The invention relates to an apparatus and a method for straightening a foil bag with a sterile object packaged therein.
For pharmaceutical and/or cosmetic applications, it is known for syringes, cartridges, vials, or other vessels to be provided in tubs. In order to satisfy high sterility requirements, it is known to seal the tubs and in addition to pack the sealed tubs in foil bags.
Accordingly, bag unpacking systems are to be provided in an automated filling plant, by means of which bag unpacking systems the tubs are removed from the foil bags.
For non-sterile applications, DE3921356 A1 discloses, for example, piercing a packaging foil by means of a hollow needle before cutting through the packaging foil for simplified removal of the packaging foil from a polyester compound, and injecting compressed air into this packaging foil by means of the hollow needle. Here, a tip of the hollow needle penetrates into the polyester compound.
It is an object of the invention to provide an apparatus and a method for straightening a foil bag with a sterile object packaged therein, which apparatus and method satisfy the high requirements of process reliability for pharmaceutical and/or cosmetic applications.
This object is solved by the apparatus and the method with the features of claims 1 and 8. Further embodiments are defined in the dependent claims.
In accordance with a first aspect, an apparatus for straightening a foil bag with a sterile object packaged therein is provided, comprising a needle unit with a hollow needle for piercing the foil bag and with a gas port for injecting gas via the hollow needle into the foil bag, wherein a detaching device is provided which is configured to apply a detaching force to the foil bag before a piercing operation, with the result that the foil bag is detached from the sterile object packaged therein at least in a region which lies opposite the hollow needle.
In conjunction with the application, the terms “a”, “an”, etc. are used merely as an indefinite article and not as numerical values. The terms “first”, “second”, etc. likewise serve merely to differentiate elements or assemblies and do not indicate any order. The use of the term “first”, etc. does not mandate presence of second or further elements or assemblies.
In conjunction with the application, a movement of the foil bag relative to the object packaged therein is referred to as “straightening of a foil bag”, wherein, in particular, folded-in or folded-away parts of the foil bag (also called tabs) which bear against a wall of the object without being fixed on another section of the foil bag are unfolded, folded out and/or tautened.
A region of the foil bag about a piercing location to be made in the foil bag is referred to as “region which lies opposite the hollow needle”.
In conjunction with the application, a device, by means of which a detaching force can be applied before a piercing operation, is called a “detaching device”. The detaching device is, for example, a device, by means of which a section of the foil bag can be gripped mechanically, by way of the application of suction force, for example means of vacuum or flow, electrostatically, by means of adhesion forces, for example by means of an adhesive bond, or in some other way and can be moved relative to the sterilely packaged object. In other embodiments, a detaching force is generated by means of pressure differences, it being possible for the pressure difference to be applied locally in a manner which is restricted to a section of the foil bag, for example by means of a sealing collar, or to act on the entire foil bag.
The detaching action generates a space between the foil bag and the packaged sterile object, with the result that a contact of the hollow needle with the sterile object is avoided during the piercing operation. In addition, it is avoided that a multiple-layer section lies opposite the needle unit on account of folded-in or folded-away parts of the foil bag or on account of folds in the foil bag, which section otherwise could be perforated during the piercing operation, with the result that injected gas escapes via the perforated section and an injection of the gas is not reliably possible.
The injected gas is air in one embodiment. In other embodiments, an inert gas, for example nitrogen, is injected. Depending on applications, other toxic or non-toxic gases are also conceivable.
In one embodiment, the detaching device comprises a vacuum chamber, into which the foil bag with the object packaged therein can be introduced, it being possible for a negative pressure or vacuum to be generated in the vacuum chamber, with the result that the foil bag is detached at least in regions from the sterile object packaged therein. In one embodiment, a pump or a vacuum ejector is provided to generate a vacuum in the vacuum chamber. In case of a vacuum chamber, depending on the application, the needle unit can be provided at a suitable point in the vacuum chamber. For reproducible positioning of a piercing point in the foil bag, it is provided in one embodiment that the foil bag is introduced into the vacuum chamber with a defined orientation.
