Assembly of packaged containers and method for packaging containers

Abstract

Assembly of packaged containers and method for packaging containers. The invention relates to an assembly (1) of packaged containers (2), comprising a package (3) and containers housed within the package, each container having a base (21) from which a side wall (22) of the container (2) extends along a principal extension direction (A-A') of the container (2), the package comprising a rigid frame (31) with an internal side wall delimiting a housing (312) and extending along an elevation direction (B-B'), the containers being arranged in the housing with their principal extension directions oriented parallel to each other and to the elevation direction of the internal side wall of the frame, and a flexible cover (32) covering the frame and the containers to immobilize the latter relative to the frame, in direct contact with the base of the containers. Assembly of packaged containers. Figure for the abstract: Fig. 1.

Description

Title of the invention: Set of packaged containers and method for packaging containers

[0001] The present invention relates to the general technical field of packaged container assemblies and to the general technical field of container packaging processes for manufacturing such packaged container assemblies, in particular sterile containers intended to contain a substance for pharmaceutical, medical or cosmetic use.

[0002] The invention relates more specifically to a set of packaged containers, comprising a package and a plurality of containers housed inside the package, said containers being preferably sterile, and for example intended to contain a substance for pharmaceutical, medical or cosmetic use, said containers each having a lower end forming a bottom, from which a side wall of the container extends along a main extension direction of the container towards an opposite upper end of the container defining an access opening to an internal cavity of said container.The invention also relates to a method of packaging containers, for example intended to contain a substance for pharmaceutical, medical or cosmetic use, said containers each having a lower end forming a base, from which a side wall of the container extends along a principal extension direction of the container towards an opposite upper end of the container defining an access opening to an internal cavity of said container.

[0003] To meet the growing demand from the pharmaceutical industry for so-called ready-to-use (RTU) or ready-to-fill (RTF) vials—that is, empty vials that have already been washed, possibly depyrogenated, and sterilized—vial manufacturers and suppliers have developed packaging systems in recent years to condition and make such ready-to-fill vials available to the pharmaceutical industry under the best possible conditions, particularly ready-to-fill glass vials. Specifically, the packaging used ensures protection of the vials from the external environment and maintains them in a sterile state during transport and storage, until they are used on a filling line.The ready-to-fill vials can thus be directly introduced into an aseptic environment for filling. Since the vials constitute primary packaging for the substance they are intended to contain, the packaging systems implemented for conditioning and... The provision of these bottles is sometimes referred to as "secondary packaging".

[0004] In this respect, two main packaging systems (or "secondary packaging") are known for making available to pharmaceutical actors ready-to-fill glass vials, for the purpose of filling them with pharmaceutical substance, which are defined by the ISO 21882:2019 standard entitled "Prefillable glass vials in sterile packaging".

[0005] A first known packaging system, called a "nest and tub" system, comprises a plastic plate ("nest") having a defined pattern of compartments or cavities for receiving bottles and a plastic container ("tub") designed to hold the plastic plate and the bottles placed in the compartments therein. The container forms a rigid plastic tub having four lateral walls extending from a base to an opening providing access to a free space defined by the lateral walls, and has a first rim forming a support for receiving and holding in position the plastic plate and the bottles placed in the compartments therein within the free space of the container.The container has a second rim near its opening, to which a gas-permeable film is attached to seal the container holding the plate and vials, thus maintaining their sterility. This initial packaging system also generally includes a flexible protective sleeve to cover the sealed container after sterilization.

[0006] A second known packaging system, called a "tray" system, comprises a plastic container ("tray") that forms a rigid tray (or container) having four lateral walls extending from a base to an opening providing access to a free space defined by the lateral walls. Near its opening, the tray has a rim to which a gas-permeable film is attached to seal the container in which the vials are placed, thus maintaining their sterility. The vials are arranged in the free space of the container directly against the base, with the necks of the vials oriented either downwards (towards the base of the container) or upwards (towards the opening of the container).The vials may be in contact with each other, or the container may include plastic structures that protrude from the bottom, allowing for physical separation of the vials. This second packaging system also generally includes a protective flexible sleeve to cover the sealed container after sterilization.

[0007] A third packaging system, derived from the "tray" system above, has also been known more recently. It comprises a rigid box which includes a lower part forming a rigid tray made of corrugated plastic having four walls. The system consists of lateral walls extending from a base to a top opening providing access to a free space defined by the side walls, and an upper section made of corrugated plastic that complements the lower section and overlaps it. One of the side walls of the lower section is removable or hinged to create a lateral access opening to the free space, thus allowing lateral extraction of the vials after removal of the upper section. This third packaging system also typically includes a sterile flexible packaging sleeve in which the rigid box containing the vials is placed. A physical separation system for the plastic vials, separate from the rigid corrugated plastic tray, may be incorporated into the latter to ensure physical separation of the vials.

[0008] Although these known packaging systems generally offer satisfaction, they nevertheless present a number of disadvantages.

[0009] Firstly, these known packaging systems have disadvantages in terms of unloading (unpacking) the packaged vials, which requires the implementation of a number of operations which can prove to be complex, tedious, and potentially a source of risk of contamination and / or damage to the vials if special precautions are not taken in this regard.

[0010] Indeed, in the case of a "nest-and-tub" system, unloading the vials for filling generally requires, after removing the flexible sleeve and then the protective film, grasping and completely extracting the tray ("nest") supporting the vials from the rigid container ("tub") by lifting said tray and the vials using specific and complex, generally automated, gripping means. Manually unpacking the vials one by one is possible, but proves particularly tedious and complex in an aseptic environment. In the case of a "tray" system, unloading the vials from the container requires manually grasping and extracting the vials from the container through its opening, if the vials are arranged in the free space of the container with their necks facing the opening.Particularly tedious, such manual unloading can lead to contamination of the vials by an operator. When the vials are arranged in the free space of the container with their necks facing the bottom, unloading them through the container's opening requires completely inverting the container and then lifting it. This inverting operation is generally complex and carries a risk of the vials being struck, potentially breaking them and / or generating problematic glass particles. Furthermore, this inverting operation can lead to... The introduction of foreign particles that may be present at the bottom of the container into the bottles. Furthermore, when removing the sealing film from the plastic container ("tub" or "tray") of these packaging systems, there is a significant risk of generating foreign particles that could contaminate the bottles and their future contents.

[0011] In the case of the third packaging system mentioned above, the vials are unloaded after the flexible sleeve and the top part of the box have been removed. Typically, the vials can then be extracted simultaneously from the bottom part of the box, through the aforementioned side opening previously formed by removing or folding down the aforementioned removable or hinged side wall, using a specific external tool forming a "U" shaped template inserted into the bottom part of the box between the side walls and the vials, through said top opening, and then moved laterally to draw and extract the vials from the bottom part of the box through said side opening.Besides the fact that a tool specifically adapted to the dimensions of the lower part of the box is therefore necessary to unload the vials, there is on the one hand a risk of damage and / or contamination of the vials when the external tool is introduced into the lower part of the box, and on the other hand, a risk of the vials falling or being struck, rendering them unusable, when the vials are extracted laterally, as they have to overcome a step several millimeters thick, corresponding to the thickness of the bottom of the lower part of the box.

[0012] Furthermore, these known packaging systems, which are single-use and therefore intended to be discarded after the bottles are unloaded, use a significant amount of plastic, which raises both economic and environmental concerns. Moreover, the "nest and tub" and "tray" (and derivative) packaging systems, as defined by ISO 21882:2019, require the implementation of a specific packaging format for each bottle size. Developing packaging specific to a given bottle size results in additional costs during the development and production phases of this packaging, as well as during the transport and unloading of the packaged bottles.

[0013] The objects assigned to the invention therefore aim to address the problems set out above and to propose in particular a new set of packaged containers, in particular empty and sterile containers, which allows a particularly simple and rapid unloading (unpacking) of the packaged containers, with a limited risk of damage to the containers.

[0014] Another object of the invention is to propose a new set of packaged containers allowing for a practical, efficient and safe provision of containers sterile in order to fill them with a substance for pharmaceutical, medical or cosmetic use.

[0015] Another object of the invention aims to propose a new set of packaged containers of particularly robust, simple and efficient design.

[0016] Another object of the invention aims to provide a new set of packaged containers whose manufacture is inexpensive.

[0017] Another object of the invention aims to propose a new set of packaged containers with a particularly limited environmental impact.

[0018] Other objects of the invention aim to propose a new method of packaging containers, in particular empty and sterile containers, which makes it possible to obtain a set of packaged containers meeting all or part of the aforementioned objects.

[0019] The objects assigned to the invention are reached using an assembly of packaged containers, comprising a package and a plurality of containers housed inside the package, said containers being preferably sterile, and for example intended to contain a substance for pharmaceutical, medical or cosmetic use, said containers each having a lower end forming a base, from which a side wall of the container extends along a principal extension direction of the container towards an opposite upper end of the container defining an access opening to an internal cavity of said container,said assembly of packaged containers being characterized in that said packaging comprises a rigid frame itself comprising an internal side wall which delimits a compartment and which extends in an upward direction from a first peripheral edge defining a first access opening to said compartment to a second opposite peripheral edge defining a second access opening to said compartment, said containers being arranged in said compartment with their principal directions of extension oriented parallel to each other and to the upward direction of the internal side wall of the frame, said packaging comprising a flexible sleeve which covers the frame and the containers to immobilize the latter relative to the frame, and which is in direct contact with the bottom of said containers.

[0020] The objects assigned to the invention are also achieved using a method for packaging containers, for example intended to contain a substance for pharmaceutical, medical or cosmetic use, said containers each having a lower end forming a base, from which a side wall of the container extends along a principal extension direction of the container towards an opposite upper end of the container defining an access opening to an internal cavity of said container, said method being characterized in that it comprises the following steps: - supply of a plurality of said containers; - supply of a frame comprising an internal side wall which delimits a dwelling and which extends in an elevation direction from a first peripheral edge defining a first access opening to said dwelling to a second opposite peripheral edge defining a second access opening to said dwelling; - arrangement of said containers in said housing with their principal directions of extension oriented parallel to each other and to the direction of extension of the internal side wall of the frame; and - manufacture of a flexible envelope which covers the frame and the containers to immobilize the latter in relation to the frame, and which is in direct contact with the bottom of said containers.

