EP3862095B1 - Support structure for simultaneously holding of a plurality of containers for substances for medical, pharmaceutical or cosmetic applications and transport assembly with same - Google Patents

Description

The present invention relates generally to the treatment of containers for substances for pharmaceutical, medical or even cosmetic uses, and more particularly relates to a holding structure for simultaneously holding a plurality of containers for substances for pharmaceutical, medical or even cosmetic uses, such as vials, ampoules or carpules .

STATE OF THE ART

Medicinal containers, such as small bottles, ampoules or carpules, are used on a large scale as containers for keeping and storing medical, pharmaceutical or cosmetic preparations administered in liquid form, in particular in pre-dosed amounts. These are generally cylindrical in shape, can be made of plastics or glass, and are available in large quantities at low cost. The containers are increasingly delivered to a pharmaceutical manufacturer or a further processing company in holding structures in a predetermined geometric arrangement and processed further while the containers are held or accommodated in the holding structure. This requires inexpensive and durable holding structures in which the containers are held or accommodated in an arrangement that is as space-saving as possible.

CN 103359348-A discloses a holding structure designed as a trough-shaped holding tray (tray), with a base on which a plurality of vertical positioning pins are provided, between which the containers can be accommodated without touching one another. The holding structure is formed from a plastic by injection molding. At the same time, the vertical positioning pins act as guide sections for inserting the containers into the receptacles formed by the positioning pins. However, the containers are held with a comparatively large amount of play. The achievable packing density of the containers is relatively low.

WO 2012/126582 A1 discloses a further holding structure for syringe barrels, with a plate-shaped carrier on which a plurality of cylindrical receptacles with circumferential side walls are formed. The syringe bodies rest with their retaining flanges on the upper ends of the cylindrical receptacles. To stiffen the carrier, the cylindrical receptacles are connected to one another via connecting webs on the underside of the carrier. The distance between the cylindrical receptacles is comparatively large, so that the packing density that can be achieved with the holding structure is not optimal.

WO 2014/130349 A1 discloses a comparable support structure. The recordings do not have a polygonal basic shape, but have a circular basic shape. Furthermore, adjacent recordings do not directly adjoin one another.

WO 2017/038878 A1 discloses a further support structure with a plate-shaped carrier on which a plurality of cylindrical receptacles with peripherally formed side walls are formed. The cylindrical receptacles are arranged at a comparatively small distance from one another, which, however, makes it necessary to produce two side walls at a relatively small distance from one another. When produced by plastic injection moulding, this requires very thin-walled, easily broken and difficult-to-cool rib-like contours. This in turn leads to a very complex and therefore also expensive tool when designing the tool. In addition, such a design can also have a negative effect on the service life of the tool used for injection molding. Since the filigree structures cannot be cooled during injection molding, or only with great effort, the design also has a negative effect on the cycle time of the manufacturing process, which leads to higher unit costs.

DE 20 2016 107 209 U1 The applicant discloses a further support structure of the aforementioned type, in which internal receptacles of the support structure are formed by axially extending positioning cylinders and separating webs which connect the positioning cylinders to one another. Although this arrangement allows a higher packing density of the container. However, the production of the holding structure by plastic injection molding is comparatively complex. DE 20 2016 107 209 U1 discloses another support structure for pharmaceutical containers made from a plastic by injection molding. However, the receptacles do not have a polygonal cross-section and are also not formed by side walls formed all around. Positioning cylinders, which are connected to one another via separators, are used to position the pharmaceutical containers. The pharmaceutical containers are actually laterally supported by guide ribs that are formed on the surfaces of the positioning cylinders.

EP 3 354 589 A1 of the applicant, which represents prior art according to Art. 54(3) EPC, discloses a further holding structure in which the receptacles are formed by comparatively thin separating and connecting webs, which makes the production of the holding structure by plastic injection molding comparatively complex.

U.S. 2015/0166217 A1 the applicant discloses a transport and packaging container for pharmaceutical containers in FIGS. 5 and 6, a holding structure with a plurality of honeycomb-shaped receptacles for receiving the pharmaceutical containers being arranged therein on a floor of the transport and packaging container. The receptacles must be designed to be flexible and expandable in order to allow the pharmaceutical containers to be inserted, but then to keep them clamped therein. Further holding structures are also disclosed in which side walls of the receptacles can be adjusted relative to one another in order to be able to temporarily widen the receptacles for inserting the pharmaceutical containers.

Comparable support structures are in the DE 10 2012 103 896 A1 disclosed to the applicant.

WO 2010/086128 A1 discloses a support structure according to the preamble of claim 1 made by plastic injection molding. The support structure has a plurality of receptacles for receiving the containers, which are arranged in a regular array and each of which is polygonal in plan view. More precisely, the housings are formed by star-shaped positioning projections which are formed in one piece with the bottom of a trough-shaped support. The star-shaped positioning projections are arranged at a distance from one another and are not directly connected to one another. It is true that this holding structure can be produced inexpensively by injection molding from a plastic. For sufficient rigidity of the carrier, however, it must be designed to be comparatively stable, which leads to a higher weight and higher material costs.

EP 2 886 983 A1 discloses a holding structure for simultaneously holding a plurality of containers for substances for medical, pharmaceutical or cosmetic use, comprising a carrier having a plurality of openings or receptacles into which the containers are insertable, and holding means for holding the containers in the openings or receptacles of the holding structure, wherein the holding structure has a longitudinal direction and a transverse direction, characterized in that immediately adjacent holding structures can be directly connected to one another in such a way that they are immovable relative to one another in the longitudinal direction and/or in the transverse direction.

There is therefore a further need for improvement in the production of holding structures of the aforementioned type.

SUMMARY OF THE INVENTION

The object of the present invention is to provide an improved holding structure for holding a plurality of containers for substances for pharmaceutical, medical or cosmetic applications at the same time, which can be produced simply and inexpensively and which enables advantageously high rigidity and a high packing density of the containers. It should be possible to insert the containers easily and reliably into the receptacles of the holding structure and to remove them from them again. Further aspects of the present invention relate to transport structures or transport or packaging containers and a sterile packaging structure with such a holding structure.

