The present invention relates to a method and a device for sterilely enclosing a container.
A sterile packaging of containers is necessary in particular in the pharmaceutical sector, since on the one hand corresponding medications should not be contaminated and on the other hand certain medications can be hazardous in the event of unintentional contact.
Vials, syringes or the like are generally used as containers. A mechanised process and a corresponding device would be particularly advantageous in this case in order to enclose an individual corresponding container completely and in a sterilely sealing manner.
A user being able to immediately recognise from the container whether the sterile seal has been maintained since manufacture would be a further advantage.
The object of the present invention is therefore to specify a corresponding method and a corresponding device.
The method according to the invention for sterilely enclosing a container by means of at least two caps comprises at least the following steps:
Here, the intermediate region is to be understood as the region which, when one cap is slipped onto the other, lies between the end of one cap and the outer wall of the other cap. The gap region is to be understood as the region between the ends of the cap when no cap is slipped onto the other and a distance may even remain between the ends of the caps. The gap region thus means both the distance that results when the first and second caps are not long enough to come into contact, as well as the region having possibly a narrow gap when the caps just meet one another or the second cap is slid on until the caps meet. The connection in a preferably sterilely sealing manner is preferably to be understood as meaning that this intermediate region and/or gap region is sealed off to such an extent that its permeability is almost equal to or equal to the permeability of the cap material. In addition to adhesively bonding a sealing film, adhesive materials, swelling materials and/or also thermal treatment and/or treatment with pressure come into consideration for this purpose, said treatment, for example, if the cap material of one cap can be bonded or adhesively bonded to the cap material of the other cap by corresponding heat and/or pressure.
These steps are preferably carried out in accordance with their alphabetical order, with further processing steps being carried out before, in between or after.
Step h) can also take place spatially separately in a product manufacturing process. So that steps c) and e) are carried out, for example, in a plant/at a production site, the container is then moved to another location - if necessary, the container provided with the caps is packaged in a suitable and preferably sterile manner for transport - and then step h) is carried out in a further plant/at a further production site.
The general advantage of the method according to the invention is that the number of processing means or processing tools, such as tongs, which touch both the outside of the container and the outside of the caps, can be significantly reduced by appropriately coordinating the shape of the caps with one another and with respect to the container.
This is particularly advantageous with regard to the safety of the products, since residues can remain on the outside of the container if the product is incorrectly filled with a medication that is hazardous, for example, in the event of unintentional exposure.
Any processing means or processing tool such as conveying means, tongs, conveyor belts, slides and the like that comes into contact both with the outside of the container and with the outside of the caps is therefore a source of risk for the transfer of hazardous substances that have accidentally come into contact with the outside of the container to the outside of the sterile sealing cap. This is also known as cross-contamination.
Reducing the number of corresponding processing means or processing tools increases the safety for the user of the product.
With a suitable shape of the caps and simultaneous or subsequent sealing of the region between the caps or the intermediate transition region with, for example, a sealing film or a corresponding sealing label, a user can also immediately see that the preferably sterile seal has been maintained since manufacuture. The sealing film or also the outside of the cap can advantageously be provided with appropriate instructions for use, date of manufacture or quality and/or degree of contamination prevention.
However, the method according to the invention can also be used in cases in which there is no sterile seal after the caps have been put on, because then there is still the advantage that maximum sterility is ensured at least at the time the caps are put on. The maintenance of sterility therefore only depends on the subsequent handling of the container.
However, since this may take place at other production sites/in other machines, the method according to the invention can at least ensure that the containers are provided for this further processing in a sufficiently sterile manner and avoiding cross-contamination.
Furthermore, the sealing film and/or the label can also be applied for reasons other than to indicate the avoidance of cross-contamination, for example product information, safety features or the like can be thereon, for example, to show the user a certain manufacturing standard or to make counterfeiting of products more difficult. However, this can of course also be combined with the fact that the sealing film and/or the label simultaneously indicate that cross-contamination was avoided during filling.