As an alternative or in addition, the detaching device in one embodiment comprises a sealing collar with a circumferential rim for bearing against the foil bag, the sealing collar being configured to apply a detaching force to the foil bag. In one embodiment, the sealing collar is mounted movably relative to the object packaged in the foil bag, it being possible for the sealing collar to be placed onto the foil bag and to be moved away from the object packaged in the foil bag with the application of a detaching force, with the result that the foil bag is detached from the sterile object packaged therein at least in a region which lies within and adjacent to the sealing collar. In other embodiments, the sealing collar is arranged spaced apart from the foil bag, the foil bag being forced in the direction of the sealing collar with application of a detaching force, with the result that the foil bag is detached from the sterile object packaged therein at least in a region which lies within and adjacent to the sealing collar. Here, in one embodiment, the application of the detaching force for moving the foil bag with respect to the sealing collar takes place by way of a generated pressure difference between the interior and the exterior of the foil bag in the vacuum chamber.
It is provided here in one embodiment that the sealing collar surrounds the hollow needle at least in sections, it being possible for the hollow needle and the sealing collar to be displaced relative to one another between a rest position and a use position, it being possible for the foil bag to be pierced by way of a relative movement out of the rest position into the use position. For high process reliability, it is provided in one embodiment that the hollow needle is mounted movably, a movement of the hollow needle out of the rest position into the use position taking place only when the foil bag has been detached at least in regions. This ensures that the foil bag is held under stress by means of the sealing collar reliably and preferably with the application of the detaching force, with the result that a piercing operation without fraying or fibre formation on the foil bag is ensured. In one embodiment, the hollow needle and the sealing collar are arranged coaxially or in parallel, a relative movement between the hollow needle and the sealing collar taking place in the longitudinal direction of the hollow needle.
It is provided in one embodiment that a needle tip of the hollow needle is arranged in the interior space of the sealing collar at least in the rest position, and the rim of the sealing collar protrudes beyond the needle tip, and it being possible for the hollow needle and the sealing collar to be displaced relative to one another out of the rest position into the use position in order to pierce the foil bag.
In one embodiment, a pressure lowering device is provided on the sealing collar, which pressure lowering device is configured to lower a pressure in an interior space of the sealing collar in such a way that a section of the foil bag bulges in the direction of the sealing collar and/or is forced into contact with the sealing collar.
Here, the sealing collar bears against the foil bag with a seal which is sufficient that, in the case of a pressure drop in the sealing collar, the foil bag bears with a sufficient stress against the sealing collar for reliable piercing by means of the hollow needle. In one embodiment, the sealing collar bears against the foil bag in an air-tight manner. In the context of the application, “air-tight” also denotes a bearing against the foil bag with a tolerable leakage flow. In one embodiment, the sealing collar is mounted movably, it being possible for the sealing collar to bear against the foil bag with a sufficient seal for a pressure drop in the sealing collar, with the result that, in the case of a movement of the sealing collar away from the object packaged in the foil bag, a section of the foil bag is detached from the sterile object packaged therein at least in a region which lies within and adjacent to the sealing collar. In one embodiment, lowering of the pressure takes place by means of a mechanically or electromechanically operated piston pump which is arranged on the sealing collar. In other embodiments, the sealing collar has a vacuum port for lowering the pressure in the sealing collar. Via the vacuum port, the sealing collar can be connected to a vacuum generator such as, for example, a pump or a vacuum ejector.
The pressure lowering device on the sealing collar can be provided as an alternative or in addition to the vacuum chamber.
In another embodiment, as an alternative to the pressure lowering device, a suction bell which surrounds the sealing collar is provided, it being possible for a gas, in particular compressed air or an inert gas which is fed in under pressure, to be fed in via a gap which is formed between the suction bell and the sealing collar, with the result that a section of the foil bag is forced in the direction of the sealing collar. The gap is designed suitably such that the gas can be fed in in such a way that a suction effect is generated, on account of which a detaching force acts on the foil bag. The detaching force forces a section of the foil bag in the direction of the sealing collar. In the next step, the sealing collar can be moved with the foil bag for further detaching of the foil bag and/or the hollow needle can penetrate the detached region of the foil bag. Here, the same gas which is also introduced into the foil bag after a piercing operation can be used to generate a suction effect in the suction bell. A further medium can be dispensed with in this case.