These objects are achieved by a support structure according to claim 1, a method of making the support structure according to claim 5, a transport structure according to claim 7, a transport and packaging container according to claim 9 and a sterile packaging structure according to claim 12. Further advantageous embodiments are the subject matter of the dependent claims.

According to the present invention, there is provided a holding structure for holding a plurality of containers for pharmaceutical, medicinal or cosmetic substances at the same time Applications provided with a plurality of receptacles for receiving the containers, the receptacles being arranged in a regular arrangement, the receptacles being formed by side walls which are each formed circumferentially, an upper side of the holding structure being formed as a plate-shaped carrier, and the side walls and receptacles of the plate-shaped carrier protrude vertically.

According to the invention, the receptacles are polygonal when viewed from above, ie with a polygonal basic shape, with a side wall being formed as a common partition wall between two immediately adjacent receptacles of the plurality of receptacles.

The recordings can therefore be directly adjacent to one another, which enables an optimal packing density. Due to the shared partition wall, filigree, double-walled structures can be effectively avoided, which considerably simplifies production by injection molding from a plastic. Thin-walled, easily broken and difficult to cool rib-like contours in the tool design can thus be avoided according to the invention, which results in a longer service life of the tool. Furthermore, the cycle time of the manufacturing process can be significantly shortened and unit costs reduced.

In particular, the partitions can be designed to be relatively thin-walled, and yet a high degree of inherent rigidity of the holding structure can be achieved. This enables a relatively low weight of the holding structure with reduced use of materials and low production costs.

At the same time, a very high inherent rigidity of the support structure can be achieved because all side walls are connected directly to one another via corner regions of the receptacles and together form a highly symmetrical hollow honeycomb structure formed by the side walls protruding perpendicularly from a plate-shaped upper side of the support structure.

In the context of the present invention, a common partition wall means in particular that the partition walls, viewed in a cross section, are each formed in one piece and without any significant openings. The height of the respective common dividing wall essentially corresponds to the axial length of the two immediately adjacent receptacles, so that the respective common dividing wall is preferably formed from a solid material over at least 80% of this height.

Because the upper side of the holding structure is designed as a plate-shaped carrier, from which the side walls and receptacles protrude perpendicularly, the inherent rigidity of the holding structure can be further increased.

According to a further embodiment, the side walls of the receptacles are each designed as level, flat partition walls, with the side walls of directly adjacent receptacles converging in a connecting area that extends in the longitudinal direction of the receptacles and is arranged in a corner area of the respective receptacles. This results in highly symmetrical connecting regions which, for example in the case of a hexagonal arrangement of the receptacles not according to the invention, are star-shaped when viewed from above. This enables forces to be dissipated in a highly symmetrical manner, which results in an advantageously high inherent rigidity of the holding structure.

According to the invention, the receptacles are each octagonal in plan view, with four adjacent receptacles arranged in a diamond-shaped arrangement enclosing a central connecting section whose thickness is greater than the thickness of the common partition walls.

According to a further embodiment, the central connecting sections each enclose a cavity which extends in the longitudinal direction of the adjacent receptacles. This cavity expediently has a circular or rectangular cross section. When the holding structure is produced by injection molding from a plastic, this cavity is expediently defined by a cuboid projection on one half of a mold, which extends in the opposite direction to the mandrels on a second half of a mold, which define the shape of the receptacles. A projection at the upper end of this cylindrical or cuboid projection of the molding tool can be used for a rigid connection with the opposite half of the molding tool, so that the holding structure can be manufactured even more precisely.

According to a further embodiment, a plurality of openings, in particular circular openings, are formed in the upper side of the plate-shaped carrier, so that a gas can flow from the upper side to the underside of the plate-shaped carrier. This can advantageously support steam sterilization of the support structure and the containers held thereon.

According to a further embodiment, the openings are formed as circular openings and projections formed in the shape of a truncated cone are formed on the underside of the plate-shaped carrier, which enclose the openings. The projections can serve, for example, as spacer elements in order to define the distance between two holding structures in an arrangement that is stacked vertically one on top of the other.

According to a further embodiment, upper ends of the side walls, which face an upper side of the holding structure, have an arcuate, concave course. In particular, the upper ends of the side walls do not protrude from the top of the support structure at any point. This makes it easier to stack the holding structures vertically one on top of the other, since undesired canting of the upper ends of the side walls is avoided.

According to a further embodiment, guide ribs are formed on the side walls, which extend in the longitudinal direction of the receptacles and support the threading or insertion of the containers into the upper ends of the receptacles. In this case, insertion bevels can be formed at the upper ends of the guide ribs, which are inclined relative to the guide ribs in order to further facilitate the insertion of the containers into the receptacles from the top side of the holding structure.

According to a further embodiment, the guide ribs are arranged in corner regions of the receptacles, with a flattened section being provided at least at the lower ends of the guide ribs, the corner regions of which are rounded. This optimized design of the guide ribs facilitates low-abrasion insertion of the containers even if they are not centered but are inserted into the receptacles at an angle relative to the central axis of the receptacles, as explained in more detail below.

According to a further embodiment, the guide ribs protrude inwards into the receptacles in a direction towards the geometric center of the respective receptacle.

According to a further embodiment, holding sections are provided at the lower ends of the receptacles in order to hold the containers in the receptacles and to limit the axial mobility of the containers in the receptacles towards the lower end of the receptacles. In principle, a holding section that is arranged at a suitable position at the lower end of a respective receptacle is sufficient for this purpose. Two holding sections are expediently located diametrically opposite one another at the lower ends of the receptacles. In principle, however, the holding sections can also be designed to be circumferential or essentially circumferential, with one or more openings along the circumference of the respective receptacle at its lower end.

