CN113272226A - Method and apparatus for aseptically enclosing containers - Google Patents

Method and apparatus for aseptically enclosing containers Download PDF

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Publication number
CN113272226A
CN113272226A CN202080007215.XA CN202080007215A CN113272226A CN 113272226 A CN113272226 A CN 113272226A CN 202080007215 A CN202080007215 A CN 202080007215A CN 113272226 A CN113272226 A CN 113272226A
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CN
China
Prior art keywords
container
cover
clamp
cap
lid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN202080007215.XA
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Chinese (zh)
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CN113272226B (en
Inventor
H·雷伯
P·肖瑟
M·施瓦泽
W·埃默特
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bausch+steller Bell Software Engineering Co ltd
Original Assignee
Bausch and Stroebel Maschinenfabrik Ilshofen GmbH and Co KG
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Publication of CN113272226A publication Critical patent/CN113272226A/en
Application granted granted Critical
Publication of CN113272226B publication Critical patent/CN113272226B/en
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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00Closing containers or receptacles after filling
    • B65B7/16Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/28Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
    • B65B7/2842Securing closures on containers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003Filling medical containers such as ampoules, vials, syringes or the like
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B43/00Forming, feeding, opening or setting-up containers or receptacles in association with packaging
    • B65B43/42Feeding or positioning bags, boxes, or cartons in the distended, opened, or set-up state; Feeding preformed rigid containers, e.g. tins, capsules, glass tubes, glasses, to the packaging position; Locating containers or receptacles at the filling position; Supporting containers or receptacles during the filling operation
    • B65B43/46Feeding or positioning bags, boxes, or cartons in the distended, opened, or set-up state; Feeding preformed rigid containers, e.g. tins, capsules, glass tubes, glasses, to the packaging position; Locating containers or receptacles at the filling position; Supporting containers or receptacles during the filling operation using grippers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B53/00Shrinking wrappers, containers, or container covers during or after packaging
    • B65B53/02Shrinking wrappers, containers, or container covers during or after packaging by heat
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00Preserving, protecting or purifying packages or package contents in association with packaging
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00Closing containers or receptacles after filling
    • B65B7/16Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/161Sealing filled ampoules
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D43/00Lids or covers for rigid or semi-rigid containers
    • B65D43/02Removable lids or covers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D77/00Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/003Articles enclosed in rigid or semi-rigid containers, the whole being wrapped
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D77/00Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04Articles or materials enclosed in two or more containers disposed one within another
    • B65D77/048Articles or materials enclosed in two or more containers disposed one within another the inner and outer containers being rigid and the outer container being of curved cross-section, e.g. cylindrical
    • B65D77/0486Articles or materials enclosed in two or more containers disposed one within another the inner and outer containers being rigid and the outer container being of curved cross-section, e.g. cylindrical the inner container being coaxially disposed within the outer container
    • B65D77/0493Articles or materials enclosed in two or more containers disposed one within another the inner and outer containers being rigid and the outer container being of curved cross-section, e.g. cylindrical the inner container being coaxially disposed within the outer container and retained at a distance of the inner side-wall of the outer container, e.g. within a bottle neck
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B2220/00Specific aspects of the packaging operation
    • B65B2220/16Packaging contents into primary and secondary packaging

Abstract

A method for aseptically enclosing a container (40) by means of at least two lids (52, 54), wherein the method comprises the following steps, preferably performed alphabetically: c) clamping a first region (42) of the container (40) by means of a first clamp (22) by clamping and gripping a first cover (52), the container having been provided with the first cover (52) in the first region (42); and e) pushing the second cap (54) onto a second region (44) of the container (40) not yet provided with one of the caps (52, 54), such that the second cap (54) snaps over the first cap (52) and/or is snapped over by the first cap (52), and/or such that the first and second caps (52, 54) are connected via complementary threads and/or projections/recesses (56) and/or engagement means (56), and/or such that a sterile, sealed connection is formed between the second cap (54) and the first cap (52) towards the outside of the caps; and preferably h) connecting the first and second lids (52, 54) in a sterile, sealed manner, preferably by affixing a sealing membrane (58) to the first and second lids (52, 54), such that the sealing membrane aseptically seals the intermediate and/or interstitial regions between the first and second lids (52, 54).