[0021] Other features and advantages of the invention will become apparent and will be described in more detail upon reading the following description, with reference to the accompanying drawings, which are given solely by way of illustrative and non-limiting examples, including:

[0022] [Fig-1] [Fig.1] illustrates, in schematic view, an example of a mode of rea production of a set of packaged containers according to the invention, which can be obtained using the packaging process according to the invention. While the frame and containers are illustrated in a side view, the flexible sleeve is illustrated in a sagittal side section. The different layers of the flexible sleeve are shown arranged apart from each other only for the purpose of facilitating the reading of [Fig. 1];

[0023] [Fig.2] [Fig.2] illustrates, in a schematic cross-sectional view, an example of container, more specifically forming a bottle, which a set of packaged containers according to the invention is likely to include;

[0024] [Fig.3] [Fig.3] illustrates, according to a schematic top view, an example of a frame which includes the set of packaged containers in [Fig. 1];

[0025] [Fig.4] [Fig.4] illustrates, according to a schematic side view, the frame of [Fig.3];

[0026] [Fig. 5] [Fig. 5] illustrates, according to a schematic lateral sagittal section view, the frame of figures 3 and 4;

[0027] [Fig.6] [Fig.6] illustrates, according to a schematic side view, the frame of figures 1 and 3 to 5, in the housing of which containers are arranged according to the example of [Fig.2];

[0028] [Fig.7] Fig.7 illustrates, in a schematic top view, the frame and the re containers of the [Fig.6];

[0029] [Fig.8] [Fig.8] illustrates, according to a schematic top view, another example of frame which may include a set of packaged containers according to the invention, in place of the frame in figures 1 to 7;

[0030] [Fig.9] [Fig.9] illustrates, according to a schematic top view, yet another example of a frame that a set of packaged containers conforming to the invention, in place of the frame in figures 1 to 7;

[0031] [Fig. 10] [Fig. 10] illustrates, according to a schematic lateral view in sagittal section, the frame of [Fig. 9];

[0032] [Fig. 11] [Fig. 11] illustrates, according to a schematic lateral view in sagittal section, a stack of five frames identical to that of [Fig.9];

[0033] [Fig. 12] [Fig. 12] illustrates, according to a schematic top view, yet another example of a frame which may comprise a set of packaged containers according to the invention, in place of the frame of figures 1 to 7;

[0034] [Fig. 13] [Fig. 13] illustrates, according to a schematic lateral view in sagittal section, the frame of [Fig. 12];

[0035] [Fig. 14] [Fig. 14] is a perspective photograph from above of an example embodiment of a set of packaged containers according to the invention, which is capable of being obtained using the packaging process according to the invention;

[0036] [Fig. 15] [Fig. 15] is a perspective photograph from below of the set of packaged containers of [Fig. 14].

[0037] The invention relates to an assembly 1 of packaged containers 2, or "unit assembly of packaged containers", comprising a package 3 and a plurality of containers 2 housed inside the package 3, i.e., contained within it. An example of an embodiment of such an assembly 1 of packaged containers 2 is illustrated schematically in [Fig. 1]. The containers 2 each have a lower end (first end) forming a bottom 21 (or a lower edge), from which a lateral wall 22 of the container 2 extends in a principal extension direction A-A' of the container 2 towards an opposite upper end (second end) of the container 2 defining an access opening 23 to an internal cavity 24 of the container 2. Advantageously, the bottom 21 allows the container 2, considered as such, to rest stably on a horizontal flat support by means of the bottom 21.Accordingly, the base 21 of each of the containers 2 is advantageously flat, that is to say, it extends substantially in a plane (but not strictly necessary, insofar as the base 21 may optionally have a slight concavity), the principal extension direction A-A' of the container 2 being advantageously orthogonal to the extension plane of the base 21 of the container 2. Preferably, the lateral wall 22 has a cylindrical shape, advantageously with a circular base. Preferably, the lateral wall 22 extends from the base 21 in an extension direction that is parallel to the principal extension direction A-A' of the container 2. Preferably, as illustrated in the figures and in particular in [Fig. 2], said containers 2 are more specifically flasks (or bottles). Accordingly, the lateral wall 22 of each container 2 therefore forms a body, the . A container 2 comprising a shoulder 25 (flat or curved) and a neck 26 extending from the body towards the upper end of the container 2, the neck 26 defining the opening 23 for accessing the internal cavity 24 of the container 2. Advantageously, the neck 26 is provided with a ring 27, which defines the upper end of the container 2, and which is preferably designed and configured to cooperate with a means for closing said opening 23 (not shown), such as a screw cap, a crimp cap, etc. However, the invention is not limited to bottle-type containers 2; the containers 2 may alternatively be jars, etc., depending on the intended application. Preferably, the containers 2 are substantially identical to one another. In particular, the containers 2 preferably have identical dimensions, and their respective internal cavities 24 define identical nominal capacities.

[0038] Said containers 2 are intended to contain, within their respective internal cavities 24, a substance which is, for example, a substance for pharmaceutical use (e.g., a parenterally administered medicinal product), a medical or cosmetic substance, a diagnostic substance, or a biological fluid. Advantageously intended to subsequently receive said substance, the containers 2 are advantageously empty, that is to say, their respective internal cavities 24 are empty. Furthermore, said containers 2 are advantageously open, their openings 23 being free and unobstructed. Said containers 2 are therefore advantageously intended to each form a primary container for said substance.

[0039] Advantageously, the containers 2 have a capacity (i.e., a nominal capacity) of between 1 mL and 500 mL. Preferably, the containers 2 are made of glass. The term "glass" should be taken here in its classical sense, and therefore refers to a mineral glass, and preferably a silica glass. It may thus be a soda-lime glass (or "soda-silico-calcium" glass, known as "Type II" or "Type III", as defined by the current European and American pharmacopoeias) or a borosilicate glass (known as "Type I"), depending on the intended application and, in particular, on the nature of the substance that the containers 2 are intended to contain. Even more preferably, the containers 2 are made of molded glass, so that they have an intrinsic mechanical strength that is better than if they were made of drawn glass. However, it is obviously still possible that containers 2 could be made of drawn glass (i.e., "tubular" glass containers).Alternatively, depending in particular on the nature of the substance they are intended to contain, containers 2 can be made of plastic (for example, high-density polyethylene (HDPE), polypropylene (PP), or glycolized polyethylene terephthalate (PETG)).

[0040] According to the invention, the packaging 3 of the set 1 of packaged containers 2 comprises a frame 31 (or "strap" or "bandage"), which is rigid. Said frame 31 therefore has in particular its own mechanical strength, and does not deform under its own weight, whether for example in compression, bending or torsion, and therefore retains its general shape, under normal use conditions of frame 31 and under normal storage, transport and handling conditions of packaging 3 of the set 1 of containers 2 (taking into account the nature / material of the latter, and the intended application for the latter).

[0041] Various examples of such a frame 31 are illustrated in the figures. For simplicity, identical references have been used in the figures to designate elements common to these different examples of frame 31, except in [Fig.

[11] where superscripts have been used for references to distinguish between three of the stacked frames 31, 31', 31”. As illustrated in the figures, the frame 31 itself comprises an internal side wall 31 IA which delimits a housing 312 (or “internal space”) in which the containers 2 are arranged, at least partially. The internal side wall 31 IA, which is therefore oriented with respect to the housing 312, extends in a general elevation direction B-B' from a first peripheral edge 313A which defines a first opening 314A for access to the housing 312 to a second opposite peripheral edge 313B, which defines a second opening 314B for access to the housing 312.The frame 31 thus forms, as such, a framing structure (containment structure) for the containers 2, which is devoid of a wall forming a bottom or a "roof" against which the containers 2 arranged in the housing 312 (and in particular the lower and / or upper ends of the containers 2) would be likely to come into contact. As illustrated in the examples in the figures, the first and second openings 314A, 314B of the frame 31, which provide access to the housing 312 of the latter, are advantageously arranged opposite each other and extend along first and second opening planes respectively, which first and second opening planes are parallel to each other, the (general) elevation direction B-B' being orthogonal to the first and second opening planes.

[0042] As illustrated in the figures, the frame 31 is typically annular, that is, it has a general annular shape, which is preferably polygonal (or even more preferably with rounded corners), as in the examples shown in the figures, but which could alternatively be oval or circular. Preferably, as in the examples shown in the figures, said internal side wall 31 IA is closed upon itself, so that it continuously delimits said housing 312 (closed frame 31). Advantageously, the frame 31 also includes an external side wall 31 IB, opposite the internal side wall 31 IA, and therefore oriented towards the outside of the frame 31. The frame 31 thus advantageously includes a side wall 315, preferably closed upon itself, which defines said internal side walls 31 IA and external side walls 31 IB. The side wall 315 of the frame 31 may be substantially solid, as in the examples illustrated in the figures. Alternatively, the side wall 315 of the frame 31 may be perforated, that is to say, it may have one or more through openings that lead from the internal side walls 31 IA and external side walls 31 IB, for example in order to reduce the weight of the frame 31.

[0043] According to one embodiment, the first and second openings 314A, 314B of the frame 31 have identical free sections. In this case, the inner side wall 31 IA can then typically extend from the first peripheral edge 313A to the opposite second peripheral edge 313B along a straight line parallel to the direction B-B' of elevation of the inner side wall 31 IA (Figures 1, 3 to 8). According to another embodiment, the first and second openings 314A, 314B of the frame 31 have different free sections. For example, the free section of the first opening 314A of the frame 31 is larger than the free section of the second opening 314B (Figures 9 to 13).

[0044] The housing 312 of the frame 21 may have a free section (i.e., a transverse section, considered in a plane orthogonal to the elevation direction B-B' of the internal side wall 31 IA) that is constant along the elevation direction B-B' of the internal side wall 31 IA (Figures 1, 3 to 8). In this case, as considered above, the first and second openings 314A, 314B of the frame 31 have identical free sections. Alternatively, the free section of the housing 312 of the frame 21 may not be constant along the B-B' elevation direction of the internal side wall 31 IA (figures 1, 3 to 8), because the first and second openings 314A, 314B of the frame 31 have different free sections from each other and / or because the internal side wall 31 IA of the frame 31 defines a narrowing zone of the free section of the housing 312.

[0045] Preferably, the frame 31 has an external rectangular shape, and in particular a square shape, whose (four) external angles are preferably rounded, chamfered, defined by a first maximum external dimension Del (or "maximum external length") and a second maximum external dimension De2 (or "maximum external width"), that is to say a rectangular shape of maximum external dimensions Del x De2 (the first and second external dimensions Del, De2 being considered in directions orthogonal to each other).Preferably, the housing 312 of the frame 31 has a rectangular shape, and in particular a square shape, whose (four) internal angles are preferably rounded, chamfered, and defined by a first minimum internal dimension Dil (or "minimum internal length") and a second minimum internal dimension Di2 (or "minimum internal width"), that is to say a rectangular shape of internal dimensions Dil x Di2 (the first and second internal dimensions Dil, Di2 being considered according to di. orthogonal relations to each other). Thus, as in the examples illustrated in the figures, the frame 31 can advantageously have four sides, the lateral wall 315 of the frame 31 advantageously comprising four portions of wall, defined by the said internal lateral walls 311A ​​and external lateral walls 311B, which extend globally parallel to each other in pairs and which thus delimit said housing 312.

[0046] As can be seen in [Fig. 1], the containers 2 are arranged in the housing 312 of the frame 31 with their principal extension directions A-A' oriented parallel to each other and to the elevation direction B of the internal side wall 31 IA of the frame 31. The frame 31, and in particular the internal side wall 31 IA of the latter, therefore surrounds the containers 2 laterally. Advantageously, the lower end (and therefore the bottom 21) of the containers 2 is arranged closer to the first peripheral edge 313A and therefore to the first opening 314A (or "lower opening") of the frame 31, than to the second peripheral edge 313B and therefore to the second opening 314B of the frame 31.In turn, the upper end (and therefore the opening 23) of the containers 2 is then advantageously arranged closer to the second peripheral edge 313B and therefore to the second opening 314B (or "upper opening") of the frame 31, than to the first peripheral edge 313A and therefore to the first opening 314A of the frame 31.