According to a further embodiment, the lower ends of the receptacles each merge into a circular closing ring with a central opening. On the one hand, this closing ring keeps the distance between the lower ends of the side walls constant, which further increases the inherent rigidity of the holding structure. On the other hand, this closing ring enables an advantageously symmetrical flow of forces, which also further increases the inherent rigidity of the holding structure

According to a further embodiment, the lower ends of the side walls of the receptacles jointly span a plane that extends parallel to an upper side of the holding structure. The lower ends of the side walls form point-symmetrical connection areas corresponding to the respective symmetry of the arrangement of the receptacles, which further improves the flow of forces in the holding structure and further increases the inherent rigidity of the holding structure.

The end rings preferably protrude beyond the plane spanned jointly by the lower ends of the side walls, ie they form a further plane in which the lower ends of the side walls of the receptacles are connected to one another.

According to a further embodiment, an outer diameter of the end rings is smaller than a minimum opening width of the receptacles on a top side of the holding structure, so that a plurality of identically designed holding structures can be arranged in a stacked arrangement in which the end rings of the upper holding structure are in the upper ends of the receptacles submerge arranged underneath lower support structure. This favors a vertically stacked arrangement of a plurality of holding structures of identical design.

According to a further embodiment, spacer elements are provided on an underside of the holding structure in order to mechanically limit an immersion depth of the end rings of an upper holding structure in the upper ends of the receptacles of the lower holding structure arranged underneath.

According to the invention, a very precise positioning and guidance of the containers in the receptacles is possible, especially in the case of long, thin or slender containers, while achieving a very high packing density, because glass-to-glass contact of containers becomes less likely as freedom of movement becomes increasingly restricted.

With greatly reduced freedom of movement of the containers in the receptacles, the required guide length can also be reduced. This is relevant, for example, in the case of long, thin or slender containers, such as carpules or syringe cylinders, especially with small formats, because these can often only be inserted into the receptacles up to the lower half. Due to the very precise positioning and guidance of the containers according to the invention, it can nevertheless be reliably ensured that there is no glass-to-glass contact. Thus, according to the invention, material can also be saved.

According to a further embodiment, the guide ribs can certainly have a certain extent in the circumferential direction of the receptacles, i.e. not only be designed as linear, very narrow ribs, because this results in lower surface pressures when the containers are received, so that the local particle quantity due to material abrasion on the Guide ribs are smaller, so this is then less critical for optical inspection systems. Because a reduction in the surface pressure generates smaller mechanical loads on the surfaces (i.e. the softer plastic surfaces of the holding structure).

According to a further embodiment, the length of the receptacles is matched to the length of the containers in such a way that the upper or lower ends of the containers protrude from the receptacles and are therefore freely accessible from above the holding structure. This can be used for further processing or treatment of the containers while they are in the Recordings are included and held on the support structure. For example, a holding structure (so-called nest) can be held temporarily in a holding frame of a process station, for example at a pharmaceutical filler, while the substance is filled into the containers held on the holding structure via the filling openings. Or plugs are pressed into the ends of the containers to close the containers while the containers are held on the support structure. Or the ends protruding from the receptacles can be used to grip the containers and remove them from the receptacles.

According to a further aspect of the present invention, there is provided a container transport assembly comprising a combination of the support structure as disclosed above and a plurality of containers for substances for pharmaceutical, medical or cosmetic applications supported thereon, the containers being seated in the receptacles of the Retaining structure are at least partially included and are held axially secured to the support structure, as explained above. For this purpose, the holding structure can be designed in particular as a so-called nest in order to hold vials, carpules or comparable pharmaceutical containers.

According to a further aspect of the present invention, there is provided a container transport structure comprising a combination of the support structure as described above and a plurality of containers for substances for pharmaceutical, medical or cosmetic use supported thereon, the containers being received in the receptacles and are held axially secured to the support structure.

According to a further aspect of the present invention, a transport or packaging container is provided for a plurality of containers for substances for pharmaceutical, medical or cosmetic applications, with the transport or packaging container being box-shaped, with a holding structure, which, as explained above, is known as a so-called A nest is housed in the box-shaped shipping or packaging container together with the containers held thereon to hold the plurality of containers in the shipping or packaging container.

The transport or packaging container can be closed or sealed in particular by means of a gas-permeable plastic film, in particular by means of a plastic film which is formed from a gas-permeable mesh of plastic fibers and is in particular a Tyveck ^® film, in order to sterilize the container by inflowing a gas through to allow through the gas-permeable plastic film.

For sterile transport and storage, a sterile packaging structure can also be provided, with at least one transport structure, as set out above, or with at least one transport or packaging container, as set out above, and with the containers accommodated therein, the at least one transport structure or the at least one transport or packaging container is accommodated in at least one sterile outer packaging bag and is packaged in a sterile manner against the environment. In this case, the at least one sterile outer packaging bag can have a gas-permeable section, which is formed in particular by a mesh of plastic fibers, such as polypropylene fibers (PP).

CHARACTER OVERVIEW

Fig. 1a

eine nicht-erfindungsgemäße Haltestruktur gemäß einer ersten Ausführungsform in einer Draufsicht;

Fig. 1b

die Haltestruktur gemäß der Fig. 1a in einer Ansicht von unten;

Fig. 1c

die Haltestruktur gemäß der Fig. 1a in einer perspektivischen Draufsicht von einer ersten Seite aus betrachtet;

Fig. 1d

die Haltestruktur gemäß der Fig. 1a in einer perspektivischen Draufsicht von einer zweiten Seite aus betrachtet;

Fig. 1e

die Haltestruktur gemäß der Fig. 1a in einem perspektivischen Teilschnitt;

Fig. 1f

eine perspektivische Ansicht der Haltestruktur gemäß der Fig. 1a von unten in einer stark vergrößerten Ansicht;

Fig. 2a

die gestapelte Anordnung zweier Haltestrukturen gemäß der einer zweiten Ausführungsform in einer perspektivischen Seitenansicht;