Description

Method and apparatus for aseptically enclosing containers
Technical Field
The present invention relates to a method and apparatus for aseptically enclosing containers.
Background
In particular in the pharmaceutical sector, sterile packaging of containers is required, since on the one hand the respective medicament should not be contaminated and on the other hand some medicaments can be harmful in the event of accidental contact.
A vial, syringe, or the like is generally used as the container. In this case, it is particularly advantageous to use mechanical methods and corresponding devices in order to completely and aseptically enclose the individual respective containers.
It would be highly advantageous if a user could immediately identify from the container whether a sterile seal has been maintained since manufacture.
Disclosure of Invention
The object of the invention is therefore: a corresponding method and a corresponding device are proposed.
The method according to the invention for the aseptic enclosure of a container by means of at least two lids comprises at least the following steps:
c) clamping a first region of the container, in which the container has been provided with the first lid, by clamping and gripping the first lid by means of a first clamp; and
e) pushing the second cap onto a second region of the container not provided with one of the caps, such that the second cap abuts the first cap, and/or the second cap snaps onto and/or the second cap is snapped off by the first cap, and/or such that the first cap and the second cap are connected via complementary threads and/or projections/grooves and/or engagement means, and/or such that a sterile sealing connection is or can be formed between the second cap and the first cap towards the outside of the caps, for example by leaving a gap between the caps that can be bridged; and preferably
h) The first and second lids are preferably connected in a preferably sterile-sealed manner by affixing a sealing film and/or label to the first and second lids such that the sealing film and/or label aseptically seals the intermediate region and/or the gap region between the first and second lids.
The intermediate region is to be understood here as meaning the region which, when one cover is snapped onto the other cover, is located between the end of this one cover and the outer wall of the other cover. The gap region is to be understood as: the region between the ends of the covers when no cover is snapped over another cover, and if necessary even when a space is left between the ends of the covers. Thus, the gap region represents the following pitch: the distance that occurs when the first and second covers are not long enough to touch, and the area of the gap that is as narrow as possible when the second cover is pushed so that the covers just abut each other or until they abut. Here, connection in a preferably sterile-sealed manner is preferably understood to mean: the intermediate zone and/or the gap zone is sealed such that its permeability is almost the same or the same as the permeability of the cover material. For this purpose, in addition to the application of the top-sealing film, adhesive materials, swelling materials and/or also heat and/or pressure treatments are also considered, the latter being considered, for example, when the cover material of one cover can be brought into connection or application with the cover material of the other cover by corresponding heat and/or pressure.
These steps are preferably performed in their alphabetical order, wherein further processing and processing steps may also be performed before, between or after them.
Step h can also be carried out spatially separately during the production of the product. I.e. steps c) and e) are for example performed in one facility/at a production site, the container is subsequently introduced into another site-possibly, the container provided with a lid is also suitable for transport and preferably aseptic packaging, and then step h) is performed in another facility/at another production site.
The overall advantages of the method according to the invention are: by adapting the shape of the lid to one another and to the container, the number of machining means or tools, i.e. for example pliers, which come into contact not only with the outside of the container but also with the outside of the lid can be significantly reduced.
This is particularly advantageous in terms of product safety, since residues can remain on the outside of the container in the event of incorrect filling with a hazardous drug in the event of optional external contact.
Thus, any processing means or processing tools that come into contact with the outside of the container and the outside of the lid, i.e. e.g. conveying means, tongs, conveyor belts, slides, etc., are a source of risk that harmful substances that accidentally reach the outside of the container may be transferred to the outside of the sterile-sealed lid. This is also known as cross-contamination.
Reducing the number of corresponding processing machines or processing tools increases the safety for the product user.
By means of a suitable cover shape and simultaneous or subsequent sealing of the regions between the covers or the transition regions located therebetween with, for example, a sealing film or a correspondingly sealed label, it is also possible for the user to directly recognize: a preferably sterile seal is maintained from the start of manufacture. Advantageously, the outside of the sealing membrane or cap can be provided with corresponding 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 where no aseptic sealing is performed after the cap is applied. Since then there are always the following advantages: the maximum sterility is ensured at least at the point in time when the set cover ends. Thereby, the maintenance of sterility is only relevant for the subsequent container operation.