[0047] According to the invention, the packaging 3 comprises a flexible sleeve 32 that covers, i.e., envelops, the frame 31 and the containers 2 to immobilize the latter relative to the frame 31 and is in direct contact with the bottom 21 of the containers 2. The flexible sleeve 32 therefore preferably completely covers the frame 31 and the containers 2 and holds the containers 2 substantially immobile in position within the recess 312 of the frame 31. Advantageously, the flexible sleeve 32 is closed. Typically, the flexible sleeve 32 is formed from at least one flexible film, for example, a synthetic material. As will be detailed later, the flexible envelope 32 can be multilayered, and for example formed of a plurality of layers 321, 322, 323, 324 of flexible envelope, preferably distinct and separable from each other, which are arranged overlapping each other.The flexible envelope 32 therefore defines an enclosure in which the frame 31 and the containers 2 arranged in the housing 312 of the latter are housed, and which has an inner face 32A which is advantageously pressed on one side against the frame 31, and on the other side against the containers 2 on either side of said first and second openings 314A, 314B of access to the housing 312, in direct contact with the bottom 21 of the containers 2, so that said containers 2 are thus immobilized in the packaging 3.

[0048] The packaging 3 is therefore specifically devoid of a frame base 31 or a separate tray from said frame 31, which would be interposed between the base 21 of the containers 2 and the flexible sleeve 32, a portion (or "lower portion") of the flexible sleeve 32 which is arranged opposite the bases 21 of the containers 2 thus forming a support against which the bottoms 21 of the containers 2 are in direct contact with. Another portion (or "upper portion") of the flexible casing 32, which is arranged opposite the openings 23 of the containers 2, advantageously exerts, directly or indirectly, a force against the upper ends of the containers 2, so that the latter are held immobile in position relative to the frame 31 that surrounds them laterally. For example, the immobilization of the containers 2 by the flexible casing 32 can be ensured by the fact that the enclosure formed by the flexible casing 32 is placed under vacuum, as will be seen below (i.e., at an internal pressure that is strictly lower than the external atmospheric pressure outside the flexible casing 32), or by the fact that the flexible casing 32 is formed of at least one flexible heat-shrinkable plastic film that has been arranged and then heat-shrinked around the frame 31 and the containers 2.Thus, the set 1 of packaged containers 2 forms a compact and substantially rigid article, that is to say, exhibiting its own mechanical strength, and which therefore does not substantially deform under the weight of the containers 2.

[0049] The assembly 1 of packaged containers 2 according to the invention is thus of a particularly simple and efficient design. The combination of the frame 31 and the flexible casing 32 ensures easy handling of the assembly 1 of packaged containers 2, with a limited risk of breakage or damage to the containers 2 contained in the packaging, in particular by friction or impact against each other.

[0050] The assembly 1 of packaged containers 2 according to the invention allows for a particularly simple and rapid unloading (unpacking) of the packaged containers 2. Indeed, the unloading of the containers 2 can then be carried out, after placing the assembly 1 of packaged containers 2 on a substantially horizontal flat surface (for example, an unloading table) with the bottoms 21 of the containers 2 oriented towards said flat surface, - by cutting the flexible casing 32, preferably following a cutting direction that laterally follows at least a portion of the external side wall 31 IA of the frame 31 (and advantageously at the level of a portion of said external side wall 31 IA from which a first portion 318A of a gripping member protrudes, as envisaged later), thus creating in the flexible casing 32 an opening of sufficient size to allow the frame 31 to pass through said opening, - then by grasping the frame 31 and extracting the latter from the cut flexible envelope 32, through said opening, by a relative sliding translation of the frame 31 and the cut flexible envelope 32 (typically by keeping the frame 31 immobile relative to the support and pulling on the cut flexible envelope 32), - then by extracting the containers 2 from the housing 312 of the frame 31, either through the first opening 314A of the frame 31 by lifting the frame 31 and moving it away from the containers 2 in an upward movement advantageously parallel to the direction A-A' of the containers 2, or through the second opening 314B of the frame 31 by raising the containers 2 relative to the frame 31 by means of a plate arranged under the bottoms 21 of the containers 2, of dimensions less than the respective dimensions of the housing 312 of the frame 31, and pushed into said housing 312 through the first access opening 314A to the latter in an upward movement advantageously parallel to the direction A-A' of main extension of the containers 2.

[0051] Thus, all the containers 2 can be extracted from the packaging 3 using the frame 31, without direct contact with the containers 2, and in particular without manual contact with them when they are unloaded manually by an operator. The frame 31 advantageously serves a dual purpose as both a packaging element and a tool for unloading the containers 2, so that it is not necessary to use a complex external tool to unload the containers 2. It should be noted here that the rigidity of the frame 31, in addition to contributing to reliable and effective immobilization of the containers 2 in the packaging 3 and protecting the containers 2 against lateral impacts, also facilitates the extraction of the containers 2 from the cut flexible sleeve 32, since the frame 31 does not deform significantly when grasped and extracted from the cut flexible sleeve 32.Furthermore, in the absence of a base or packaging tray between the base 21 of the containers 2 and the flexible sleeve 32, only the thickness of the latter (or at least one of the layers of the flexible sleeve 32) is likely to form a "step" that the containers 2 must overcome when being removed from the flexible sleeve 32. This step can therefore be of particularly low height, if not negligible compared to the dimensions of the containers 2, so that the risk of damage to the containers 2 from impacts with each other and / or with the underlying flat surface is particularly low. Moreover, as explained later, the design of the packaged assembly 1 of containers 2 advantageously allows for a significant reduction in the mass of packaging material, particularly in relation to the respective mass of the containers 2 involved, compared to known packaging systems.This has a favorable impact both in terms of the cost of manufacturing and transporting the set 1 of packaged containers 2, and in terms of the environment in terms of managing the waste generated during the unloading of containers 2.

[0052] Advantageously, the frame 31 has fixed, predefined dimensions, and is therefore non-modifiable and non-adjustable. In particular, the housing 312 of the frame 31 therefore has fixed, predefined dimensions, and is therefore non-modifiable and non-adjustable. As such, the The frame 31 advantageously forms a monolithic, single-piece unit. This helps to simplify the design and manufacture of the frame 31, and therefore to limit the design and manufacture costs of the packaging 3 and thus of the set 1 of packaged containers 2.

[0053] Advantageously, the first and second maximum external dimensions Del, De2 are each chosen to be between 150 mm and 450 mm, preferably between 150 mm and 360 mm, and even more preferably between 150 mm and 220 mm, in order in particular to limit the overall size of the frame 31, and therefore of the assembly 1 of packaged containers 2, and to facilitate its handling, transport and / or storage. Such external dimensions of the frame 31 also contribute advantageously to the robustness of the assembly 1 of packaged containers 2.Advantageously, the aforementioned first and second minimum internal dimensions Dil, Di2 are each chosen to be between 120 mm and 420 mm, which notably allows for optimizing the number of containers 2 contained in said assembly 1 (based on a nominal value for the external diameter of the container bodies 2 and minimum and maximum dimensional tolerances), and thus giving said assembly 1 a particularly economical aspect, while still maintaining a limited footprint. Even more advantageously, the first and second maximum external dimensions Del, De2 are each chosen to be between 150 mm and 450 mm, preferably between 150 mm and 360 mm, and preferably between 150 mm and 220 mm, and the first and second minimum internal dimensions Dil, Di2 are in turn each chosen to be between 120 mm and 420 mm.

[0054] Preferably, the frame 31 is made of (rigid) plastic, for example polycarbonate (PC) or polypropylene (PP), which provides a good compromise between the mechanical strength of the frame 31 and its weight, and also ensures a relatively low manufacturing cost. Even more preferably, the frame 31 is a monolithic injection-molded or thermoformed piece, which gives it a particularly smooth surface, thus limiting the risk of abrasion of the inner side wall 31 IA of the frame 31 by friction against the containers 2, and therefore the risk of generating foreign particles that could enter the containers 2.

[0055] Advantageously, the housing 312 of the frame 31 is dimensioned so that, with the containers 2 housed in the housing 312, the latter has a minimum usable cross-section (considered in a plane orthogonal to the elevation direction B-B' of the internal side wall 31 IA of the frame 31) having a void ratio of between 1% and 80%, and preferably between 4% and 60%. Depending in particular on the external diameter and the number of containers 2, the void ratio therefore corresponds to the portion of the total minimum usable cross-section of the housing 312 of the frame 31 that is not occupied by the containers 2. 2. By "minimum usable area", we advantageously mean the smallest usable area of ​​the housing 312 when it is empty of containers, considered in a plane orthogonal to the B-B' elevation direction of the side wall internal 31 IA of the frame 31, and which therefore defines the said first and second minimum internal dimensions Dil, Di2. Such a void ratio advantageously guarantees easy extraction of the containers 2 from the housing 312 during unloading, while limiting the space left free in the housing 312, which could allow a container 2 to fall and lie down in the housing 312 during a relative movement of the frame 31 and the flexible envelope 32 once the latter has been cut.

[0056] Preferably, the side wall 22 of at least part of the containers 2 arranged in the housing 312 is in direct contact with at least a portion of the internal side wall 31 IA of the housing 312. This makes it possible in particular to further improve the retention of the containers 2 immobile relative to the frame 31 by means of the flexible casing 32.

[0057] The frame 31, and in particular its internal side wall 31 IA, has a maximum height H along the elevation direction B-B' of said internal side wall 31 IA, which is preferably less than or equal to a height h that each container 2 has along its principal extension direction A-A' (said total height h thus corresponding to the distance between the lower end and the upper end of each container 2 along its principal extension direction A-A'). Advantageously, each container 2 is arranged in the housing 312 of the frame 31 with - their lower end positioned flush with the first opening 314A providing access to dwelling 312, that is to say, inscribed in the first plane of the opening, or beyond the first opening 314A providing access to dwelling 312, and therefore outside dwelling 312, and - their upper end positioned flush with the second opening 314B for access to the dwelling 312, that is to say inscribed in the second opening plane, or beyond the second opening 314B for access to the dwelling 312, and therefore outside the dwelling 312.

[0058] Such a configuration advantageously contributes to the reliable immobilization of the containers 2 relative to the frame 31 by the flexible casing 32 that covers them. Even more preferably, for at least the same reasons, the maximum height H of the frame 31 is strictly less than the total height h of the containers 2, and each of the containers is arranged in the housing 312 of the frame 31 with - their lower end (and therefore their bottom 21) positioned flush with the first access opening 314A to said housing 312, or beyond the first access opening 314A to the housing 312, and therefore outside the housing 312, and - their upper end (and therefore their opening 23) positioned beyond the second opening 314B providing access to housing 312, and therefore outside housing 312.