Fig. 2b

die gestapelte Anordnung zweier Haltestrukturen gemäß der Fig. 2a in einer perspektivischen Ansicht von unten;

Fig. 2c

die gestapelte Anordnung zweier Haltestrukturen gemäß der Fig. 2a in einem perspektivischen Teilschnitt und von oben her betrachtet;

Fig. 2d

die gestapelte Anordnung zweier Haltestrukturen gemäß der Fig. 2a in einem perspektivischen Teilschnitt und von unten her betrachtet;

Fig. 3a

eine erfindungsgemäße Haltestruktur gemäß einer dritten Ausführungsform in einer Draufsicht;

Fig. 3b

die Haltestruktur gemäß der Fig. 3a in einer perspektivischen Ansicht von unten;

Fig. 3c

die Haltestruktur gemäß der Fig. 3a in einer perspektivischen Ansicht von oben;

Fig. 3d

die Haltestruktur gemäß der Fig. 3a in einer weiteren perspektivischen Ansicht von unten;

Fig. 3e

die Haltestruktur gemäß der Fig. 3a in einer weiteren perspektivischen Ansicht von oben unter einem anderen Blickwinkel;

Fig. 3f

die Haltestruktur gemäß der Fig. 3a in einem perspektivischen Teilschnitt;

Fig. 3g

die Haltestruktur gemäß der Fig. 3a in einer stark vergrößerten Teilansicht von unten;

Fig. 4a

in einer schematischen Draufsicht die Abstützung des Rands eines Vials an zwei Führungsrippen bei einer Haltestruktur gemäß der vorliegenden Erfindung;

Fig. 4b

die Aufnahme einer Karpule in einer Aufnahme einer Haltestruktur gemäß der vorliegenden Erfindung; und

Fig. 4c

die Aufnahme eines Vials in einer Aufnahme einer Haltestruktur gemäß der vorliegenden Erfindung.

In the following, the invention will be described by way of example and with reference to the accompanying drawings, from which further features, advantages and objects to be achieved will emerge. Show it:

Fig. 1a

a non-inventive holding structure according to a first embodiment in a plan view;

Fig. 1b

the holding structure according to the Fig. 1a in a view from below;

1c

the holding structure according to the Fig. 1a seen in a perspective top view from a first side;

Fig. 1d

the holding structure according to the Fig. 1a viewed from a second side in a top perspective view;

Fig. 1e

the holding structure according to the Fig. 1a in a perspective partial section;

1f

a perspective view of the support structure according to FIG Fig. 1a from below in a greatly enlarged view;

Figure 2a

the stacked arrangement of two holding structures according to a second embodiment in a perspective side view;

Figure 2b

the stacked arrangement of two support structures according to Figure 2a in a perspective view from below;

Figure 2c

the stacked arrangement of two support structures according to Figure 2a in a perspective partial section and viewed from above;

Fig. 2d

the stacked arrangement of two support structures according to Figure 2a in a perspective partial section and viewed from below;

Figure 3a

a holding structure according to the invention according to a third embodiment in a plan view;

Figure 3b

the holding structure according to the Figure 3a in a perspective view from below;

3c

the holding structure according to the Figure 3a in a perspective view from above;

3d

the holding structure according to the Figure 3a in another perspective view from below;

Figure 3e

the holding structure according to the Figure 3a in a further perspective view from above from a different angle;

Fig. 3f

the holding structure according to the Figure 3a in a perspective partial section;

3g

the holding structure according to the Figure 3a in a greatly enlarged partial view from below;

Figure 4a

in a schematic top view, the support of the edge of a vial on two guide ribs in a holding structure according to the present invention;

Figure 4b

receiving a carpule in a receptacle of a support structure according to the present invention; and

Figure 4c

receiving a vial in a receptacle of a holding structure according to the present invention.

In the figures, identical reference symbols designate elements or groups of elements that are identical or have essentially the same effect.

DETAILED DESCRIPTION OF EMBODIMENTS

the Figures 1a to 1d show a holding structure 1 not according to the invention according to a first embodiment in different views. The holding structure 1 has a plurality of receptacles 5 which are arranged in a regular arrangement (array) and are used to hold pharmaceutical containers therein, in particular vials or carpules. The recordings 5 have a hexagonal basic shape, as in the non-inventive embodiment according to the Figures 1a to 1f shown, or an octagonal basic shape, as in the inventive embodiment according to the Figures 3a to 3g shown..

According to the basic shape of the receptacles 5, these are arranged directly adjacent to one another in a regular arrangement. So is in the Fig. 1a a non-inventive hexagonal honeycomb arrangement of the recordings 5 recognizable in which Figure 3a an octagonal arrangement according to the invention. In principle, however, the receptacles 5 can be arranged, for example, in rows and columns running perpendicular thereto.

The opening width of the identically designed receptacles 5 is matched to a maximum external diameter or a maximum external dimension of the containers to be accommodated in such a way that they are accommodated therein with only a comparatively small amount of play. In this case, it is preferred if the containers are held in the receptacles 5 over by far the largest part of their axial length, in order to prevent the containers from tilting or wobbling in the receptacles in an undesired manner. The play of the containers in the receptacles 5 is expediently adjusted via guide ribs, as explained in more detail below.

The receptacles 5 are formed by side walls 10, which are formed circumferentially, which should not rule out the possibility that, for example, to reduce weight or save material, openings or recesses are formed in sections in the side walls 10. The side walls 10 preferably protrude at right angles from the plate-shaped upper side 2 of the holding structure 1 . In order to facilitate removal of the holding structure 1 from a tool used for injection molding, the side walls can in principle also be inclined radially inwards at a comparatively small angle of, for example, a maximum of 1° or a maximum of 2° to a vertical on the upper side 2 .