However, since the above-described operations may be carried out at other production sites/in other machines, it is at least possible to ensure by the method according to the invention that: the containers are provided in a sufficiently sterile manner and with cross-contamination avoided for further processing.
Further, sealing films and/or labels may also be applied for reasons other than to indicate avoidance of cross-contamination, e.g., product information, security features, etc., may be present thereon. For example, to indicate to the user a particular manufacturing standard or to make the product more difficult to counterfeit. However, of course, this can also be combined with the fact that: the sealing film and/or label also indicates that cross-contamination has been avoided at the time of filling.
For the user, such a property can be recognized, in particular, from whether the sealing film and/or the label is intact.
The choice of whether the covers should be superimposed, should be pushed until they abut each other, or whether the spacing between the cover ends is intentionally preserved, is mainly related to the fact that: how large the respective tolerance ranges have to be selected due to predictable deviations/inaccuracies in the lid size/shape, container size/shape and/or pincer shape/movement.
In general, a design that maintains a small spacing between the two ends of the cover is most advantageous.
Furthermore, the method according to the invention preferably further comprises one or more of the following steps:
a) lifting the container from the first conveying means by means of lifting tongs, which do not grip and/or clamp the container in the first region, wherein the lifting tongs preferably grip and/or clamp the container in the second region;
b) pushing the first cover onto the first area;
d) disengaging the lifting clamp from the container and preferably removing the lifting clamp from the container;
f) clamping a second region of the container by clamping and gripping a second lid with a second clamp;
i) placing the container on a second conveyor; and/or
x) moving the container along the processing path and/or towards and/or from the first conveying mechanism, the second conveying mechanism, the first capping station and/or the second capping station by means of one of the jaws gripping and/or gripping the container as an intermediate step between the respective two other steps.
In addition to step x), which is preferably performed alphabetically together with the previously proposed steps of the method according to the invention, step x) can be performed a plurality of times and in particular can be performed between two other respective steps following one another.
This advantageous development allows a further reduction in the number of machining means/tools that come into contact with the outside of the container and the outside of one of the covers.
In an advantageous development of the method, it is proposed that: the lifting clamp, the first clamp, the second clamp, the first conveying mechanism and/or the second conveying mechanism are not in contact with the outside of the container nor with the outside of the lid during the execution of the method.
The risk of cross-contamination of the outside of the sanitary enclosure of the container with filling agent or pharmaceutical product or the container contents can thereby advantageously be avoided almost completely.
Particularly preferably, this is achieved by: all the steps previously proposed, except the corresponding step x), are performed in alphabetical order. This is a possibility to ensure that the processing means/tools do not come into contact with the outside of the container and the outside of the enclosing cover.
It should be emphasized here that: the first conveying mechanism, the second conveying mechanism, the lifting clamp, the first clamp and the second clamp do not necessarily have to be physically completely separate objects from each other. For example, it is sufficient to form the overall conveying mechanism as a whole, a first section of which corresponds to a first conveying mechanism in contact with the outside of the container, and a second section of which corresponds to a second conveying mechanism in contact only with the outside of the lid.
Accordingly, in one embodiment, the lifting clamp, the first clamp, the second clamp may also be part of the same transport rake comprising a plurality of clamps, and/or in another embodiment, the lifting clamp, the first clamp, the second clamp may be part of different transport rakes.
Here, mainly only attention needs to be paid to: the respective section of the transport rake having the jaws corresponding to the lifting jaws only also serves as lifting jaws in the sense of the method and is in contact only with the outside of the container and not with the lid.
The same applies to the first and second pincers, i.e. a transport rake with pincers corresponding to the first or second pincers and/or corresponding sections of the same transport rake serve only as the first or second pincers in the sense of the method and do not make contact with the outside of the container but only with the lid.
In a preferred embodiment, a first transport rake is used for the method, the first transport rake comprising in a first region lifting pincers and in a second region second pincers. The first transport rake extends along one side of the overall conveyor mechanism. A second transport rake, which usually contains only half the number of tongs, whose tongs serve as first tongs, preferably extends on the opposite side.