[0059] In any event, the maximum height H of the frame 31 is preferably at least equal to 20%, preferably even more at least equal to 30%, preferably even more at least equal to 40%, preferably even more at least equal to 50%, of the total height h of the containers 2, which advantageously contributes to ensuring firstly good immobilization of the containers 2 in relation to the frame 31 using the flexible envelope 32, and then to limiting the risk of collision, or even tipping, of containers 2 during the handling of the frame 31 once the flexible envelope 32 has been cut for the purpose of unloading the containers 2.

[0060] The frame 31 preferably has vertical reinforcing ribs 316, which project from the external side wall 31 IB of the frame 31, extending between said first peripheral edge 313A and said second opposite peripheral edge 313B (and preferably also from the first peripheral edge 313A to the second peripheral edge 313B) in a direction preferably parallel to said direction B-B' of elevation of the frame 31. Alternatively, or preferably in addition, the frame 31 preferably has at least one horizontal reinforcing rib 317, which projects from the external side wall 31 IB of the frame 31, preferably along the entire perimeter of the latter, said horizontal reinforcing rib 317 advantageously being inscribed in a plane orthogonal to the direction B-B' of elevation of the frame 31.Thus, the frame 31 can, for a limited amount of material, nevertheless exhibit excellent mechanical robustness, and in particular excellent rigidity. Advantageously, the horizontal reinforcing rib 317 has a thickness of between 1 mm and 6 mm, preferably between 1 mm and 5 mm, preferably between 1 mm and 3 mm, and for example equal to 1.8 mm.

[0061] In order to facilitate the gripping and handling of the frame 31 when unloading the containers 2 from the packaging 3, while limiting a risk of unintentional interaction with the containers 2, which could damage and / or contaminate them (in particular in the case where the containers 2 are sterile), the frame 31 advantageously includes a gripping member of the frame 31 which is arranged in projection from the external side wall 31 IB of the latter, and which is therefore advantageously distinct from the side wall 315 of the frame 31.The said gripping member is thus specifically designed and configured at least to allow the exercise, by means of it, of an external force either to maintain the frame 31 substantially immobile, or to pull against the frame 31, in particular during an operation of separating the frame 31 and the containers 2 from the flexible casing 32 (or at least one of the layers 321-324 of the flexible casing of the latter), and / or during an operation of extracting the containers 2 from the housing 312 of the frame 31. Such an arrangement in . The projection of the external side wall 31 IB thus allows, in particular, the frame 31 to be gripped at a distance from the containers 2 arranged in the housing 312 of the latter, and advantageously by a lateral approach, i.e. without having to place a means of gripping, whether a human hand or a mechanical gripper (for example of the gripper type), above the upper end of the containers 2, and therefore of their openings 23. Advantageously, the gripping member is made of the same material as the external side wall 31 IB of the frame 31, so that the gripping member and the external side wall 31 IB together form a monolithic part, which facilitates the design and manufacture of the packaging 3, and in particular of the frame 31.

[0062] As in the embodiment illustrated in the figures, said gripping member thus preferably comprises at least one (first) portion 318A of gripping member which is designed and configured to allow the exercise, by means of it, of an external force which is either a force to keep the frame 31 immobile, or a traction force against the frame 31 in a direction orthogonal to the direction B-B' of elevation of the internal side wall 31 IA of the frame 31, in particular during an operation of separating the frame 31 and the containers 2 from the flexible casing 32 (or from at least one of the layers 321-324 of the flexible casing of the latter).For example, as in the embodiment illustrated in the figures, the first portion 318A of the gripping member can be formed by a (first) gripping tongue, which therefore protrudes from the external lateral wall 31 IB of the frame 31, and advantageously extends along a mean plane substantially orthogonal to the elevation direction B-B' of the frame 31. Said gripping tongue therefore advantageously has dimensions sufficient to be able to be firmly grasped between the fingers of a hand or by a pair of grippers of a mechanical gripping means. The first portion 318A of the gripping member advantageously extends over at least part of the perimeter of the external side wall 31 IB of the frame 31. Even more advantageously, the first portion 318A of the gripping member extends, from the internal side wall 311A ​​of the frame 31 and away from the latter, over a substantially constant width L1.When, as in the embodiment illustrated in the figures, the frame 31 has a plurality of sides, the first portion 318A of the gripping member may advantageously extend continuously along at least half, and preferably along the entire length, of one of said sides (said length being advantageously considered along a direction orthogonal to the elevation direction B-B' of the frame 31), in order to facilitate the gripping and manipulation of the frame 31 by means of the first portion 318A of the gripping member.

[0063] As in the examples illustrated in the figures, said grasping organ is in furthermore advantageously designed and configured to allow the exercise, by means of it, of an external upward traction force against the frame 31 in a direction having at least one component parallel to the direction B-B' of elevation of the internal side wall 31 IA of the frame 31, in particular during an operation of extracting the containers 2 out of the housing 312 of the frame 31 by lifting the latter. Accordingly, said gripping organ further preferably includes at least two gripping organ portions 318B, 318C (second and third gripping organ portions 318B, 318C), which are positioned diametrically opposite and which are designed and configured to allow the exercise, through them, of such an external upward traction force against the frame 31 in a direction having at least one component parallel to the direction B-B' of elevation of the internal side wall 31 IA of the frame 31.The implementation of such a pair of (second and third) gripping member portions 318B, 318C, instead of a single gripping member portion, facilitates and improves the reliability of such an operation of extracting the containers 2 from the housing 312 of the frame 31 by lifting the latter, while limiting the risk of tipping the containers 2. For example, as in the embodiment illustrated in the figures, said second and third gripping member portions 318B, 318C can each be formed by a (second or third) gripping tab, which therefore protrudes from the external side wall 31 IB of the frame 31, and advantageously extends along a mean plane substantially orthogonal to the direction B-B' of elevation of the frame 31. Said second and third gripping tabs therefore advantageously have sufficient dimensions to be engaged, grasped, by fingers with one hand or by a mechanical gripping device.Each of said second and third gripping tabs advantageously extends over at least part of the perimeter of the external side wall 31 IB of the frame 31. When, as in the embodiment illustrated in the figures, the frame 31 has a plurality of sides, said second and third portions 318B, 318C of gripping member can advantageously each extend continuously along at least one-third, preferably along at least half, and preferably still along the entire length of one of said sides (said length being advantageously considered along a direction orthogonal to the direction B-B' of elevation of the frame 31, in order to facilitate the gripping and manipulation of the frame 31 by means of said second and third portions 318B, 318C of gripping member.Even more advantageously, the said second and third portions 318B, 318C of the grasping organ extend respectively, from the external lateral wall 31 IB of the frame 31 and away from it, over a substantially constant width L2, L3. When, as in the examples illustrated in the figures, the frame 31 is rec. The tangential gripping element may advantageously comprise a pair of second and third gripping elements 318B, 318C, such that each of the four sides of the frame 31 is thus provided with a second or third gripping element 318B, 318C, which further facilitates gripping and handling the frame 31. Preferably, the second and third gripping elements 318B, 318C have identical widths L2, L3. Preferably, to simplify the design and manufacture of the frame 31, one of the second and third gripping elements 318B, 318C is combined with, or formed by, the first gripping element 318A.

[0064] Advantageously, as in the examples illustrated in the figures, said gripping member can also advantageously form, or contribute to forming, a horizontal rib 317 for reinforcing the frame 31 as mentioned above.

[0065] For example, the first portion 318A of the gripping member can be formed by a gripping tab, as described above, extending from the outer side wall 31 IB of the frame 31 over a width L1 which is preferably between 6 mm and 70 mm. For example, the second and third portions 318B, 318C of the gripping member can each be formed by a gripping tab, as described above, extending from the outer side wall 31 IB of the frame 31 over a width L2, L3 which is preferably between 7 mm and 50 mm. Advantageously, the aforementioned gripping tab(s) have a thickness of between 1 mm and 6 mm, preferably between 1 mm and 5 mm, preferably between 1 mm and 3 mm, and for example equal to 1.8 mm. This allows for good mechanical resistance of the gripping tab(s), while maintaining a limited mass.

[0066] According to one variant, visible in figures 1 to 7, the first, second(s) and third(s) portions 318B, 318C of the gripping member are of identical widths L1, L2, L3, which has the particular advantage of facilitating the design and manufacture of the frame 31 and of contributing to giving the latter a reversible character to further simplify the manufacture of the set 1 of packaged containers 2. According to another variant, illustrated as an example in [Fig.8], the gripping organ of the frame 31 can comprise at least one pair of second and third portions 318B, 318C of gripping organ, of which the second portion 318B is formed by the first portion 318A of the gripping organ, the first portion 318A of the gripping organ being of a width L1 greater, and for example twice greater, than the width L3 of the third portion 318C of the gripping organ.This advantageously facilitates the grasping and manipulation of the frame 31 via the first portion 318A of the grasping member, particularly during an operation to separate the envelope 32. flexible and frame 31, as mentioned previously.

[0067] Advantageously, as in the examples of Figures 12 and 13, the gripping member of the frame 31 (and in particular all or part of said first, second and third portions 318A, 318B, 318C of the gripping member) and / or said horizontal reinforcing rib 317 may be perforated, i.e., have one or more through openings 319 (for example, circular or oblong). This notably allows for a reduction in the mass of the frame 31, without negatively impacting the mechanical strength of the gripping member and / or the horizontal reinforcing rib 317.Even more advantageously, when said first portion 318A of the gripping member forms a gripping tongue, the or at least one of the through openings 319 is configured and dimensioned to permit the introduction of at least part of a finger of a human hand (possibly gloved) into the through opening(s) 319, in order to facilitate the exercise of said external holding or pulling force against the frame 31 during the unpacking of the containers 2.

[0068] According to one variant, implemented in the example embodiment illustrated in [Fig. 1], the packaging 3 lacks a physical separation element between the containers 2 in the recess 312 of the frame 31. Thus, the recess 312 of the frame 31 is occupied only by the containers 2, which may be in contact with each other. According to another variant, not illustrated, the packaging 3, on the contrary, includes one or more physical separation elements between the containers 2 in the recess 312 of the frame 31, thereby preventing direct contact between adjacent containers 2. The physical separation element(s) may, for example, form crossbars defining compartments, each receiving one of the containers 2, the walls of said compartments being thus interposed between the side walls 22 of adjacent containers 2.Preferably, the physical separation element(s) are integral with the frame 31, forming, for example, a monolithic and therefore single piece with it. This facilitates the design of the packaging and the unloading of containers 2, since the frame 31 and the physical separation element(s) can thus be simultaneously separated from the containers 2 during unloading. Preferably, the physical separation element(s) extend, along the elevation direction B-B' of the internal side wall 31 IA of the frame 31, over a height less than or equal to the maximum height H of the internal side wall 31 IA along said elevation direction B-B', so as to ensure that the containers 2 are properly immobilized by the flexible sleeve 32 relative to the frame 31.

[0069] Preferably, the frame 31 is devoid of a sharp edge (or sharp edge), so as to limit the risk of damage to, or tearing of, the flexible cover 32 by frame 31, for example during handling or transport of the set 1 of packaged containers 2. Thus, all edges or angles of frame 31 are preferably rounded or chamfered.

