diameter than the second stop step 26. The piercing elements 14 each have a circumferential projection 27.The projections 27 abut the first stop step 25 of the associated through-opening 23, thereby preventing radial inward displacement of the piercing elements 14. A sealing element 28 is arranged between each projection 27 and the second stop steps 26. The sealing elements 28 form a sealing contact with the stop surface of the respective second stop step 26 on the one hand and the respective projection 27 on the other hand.

[0047] In the embodiment shown in the figures, several piercing elements 14 are present. The arrangement of the piercing elements 14 is explained in more detail below, with particular reference to Figure 2Specifically, in the present embodiment, twenty-seven piercing elements 14 are provided. The piercing elements 14 are arranged in nine rows 29 of three piercing elements 14 each. Each row 29 has a front piercing element 14a in the direction of rotation, a middle piercing element 14b in the direction of rotation, and a rear piercing element 14c in the direction of rotation. This has the advantage that piercing elements 14 can be pierced into the outer packaging 3 over a large rotational position range of the tensioning roller 9. For example, in the Figure 3In the rotational position of the tensioning roller 9 shown, the piercing elements 14a at the front in the direction of rotation are pierced into the outer packaging 3. The piercing elements 14c at the rear in the direction of rotation are arranged outside the outer packaging 3. The rows 29 are distributed along the longitudinal extent of the tensioning roller 9. This results in the advantage that gas can be blown into the outer packaging 3 at various points along the longitudinal extent of the tensioning roller 9.

[0048] The additional clamping element 10 has a circumferential groove 30 for each of the rows 29, which is arranged axially at the same height as the associated row 29 with respect to the longitudinal center axis of the clamping roller 9. The circumferential grooves 30 prevent contact between the tips 20 of the piercing elements 14 and the additional clamping element 10. Instead, the piercing elements 14 only project radially into the circumferential grooves 30, depending on the rotational position of the clamping roller 9.

[0049] In the following, with reference to the Figures 3 and 5 the design of the holding device 6 is explained in more detail. The holding device 6 is located opposite a horizontally extending flat section 31 of the outer packaging 3 during removal. It should be noted that the Figures 3 and 5 The holding device 6 shown in the drawing differs slightly in its construction from that shown in Figure 1 holding device 6 shown.

[0050] The holding device 6 comprises a support structure 32, which in this case is designed in the shape of a frame. A hold-down device 33 is held vertically displaceably on the support structure 32. In this case, the hold-down device 33 is designed as a flat hold-down plate 33. A plurality of guide pins 34 are fastened to the hold-down device 33 and protrude from the hold-down device 33 in the direction of the support structure 32, i.e. vertically upwards. The guide pins 34 protrude into through-openings 35 in the support structure 32 to guide the hold-down device 33 on the support structure 32. In this case, the hold-down device 33 can be displaced vertically upwards against the spring force of a spring device 36. In order to displace the hold-down device 33 vertically upwards, the weight of the hold-down device 33 and the spring force of the spring device 36 must be overcome. The spring device 36 comprises a plurality of spring elements 37 which are held pre-tensioned between the hold-down device 33 and the support structure 32.In the present case, each of the spring elements 37 encloses a different one of the guide pins 34.

[0051] The holding device 6 also comprises a plurality of suction elements 38. The suction elements 38 are designed to suction the flat section 31 of the outer packaging 3. The suction elements 38 can thus apply a vertically upward tensile force to the flat section 31. In the present case, a plurality of first suction elements 38a are arranged on an edge of the flat section 31 facing the clamping device 4. In addition, a plurality of second suction elements 38b are provided. The second suction elements 38b each protrude through a different opening 40 of the hold-down device 33.

[0052] The device 1 further comprises at least one piercing unit 41 for piercing the flat section 31 of the outer packaging 3. In the present case, the piercing unit 41 is arranged on the support structure 32 such that the piercing unit 41 extends vertically downward from the support structure 32. If the outer packaging 3 is filled with gas by the piercing elements 14, the flat section 31 bulges vertically upward. The piercing unit 41 then pierces the flat section 31, creating an opening in the flat section 31. Figure 5 An end face 42 of the hold-down device 33 facing the flat section 31 is arranged vertically below the tip of the piercing unit 41. Based on this arrangement of the hold-down device 33, the hold-down device 33 must first be displaced vertically upward through the flat section 31 before the piercing unit 41 then piercing the flat section 31.

[0053] In the following, with reference to Figure 1 The design of the cutting device 5 is explained in more detail. The cutting device 5 comprises a knife 43, which in this case extends obliquely downwards. The knife 43 is horizontally movable via a linear guide 44 and is arranged such that it can create a cut in a third section 18 of the outer packaging 3, arranged between the first section 11 and the flat section 31. The knife 43 is also displaceable along its longitudinal extent, so that it can perform a sawing movement by simultaneous horizontal displacement and displacement along its longitudinal extent. This enables a better cutting of the outer packaging 3.