In one embodiment, the sealing collar is arranged on a wall element with a contact surface to the foil bag, in particular on a base, the rim of the sealing collar being arranged spaced apart from the contact surface. In this case, at least one region of the foil bag is forced in the direction of the sealing collar by means of the detaching force which is applied by way of the detaching device, in particular the sealing collar and/or the vacuum chamber. In one embodiment, the needle tip of the hollow needle is shielded by the sealing collar at least in the rest position. As a result, undesired contact of the hollow needle with the foil bag is reliably avoided. In one embodiment, the sealing collar is mounted movably and can be displaced out of a use position, in which the rim of the sealing collar is arranged spaced apart from the contact surface, in the direction of the contact surface, in order to “fetch” a section of the foil bag and to transfer it with the sealing collar for piercing into the use position.
In one embodiment, a transport device is provided, the needle unit being arranged on the transport device in order to transport the foil bag with injection of gas to a subsequent device. The transport device is, for example, a carriage or moving table, on which the foil bag with the object arranged therein is deposited.
In accordance with a second aspect, a method for straightening a foil bag with a sterile object packaged therein is provided, wherein the foil bag is pierced by means of a hollow needle and gas is injected into the foil bag, and wherein a detaching force is applied to the foil bag before piercing into the foil bag, with the result that the foil bag is detached from the sterile object packaged therein at least in a region which lies opposite the hollow needle. By detaching the foil bag from the sterile object at least in regions, a clearance is formed between the foil bag and the sterile object packaged therein, into which clearance the hollow needle can penetrate during the piercing operation, without the hollow needle coming into contact with the sterile object.
In one embodiment, in order to generate the detaching force, the foil bag with the object packaged therein is introduced into a vacuum chamber, wherein a negative pressure or vacuum is generated in the vacuum chamber, with the result that the foil bag is detached at least in regions from the sterile object packaged therein.
As an alternative or in addition, in one embodiment, for a piercing operation, a sealing collar with a circumferential rim is brought into contact with the foil bag. A section of the foil bag can be held or fixed in a defined position for a piercing operation by means of the sealing collar.
It is provided here in one embodiment that the sealing collar surrounds the hollow needle at least in sections, the hollow needle and the sealing collar being displaced relative to one another between a rest position and a use position. Depending on the application, the sealing collar and/or the hollow needle are/is mounted movably, the hollow needle and/or the sealing collar being displaced out of the rest position into the use position in order to pierce the foil bag. In embodiments, the hollow needle and the sealing collar are arranged coaxially or in parallel, the hollow needle and the sealing collar being moved relative to one another in the longitudinal direction of the hollow needle.
In one embodiment, a needle tip of the hollow needle is arranged in the interior space of the sealing collar at least in the rest position, the rim of the sealing collar protruding beyond the needle tip, and the hollow needle and the sealing collar are displaced relative to one another out of the rest position into the use position in order to pierce the foil bag.
In one embodiment, a pressure in an interior space of the sealing collar is lowered in such a way that a section of the foil bag is forced into contact with the sealing collar. It is provided here in one embodiment that the sealing collar is brought into contact with the foil bag before lowering of the pressure, the sealing collar being moved away from the object with a bearing region of the foil bag in order to form a clearance between the foil bag and the object packaged therein. It is provided in other embodiments that the sealing collar is arranged in a stationary manner spaced apart from the foil bag, a detaching force being applied to a section of the foil bag by way of lowering of the pressure, which detaching force forces the foil bag in the direction of the sealing collar into contact with the sealing collar.
As an alternative, in one embodiment, a suction bell which surrounds the sealing collar is provided, a gas, in particular compressed air or an inert gas which is fed in under pressure, being fed in via a gap which is formed between the suction bell and the sealing collar, with the result that a section of the foil bag is forced in the direction of the sealing collar.