Like in the Fig. 1a shown, due to the polygonal basic shape of the receptacles 5, a common partition wall is formed between two directly adjacent receptacles 5, which at the same time serves as a side wall 10 of the two receptacles 5 that are adjacent to one another. This means that the side walls 10 are formed in one piece and from a solid material, that is to say with a rectangular cross section. This is expressly not intended to rule out the possibility of slots or recesses being provided at the lower or upper ends of the side walls 10 after all. In any case, the side walls used as a common partition wall are at least 80% of their height (H; cf. Fig. 1e or 3d ) formed from a solid material.

In order to facilitate the handling of the holding structure 1, its upper side is designed as a plate-shaped carrier 2, which expediently has rounded corners. Access openings 9 in the upper side 2, which are provided offset to one another on two opposite sides of the holding structure 1, are used to grip the holding structure 1. Furthermore, openings 25 are formed as through holes in several positions in the plate-shaped carrier 2, which can serve in particular as positioning holes in order to enable the holding structure 1 to be positioned precisely on a holding structure receptacle with corresponding positioning pins or projections, which is particularly useful, for example when inserting (nesting), filling, closing or removing (denesting) the containers accommodated in the holding structure. On the underside of the support 2, these openings 25 can be enclosed by frustoconical projections 26, as in FIG Fig. 1b shown, which can also serve as spacers to adjust the spacing between support structures when they are stacked one on top of the other, as described below with reference to FIGS Figures 2a to 2d described in more detail.

As in the Figures 1c to 1e shown, the upper ends of the side walls 10, which face the top 2 of the support structure 1, can have an arcuately concave course, with a turning point in the middle between respective corner regions 12 of the receptacles 5 and with apexes at the connecting regions 11 of several side walls 10. In any case, it is preferred if the upper ends of the side walls 10 do not protrude beyond the top 2 of the holding structure 1, which allows the holding structures to be stacked, as will be explained below with reference to FIG Figures 2a to 2d described in more detail.

Like in the Fig. 1b shown, in the hexagonal arrangement of the receptacles 5 shown, which is not according to the invention, three side walls 10 in each case converge in star-shaped connecting regions 11 . All connection areas 11 are directly connected to one another via the associated side walls 10 . There are no double-walled structures on the underside of the holding structure 1, so that the holding structure 1 has an advantageously high inherent rigidity even with a small wall thickness of the side walls 10 and the upper side 2. This inherent rigidity is increased by the fact that according to the Fig. 1b the edge 3 of the support structure 1 facing outer side walls 10 of Receptacles 5 are connected directly to one another, forming a peripheral, zigzag-shaped edge web on the underside of the support structure 1. To further increase the rigidity of the support structure 1, the edge 3 is angled at right angles from the top side 2 (cf. 1c ). To further increase the rigidity of the holding structure 1 , the aforementioned peripheral, zigzag-shaped edge web on the underside of the holding structure 1 is connected to the angled edge 3 at several positions via connecting webs 28 .

At the lower ends of the receptacles 5 , retaining projections 22 acting as retaining sections are provided, which extend radially inward into the receptacles 5 . Each receptacle 5 expediently has two holding projections 22 which are diametrically opposed to one another. The retaining projections 22 limit the axial mobility of the receptacles accommodated in the receptacles 5 by means of a form fit and hold the receptacles in the receptacles 5, as will be explained below with reference to FIG Figures 4b and 4c described in more detail. In principle, a single holding projection 22 is also sufficient for this purpose, which can also be configured circumferentially or essentially circumferentially.

The receptacles 5 are axially delimited at their lower ends by circumferential end rings 14 which are connected to the lower ends of the side walls 10 . The aforementioned holding projections 22 are preferably formed on these end rings 14 . How to 1f can be seen, the lower ends of the side walls 10 together form a hexagonal pattern with openings (the openings 15). The lower ends of the side walls 10 preferably jointly span a plane that extends parallel to the plate-shaped upper side 2 of the holding structure 1 . The end rings 14 project downwards from this level. The end rings 14 form a continuous transition between the polygonal (here hexagonal) basic shape of the receptacles 5 and a circular ring that encloses the openings 15 at the lower ends of the receptacles 5 . This offers advantages in the design of tool halves for injection molding of the holding structure 1.

How to 1f can be seen, the side walls 10 are connected to one another in the corner regions 12 over the entire axial length of the receptacles 5 . The point-symmetrical (here star-shaped) connection areas 11 ensure an even flow of forces. Overall, these measures increase the inherent rigidity of the support structure 1.

Guide ribs 18 are provided on all side walls 10 of the receptacles 5 and protrude radially inwards into the receptacles 5 so that the side walls of the containers rest directly against the guide ribs 18 and are guided by them when inserted into the receptacles 5 . The guide ribs 18 extend essentially over the entire length of the receptacles 5 in their longitudinal direction. The guide ribs 18 can begin a little spaced from the top 2 of the support structure 1 and each extend down to the lower end of the receptacles 5, more precisely to the transition area to the end rings 14. At the upper ends of the guide ribs 18 can Bevels 19 are formed, which are inclined relative to the guide ribs 18 at an acute angle. At the in the 1f illustrated embodiment, the guide ribs 18 are formed as flat insertion slopes. The upper ends of the chamfers 19 merge into the side walls 10 . In the longitudinal direction of the receptacles 5, the guide ribs 18 can be symmetrically wider from the upper end to the lower end.

Although it is shown for the first embodiment, which is not according to the invention, that the guide ribs 18 are arranged in the central area of the side walls 10, it is preferred according to the invention if the guide ribs 18 are arranged in the corner areas 12 of the receptacles 5, as is the case for the third and embodiment according to the invention Figures 3a to 3g is shown. The play of the containers in the receptacles 5 can be precisely adjusted via the overhang of the guide ribs from the associated side wall 10 or from the associated corner area 12 .

How to 1f can be seen, an outer diameter of the end rings 14 is smaller than a minimum opening width of the receptacles 5 at their upper ends. This makes it possible for holding structures of identical design to be stacked one on top of the other in a space-saving manner. Such a stacked arrangement of two identically designed holding structures 1a and 1b is described below with reference to FIG Figures 2a to 2d described in more detail.