[0054] In the following, with reference to Figure 1 The design of the removal device 7 is explained in more detail. The removal device 7 comprises several suction cups 45 and is horizontally movable. As can be seen from Figure 1As can be seen, the removal device 7 is arranged laterally next to the sterile object 2 to be removed.

[0055] The device 1 also has a Figure 6 The gas supply device 46 is integrated into a base 51 of the device 1. It should be noted that in Figure 6the substructure 51 in the foreground is shown in dashed lines for clarity. The gas supply device 46 has a valve unit 47 with a pressure control valve. The valve unit 47 has a gas inlet 48. The gas inlet 48 is fluidically connected or connectable to a compressed gas source (not shown). The valve unit 47 also has a gas outlet 49. The gas outlet 49 is fluidically connected or connectable to the cavity 22 of the tensioning roller 9, for example via a pressure hose. Gas provided by the compressed gas source can then be fed back to the cavity 22 of the tensioning roller 9 in order to blow the gas into the outer packaging 3 via the piercing units 14.

[0056] A method for removing the sterile object 2 from the outer packaging 3 using the device 1 is explained in more detail below. The sterile nature of the sterile object 2 is maintained. First, the outer packaging 3, with the sterile object 2 packaged therein, is brought into the removal area by the transport device 8.

[0057] Once the outer packaging 3 containing the sterile object 2 is in the removal area, the first section 11 of the outer packaging 3 is clamped by the clamping device 4. In this case, the clamping roller 9 is lowered for this purpose, so that the first section 11 is clamped between the clamping roller 9 and the additional clamping element 10. A guide element (not shown) may be provided to guide the first section 11 between the clamping roller 9 and the additional clamping element 10 when the outer packaging 3 is brought into the removal area.

[0058] In addition, the flat section 31 is sucked by the suction elements 38 of the holding device 6. The outer packaging 3 is then held by the holding device 6.

[0059] The process steps "clamping the first section 11" and "suctioning the flat section 31" can be carried out both simultaneously and sequentially, whereby both the process step "clamping the first section 11" and the process step "suctioning the flat section 31" can be carried out first.

[0060] Once the first section 11 is clamped by the clamping device 4, the clamping roller 9 is rotated to clamp the outer packaging 3. Alternatively, the clamping roller 9 is rotated during lowering, so that the process steps "clamping the first section 11" and "clamping the outer packaging 3" are performed in a temporally overlapping manner. By rotating the clamping roller 9, at least some of the piercing elements 14 are pierced into the outer packaging 3. Gas is then blown into the outer packaging 3 through the outlet openings 17 of the pierced piercing elements 14. Preferably, the gas supply device 46 provides the gas before the piercing elements 14 are pierced, so that the gas flows out of the piercing elements 14 through the outlet openings 17 even before piercing. However, the gas flow can also be started only after the piercing elements 14 have been pierced. The preferred gases are nitrogen, sterile compressed air, protective gas, etc.provided.

[0061] By injecting gas into the outer packaging 3, the outer packaging 3 is inflated. This causes the flat section 31 to bulge and lift the hold-down device 33. The piercing unit 41 is then pierced into the flat section 31, creating an opening in the flat section. As a result, gas can escape from the outer packaging 3 through the opening, and the outer packaging 3 is inflated in a controlled and even manner by the piercing elements 14.

[0062] In a next step, the knife 43 is moved along the linear guide 44 such that the knife 43 cuts a slit in the third section 18 of the outer packaging 3. The knife 43 is moved such that it only cuts the third section 18 of the outer packaging 3, but not the section 21 arranged vertically below it. The first section 11 is therefore not severed from the outer packaging 3. Rather, the outer packaging 3 remains as a continuous part. Precisely creating the desired cut is facilitated by inflating the outer packaging 3 beforehand.

[0063] In a next step, the clamping device 4 with the clamped first section 11 is lowered vertically. Alternatively or additionally, the holding device 6 with the suctioned flat section 31 is raised. Both of these actions result in the incision in the third section 18 being kept open. Subsequently, the removal device 7 is moved horizontally through the incision that is held open, and the sterile object 2 is sucked in by the suction cups 45 of the removal device 7. Finally, the removal device 7 is moved back horizontally, whereby the sucked-in sterile object 2 is removed from the outer packaging 3. Because the outer packaging 3 was previously inflated via the piercing elements 14, the outer packaging 3 does not adhere, or at most adheres slightly, to the sterile object 2, thereby simplifying removal.