[0070] As in the examples illustrated in Figures 1 to 8, the frame 31 may advantageously have a transverse plane Pt, which is orthogonal to the elevation direction B-B' of the internal side wall 31 IA of the frame 31, which preferentially forms a plane of symmetry of the frame 31. This helps to further simplify the design and manufacture of the frame 31 as such, but also the manufacture of the set 1 of packaged containers 2, insofar as the frame 31 is thus advantageously reversible.

[0071] As in the examples illustrated in Figures 9 to 13, the frame 31 can be advantageously designed and configured to be stably stacked, for example by nesting, on at least one other identical frame 31' ([Fig. 11]). This makes it possible to reduce the manufacturing costs of the set 1 of packaged containers, particularly in a high-speed, industrial-scale production context, by facilitating a step of supplying a frame 31. It also makes it easier to facilitate a subsequent step of storing frames 31, by stacking frames 31 on top of each other, as part of unpacking a plurality of sets 1 of packaged containers whose frames 31 are identical. For example, as illustrated in Figures 10 and 13,The side wall 315 of the frame 31 may have a section (called a "stepped section") that allows: - a first part (or "lower part") of the frame 31 extending from the first peripheral edge 313A towards the second peripheral edge 313B to be fitted onto, and overlapped by, - a second part (or "upper part") of another identical frame 31' extending from the second peripheral edge 313B' towards the first peripheral edge 313A' of that other frame 31', so that this part is arranged in the recess 312 of the frame 31; and - a second part (or "upper part") of the frame 31 extending from the second peripheral edge 313B towards the first peripheral edge 313A to be fitted into the recess 312" of another identical frame 31', a first part (or "lower part") of that other frame 31”,which extends from the first peripheral edge 313A” towards the second peripheral edge 313B” of the latter, being arranged on - and overlapping - the second part (or “upper part”) of the frame 31. ,

[0072] It is understood that in this case, and as previously envisaged, the first and second openings 314A, 314B of the frame 31 can therefore be of different useful sections.

[0073] Preferably, as illustrated in the figures, the flexible casing 32, and in particular its inner face 32A, is in direct contact with the upper extremities containers 2, which simplifies the manufacture of the set 1 of packaged containers 2, as well as the subsequent unloading of the containers 2. In this case, the upper portion of the flexible sleeve 32 therefore exerts a direct force against the upper ends of the containers 2 to immobilize them within the frame 31. Alternatively, the packaging 3 may include a flexible interlayer sheet, for example made of plastic, which is interposed between the inner face 32A of the flexible sleeve 32 and the upper ends of the containers 2, thus covering the openings 23 of the latter, for example to limit the risk of introducing foreign particles into the internal cavities 24 of the containers 2 during unloading. In this case, the upper portion of the flexible sleeve 32 therefore exerts an indirect force against the upper ends of the containers 2 to immobilize them within the frame 31.

[0074] A portion (or "lateral portion") of the flexible casing 32, which is arranged opposite the external side wall 31 IB of the frame 31, is preferably in direct contact with the frame 31, and even more preferably along the entire outer perimeter of the frame 31. In other words, at least part of an internal face portion 32A defined by said lateral portion of the flexible casing 32 is therefore preferably pressed directly against the frame 31 (and in particular advantageously directly against the gripping member of the frame 31 mentioned above), the packaging 3 thus being advantageously devoid of any physical element, distinct and separable from the frame 31, which would be interposed between the frame 31 and said lateral portion of the flexible casing 32.Besides simplifying the design and manufacture of the packaging 3 and more generally of the set 1 of packaged containers 2, this also facilitates the unloading of the containers 2 by facilitating access to the frame 31 after opening the flexible sleeve 32.

[0075] The flexible envelope 32 has a total thickness (i.e., including all layers 321, 322, 323, 324 where applicable) which is preferably between 50 pm and 800 pm, and even more preferably between 80 pm and 360 pm, which helps to minimize the "step" that the flexible envelope 32 is likely to form when unloading the containers 2, while still allowing the containers 2 to be reliably and robustly immobilized within the frame 31 of the set 1 of packed containers 2 before unloading.

[0076] According to a preferred embodiment, implemented in the examples shown in the figures, the containers 2 are sterile, that is, they are advantageously free from any viable microorganisms. The set 1 of packaged containers 2 then constitutes a set 1 of packaged sterile containers 2. The containers 2 may, therefore, have been subjected to a sterilization treatment. Advantageously, "sterile" is understood here and in what follows to mean a guaranteed level of Sterility (or "Sterility Assurance Level" (SAL)) of 106. Preferably, the containers 2 are also pyrogen-free, that is, advantageously free from bacterial endotoxins. These containers 2 may have undergone depyrogenation treatment, typically in accordance with the requirements of the current European and American pharmacopoeias. Thus, the set 1 of packaged containers 2 is particularly well suited for pharmaceutical or medical applications of the containers 2. Advantageously, the frame 31 is also sterile, as are any physical separation elements of the containers 2 and any flexible interleaving sheet, so as to prevent contamination of the containers 2 by either of them.

[0077] Advantageously, the internal cavities 24 of the containers 2 are free from foreign particles, and in particular from solid particles (glass particles, metal particles, etc.). The containers 2 may therefore have been subjected to a cleaning treatment, for example washing and then possibly drying, to guarantee such an absence of foreign particles in their internal cavities 24.

[0078] Said flexible envelope 32 then preferably comprises a plurality of flexible envelope layers, and in particular: - at least one (first) inner layer 321, which defines a first enclosure in which the frame 31 and the containers 2 are housed, said first inner layer 321 being in direct contact with the bottom 21 of the containers 2, said first enclosure being sterile, and - at least one (first) outer layer 322, which covers said first inner layer 321 and defines a second enclosure containing said first enclosure, said first outer layer 322 being impermeable to gases, said first and second enclosures being placed under vacuum.

[0079] An inner face of the first inner layer 321, oriented towards the frame 31 and the containers 2, thus forms the aforementioned inner face 32A of the flexible casing 32. The first inner layer 321 therefore constitutes the innermost layer of the flexible casing 32. Advantageously, the first inner layer 321 forms a flexible casing layer referred to as a "sterile barrier," capable of maintaining the sterility of the first enclosure it defines and its contents. The first outer layer 322 advantageously forms a flexible casing layer referred to as a "protective layer," designed to protect the physical integrity of the first inner layer 321 against external aggressions and / or contamination.

[0080] Preferably, the first outer layer 322 is separable from the first inner layer 321, so that it is possible to separate the first outer layer 322 from the first inner layer 321 first (typically after opening the second enclosure, by cutting or tearing the first outer layer 322), then to separate the first inner layer 321 from the frame 31 and the containers 2 arranged in the housing 312 of the latter. Thus, the operation of separating the flexible casing 32 from the frame 31 and containers 2 during the unloading of the containers 2 can be carried out sequentially, so as to limit the risk of contamination of the containers 2 by a contaminant that could be carried by the first outer layer 322.

[0081] Since the first and second enclosures are placed under vacuum, it is understood that at least the second enclosure (and preferably each of the first and second enclosures) is therefore sealed. Furthermore, an inner face of the first outer layer 322 is thus pressed (possibly indirectly, as envisaged later) against an outer face of the first inner layer 321.

[0082] Advantageously, as in the embodiment illustrated in [Fig. 1], the flexible casing 32 comprises a second inner layer 323, which covers said first inner layer 321, and which is sandwiched between the latter and said first outer layer 322. Distinct from and separable from the first inner layer 321, the second inner layer 323 defines a third enclosure containing said first enclosure, which third enclosure is sterile and placed under vacuum. The second enclosure defined by the first outer layer 322 therefore contains the second inner layer 323, and the third enclosure defined by the latter itself contains the first inner layer 321.Thus, the second enclosure defined by the first outer layer 322 may advantageously not be sterile, the sterile nature of the third enclosure defined by the second inner layer 323 guaranteeing the sterility of the outer face of the first inner layer 321. This advantageously allows for the final unloading of the containers 2 for filling under aseptic conditions.

[0083] The third enclosure being placed under vacuum, an inner face of the second inner layer 323 is thus pressed, advantageously in direct contact, against the outer face of the first inner layer 321. Said second enclosure being placed under vacuum, the inner face of the first outer layer 322 is thus pressed, advantageously in direct contact, against an outer face of said second inner layer 323.

[0084] Preferably, the first inner layer 321, and even more preferably the second inner layer 323, have at least one portion that is permeable to gases, and therefore in particular to at least one sterilizing gas (i.e., a gaseous fluid capable of sterilizing an element with which it comes into contact, such as, for example, ethylene oxide or steam). The manufacture of the set 1 of packaged (sterile) containers 2 is thus facilitated, since it is thereby possible to carry out simultaneous, simple, and rapid sterilization of the containers 2, of the frame 31 (and of the physical separation element(s) possibly present in the housing 312 thereof), and of the inner and outer faces of the first inner layer 321, by introducing a sterilizing gas into the first chamber (as well as preferably into the third chamber) via the gas-permeable portion(s) of the inner layer. Then, the first inner layer 321, and even more preferably the second inner layer 323, can then be covered by the first inner layer 321, before a vacuum is created in the third chamber, thus resulting in the simultaneous evacuation of the first, second and third chambers.

[0085] Said gas-permeable portion of the first inner layer 321, and more advantageously said gas-permeable portion of the second inner layer 323, is (are) preferably positioned opposite the openings 23 of the containers 2, so as to allow rapid and efficient sterilization of the containers 2 and thus to facilitate and make more reliable the manufacture of the set 1 of packaged containers 2.

[0086] The flexible casing 32 further advantageously has an outer face 32B which, being opposite said inner face 32A, is therefore oriented towards the outside of the assembly 1 of containers 2, and thus defines a surface area of ​​the flexible casing 32 in contact with the external environment. Said (first) outer layer 322 itself has an outer face, which may optionally constitute said outer face 32B of the flexible casing 32, so that the (first) outer layer 322 thus constitutes a surface layer of the flexible casing 32. Alternatively, as in the embodiment illustrated in [Fig. 1], the flexible casing 32 advantageously comprises at least one other outer layer 324 (or "second outer layer"), which covers the first outer layer 322 and which defines a fourth enclosure containing said second enclosure, the second outer layer 324 being distinct from and separable from the first outer layer 322.The second outer layer 324 can then have an outer face which constitutes the outer face 32B of the flexible casing 32. The implementation of such a second outer layer 324, which advantageously forms a so-called "protective" layer of the flexible casing, contributes in particular to further strengthening the resistance of the flexible casing 32 and the protection of the containers 2 against external aggressions.

[0087] Advantageously, the second outer layer 324 is gas-impermeable, and said fourth enclosure is placed under vacuum, so that an inner face of the second outer layer 324 is pressed, advantageously in direct contact, against the outer face of the first outer layer 322. This further improves the reliability of immobilizing the containers 2 in the frame 31, and reinforces the rigidity and compactness of the assembly 1 of packaged containers 2. Alternatively, but less preferably, the second outer layer 324 could be formed, in the same purpose, by a flexible heat-shrinkable plastic film which has been thermally shrunk around said second enclosure.