In this stacked arrangement, the end rings 14 at the lower ends of the receptacles 5 of an upper retaining structure 1a dip slightly into the upper ends of the receptacles 5 of the lower retaining structure 1b arranged underneath, so that the upper retaining structure 1a is not laterally relative to the lower one due to the form fit formed in this way Holding structure 1b can slip. In the exemplary embodiment shown, the immersion depth or the distance between the holding structures 1a, 1b is adjusted by means of spacer elements 31, which lie on an assigned structure on the upper side of a lower holding structure 1b or engage in it. How to Figure 2a As can be seen, a plurality of rectangular slots or recesses 30 are formed on the upper sides 2 of the holding structures 1a, 1b and a plurality of correspondingly formed (rectangular) spacer elements 31 are provided on the undersides of the holding structures 1a, 1b, which engage in a form-fitting manner in the stacked arrangement.

The sectional views according to Figures 2c and 2d it can be seen that the lower ends of the side walls 10 are widened to form connecting webs 16 which fill up the entire space between the end rings 14 and jointly span a plane which extends parallel to the plate-shaped upper side 2 of the holding structure 1. The end rings 14 protrude from these connecting webs 16 . The Figures 2c and 2d it can be seen that in the stacked arrangement between the upper edge 13 of the side walls 10 and the connecting web 16, a sufficiently large game can remain, which facilitates stackability, since an undesirable canting of the upper ends 13 of the Side walls 10 of a lower support structure 1b is always prevented in the spaces between the end rings 14 of an upper support structure 1a. An upper holding structure 1a is therefore expediently always only in the area of spacer elements 31 (or the frustoconical projections 26 (cf. 1c )) on the top 2b of a lower support structure 1b.

the Figures 3a to 3g show in different views a holding structure according to the invention according to a third embodiment. In contrast to the first embodiment, the receptacles 5 are octagonal in this embodiment. Thus, two immediately adjacent receptacles 5 always share only a single side wall 10. A central connecting section 40 with a substantially rectangular basic shape is thus formed centrally between four receptacles 5 that are adjacent to one another and are arranged in a diamond-shaped arrangement. In principle, this central connecting section 40 can also be made in one piece from a solid material. However, it is preferred if this central connecting section 40 is designed as a cuboid cavity 43 which extends from the upper side 2 of the holding structure 1 over the entire length of the receptacles 5 and whose lower end is open. As a result, sufficient inherent rigidity of the holding structure 1 can nevertheless be achieved. How to figures 3a and 3b can be seen, an opening is formed at the upper end of the cavity 43 . When such a holding structure is produced by injection molding from a plastic, this cavity 43 is defined by a cuboid projection on one half of the mold. A projection at the upper end of this cuboid projection is used for a rigid connection to the opposite half of the mold, so that the holding structure 1 can be manufactured even more precisely. The opening 42 formed by this projection can later serve as a vent opening to allow a gas to flow between the bottom and the top of the support structure 1, for example a gas used to sterilize the support structure 1 and/or the containers held thereon such as ethylene oxide (ETO). How to 3g can be seen, the guide ribs 18 are always arranged in the corner regions 12 of the receptacles 5 in the third embodiment. The guide ribs 18 can protrude inwards into the receptacles 5 in a direction (x) toward the geometric center M of the respective receptacle 5, so that the guide ribs 18 are diametrically opposite one another. However, it is also conceivable for the guide ribs to protrude inwards into the receptacles 5 in a direction which deviates from this direction (x) at a small angle (for example in the range between 1° and 10°).

A holding structure not according to the invention according to the first and second exemplary embodiment with a hexagonal basic shape of the receptacles 5 can be used in particular for containers with a comparatively small nominal volume (e.g. up to a maximum of 15 ml), with a comparatively small diameter or for tall, relatively slim containers . A holding structure according to the invention according to the third embodiment with an octagonal basic shape of the recordings 5 can in particular for containers with a comparatively large nominal volume (e.g. greater than 15 ml), with a comparatively large diameter or for low, relatively wide containers.

In particular, the inherent rigidity of the holding structure 1 also enables the containers to be processed further while they are held in the receptacles 5 . It is conceivable, for example, that a holding structure 1 is placed on a holding frame along the edge of its underside and then closure elements, for example closure plugs, are placed on the ends of the containers and these are displaced axially, preferably at the same time for all of the containers accommodated in the receptacles of the holding structure or for one or multiple rows of containers. The prevailing forces are compensated by the holding structure to a sufficient extent, so that there is only a slight deflection of the holding structure (for example of a maximum of 2.0 mm over the length of the holding structure), so that tilting of the closure elements can be avoided.

Conventionally, the axial course of the guide ribs 18 is optimized for better threading and inserting of the containers into the receptacles. Examples of this can be found in German utility model 20 2016 107 209 and in the undisclosed German

Patent application 10 2017 101 398.9 of the applicant or in the WO 2017/038878 A1 . However, the guide ribs 18 are not conventionally optimized with regard to their cross section. However, an unfavorable cross-section of the guide ribs, particularly if the container is slightly off-centre, can result in unwanted abrasion or visible damage such as scratch marks (so-called vial marks), which the customer will not accept.

• Fall a) die Vorderseite der Führungsrippen 18 ist abgeflacht, eben ausgebildet, Eckbereiche der Führungsrippen 18 sind abgerundet ausgebildet;
• Fall b) die Vorderseite der Führungsrippen 18 ist abgeflacht, eben ausgebildet, Eckbereiche der Führungsrippen 18 sind kantig, rechtwinklig ausgebildet;
• Fall c) die Vorderseite der Führungsrippen 18 ist konkav gewölbt ausgebildet (mit einem Krümmungsradius, der auf die Außenkontur des aufzunehmenden Behälters abgestimmt ist), Eckbereiche der Führungsrippen 18 sind abgerundet ausgebildet.