Such properties can be recognised by a user in particular from whether the sealing film and/or the label are undamaged.
The choice of whether the caps should overlap, should be slid on until they meet one another, or whether a distance is intended to remain between the ends of the caps depends substantially on how large the corresponding tolerance ranges have to be selected due to the expected deviations/inaccuracies in the cap size/shape, container size/shape and/or tong shape/movement.
Most advantageous is a configuration in which a small distance remains between the two ends of the caps.
The method according to the invention preferably further comprises one or more of the following steps:
These steps are preferably carried out together with the aforementioned steps of the method according to the invention in alphabetical order, with the exception of step x), which can be carried out several times and in particular between two other successive corresponding steps.
This advantageous development allows the number of processing means/tools that touch both the outside of the container and an outside of one of the caps to be further reduced.
In an advantageous development of the method, it is provided that none of the lifting tongs, first tongs, second tongs, first conveying means and/or second conveying means come into contact with both an outside of the container and an outside of a cap during the process.
In this way, the risk of cross-contamination of the outside of the sterile enclosure of the container with the filling material or the medication or the contents of the container can advantageously be almost completely avoided.
This is particularly preferably implemented by carrying out all of the aforementioned steps in alphabetical order, with the exception of the corresponding step x). This is a way of ensuring that no processing means/tool comes into contact with both the outside of the container and the outside of the enclosing caps.
It should be emphasised that the first conveying means, second conveying means, lifting tongs, first tongs and second tongs do not necessarily have to be objects that are physically completely separate from one another. For example, it is sufficient overall to have a whole conveying means of which a first portion corresponds to the first conveying means that comes into contact with the outside of the container, while a second portion of the whole conveying means corresponds to the second conveying means that only comes into contact with the outside of the caps.
Correspondingly, in one embodiment the lifting tongs, the first tongs and/or the second tongs can also be part of the same transport rake comprising a plurality of tongs and/or in other embodiments the lifting tongs, the first tongs and/or the second tongs can be part of different transport rakes.
Essentially, it is only necessary to ensure that corresponding portions of a transport rake having tongs, which correspond to the lifting tongs, are only used as lifting tongs in the sense of the method and only come into contact with the outside of the container and not with the caps.
The same applies to the first and second tongs, namely that corresponding portions of a transport rake and/or the same transport rake having tongs that correspond to the first and second tongs are only used as first and second tongs in the sense of the method and do not come into contact with the outside of the container and only with the caps.
In a preferred embodiment, a first transport rake is used for the method, which comprises lifting tongs in a first region and second tongs in a second region. This first transport rake extends along one side of a whole conveying means. On the opposite side, a second transport rake, generally comprising only half as many tongs, preferably extends, the tongs of which serve as the first tongs.
The transport rakes can also provide propulsion along the conveying means, with the corresponding transfer from the lifting tongs to the first tongs of the opposite or second transport rake transporting the containers further along the conveying direction by clamping the caps, in such a way that the second tongs of the first transport rake can clamp the container or the outside of the caps in the corresponding step.
Accordingly, a plurality of lifting tongs, first tongs and/or second tongs for the method according to the invention are preferably provided in order to process a plurality of containers simultaneously in accordance with any variant of the method according to the invention. The same applies to the first and second conveying means.
The lifting tongs, the first tongs, the second tongs and/or a transport rake comprising the lifting tongs, the first tongs and/or the second tongs are preferably rotated away from the container before and/or after gripping/clamping the container and/or one of the caps. When implementing a specific machine, this can be technically advantageous to a lateral movement, in particular if rotating away takes place about an axis parallel to a direction of longitudinal extension of the first conveying means, the second conveying means and/or the transport rake(s).
Accordingly, transport rakes, lifting tongs, first tongs and/or second tongs are preferably movable along the conveying means.