In this case, the transport rake can also each provide a propulsion force along the conveying mechanism, wherein the containers are transported further in the conveying direction by the clamping cover when the containers are respectively transferred from the lifting tongs to the first tongs of the opposite or second transport rake, so that the second tongs of the first transport rake can correspondingly clamp the outside of the containers or covers in the respective step.
It is therefore preferred for the method according to the invention to provide a plurality of lifting tongs, first tongs and/or second tongs in order to simultaneously handle a plurality of containers corresponding to any variant of the method according to the invention. The same applies correspondingly to the first and second conveying means.
Preferably, the lifting clamp, the first clamp, the second clamp and/or the transport rake comprising the lifting clamp, the first clamp and/or the second clamp are rotated away from the container before and/or after gripping/clamping one of the container and/or the lid. This can be technically advantageous for a transverse path movement when realizing a particular machine, in particular when rotating away about an axis parallel to the longitudinal extension of the first conveyor mechanism, the second conveyor mechanism and/or the transport rake.
Preferably, the transport rake, the lifting clamp, the first clamp and/or the second clamp can be moved along the conveying mechanism accordingly.
Preferably, the lifting clamp, the first clamp and/or the second clamp are each formed by two jaws which are movable relative to one another, between which the container or the lid can be clamped.
Preferably, the first and/or second conveying means are a conveyor belt, a combination of a conveying surface and a conveying slide, a conveying rake and/or a conveying container, such as a bucket or a nest.
The container is preferably a vial, a syringe or a similar container that can be used for medical products.
The first and/or second lid is preferably designed as a one-sided open and preferably circular or rectangular cylinder, the diameter of which is greater than the maximum diameter of the container in the first or second region, respectively.
In this way, the basic shape or the basic surface of the cylinder can be selected to match the circumference of the container or the outside of the container, which occurs in the displacement direction, and can be simply displaced onto the container.
The variant with a cylinder with one-sided opening is preferred here because then only the first and second lids have to be pushed, if necessary the middle region has to be sealed, and the container is completely surrounded by the two lids and is packaged sufficiently sterile due to the sealed or isolation-sealed connection between the two.
This variant is particularly preferred, since most corresponding containers have such a simple shape that the lid can be simply pushed onto the container from two directions.
In the case of more complex or also significantly larger containers, it is, of course, proposed in an advantageous variant of the method according to the invention that: only the first cover is designed as a cylinder with one-sided opening and the second cover is designed as a cylinder with two-sided opening, wherein the method further comprises the following steps:
ey) a further cover embodied as a single-sided or double-sided open cylinder is pushed onto a further region of the container not yet provided with a cover, such that the further cover is snapped over and/or by the previously last pushed cover and/or such that the further cover and the previously last pushed cover are connected via complementary threads and/or projections/recesses and/or engagement means and/or such that a connection which is sealed in a sterile manner towards the outside of the cover is formed or can be formed between the further cover and the previously last pushed cover, preferably by a bridging-capable distance remaining between the covers; and
hy) the further cap and the previously finally pushed cap are connected in a sterile-tight manner, preferably by affixing a sealing membrane to the further cap and the previously finally pushed cap, such that the sealing membrane aseptically seals the intermediate and/or interstitial regions between the further cap and the previously finally pushed cap, wherein steps ey) and hy) are preferably repeatedly carried out after step h), wherein at least one step ey) comprises pushing a cap formed as a cylinder with a one-sided opening, which is preferably the last step ey).
In this refinement of the method according to the invention, it is therefore proposed that: the first cover, which is a cylinder with a single-sided opening, is exposed at one end of the container, then a second cover, which is designed as a cylinder with two-sided openings, and further covers are pushed onto the container in succession until the covers sufficiently cover the container, so that the last cover, which is also designed as a cylinder with a single-sided opening, can be pushed over, and then the container is enclosed or enclosed again by the covers, if necessary, in addition to the intermediate and/or gap regions still to be closed.
Here, accordingly, additional pliers can be used between steps ey) and eh) according to step f) presented before. Alternatively, however, it is also possible to design the first and second jaws such that they alternately grip a further lid that is placed onto one another and move the container accordingly, in order to be able to move the further lid.