Claims

1. Apparatus (1) for removing a sterile object (2), in particular a tub (2), from an outer packaging (3), in particular a film bag (3), having a tensioning device (4) which comprises a rotatable tensioning roller (9) and a further tensioning element (10), a first portion (11) of the outer packaging (3), in particular a tab-shaped portion, being clampable between the tensioning roller (9) and the further tensioning element (10) during a removal process, and the outer packaging (3) being tensionable by rotating the tensioning roller (9) when the first portion (31) is clamped, having a cutting device (5) for cutting open the tensioned outer packaging (3), and having a removal device (7) for removing the sterile object (2) from the cut-open outer packaging (3), characterized in that at least one piercing element (14) is arranged on the tensioning roller (9), which piercing element comprises a gas supply channel (15) having at least one inlet opening (16) for supplying gas and at least one outlet opening (17), the piercing element (14) being able to pierce into the outer packaging (3), in particular by rotating the tensioning roller (9), and gas being able to be injected into the outer packaging (3) via the outlet opening (17) of the pierced piercing element (14) in order to fill the outer packaging (3) with gas.

2. Apparatus (1) according to claim 1, characterized in that the tensioning roller (9) is tubular, having a cavity (22) extending along its length, and in that the cavity (22) is fluidically connected to the inlet opening (16) of the gas supply channel (15).

3. Apparatus (1) according to either claim 1 or claim 2, characterized in that the piercing element (14) is arranged in a through-opening (23) of a lateral wall (22) of the tensioning roller (9), an in particular circumferential projection (27) of the piercing element (14) in particular resting against a stop step (25) of the through-opening (23).

4. Apparatus (1) according to any of claims 1 to 3, characterized in that the piercing element (14) comprises a conical end portion (19), and in that the outlet opening (17) is formed in the end portion (19) at a distance from the tip (20) of the end portion (19), a plurality of outlet openings (17) in particular being present which are formed in the end portion (19) so as to be distributed in the circumferential direction of the end portion (19).

5. Apparatus (1) according to any of claims 1 to 4, characterized in that the further clamping element (10) comprises a circumferential groove (30) radially opposite the piercing element (14).

6. Apparatus (1) according to any of claims 1 to 5, characterized in that a plurality of piercing elements (14) are arranged on the tensioning roller (9), at least two piercing elements (14) in particular being arranged one behind the other in the circumferential direction of the tensioning roller (9), at least two piercing elements (14) in particular being arranged one behind the other with respect to a longitudinal center axis of the tensioning roller (9).

7. Apparatus (1) according to any of claims 1 to 6, characterized in that at least one resiliently deformable annular element (13) is arranged on the tensioning roller (9).

8. Apparatus (1) according to any of claims 1 to 7, characterized in that it comprises a holding device (6) for holding a planar portion (31) of the outer packaging (3) which in particular extends horizontally.

9. Apparatus (1) according to claim 8, characterized in that the holding device (6) comprises at least one suction element (38) for suctioning the planar portion (31) of the outer packaging (3), the suction element (38) in particular being arranged on a support structure (32) of the holding device (6).

10. Apparatus (1) according to either claim 8 or claim 9, characterized in that the holding device (6) comprises a hold-down device (33), in particular a hold-down plate (33), which can be displaced in the vertical direction, for applying a compressive force to the planar portion (31) of the outer packaging (3), the hold-down device (33) in particular being held displaceably on the support structure (32).

11. Apparatus (1) according to claim 10, characterized by a spring device (36) which applies a spring force acting in the direction of the planar portion (31) of the outer packaging (3) to the hold-down device (33).

12. Apparatus (1) according to either claim 10 or claim 11, characterized in that at least one of the suction elements (38) projects through an opening (40) or a recess in the hold-down device (33).

13. Apparatus (1) according to any of claims 1 to 12, characterized in that it comprises at least one, in particular solid, piercing unit (41) for piercing into the planar portion (31), the piercing unit (41) in particular being arranged on the support structure (32) or on the hold-down device (33).

14. System comprising a sterile object (2), in particular a tub (2), which is packaged in an outer packaging (3), in particular a film bag (3), and an apparatus (1) according to any of claims 1 to 13 for removing the sterile object (2) from the outer packaging (3).

15. Method for removing a sterile object (2), in particular a tub (2), from an outer packaging (3), in particular a film bag (3), comprising the following steps: a. clamping an, in particular tab-shaped, first portion (31) of the outer packaging (3) between a rotatable tensioning roller (9) and a further tensioning element (10), wherein at least one piercing element (14) is arranged on the tensioning roller (9), which piercing element comprises a gas supply channel (15) having at least one inlet opening (16) and at least one outlet opening (17), b. tensioning the outer packaging (3) by rotating the tensioning roller (9), c. piercing the piercing element (14) into the outer packaging (3), in particular by rotating the tensioning roller (9), d. injecting gas through the outlet opening (17) of the pierced piercing element (14) into the outer packaging (3), e. cutting open the tensioned and inflated outer packaging (3), and f. removing the sterile object (2) from the outer packaging (3).

16. Method according to claim 15, characterized in that a planar portion (31) of the outer packaging (3), which in particular extends horizontally, is held by means of a holding device (6).

17. Method according to either claim 15 or claim 16, characterized in that at least one, in particular solid, piercing unit (41) is pierced into the planar portion (31) for pressure control, in particular during the injection of the gas.

Citation Information

Patent Citations

  • Apparatus and method for removing a sterile item from a sterile package

    DE102007027878A1