In principle, the following geometries are conceivable for the front side of the guide ribs 18 (facing the container):

• Case a) the front side of the guide ribs 18 is flattened, flat, corner areas of the guide ribs 18 are rounded;
• Case b) the front side of the guide ribs 18 is flattened and flat, corner areas of the guide ribs 18 are angular and rectangular;
• Case c) the front side of the guide ribs 18 is concave (with a radius of curvature that is matched to the outer contour of the container to be accommodated), corner areas of the guide ribs 18 are rounded.

Extensive investigations by the inventors have shown that if the containers are perfectly centered in the receptacles 5, the geometry according to case a) enables a good contact and guide surface for the containers, that good results can also be achieved with the geometry according to case b), that, however, with the geometry according to case c), an optimal contact and guiding surface for the containers is made possible.

Surprisingly, however, if the containers are not perfectly aligned when they are inserted into the receptacles, the result is completely different. For example, when inserting the containers into the receptacles if the containers are not perfectly aligned, the geometry according to case a) enables an optimal contact and guide surface for the containers, and good results are also achieved with the geometry according to case b). that, however, with the geometry according to case c), only an insufficient contact and guide surface results for the containers, which in particular leads to undesirable abrasion or optically visible damage, such as scratch marks (so-called vial marks).

Since imperfect alignment of the containers when inserting the containers into the receptacles is the more common case, a compromise for the geometry of the guide ribs 18 is preferred according to the invention, namely that at least at the lower ends of the guide ribs 18 (or over the entire length of the guide ribs 18 ) In each case a flattened section 18a is provided, the corner areas 18b of which are rounded, as in FIG Figure 4a shown.

the Figure 4b shows the recording of a carpule 50, which can be inserted vertically from above into the recording 5 of a holding structure. Carpules 50 are hollow-cylindrical, with a cylindrical side wall 52 which, via a shoulder section 54 extending at an angle thereto, merges into a narrowed neck section 55 with a smaller outer diameter than the cylindrical side wall 52, at the front end of which a widened edge 56 with an ejection opening 58 is formed is. This can be closed by a plug (not shown). The stopper can be secured by means of a metal cover crimped onto the front end of the carpule 50 (so-called pre-crimped cartridge). The carpule 50 is designed to be open at its rear end, with a filling opening 57 through which a liquid substance can be filled.

When a carpule 50 is inserted vertically from above into the receptacle 5, the shoulder section 54 is finally supported directly on the holding projections 22. In this state, in any case, the front end of the cylindrical side wall 52 lies directly against the lower end of the side wall 10 and is thus centered and supported in the receptacle 5 . In this condition, the front end of the carpule, including the narrowed neck portion 55 and the widened upper edge 56, extends through the opening between the retaining projections 22, optionally including a metal cover (not shown) crimped thereon. The metal lid does not come into contact with the retaining projections 22, so that no forces are exerted on it and the stopper can securely close the filling opening 57 of the carpule 50, even if large axial forces act on the carpule 50, for example when inserting a stopper into the Filling opening 57, while the carpule 50 in the position according to the Figure 4b is added and supported upside down in the recordings 5. In this position, the rear ends of the carpules 50 protrude from the receptacles 5.

Correspondingly, the Figure 4c the inclusion of a vial 51, which is inserted from vertically above into the receptacle 5 of a holding structure. It is shown that the vial 51 was inserted upright. In principle, however, the vial 51 can also be introduced upside down, in the manner of the carpule, as in FIG Figure 4b shown. In the fully inserted state, the bottom 53 of the vial 51 is supported on the holding projections 22 and the vial 51 is thus held in the receptacle 5 in an axially secured manner.

A holding structure 1, as described above, can be used to store and transport pharmaceutical containers, such as vials or carpules. For handling, the holding structure 1 can be gripped and guided by means of the access openings 9 by grippers or the like. The pharmaceutical containers can be further processed or treated while supported by the support structure 1 as described above. For sterile transport, such a holding structure can be stored as a so-called nest in a trough-shaped transport or packaging container (so-called. Tub), for example in the way in which EP 2 868 593 A1 is disclosed to the applicant, the content of which is hereby included by way of reference for disclosure purposes. The transport or packaging container can be closed or sealed using a gas-permeable plastic film, in particular using a plastic film which is formed from a gas-permeable mesh of plastic fibers and is in particular a ^Tyveck® film.

For sterile transport, such a transport or packaging container, optionally together with other transport or packaging containers of the same type, can be accommodated in at least one sterile outer packaging bag and packaged in a sterile manner with respect to the environment. The at least one sterile outer packaging bag can have a gas-permeable section or even be formed entirely by this section, which is formed in particular by a mesh made of plastic fibers, such as polypropylene fibers (PP).

As explained above, the design of the holding structure is optimized in particular with regard to the achievable packing density. In the solution according to the invention, the respectively adjacent walls of the receptacles are combined to form a wall that is shared by two adjacent receptacles. Thin-walled, easily broken and difficult to cool rib-like contours in the tool design can thus be avoided according to the invention, which results in a longer service life of the tool. Furthermore, the cycle time of the manufacturing process can be significantly shortened and unit costs reduced.

The conventionally round geometry of the receptacles can be converted into a hexagonal structure for relatively small container volumes (e.g. up to 15 ml) and is converted according to the invention into an octagonal structure for even larger container volumes (e.g. greater than 15 ml), in which a 45th ° and 90° arrangement of the recordings is possible. Very high packing densities can be achieved in this way. At the same time, the design of the tool for production by injection molding from a plastic is significantly simplified.

It is very easy to cool the tools and the material, and the cores of the tools can be produced easily and in a standardized manner.

Furthermore, the design of the holding structure is also optimized with regard to rigidity and lightweight construction. The honeycomb design in particular offers considerable advantages in terms of deflection requirements (a deflection of max. 2 mm in relation to the entire surface of the holding surface and measured in an empty state could be achieved without any problems).

The angular design of the receptacles in combination with the guide ribs also enables good accessibility for steam sterilization (e.g. using ETO in an autoclave).