In this way, even larger and/or more complex structured containers can be sealed in a completely isolated manner by means of a corresponding lid, wherein it is always ensured that: the processing means/processing tool does not come into contact with the outside of the container or the outside of the lid.
Preferably, the first, second and/or further cap and/or sealing membrane comprises a plastic material and/or further materials and/or walls which can be easily shaped, which materials and/or walls are permeable to meet the sterility requirements for the medical product contained or filled in the container.
The device according to the invention may be constituted according to the technical features described above in relation to the method, respectively.
With regard to the device according to the invention, in particular a design is considered which does not comprise a mechanism for carrying out step h). Since in the respective facilities for filling pharmaceutical products the labelling/sealing/packaging station is usually placed in other facilities/machines than the filling itself.
Accordingly, one variant is: the device according to the invention is not equipped with means for performing step h).
Avoiding cross-contamination and providing sterile products provided with lids are always advantageous features of the machine according to the invention here, even if the user of the machine uses the machine in a facility chain, wherein, for example, in the case of such a machine, subsequent labeling or transport of containers provided with lids is carried out less sterile and/or does not completely avoid cross-contamination.
An embodiment of the method according to the invention or of the device/machine according to the invention without step h) or without means for this has the further advantage that: the method/apparatus according to the invention can then be used flexibly in applications where sterility is highly emphasized and cross-contamination is avoided in the application of labels/sealing films, as well as in applications where the importance of the above is low. Thus, it is not necessary to provide different devices for the two cases.
Preferably, the device according to the invention for performing the method according to the invention comprises:
-at least one first cap application station for advancing a first cap onto the container;
-at least one first jaw for gripping the container after the first lid has been pushed, by gripping the first lid pushed onto the container; and
at least one second cap application station for pushing a second cap onto the container, which is preferably transported by means of the first gripper, or alternatively the first cap application station is also designed for pushing a second cap onto the container, which is preferably handled by means of the first gripper; and preferably
At least one sealing device for the sterile sealed connection of the first cap and the second cap, or alternatively the first and/or second cap application station is also designed for the sterile sealed connection of the first cap and the second cap.
Preferably, the apparatus according to the invention further comprises:
-at least one first transport mechanism for transporting the containers;
-at least one lifting pincer adapted to lift the container from the conveying means and/or adapted to convey the container to the first capping station;
-at least one second jaw for gripping the container by gripping the second lid pushed onto the container after pushing the second lid; and/or
At least one second conveying device for further conveying the containers, which are preferably conveyed by the second gripper and are covered at least by the first and second lids.
As already described with respect to the method, the device according to the invention can also preferably be designed such that a transport rake comprising a plurality of lifting tongs, a first tong or a second tong, respectively, is provided. In particular, it is conceivable to provide a transport rake comprising a lifting tong and a second tong and a further transport rake arranged opposite on the other side of the conveying mechanism, which further transport rake comprises the first tong.
In the case of the method according to the invention and in the case of the device according to the invention, the first cover, the second cover and/or the further cover are preferably formed non-rigidly. The cover is thus designed, in particular, elastically and/or resiliently, to such an extent that it yields to the clamping, so that the inner side of the cover contacts the container at some points and thus transmits the clamping force to the container via the cover.
Drawings
Various embodiments or examples of the invention are set forth below in accordance with the following drawings, wherein:
fig. 1.1 to 1.15 each show, in a schematic view along the viewing direction of the conveying means, the execution of a first embodiment of the method according to the invention by means of the device according to the invention; and
fig. 2.1 and 2.2 show the steps of a second embodiment of the method according to the invention, which are carried out by means of the same apparatus according to the invention as fig. 1.1 to 1.15, but with further covers, which correspond to fig. 1.8 and 1.10.
Detailed Description
Fig. 1.1 shows the situation at the beginning of an embodiment of the method according to the invention using an embodiment of the apparatus of the invention.
The containers (40) are guided to the working area of the lifting tongs (14) by means of a first conveying mechanism (10), which is part of the device according to the invention, but which can also be separated from the device according to the invention. The lifting jaws (14) are aligned with their jaws (16, 18) that can be moved relative to one another in a second region (44) of the container (40).
With reference to fig. 1.2, the jaws (16, 18) of the lifting clamp (14) move away from each other, push around the first lid, move together, and clamp the second region (44) of the container (40) from now on.