The lifting tongs, the first tongs and/or the second tongs are preferably each formed by two jaws movable relative to one another, between which the container or the caps can be clamped.
The first and/or the second conveying means, a conveyor belt, a combination of a transport surface and transport pushers, transport rakes and/or a transport container, for example a tub or a nest, are preferred.
The container is preferably a vial, a syringe or a similar container that can be used for medical products.
The first and/or the second cap is preferably designed as a cylinder open on one side and preferably circular or rectangular having a diameter greater than the largest diameter of the container, in the first or in the second region respectively.
This allows simple sliding onto the container, provided that the basic shape or bottom surface of the cylinder is chosen to match the container circumference or the outside of the container occurring in a sliding-on direction.
The variant with cylinders open on one side is preferred, because then only the first and second caps have to be slid on, an intermediate region may have to be sealed and the container is completely enclosed by the two caps and, as a result of the sealed or isolating sealing connection between the two, the container is packed in a sufficiently sterile manner.
This variant is particularly preferred since most of the corresponding containers are of such a simple shape that caps can simply be slid onto a container from two directions.
In the case of more complex or considerably larger containers, however, an advantageous variant of the method according to the invention provides that only the first cap is designed as a cylinder open on one side and the second cap as a cylinder open on both sides, the method further comprising the following steps:
In this development of the method according to the invention, it is thus provided that the first cap is exposed as a cylinder open on one side at one end of a container and then second and further caps, which are designed as cylinders open on both sides, are slid onto the container one after the other until the container is so sufficiently covered with caps that a last cap, also designed as a cylinder open only on one side, can be slid on and then the container is in turn surrounded or enclosed by caps, possibly with the exception of intermediate and/or gap regions that have yet to be closed.
Further tongs can be used accordingly between steps ey) and eh) in accordance with the aforementioned step f). Alternatively, however, the first and second tongs can also be designed in such a way that they alternately clamp the further caps put on one after the other and move the container accordingly so that further caps can be slid on.
In this way, larger and/or more complexly structured containers can be completely sealed with appropriate caps in an isolating manner, whereby it is ensured in each case that no processing means/processing tool comes into contact with both the outside of the container and the outside of a cap.
The first, second and/or further caps and/or the sealing film preferably comprise a plastics material and/or another easily formable material and/or walls which, in terms of permeability, meet sterility requirements for medical products contained or filled in the container.
A device according to the invention can be designed in accordance with the technical features described above with regard to the method.
With regard to the device according to the invention, an embodiment that does not comprise any means for performing step h) comes into particular consideration, because in corresponding systems for filling pharmaceutical products, labelling/sealing/packing stations are often located in other systems/machines than the bottling itself.
Accordingly, one variant is to equip a device according to the invention without means for carrying out step h).
The avoidance of cross-contamination and the provision of a sterile product provided with caps is still an advantageous property of the machine according to the invention, even if a user of the machine uses this in a system chain in which, for example, the subsequent labelling or the transport of the containers provided with caps there is less sterile and/or does not completely avoid cross-contamination.
A further advantage of an embodiment of the method according to the invention or the device/machine according to the invention without step h) or without means for this is that the method/device according to the invention can then be used flexibly with regard to applications in which high value is placed on sterility and the avoidance of cross-contamination with regard to the application of the label/sealing film, as well as with regard to applications in which this is of lesser importance. Different devices then do not have to be provided for the two cases.
A device according to the invention for carrying out a method according to the invention preferably comprises:
The device according to the invention preferably further comprises:
As already described with regard to the method, a device according to the invention can preferably also be designed such that a plurality of lifting tongs, first tongs or transport rakes comprising second tongs are provided in each case. In particular, it is possible to provide a transport rake comprising lifting tongs and second tongs and to provide a further transport rake opposite on the other side of a conveying means comprising the first tongs.