[0088] In other words, the first internal layer 321 advantageously forms a "primary layer", the second internal layer 323 advantageously forms a "secondary layer", the first external layer 322 advantageously forms a "tertiary layer", the second external layer 324 advantageously forms a "quaternary layer".

[0089] It is understood from the foregoing that, while the first inner layer 321 (and, where applicable, the second inner layer 323) has as its principal role the guarantee of the sterility of the packaged containers 2, the first outer layer 322 (and, where applicable, the second outer layer 324) therefore has, in particular, the role of ensuring the immobilization of the packaged containers 2. It is further understood from the foregoing that, in the case where the flexible envelope 32 comprises a plurality of flexible envelope layers 321-324, each of the flexible envelope layers 321-324 forms, as such, a flexible envelope.

[0090] Advantageously, the first inner layer 321, as well as preferably said second inner layer 323 where applicable, is formed by a flexible plastic bag heat-sealed along at least one edge to close the corresponding enclosure defined by said bag. For example, of the "Steribag" type, said bag may be formed of a gas-impermeable high-density polyethylene (HDPE) film, preferably colorless and transparent, and a porous sheet of a non-woven material based on high-density polyethylene (HDPE), for example Tyvek®, developed by DuPont de Nemours, which forms said gas-permeable portion.

[0091] Advantageously, the first outer layer 322, as well as preferably the second outer layer 324 where applicable, is (or are each) formed by a flexible plastic bag heat-sealed along at least one edge to close the corresponding enclosure defined by said bag. For example, of the "Steribag" type, and preferably colorless and transparent, said (or each of said) bag(s) may, for example, be formed of several layers of polyethylene and polyamide with a total thickness advantageously between 70 µm and 120 µm, or of several layers of polyethylene (PE) and ethylene vinyl alcohol (EVOH) with a total thickness advantageously between 70 µm and 120 µm.

[0092] By "vacuum-sealed" or "vacuum-sealed," it is advantageously understood that the internal pressure inside the enclosure(s) concerned is strictly lower than the external atmospheric pressure outside the flexible casing 32. Preferably, the internal pressure, expressed as absolute pressure, is between 20 mbar and 100 mbar (i.e., between 2 x 10⁶ Pa and 1 x 10⁷ Pa). By "gas-impermeable," it is advantageously understood that the layer(s) concerned form a barrier Gas-tight, meaning impermeable to "pure" gases or gaseous mixtures, and in particular to air and water vapor, with the possible exception of hydrogen (H2) and helium (He). Impermeability to gases advantageously implies impermeability to liquids.

[0093] Thanks to the specific design of the packaging 3 described above, and in the case where the frame 31 is made of plastic, the mass of plastic material (excluding the flexible sleeve) comprising the packaging 3 is ultimately significantly lower than that of known "tray" or "nest and tub" type packaging systems. Indeed, it has been observed that, for 64 identical 20 ml bottle-type containers, the frame 31 can have a mass of 130 g, or 2.03 g of plastic per container. This typically represents a reduction of approximately 74% per container compared to a conventional "nest and tub" system, and approximately 48% per container compared to a conventional "tray" system.

[0094] In order to facilitate storage, handling and transport, the set 1 of packaged containers 2 may optionally be arranged in a rigid or semi-rigid box, for example made of plastic or cardboard.

[0095] The invention also relates, as such, to a method of packaging containers 2, for example intended to contain a substance for pharmaceutical, medical or cosmetic use, which containers 2 each have a lower end (first end) forming a base 21, from which a side wall 22 of the container 2 extends in a direction A-A' of principal extension of the container 2 towards an opposite upper end (second end) of the container 2 defining an opening 23 for access to an internal cavity 24 of said container 2. The containers 2 advantageously conform to the description given above in connection with the set 1 of containers 2 packaged according to the invention, so that the description of the containers 2 given previously applies advantageously mutatis mutandis to the containers 2 concerned by the method according to the invention.The process according to the invention advantageously constitutes a method for manufacturing an assembly 1 of packaged containers 2 according to the invention, as described above. Thus, the above description of the assembly 1 of packaged containers 2 advantageously applies mutatis mutandis to the process according to the invention, and conversely, the following description of the process according to the invention advantageously applies mutatis mutandis to the assembly 1 of packaged containers 2 according to the invention.

[0096] Preferably, the container packaging process 2 is an automated process, thus advantageously enabling the production of a large number of assemblies 1 of packaged containers at a high rate. Therefore, the steps of the process described below are advantageously automated and typically implemented using suitable automated industrial technical means.

[0097] The method according to the invention comprises at least the following steps: - Step 1: provision of a plurality of said containers 2; - Step 2: provision of a rigid frame 31 comprising an internal side wall 31 IA which delimits a housing 312 and which extends in a direction B-B' of elevation from a first peripheral edge 313A defining a first opening 314A of access to said housing 312 to a second opposite peripheral edge 313B defining a second opening 314B of access to said housing 312; - Step 3: arrangement of the containers 2 in said housing 312 of the frame 31 with their principal extension directions A-A' oriented parallel to each other and to the elevation direction B-B' of the internal side wall 31 IA of the frame 31; and

[0098] - Step 4: manufacturing a flexible envelope 32 which covers, preferably internally gralement, the frame 31 and the containers 2 to immobilize the latter in relation to the frame 31, and which is in direct contact with the bottom 21 of the containers 2.

[0099] The process according to the invention thus makes it possible to pack containers 2 in a simple, quick and efficient manner, and to obtain advantageously, in a simple and efficient manner, a set 1 of packed containers 2 in accordance with the invention, as described above, and thus presenting the various advantages mentioned above.

[0100] Advantageously intended to subsequently receive said substance, the containers 2 provided in Step 1 are advantageously empty, that is to say, their respective internal cavities 24 are empty. Furthermore, the containers 2 are advantageously open, their openings 23 being free and unobstructed by any means of closure. The containers 2 are therefore advantageously intended to each form a primary container for said substance.

[0101] The frame 31 supplied during Step 2 advantageously conforms to the description given above in relation to the set 1 of containers 2 packaged according to the invention, so that the description of the frame 31 given previously applies advantageously mutatis mutandis to the frame 31 supplied during Step 2 of the process according to the invention. As mentioned previously, as in the examples illustrated in Figures 9 to 13, the frame 31 can advantageously be designed and configured to be stably stacked, for example by nesting, on at least one other identical frame 31 ([Fig. 11]). In this case, Step 2 advantageously includes an operation of removing the frame 31 from a stack of frames 31 stacked one on top of the other.

[0102] Advantageously, the frame 31 is manufactured upstream of Step 2 and then supplied during Step 2 under filtered laminar flow, typically obtained at a minimum with a grade H14 HEPA filter according to EN 1822 and ISO 14644 for clean environment design, classification, and testing. In this way, it is Thus, advantageously, it is not necessary to wash frame 31 to remove any foreign particles prior to carrying out Step 3.

[0103] For the reasons set out above in connection with the set 1 of containers 2 packaged according to the invention, the housing 312 of the frame 31 provided during Step 2 preferably has a rectangular shape, and in particular a square shape, the (four) internal corners of which are preferably rounded, chamfered, and defined by a first minimum internal dimension Dil and a second minimum internal dimension Di2, as defined above, which are each chosen to be between 120 mm and 420 mm (in particular when the containers 2 are intended to be arranged in the housing 312 without any physical separating element of the containers 2 from each other in the housing 312).Even more preferably, the first and second minimum internal dimensions Dil, Di2 are chosen such that Dil = Di2 = 203 mm ± 2 mm, Dil = Di2 = 198 mm ± 2 mm, Dil = Di2 = 192 mm ± 2 mm, Dil = Di2 = 184 mm ± 2 mm; Dil = Di2 = 135 mm ± 2 mm, Dil = Di2 = 131 mm ± 2 mm or Dil = Di2 = 128 mm ± 2 mm (in particular when the containers 2 are intended to be arranged in the housing 312 without any physical separation element between the containers 2 in the housing 312).

[0104] Indeed, these seven specific dimensions of the housing 312 of the frame 31 advantageously allow for optimal framing of a large number of containers 2 of the bottle type to be packaged, for example made of glass, with a nominal capacity ranging from 1 mL to 500 mL (nominal value of external diameter of the body of the containers 2 ranging from 22 mm (± 0.7 mm) to 86 mm (± 1.2 mm)).

[0105] For example, for vial-type containers 2 with a nominal external diameter of approximately 25.4 mm, 50.8 mm, or 75.4 mm, and respective nominal capacities of 10 ml, 150 ml, and 500 ml, it is advantageous to use minimum internal first and second dimensions Dil, Di2 such that Dil = Di2 = 184 mm ± 2 mm. Indeed, it is then advantageously possible to pack 49, 9, or 4 identical containers 2 in the same frame, respectively, in the absence of any physical separation element between the containers 2.

[0106] For vial-type containers 2 with a nominal external diameter of approximately 22 mm, 32 mm, or 49 mm, and a nominal capacity of 5 ml, 20 ml, and 100 ml respectively, it is advantageous to use minimum internal dimensions Dil and Di2 for the first and second dimensions such that Dil = Di2 = 203 mm ± 2 mm. This makes it advantageous to pack 64, 36, or 16 identical containers 2 in the same frame 31, respectively, without any physical separation between the containers 2.

[0107] For 2-type vial-type containers with a nominal external diameter of approximately 20.8 mm, 46 mm or 60.3 mm, and a respective nominal capacity of 5 ml, For 50 ml and 250 ml containers, it is advantageous to use minimum internal first and second dimensions Dil, Di2 such that Dil = Di2 = 198 mm ± 2 mm. This makes it advantageous to pack 31, 81, 16, or 9 identical containers 2 respectively within the same frame, without any physical separation between the containers 2.

[0108] According to one embodiment, Step 3 is carried out by arranging the containers 2 in the housing 312 of the frame 31 after the latter has been stably placed on a flat support, for example on a preparation table. Typically, the frame 31 is then placed with the first peripheral edge 314A of the frame 31 oriented towards the flat support (i.e. downwards), and the second peripheral edge 314B of the frame 31 oriented in the opposite direction to said flat support (i.e. upwards), the direction B-B' of elevation of the internal side wall 311A ​​of the frame 31 being oriented vertically. According to another, more preferred variant, Step 3 is carried out by placing the frame 31 around the containers 2, which have been arranged immobile on a flat support (for example on a preparation table) at the end of Step 1, by a downward or, on the contrary, upward movement of the frame 31 with respect to the containers 2.

[0109] Advantageously, the frame 31 is supplied during Step 2 and / or the containers 2 are arranged in the housing 312 of the frame 31 during Step 3 by gripping (preferably mechanized, for example robotic) the frame 31 via the second and third portions 318B, 318C of the gripping member of the frame 31, as described above. This limits the risk of contact between an operator or a mechanical gripping means, handling the frame 31 during Step 2 and / or Step 3, and the inner side wall 31 IA of the frame 31 and / or the containers 2, which could damage or contaminate said inner side wall 31 IA and / or said containers 2.