With reference to fig. 1.3, the container (40) is lifted by means of the lifting clamp (14) and removed from the first conveying mechanism (10). Fig. 1.3 shows how the first lid (52) is lowered from above with respect to fig. 1.3 onto the first region (42) of the container (40) located above.
Here, for example, during the lowering process, the cover (52) can be held at the tube (60) by means of a negative pressure. With reference to fig. 1.4, the lowering process is ended, the underpressure is ended and the cover (52) remains on the now covered first region (42) of the container (40).
The cover (52) is dimensioned and the attachment point of the lifting clamp (14) is selected such that there is no contact between the first cover (52) and the lifting clamp (14) and their jaws (16, 18).
Fig. 1.5 and 1.6 show how the first gripper (22) is introduced and the first cover (52) is clamped by means of its jaws, which are constructed analogously to the jaws (16, 18) of the lifting gripper (14). Thereby, the first jaw (22) grips the container (40) from now on, more precisely by contacting the lid (52) without contacting the actual body of the container (40).
Fig. 1.7 and 1.8 show how the lifting pliers (14) are then removed from the container (40) and how the container (40) is moved by means of the first pliers (22) relative to the first conveying device (10), which is embodied, for example, as a conveyor belt, so that the second lid (54) can now be moved from below by means of the tube (62) to the container (40) and brought closer in alignment with the second region (44) in a manner similar to the previous conveying of the first lid (52) from above.
The cover (54) has an engagement means (56) on the outside, which can interact with a complementary engagement means on the inside or on the inner circumference of the cover (52). As shown here, the engagement mechanism (56) may 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 second cap (54) is moved over by the first cap (52) and the engagement mechanisms (56) engage into each other.
Then, as shown in fig. 1.9, the second jaw (24) is moved closer to grip the second lid (54), whereby the container (40) which is now completely covered by the two lids (52, 54) can be held by the second jaw (24).
The adjusting tube (62) is moved away downwards during this time.
The first jaw (22) is then removed from the cover (52) and removed, as shown in fig. 1.10.
Fig. 1.11 shows: from now on, by means of the setting ring (59), the sealing film (58) is pushed from above, via the first cover (52) until the state shown in fig. 1.12 is reached, the sealing film (58) just covering the transition or gap region between the first cover (52) and the second cover (54).
In this state, the sealing film (58) is pressed against the two caps (52, 54) by means of a setting ring (59) and is affixed thereto in a sterile-sealing manner, for example by means of heat action.
Alternatively, the sealing film or label can also be applied to the gap region by rolling off. For this purpose, it is possible to consider moving the respective unwinding device around the container, rotating the container, and/or a combination of the two. If the container is to be rotated, it is moved, if necessary, onto a turntable or the like by means of a second gripper.
However, it is also possible to dispense with the application of the sealing film at the location where the ring (59) or the unwinding device is provided and to dispense with the provision of a mechanism for this purpose. For example, the sealing film can also be applied subsequently by means of a further machine.
The container (40) is thereby isolated from its environment in a completely sterile-sealed manner.
Fig. 1.13 to 1.15 also show from now on: how the setting ring (59) is moved away upwards again and how the completely covered containers (40) are placed in the second conveying means (12), in this case, for example, the pockets of a nest, by means of the second gripper (24).
Neither the container (40) nor one of the lids (52, 54) is contacted by any processing tool or mechanism during the entire process. In addition, the processing means or tool that also contacts the container (40) is not in contact with one of the processing means/processing tools that contacts one of the lids (52, 54).
In this way, cross-contamination is virtually completely ruled out, and the user can recognize from the undamaged sealing film: the material, which is not filled at all, is located on the outside of the covers (52, 54).
In the embodiment shown, the cover is dimensioned such that it forms a snap. However, in other embodiments, the cover can also be dimensioned such that it has approximately the same diameter and brings the two ends of the cover into contact, or that, after sheathing, a spacing remains between the cover ends, which spacing is then covered, for example, by a sealing film.
Since this only requires the cover to be designed with different dimensions, this can be combined in each case with all the features mentioned for the illustrated embodiments.