Both with regard to the method according to the invention and with regard to the device according to the invention, the first cap, second cap and/or further caps are preferably not designed to be rigid, i.e. in particular, elastic and/or resilient to the extent that the caps yield to the clamping such that the inside of the caps comes into contact with the container at some points and the clamping force is thus transmitted to the container via the cap.
Several embodiments of the present invention are explained below with reference to the accompanying drawings. In the drawings:
The container (40) has been brought to the work area of the lifting tongs (14) by means of a first conveying means (10), which is part of the device according to the invention, but can also be separate from it. The lifting tongs (14) are aligned with their mutually movable jaws (16, 18) on a second region (44) of the container (40).
In
In
For example, the cap (52) can be held on the tube (60) during the lowering process by means of negative pressure. In
The cap (52) is dimensioned and the attachment point of the lifting tongs (14) is selected so that there is no contact between the first cap (52) and the lifting tongs (14) and the jaws (16, 18) thereof.
The cap (54) has an engagement element (56) on the outside, which can interact with a complementary engagement element on the inside or on the inner circumference of the cap (52). As indicated here, the engagement element (56) can be, for example, an annular protrusion.
Since the diameter of the second cap (54) is slightly smaller than the diameter of the first cap (52), the first cap (52) slips over the second cap (54) and the engagement elements (56) engage with one another.
Then, as shown in
The setting tube (62) is now moved downwards.
Then, as shown in
In this state, the sealing film (58) is pressed against the two caps (52, 54) with the aid of the setting ring (59) and adhesively bonded thereto in a sterilely sealing manner, for example by means of heat.
Alternatively, the sealing film or a label can also be applied to the gap region by unrolling. For this purpose, both a movement of a corresponding roll-off device around the container and a rotation of the container and/or a combination of both are conceivable. If the container is to be rotated, it may have to be moved onto a turntable or the like by means of the second tongs.
However, the application of the sealing film can also be omitted at this point and the provision of means for this, such as the setting ring (59) or roll-off devices, can be dispensed with. The sealing film can, for example, also be applied subsequently using another machine.
As a result, the container (40) is isolated from its surroundings in a completely sterile, sealed manner.
During the entire process, neither the container (40) nor one of the caps (52, 54) came into contact with any processing tool or processing means.
Furthermore, none of the processing means or tools that came into contact with the container (40) came into contact with one of the processing means/processing tools that came into contact with one of the caps (52, 54).
As a result, cross-contamination is practically completely excluded, and a user can see from the undamaged sealing film that there is a high probability that none of the filled material is on the outside of the caps (52, 54).
In the embodiment shown, the caps are dimensioned in such a way that they are slipped over. In other embodiments, however, the caps can also be dimensioned so that they have almost the same diameter and the two ends of the caps come into contact or a certain distance remains between the cap ends after they have been put on, which distance is then bridged by the sealing film, for example.
Since this only requires a different dimensioning of the caps, this can in each case be combined with all of the features specified for the embodiment explained.
As can be seen, the first cap 52 has the same design, but the second cap 54 is designed to be shorter in length and has a diameter similar to the first.
As a result, there is no offset between the walls of the caps 52, 54, but a certain intermediate region 100 remains between the caps 52, 54 after they have been put on.
This can be bridged and closed by a correspondingly dimensioned sealing film 58.
Since there is no overlap, no engagement elements 56 are provided on the outside or inside of the caps 52, 54 either.
It is also possible to use a somewhat longer second cap 54, as in
It is also possible to coordinate the lower end of the first cap 52 and the upper end of the second cap 54 so that they can be closed, latched and/or connected to one another during or after putting on the second cap 54.
In addition to complementary engagement elements 56 on the underside or upper side of the caps 52, 54, a choice of material is also possible, so that the caps 52, 54 are already connected in the contact region by pressure and/or strands, preferably in a sterilely sealing manner.
Number | Date | Country | Kind |
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10 2019 201 028.8 | Jan 2019 | DE | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2020/050817 | 1/14/2020 | WO | 00 |