[0110] Typically, Step 4 of manufacturing the flexible envelope 32 includes the supply of at least one flexible film, for example of synthetic material, and the formation of the flexible envelope 32 from said flexible film. Step 4 thus consists of manufacturing said flexible envelope 32, so that the latter covers, i.e. envelope, the frame 31 and the containers 2 and thus immobilizes the latter in position in the housing 312 of the frame 31, the flexible envelope 32 coming into direct contact with the bottom 21 of the containers 2. As mentioned previously in connection with the assembly 1 of containers 2 packaged according to the invention, the flexible envelope 32 can be multilayer, and for example formed of a plurality of layers 321, 322, 323, 324 of flexible envelope, preferably distinct and separable from each other, which are arranged overlapping each other.At the end of Step 4, the flexible envelope 32 therefore defines an enclosure in which the frame 31 and the containers 2 arranged in the housing 312 of the latter are housed, and which . presents an internal face 32A which is advantageously pressed against the frame 31 on one side, and against the containers 2 on either side of the first and second openings 314A, 314B for access to the housing 312, in direct contact with the bottom 21 of the containers 2, so that the containers 2 are thus immobilized with respect to the frame 31.

[0111] In view of the foregoing, it is understood that the method according to the invention is therefore devoid of a step of supplying a frame base 31 or a separate platform for the frame 31, which would be intended to be interposed between the base 21 of the containers 2 and the flexible casing 32, since at the end of Step 4, a portion (or "lower portion") of said flexible casing 32, which is arranged opposite the bases 21 of the containers 2, thus forms a support against which the bases 21 of the containers 2 rest directly. Another portion (or "upper portion") of the flexible casing 32, which is arranged opposite the openings 23 of the containers 2, advantageously exerts, directly or indirectly, a force against the upper ends of the containers 2, so that the latter are therefore held immobile in position relative to the frame 31 which surrounds them laterally.

[0112] For example, the immobilization of the containers 2 by the flexible sleeve 32 can be achieved by evacuating the enclosure formed by the flexible sleeve 32, as will be seen below (i.e., to an internal pressure that is strictly lower than the external atmospheric pressure outside the flexible sleeve 32), or by thermal shrinking around the frame 31 and the containers 2 with at least one flexible heat-shrinkable plastic film from which the flexible sleeve 32 is formed in this case. Thus, Step 4 makes it possible to obtain an assembly 1 of packaged containers 2 that forms a compact and substantially rigid article, i.e., one with inherent mechanical strength, and which therefore does not deform under the weight of the containers 2.The resulting set 1 of packaged containers 2 thus comprises a package 3 and a plurality of containers 2 housed inside the package, which package 3 comprises the rigid frame 31 and the flexible envelope 32 (but is, on the other hand, devoid of a frame base 31 or a tray separate from the frame 31, which would be interposed between the base 21 of the containers 2 and the flexible envelope 32).

[0113] According to a preferred embodiment, the process according to the invention constitutes, more specifically, a process for manufacturing a set 1 of packaged sterile containers 2 (according to the definition of "sterile" already given above), and in particular a set 1 of packaged sterile containers 2.

[0114] In this respect, Step 4 of manufacturing the flexible casing 32 preferably includes an operation of manufacturing at least one first inner layer 321 of the flexible casing 32 which defines a first enclosure in which the frame 31 and the containers 2 are housed, the first inner layer 321 being in direct contact with The bottom 21 of the containers 2, said first inner layer 321 having at least one portion that is gas-permeable. Step E4 then advantageously comprises at least one sterilization operation of said first enclosure defined by the first inner layer 321, by introducing a sterilizing gas into said first enclosure through said gas-permeable portion of the first inner layer 321. Then, Step E4 advantageously comprises an operation for manufacturing at least one first outer layer 322, which covers said first inner layer 321, and which defines a second enclosure containing said first enclosure, said first outer layer 322 being gas-impermeable.Subsequent to this operation, step E4 then advantageously includes a vacuum operation of the first and second enclosures, in order to press the first inner layer 321 and first outer layer 322 against the frame 31 and the containers 2 and thus ensure the immobilization of the latter with respect to the frame 31. .

[0115] Thus, the frame 31 and the containers 2 are sterilized simultaneously, within the first enclosure, during the packaging of the containers 2, which proves to be much faster and simpler in practice than sterilizing the frame 31 and the containers 2 separately before packaging them, and which also limits a risk of recontamination of the latter.

[0116] Preferably, the first outer layer 322 is manufactured to be subsequently separable from the first inner layer 321. Thus, it will subsequently be possible to separate first the first outer layer 322 from the first inner layer 321 (typically after opening the second enclosure, by cutting or tearing the first outer layer 322), and then to separate the first inner layer 321 from the frame 31 and the containers 2 arranged in the housing 312 of the latter, and this for the reasons and with the advantages set out above in connection with the set 1 of containers 2 packaged according to the invention.

[0117] Still for the reasons and with the advantages set out above in connection with the set 1 of containers 2 packaged according to the invention, Step 4 of manufacturing the flexible envelope 32 comprises, even more preferably: - an operation of manufacturing at least one second inner layer 323 of the flexible envelope 32, which covers the first inner layer 321 and which defines a third enclosure containing the first enclosure, the second inner layer 323 being distinct and separable from the first inner layer 321 and being intercalated between the first inner layer 321 and the first outer layer 322, the second inner layer 323 having at least one portion which is permeable to gases; - at least one sterilization operation of the third chamber by introducing a sterilizing gas into the third chamber via said gas-permeable portion of the second inner layer 323; and - a vacuum sealing operation of the first, second and third chambers.

[0118] In other words, step E4 comprises successively, in this particular: - the manufacturing operation of said first inner layer 321, to form said first enclosure; - the manufacturing operation of said second inner layer 323, to form said third enclosure which contains said first enclosure, - the manufacturing operation of the first outer layer 322, to form said second enclosure, which then contains said first and third enclosures, and - the operation of vacuuming the second chamber, which has the effect of simultaneously vacuuming the said first and third chambers, since the latter are not impermeable to gases.

[0119] Preferably, Step 4 includes a closing operation of the first chamber, which is carried out before the sterilization operation of the first chamber, and where applicable, before the manufacturing operation of the second inner layer 323. Preferably, Step 4 includes a closing operation of the third chamber, which is carried out before the sterilization operation of the third chamber. It is further understood that Step 4 advantageously includes a closing operation of the second chamber, in a gas-tight manner, in order to maintain the latter under vacuum after the vacuuming operation of the second chamber.

[0120] It is possible to perform the sterilization operation on the first chamber first, and then subsequently the sterilization operation on the third chamber. However, it proves simpler and faster to perform these two sterilization operations simultaneously, that is to say, by introducing a treatment gas into the third chamber, the treatment gas then also penetrating the first chamber through the gas-permeable portion of the first inner layer 321.Said gas-permeable portion of the first inner layer 321, and more advantageously said gas-permeable portion of the second inner layer 323, is (are) preferably positioned opposite the openings 23 of the containers 2, so as to allow rapid and efficient sterilization of the containers 2 using the sterilizing gas, and thus to facilitate and make more reliable the implementation of the process, and thus the manufacture of the set 1 of packaged containers 2.

[0121] Preferably, the sterilizing gas(es) are chosen from ethylene oxide (EtO) and steam. However, other suitable sterilizing gases could be used. Obviously, the containers 2, the frame 31, and the first inner layer 321 and the second inner layer 323, if applicable, are then chosen to be made of material(s) resistant to such sterilization with ethylene oxide (EtO) or steam. For health and environmental reasons, steam sterilization is even more preferable. Typically, the operation(s) Sterilization can be carried out by subjecting the containers 2 and the frame 31, wrapped in the first inner layer 321 and, where applicable, the second inner layer 323, to steam in an autoclave. In any case, the absence of a base, tray, or "roof" for the frame 31 greatly facilitates the diffusion and circulation of the sterilizing gas(s) within the first housing unit, particularly in and between the containers 2, which contributes to excellent sterilization reliability and therefore to the safety of the containers 2.

[0122] Alternatively, the sterilization of the first enclosure during Step E4 could be carried out by ionizing radiation, that is, by subjecting said first enclosure (and therefore the frame 31 and the containers 2 it contains) to a flux of ionizing radiation, for example, to a flux of ionizing X-rays or gamma rays. Similarly, the sterilization of the third enclosure (and therefore its contents) could alternatively be carried out by ionizing radiation, for example, under a flux of ionizing X-rays or gamma rays. Assuming that these two sterilization operations are carried out concurrently, as previously envisaged, the sterilization operations can therefore be performed by simultaneously subjecting the first and third enclosures (and therefore their contents) to a flux of ionizing radiation, for example, to a flux of ionizing X-rays or gamma rays.It is also conceivable, in the case where the sterilization operation(s) are carried out by ionizing irradiation, that the sterilization operation(s) be carried out after the corresponding vacuum operation(s) (and not before, as previously envisaged in the case of sterilization using sterilizing gas).

[0123] Optionally, for the reasons previously set out in connection with the assembly 1 of containers 2 packaged according to the invention, Step 4 may further include an operation of manufacturing at least one second outer layer 324, which covers the first outer layer 322 and which defines a fourth enclosure containing the second enclosure, the second outer layer 324 being distinct from and separable from the first outer layer 322. Advantageously, the second outer layer 324 is gas-impermeable, and Step 4 then includes an operation of evacuating said fourth enclosure (followed therefore by an operation of sealing said fourth enclosure in a gas-impermeable manner). Alternatively, the second outer layer 324 could be formed by a flexible heat-shrinkable plastic film, and Step 4 could then include an operation of heat-shrinking the second outer layer 324 around the second enclosure.

[0124] Preferably, said first inner layer 321, as well as preferably said second inner layer 322 where applicable, is (are each) formed by A flexible plastic bag with an opening providing access to the inside of the bag and which can be sealed by welding (for example, using a heated mechanical clamp or ultrasound) along at least one edge to close the corresponding enclosure defined by said bag. For example, of the "Steribag" type, said bag (or each of said bags) may be formed of a gas-impermeable high-density polyethylene (HDPE) film, preferably colorless and transparent, and a porous sheet of a non-woven material based on high-density polyethylene (HDPE), for example Tyvek®, developed by DuPont de Nemours, which forms said gas-permeable portion. Advantageously, the bag(s) are supplied and installed under filtered laminar flow at level H14, to prevent the risk of particulate contamination.

[0125] Advantageously, the first outer layer 322, as well as the second outer layer 324 where applicable, are manufactured under an ISO 7 atmosphere (according to ISO 14644-1:2015), to prevent the risk of particulate contamination. Preferably, said first outer layer 322, as well as preferably said second outer layer 324 where applicable, is (are each) formed by a flexible plastic pouch having an opening that provides access to the inside of the pouch and that is closable by welding (for example, using a heated mechanical clamp or by ultrasound) along at least one edge to close the corresponding enclosure defined by said pouch.For example, of the "Steribag" type, and preferably colorless and transparent, said (or each of said) bag(s) may, for example, be formed of several layers of polyethylene and polyamide with a total thickness advantageously between 70 µm and 120 µm, or of several layers of polyethylene (PE) and ethylene vinyl alcohol (EVOH) with a total thickness advantageously between 70 µm and 120 µm.