Fig. 2.1 and 2.2 show the use of covers 52, 54 having different design dimensions and the machine also shown in fig. 1.1 to 1.15. Fig. 2.1 corresponds to fig. 1.8 and fig. 2.2 corresponds to fig. 1.10.
As can be seen, the first cap 52 has the same design, however, the second cap 54 is designed to be shorter in length and to have a similar diameter as the first cap.
Thus, there is no offset between the walls of the covers 52, 54, but after nesting, a certain intermediate area 100 remains between the covers 52, 54.
This central region can be bridged and closed by a correspondingly dimensioned sealing film 58.
Since no overlap occurs, the engagement mechanism 56 is not provided either on the outside or inside of the covers 52, 54.
It is also possible to consider: as shown in fig. 2.1 and 2.2, a second, somewhat longer cover 54 is used, so that the covers 52, 54 nest abutting, i.e. just abutting together or touching each other when nested. The intermediate region 100 is then a narrow slit or has an almost zero extent.
It is also possible to consider: the lower end of the first cover 52 and the upper end of the second cover 54 are coordinated so that they can be closed, locked and/or connected to each other when or after the second cover 54 is nested.
In addition to the complementary engagement means 56 at the lower or upper side of the covers 52, 54, a material selection can also be considered for this purpose, so that the covers 52, 54 are already connected in the contact region by pressure and/or heat, preferably in a sterile-sealing manner.

Claims (13)

1. A method for aseptically enclosing a container (40) with at least two lids (52, 54), wherein the method comprises the following steps, preferably performed alphabetically:
c) -gripping a first region (42) of the container (40) by gripping and clamping a first lid (52) by means of a first clamp (22), the container having been provided with the first lid (52) in the first region (42); and
e) -pushing a second cover (54) onto a second region (44) of the container (40) not yet provided with one of the covers (52, 54), such that the second cover (54) abuts the first cover (52) and/or the second cover (54) snaps onto the first cover (52) and/or the second cover is snapped onto by the first cover (52), and/or such that the first and second caps (52, 54) are connected via complementary threads and/or projections/recesses (56) and/or engagement means (56), and/or such that a sterile, sealed connection is formed or can be formed between the second cover (54) and the first cover (52) towards the outside of the covers, the sterile sealing connection is preferably formed or can be formed in such a way that a span-able distance remains between the covers.
2. The method of claim 1, wherein the method further comprises the steps of:
h) the first and second lids (52, 54) are preferably connected in a preferably sterile-sealing manner by affixing a sealing film (58) to the first and second lids (52, 54), such that the sealing film aseptically seals the intermediate and/or gap regions between the first and second lids (52, 54).
3. The method according to any of the preceding claims, wherein the method further comprises one or more of the following steps, preferably performed in alphabetical order together with the steps of claim 1 and/or 2, in addition to step x):
a) -lifting the container (40) from the first conveying means (10) by means of lifting tongs (14) which do not grip and/or clamp the container (40) in the first region (42), wherein the lifting tongs (14) preferably grip and/or clamp the container (40) in the second region (44);
b) -pushing the first cover (52) onto the first area (42);
d) -disengaging the lifting clamp (14) from the container (40) and preferably removing the lifting clamp (14) from the container (40);
f) -gripping the second area (44) of the container (40) by gripping and clamping the second lid (54) by means of a second jaw (14);
i) -placing the container (40) on a second conveyor mechanism (12); and/or
x) moving the container (40) along a processing path and/or towards and/or from the first conveyor (10), the second conveyor (14), the first capping station and/or the second capping station by means of one of the jaws (14, 22, 24) gripping and/or gripping the container (40) as an intermediate step between each two further steps.
4. Method according to any one of the preceding claims, wherein the lifting clamp (14), the first clamp (22), the second clamp (24), the first conveying mechanism (10) and/or the second conveying mechanism (12) are not in contact with the container (40), in particular not with the outside of the container (40), nor with the lid, in particular not with the outside of the lid (52, 54), during the execution of the method.
5. The method according to any one of the preceding claims, wherein the lifting clamp (14), the first clamp (22), the second clamp (24) are part of the same transport rake comprising a plurality of clamps, and/or wherein the lifting clamp (14), the first clamp (22), the second clamp (24) are part (24) of different transport rakes.