A horizontal (flat) mold separation also has a very favorable effect on the separating forces when demolding the holding structure and thus on the risk of the formation of disruptive burrs and thus potential particles due to mold wear. In addition, the tool separation no longer takes place in the immediate area of the holding structure itself.

Due to the optimized position of the tool parting line, a holding structure according to the present invention has proven to be fully suitable for use in clean rooms, because the risk of particles forming when the holding structure is demoulded and also during later use (particularly due to the optimized geometry of the guide ribs 18) is significant can be reduced.

A holding structure within the meaning of the present invention can be formed in one piece from a plastic, in particular by injection molding. In principle, production by 3D printing from a plastic is also conceivable. Thus, a further aspect of the present invention, which can also be explicitly claimed as an independent invention by means of an independent patent claim, relates to a computer or processor-readable file, also for transmission over networks, such as a company-internal computer network or over the Internet, comprising instructions or Control commands which, when loaded by a computer or a processor, cause a 3D printer, under the control of the computer or processor, to produce a support structure, as disclosed in the present application, made of a suitable material, in particular a plastic material, in printed out in three-dimensional form.

Reference List

1

holding structure

1a

upper support structure

1b

lower support structure

2

Top / plate-shaped support

2a

Top of upper support structure 1a

2 B

Top of upper support structure 1b

3

angled edge

4

rounded corner area

5

Recording (polygonal design)

7

rounded edge area

10

Side wall

11

Connection area of several side walls 10

12

Corner area of shot 5

13

top edge of side wall 10

14

closing ring

15

opening

16

connecting bar

18

guide rib

18a

flattened front end of guide rib 18

18b

rounded corner area of guide rib 18

19

Introductory bevel of guide rib 18

22

retaining projection

25

opening

26

frustoconical projection

28

connecting bar

30

slot

31

spacer element

40

central connection section

41

upper edge of central connecting section

42

opening

43

cavity

50

carpule / container

51

vial / container

52

Side wall

53

floor

54

shoulder section

55

narrowed neck section

56

upper edge

57

filling hole

58

ejection port

H

Height of side wall 10

M

geometric center of shot 5

x

Extension direction of guide rib 18

Claims (15)

1. A holding structure (1) for simultaneously holding a plurality of containers (50, 51) for substances for pharmaceutical, medical or cosmetic applications, comprising a plurality of receptacles (5) for receiving the containers (50, 51),

   whereby the receptacles (5)

   a. are arranged in a regular array, and

   b. of respective circumferentially formed side walls (10),

   wherein an upper side of the holding structure (1) is formed as a plate-shaped support (2), wherein the side walls (10) and receptacles (5) project vertically from the plate-shaped support (2),

   wherein a side wall (10) is formed as a common partition between each two directly adjacent receptacles (5) of the plurality of receptacles,

   characterized in that the receptacles (5) are each octagonal when viewed from above, and

   each of four adjacent receptacles (5) arranged in a diamond-shaped arrangement enclose a central connecting portion (40) whose thickness is greater than the thickness of the common partition walls.
2. The holding structure (1) according to claim 1, wherein the central connecting portions (40) each enclose a cavity (43) extending in the longitudinal direction of the adjacent receptacles (5).
3. The holding structure (1) according to claim 2, wherein the cavity (43) has a circular or rectangular cross-section.
4. The holding structure (1) according to one of the preceding claims, wherein a plurality of openings (25), in particular circular openings, are formed in the upper side of the plate-shaped carrier (2) for positioning the retaining structure (1) by means of correspondingly formed positioning projections on an associated retaining structure receptacle,
   wherein the openings are preferably formed as circular openings (25) and frustoconical projections (26) are formed on the underside of the plate-shaped carrier (2), which enclose the openings (25).
5. A method of manufacturing the holding structure (1) according to any one of claims 2 to 4 by injection moulding from a plastics material,
   wherein the cavity (43) is defined by a cylindrical or parallelepipedal protrusion on a first half of a mould, each of which extends in an opposite direction to mould mandrels on a second half of the mould, which mandrels define the shape of the receptacles (5).
6. The method of claim 5, wherein a projection at an upper end of the cylindrical or parallelepipedal projection of the first half of the mould serves a rigid connection to the second half of the mould.
7. A transport structure consisting of a combination of the holding structure (1) according to any one of claims 1 to 4 and a plurality of containers (50, 51) held thereon for substances for pharmaceutical, medical or cosmetic applications, wherein the containers are received in the receptacles (5) at least in sections.
8. The transport structure according to claim 7, wherein the containers (50, 51) are received in the receptacles (5) and held axially secured to the holding structure (1).
9. A transport or packaging container for a plurality of containers (50, 51) for substances for pharmaceutical, medical or cosmetic applications, wherein the transport or packaging container is box-shaped,
   wherein the holding structure (1) according to any one of claims 1 to 4 is received in the box-shaped transport or packaging container together with the containers (50, 51) held thereon to hold the plurality of containers (50, 51) in the transport or packaging container.
10. The transport or packaging container according to claim 9, which is closed or sealed by means of a gas-permeable plastic film to enable sterilisation of the containers (50, 51) by inflow of a gas through the gas-permeable plastic film.
11. The transport or packaging container according to claim 10, wherein the gas-permeable plastic film is formed from a gas-permeable mesh of plastic fibres.
12. A sterile packaging structure for sterile transport and storage, the sterile packaging structure comprising at least one transport structure according to claim 7 or 8, or at least one transport or packaging container according to any one of claims 9 to 11, and having the containers (50, 51) received therein,
    wherein the at least one transport structure or the at least one transport or packaging container is received in at least one sterile outer packaging bag and is sterilely packaged against the environment.
13. The sterile packaging structure of claim 12, wherein the at least one sterile outer packaging bag comprises a gas permeable portion.
14. The sterile packaging structure of claim 13, wherein the at least one gas permeable portion is formed by a braid of plastic fibres.
15. The sterile packaging structure of claim 14, wherein the plastic fibres are polypropylene fibres.

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