[0126] Preferably, the said pocket(s) are arranged in relation to the frame 31 during Step 4 so that the welded opening of the pocket(s) extends longitudinally opposite a portion of the external side wall 31 IA of the frame 31 from which the aforementioned first portion 318A of the gripping member of the frame 31 protrudes.

[0127] Advantageously, regardless of the number of layers comprising the envelope 32, the latter has, at the end of Step 4, a total thickness of between 50 pm and 800 pm, and preferably between 80 pm and 360 pm.

[0128] Preferably, the method is devoid of steps involving the supply and placement of a flexible interlayer sheet, for example made of plastic, inserted between the inner face 32A of the flexible envelope 32 and the upper ends of the containers 2, thus covering the openings 23 of the latter. In this case, at the end of Step 4, the upper portion of the flexible envelope 32 therefore directly exerts an effort against the upper ends of containers 2 to immobilize them in frame 31.

[0129] Alternatively, the packaging process may instead include: - a step of supplying a flexible interlayer sheet, for example made of plastic, preferably made of a gas-permeable material (for example, Tyvek®) and, - prior to or during Step 4 of manufacturing the flexible envelope 32, a step of positioning said flexible interlayer sheet covering the openings 23 of the containers 2.

[0130] In this case, at the end of Step 4, said flexible interleaving sheet is interleaved between the inner face 32A of the flexible envelope 32 and the upper ends of the containers 2, thus covering the openings 23 of the latter.

[0131] Advantageously, the process includes, after Step 1 and before Step 3, a washing step for the supplied containers 2, and in particular their internal cavity 24, preferably with water for injection (WFI). Preferably, the washing step is followed by a drying step for the washed containers 2, preferably under ISO 5 conditions (according to ISO 14644-1:2015). Such washing and drying steps advantageously aim to ensure the absence of foreign particles, and in particular solid particles (glass, metal, etc.), in the internal cavity 24 of the containers 2.

[0132] Preferably, the process includes a depyrogenation step for the containers 2, in order to obtain pyrogen-free containers 2, i.e., containers 2 free of bacterial endotoxins. Advantageously, this depyrogenation step is carried out before Step 3 (i.e., only said containers 2 are subjected to it), which makes it possible to use materials for the frame 31 and the flexible casing 32 that are not necessarily resistant to the temperature conditions required for depyrogenation, and are therefore less expensive. Typically carried out in accordance with the requirements of the current European and American pharmacopoeias, the depyrogenation step can be performed, for example, by passing the containers 2 through a depyrogenation tunnel in which the containers 2 are subjected to a dry heat flux at a predefined temperature and for a predefined treatment time.

[0133] Optionally, the packaging process may include a step of packaging the set 1 of packaged containers 2 obtained at the end of Step 4 in a rigid or semi-rigid box, for example made of plastic or cardboard, in order to facilitate storage, handling and transport.

[0134] It should be noted that the terms "first", "second", "third", and "fourth" are used in the foregoing only to facilitate understanding of the invention. These terms do not, as such, imply any notion of order or importance of the elements they designate, nor any technically limiting character. particular, and could therefore possibly be omitted.

Claims

Demands

1. Assembly (1) of packaged containers (2), comprising a package (3) and a plurality of containers (2) housed within the package (3), said containers (2) preferably being sterile, and for example intended to contain a substance for pharmaceutical, medical or cosmetic use, said containers (2) each having a lower end forming a base (21), from which a side wall (22) of the container (2) extends in a principal extension direction (A-A') of the container (2) towards an opposite upper end of the container (2) defining an opening (23) for access to an internal cavity (24) of said container (2),said assembly (1) of packaged containers (2) being characterized in that said packaging (3) comprises a rigid frame (31) itself comprising an internal side wall (311 A) which delimits a housing (312) and which extends in a direction (B-B') of elevation from a first peripheral edge (313 A) defining a first access opening (314 A) to said housing (312) to a second opposite peripheral edge (313 B) defining a second access opening (314 B) to said housing (312), said containers (2) being arranged in said housing (312) with their principal directions (A-A') of extension oriented parallel to each other and to the direction (B-B') of elevation of the internal side wall (311 A) of the frame (31), said packaging (3) comprising a flexible cover (32) which covers the frame (31) and the containers (2) to immobilize them last in relation to the frame (31), and which is in direct contact with the bottom (21) of said containers (2).

2. Assembly (1) according to the preceding claim, wherein said flexible envelope (32) comprises - at least one first inner layer (321), which defines a first enclosure in which the frame (31) and the containers (2) are housed, said first inner layer (321) being in direct contact with the bottom (21) of the containers (2), said first enclosure being sterile, and - at least one first outer layer (322), which covers said first inner layer (321) and defines a second enclosure containing said first enclosure, said first outer layer (322) being gas-impermeable, said first outer layer (322) preferably being separable of said first inner layer (321), said first and second enclosures being placed under vacuum.

3. Assembly (1) according to the preceding claim, wherein the first inner layer (321) has at least one portion which is gas permeable, and which is preferably positioned opposite the openings (23) of the containers (2).

4. Assembly (1) according to any one of claims 2 and 3, wherein said flexible envelope (32) comprises a second inner layer (323), which covers said first inner layer (321) and which defines a third enclosure containing said first enclosure, said second inner layer (323) being distinct and separable from said first inner layer (321) and being intercalated between said first inner layer (321) and said first outer layer (322), said third enclosure being sterile and placed under vacuum.

5. Assembly (1) according to the preceding claim, wherein the second inner layer (323) has at least one portion which is gas permeable, and which is preferably positioned opposite the openings (23) of the containers (2).

6. Assembly (1) according to any one of the preceding claims, wherein the frame (31) comprises an external side wall (31 IB), opposite said internal side wall (21 IA), and a frame gripping member (31) which is arranged projecting from the external side wall (31 IB), said gripping member comprising at least a first portion (318A) of gripping member which is designed and configured to allow the exercise of an external force either to hold the frame (31) stationary, or to pull against the frame (31).

7. Assembly (1) according to the preceding claim, wherein said gripping member comprises second and third gripping member portions (318B, 318C), which are positioned diametrically opposite and are designed and configured to permit the exercise of an external upward pulling force against the frame (31) in a direction having at least one component parallel to the direction (B-B') of elevation of the inner side wall (311 A) of the frame (31), one of said second and third gripping member portions (318B, 318C) being preferably coincident with, or formed by, said first gripping member portion (318A).

8. Assembly (1) according to any one of the preceding claims, wherein the frame (31) has a maximum height (H) along the (B-B') elevation direction of said internal side wall (311 A) which is strictly less than a total height (h) that said containers (2) have along their main extension direction (A-A'), the containers (1) each being arranged in the housing (312) of the frame (31) with their lower end positioned flush with the first access opening (314A) to the housing (312), or beyond the first access opening (314A) to said housing (312), and their upper end positioned beyond the second access opening (314B) to the housing (312).

9. Assembly (1) according to any one of the preceding claims, wherein said flexible envelope (32) has a total thickness of between 50 pm and 800 pm, and preferably between 80 pm and 360 pm.

10. Assembly (1) according to any one of the preceding claims, wherein the frame (31) is made of plastic, for example of polycarbonate or polypropylene, the frame (31) preferably forming a monolithic injection-molded or thermoformed piece.

11. Assembly (1) according to any one of the preceding claims, wherein said packaging (3) is devoid of a physical separating element of the containers (2) from each other in the housing (312) of said frame (31).

12. Assembly (1) according to any one of claims 1 to 10, wherein said packaging (3) comprises one or more physical separation elements of the containers from each other in the housing (312) of said frame (31).

13. A method for packaging containers (2), for example intended to contain a substance for pharmaceutical, medical or cosmetic use, said containers (2) each having a lower end forming a base (21), from which a side wall (22) of the container (2) extends in a principal extension direction (A-A') of the container (2) towards an opposite upper end of the container (2) defining an opening (23) for access to an internal cavity (24) of said container (2), said method being characterized in that it comprises the following steps: supply of a plurality of said containers (2); - supply of a frame (31) comprising an internal side wall (311 A) which delimits a housing (312) and which extends along a direction (B-B') of elevation from a first peripheral edge (313A) defining a first opening (314A) of access to said housing (312) to a second opposite peripheral edge (313B) defining a second opening (314B) of access to said housing (312); - arrangement of the containers (2) in the housing (312) with their principal extension directions (A-A') oriented parallel to each other and to the extension direction (B-B') of the internal side wall (311 A) of the frame (31); and - manufacture of a flexible envelope (32) which covers the frame (31) and the containers (2) to immobilize the latter in relation to the frame (31), and which is in direct contact with the bottom (21) of said containers (2).

14. A method according to the preceding claim, wherein the housing (312) of the frame (31) has a rectangular shape and is defined by a first minimum internal dimension (Dil) and a second minimum internal dimension (Di2), each of which is chosen to be between 120 mm and 420 mm, and more preferably chosen such as Dil = Di2 = 203 mm ± 2 mm, Dil = Di2 = 198 mm ± 2 mm, Dil = Di2 = 192 mm ± 2 mm, Dil = Di2 = 184 mm ± 2 mm, Dil = Di2 = 135 mm ± 2 mm, Dil = Di2 = 131 mm ± 2 mm or Dil = Di2 = 128 mm ± 2 mm.

15. A method according to any one of claims 13 and 14, wherein the manufacturing step of the flexible casing (32) comprises: - an operation of manufacturing at least one first internal layer (321) of said flexible envelope (32) which defines a first enclosure in which said frame (31) and said containers (2) are housed, said first internal layer (321) being in direct contact with the bottom (21) of said containers (2), said first internal layer (321) having at least one portion which is permeable to gases, and which is preferably positioned opposite the openings (23) of the containers (2); - a sterilization operation of said first enclosure by introducing a sterilizing gas into said first enclosure via said permeable portion gas, or by ionizing radiation; - a manufacturing operation of at least one first outer layer (322), which covers said first inner layer (321), and which defines a second enclosure containing said first enclosure, said first outer layer (322) being impermeable to gases; and - a vacuum sealing operation of the said first and second enclosures.

16. A method according to the preceding claim, wherein the manufacturing step of the flexible casing (32) comprises: - an operation of manufacturing at least one second inner layer (323) of said flexible envelope (32), which covers said first inner layer (321) and defines a third enclosure containing said first enclosure, said second inner layer (323) being distinct and separable from said first inner layer (321) and being interposed between said first inner layer (321) and said first outer layer (322), said second inner layer (323) having at least one portion which is permeable to gases, and which is preferably positioned opposite the openings (23) of the containers (2); - a sterilization operation of said third enclosure by introducing a sterilizing gas into said third enclosure via the gas-permeable portion of the second inner layer (323), or by ionizing irradiation; and - a vacuum sealing operation of the said first, second and third enclosures.

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