6. Method according to any one of the preceding claims, wherein the lifting clamp (14), the first clamp (22), the second clamp (24) and/or a transport rake comprising the lifting clamp (14), the first clamp (22) and/or the second clamp (24) are rotated away from the container (40), preferably about an axis parallel to the longitudinal extension of the first conveying mechanism (10), the second conveying mechanism (12) and/or the transport rake, before and/or after clamping/gripping the container (40) and/or one of the covers (52, 54).
7. Method according to any one of the preceding claims, wherein the lifting clamp (14), the first clamp (22) and/or the second clamp (24) are formed by two jaws (16, 18) that are movable relative to each other, between which the container (40) can be clamped.
8. Method according to any one of the preceding claims, wherein the first and/or the second conveying mechanism (10, 12) is a conveyor belt (10), a combination of a conveying surface and a conveying slide, and/or a conveying rake, and/or a conveying container (12), such as a tub or nest (12), and/or wherein the container (40) is a vial, a syringe or a similar container that can be used for medical products.
9. Method according to any one of the preceding claims, wherein the first and/or second lid (52, 54) is configured as a one-sided open and preferably circular or rectangular cylinder having a diameter larger than the largest diameter of the container (40) in the first or second region (42, 44), respectively.
10. Method according to claim 9, wherein only the first cover (52) is configured as a single-sided open cylinder and the second cover is configured as a double-sided open cylinder, wherein the method preferably further repeats after step h) comprising the steps of:
ey) a further cover configured as a single-sided or double-sided open cylinder is pushed onto a further region of the container (40) which is not yet provided with a cover (52, 54), such that the further cover is snapped over and/or by the previously last pushed cover and/or the further cover and the previously last pushed cover are connected via complementary threads and/or projections/recesses and/or engagement means and/or a connection which is/are preferably formed or can be formed in an aseptic-tight manner towards the outside of the cover by means of a bridging-able distance remaining between the covers; and
hy) connecting the further cap and the last previously pushed cap in a sterile and sealed manner, preferably by sticking a sealing membrane (58) onto the further cap and the last previously pushed cap, such that the sealing membrane (58) seals the intermediate region and/or the gap region between the further cap and the last previously pushed cap in a sterile manner,
wherein at least one step ey) comprises pushing a cover formed as a cylinder open on one side, which is preferably the last step ey) performed.
11. The method according to any one of the preceding claims, wherein the first, second and/or further caps (52, 54) and/or the sealing membrane (56) comprise a plastic material, a further material and/or a wall portion, which meets the sterility requirements of the medical product contained in the container (40) in terms of permeability.
12. An apparatus for performing the method of any of the preceding claims, comprising:
at least one first cap application station for advancing a first cap (52) onto the container (40); at least one first gripper (22) for gripping the container (40) by clamping the first lid (52) pushed onto the container (40) after pushing the first lid; and at least one second cap application station for pushing a second cap (54) onto the container, preferably transported by means of the first gripper (22), or the first cap application device is also adapted to push the second cap (54) onto the container (40), preferably operated by means of the first gripper (22).
13. The apparatus of claim 12, further comprising:
at least one sealing device for aseptic sealed connection of the first and second lids (52, 54), or a first and/or second lid nesting station adapted for aseptic sealed connection of the first and second lids (52, 54);
at least one first conveyor mechanism (10) for transporting the containers (40);
at least one lifting pincer (14) adapted to lift said container (40) from said conveying means and/or adapted to convey said container to said first capping station;
at least one second gripper (24) for gripping the container (40) by clamping the second lid (54) pushed onto the container (40) after pushing the second lid (54); and/or
At least one second conveying device (12) for further transporting the containers (40), which are preferably conveyed by the second gripper (24) and are covered at least by the first and second covers (52, 54).
CN202080007215.XA 2019-01-28 2020-01-14 Method and apparatus for aseptically enclosing containers Active CN113272226B (en)

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DE102019201028.8A DE102019201028A1 (en) 2019-01-28 2019-01-28 Method and device for sterile enclosing a container
PCT/EP2020/050817 WO2020156803A1 (en) 2019-01-28 2020-01-14 Method and device for sterilely enclosing a container

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US20220097879A1 (en) 2022-03-31

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