It is provided in one embodiment that the foil bag is transported in the direction of a subsequent device while gas is injected by means of the needle unit. Here, straightening of the foil bag can be maintained by way of an injection of gas during the transport.
Further features, details and merits of the invention result from the claims and the abstract, the wording of both of which is incorporated into the description by reference, and from the following description of exemplary embodiments of the invention, and from the drawings, in which:
A consequence of contact of the hollow needle 40 with the object 20 can be that the object 20 is damaged, a sealing foil which is provided on the object 20 is unintentionally perforated and/or contaminations or downtimes as a result of damage of the hollow needle 40 occur.
In order to ensure that the foil bag 2 is penetrated reliably without the hollow needle 40 making contact with the object 20, the apparatus 1 comprises, furthermore, a detaching device 5 which is configured to apply a detaching force to the foil bag 2, with the result that the foil bag 2 is detached from the sterile object 20 packaged therein at least in a region which lies opposite the hollow needle 40.
In the exemplary embodiment according to
The sealing collar 50 has a vacuum port 54, by means of which a pressure in the sealing collar 50 can be lowered, with the result that a section of the foil bag 2 is forced into contact with the sealing collar 50 as shown schematically in
In the exemplary embodiment shown in
The pressure is lowered in the sealing collar 50, with the result that the foil bag 2 is forced into contact with the sealing collar 50 and, in the case of a movement of the sealing collar 50, a section of the foil bag 2 is moved with the sealing collar 50 into the position which is shown in
As soon as the foil bag 2 is detached from the object 20 at least in regions, the foil bag 2 can be pierced reliably by means of the hollow needle 40. Here, contact between the hollow needle 40 and the sterile object 20 is avoided.
For reliable piercing, the hollow needle 40 can be displaced in the exemplary embodiment shown in the longitudinal direction of the hollow needle 40 relative to the sealing collar 50 between a rest position which is shown in
In the embodiment shown, in the rest position, a needle tip 44 of the hollow needle 40 is arranged in the interior space of the sealing collar 50 and the rim 52 of the sealing collar 50 protrudes beyond the needle tip 44, wherein the hollow needle 40 can be displaced relative to the sealing collar 50 out of the rest position which is shown in
After the fetching of the foil bag 2, in the state which is shown in
In the exemplary embodiment shown in
In an alternative exemplary embodiment which is similar to
In the embodiment of
In one embodiment, the hollow needle 40 of the needle unit 4 is mounted in the base 3 in a stationary manner, piercing of the foil bag 2 taking place on account of a movement of the sealing collar 50. As an alternative, the hollow needle 40 can likewise be displaced, a detaching force first of all being applied to the foil bag 2 by way of movement of the sealing collar 50 out of the rest position, and, subsequently or in a temporally overlapping manner, the hollow needle 40 being moved relative to the already detached foil bag 2 in order to pierce the foil bag 2.
In contrast to the embodiment according to
The detaching device 5 according to
A gap 57 is provided between the sealing collar 50 and the suction bell 55, it being possible for the gas to be fed in via the gap 57 in such a way that a suction effect is generated, with the result that a section of the foil bag 2 is forced in the direction of the sealing collar 50. The detaching device 5 according to
In order to prevent rising of the foil bag 2 in the case of a pressure drop, the detaching device 5 which is shown has, furthermore, a hold-down device 59 which is arranged above the foil bag 2 at a slight spacing from the latter.
The apparatus 1 which is shown in
In other embodiments, transport takes place directly by means of the transport apparatus 6 without an additional gripping device.
In the exemplary embodiment shown in
The drawings which are shown are merely diagrammatic. In particular, bearing elements, sealing elements or the like are not shown. These can be selected suitably by a person skilled in the art depending on the application.
The exemplary embodiments which are shown are merely by way of example, and numerous modifications are conceivable in order to obtain further embodiments. In particular, features which are described or shown as part of one exemplary embodiment can likewise be used in another exemplary embodiment, in order to obtain a further embodiment of the invention.
Number | Date | Country | Kind |
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10 2022 201 965.2 | Feb 2022 | DE | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2023/054268 | 2/21/2023 | WO |