Set of packaged containers and method of packaging containers

Abstract

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

Description

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

[0001] The present invention relates to the general technical field of sets of packaged containers and to the general technical field of methods of packaging containers for manufacturing such sets of packaged containers, 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 preferably being 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 in a main direction of extension 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 bottom, from which a side wall of the container extends in a main direction of extension 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 a growing demand from the pharmaceutical industry for the supply of so-called ready-to-use (RTU) or ready-to-fill (RTF) bottles, i.e. empty bottles that have already been washed, possibly depyrogenated, and sterilized, bottle manufacturers and suppliers have developed packaging systems in recent years to package and make such ready-to-fill bottles, in particular ready-to-fill glass bottles, available to the pharmaceutical industry in the best possible conditions. In particular, the packaging implemented ensures protection of the bottles from the external environment and allows the bottles to be maintained in a sterile state during their transport and storage, until their use on a filling line.Ready-to-fill bottles can thus be directly introduced into an aseptic environment for filling. Since the bottles constitute so-called primary packaging for the substance they are intended to contain, the packaging systems implemented for the conditioning and . the provision of these bottles is sometimes referred to as “secondary packaging”.

[0004] Two main packaging systems (or "secondary packaging") are known for providing pharmaceutical companies with ready-to-fill glass bottles for filling with pharmaceutical substances, which are defined by the ISO 21882:2019 standard entitled "Pre-fillable glass bottles in sterile packaging".

[0005] A first known packaging system, called a "nest and tub" system, comprises a plastic plate ("nest") having a pattern of housings or cells defined for receiving bottles and a plastic container ("tub") provided for receiving the plastic plate and the bottles placed in the housings of the latter. The container forms a rigid plastic tub having four side walls which extend from a bottom to an access opening to a free space thus defined by the side walls, and has a first rim forming a support for receiving and holding in position the plastic plate and the bottles placed in the housings of the latter in the free space of the container.The container has, near its opening, a second rim along which is fixed a covering film permeable to a sterilization gas to seal the container in which the plate and the bottles are housed, and to ensure that the latter remain sterile. This first packaging system also generally comprises a flexible protective envelope to cover the sealed container after sterilization.

[0006] A second known packaging system, called a "tray" system, comprises a plastic container ("tray") which forms a rigid tub (or tray) having four side walls which extend from a bottom to an opening providing access to a free space thus defined by the side walls, and which has, in the vicinity of its opening, a rim along which is fixed a covering film permeable to a sterilizing gas to seal the container in which the bottles are housed, and ensure that the sterility of the latter is maintained. The bottles are arranged in the free space of the container directly in contact with the bottom of the container, the neck of the bottles being oriented either downwards (towards the bottom 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 of the container, allowing physical separation of the vials. This second packaging system generally further includes a flexible protective wrapper to cover the sealed container after sterilization.

[0007] A third packaging system has also been known more recently, derived from the above “tray” system, comprising a rigid box which includes a lower part forming a rigid cellular plastic container having four walls. side walls which extend from a bottom to an upper opening for access to a free space thus defined by the side walls, and an upper part made of cellular plastic complementary to the lower part, arranged to cover the latter. One of the side walls of the lower part is provided to be removable or hinged to form a lateral opening for access to the free space and thus allow lateral extraction of the bottles after removal of the upper part. This third packaging system generally further comprises a flexible sterile packaging envelope in which the rigid box containing the bottles is arranged. A system for physical separation of the plastic bottles, distinct from the rigid cellular plastic tray, can be arranged in the latter to ensure physical separation of the bottles.

[0008] Although these known packaging systems generally provide satisfaction, they nevertheless present a certain number of drawbacks.

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

[0010] Indeed, in the case of a “nest-and-tub” system, unloading the bottles for filling generally requires, after removal of the flexible envelope and then the covering film, gripping and complete extraction of the plate (“nest”) supporting the bottles from the rigid container (“tub”), by lifting said plate and the bottles, using specific and complex gripping means for the plate, generally automated. Manual unpacking of the bottles one by one is possible, but proves to be particularly tedious and complex in an aseptic zone. In the case of a “tray” system, unloading the bottles from the container requires manual gripping and extraction of the bottles from the container, via the opening of the latter, in the case where the bottles are arranged in the free space of the container with their necks oriented towards the opening of the container.Particularly tedious, such manual unloading can be a source of contamination of the bottles by an operator. In the case where the bottles are arranged in the free space of the container with their necks oriented towards the bottom of the container, unloading the bottles from the container, via the opening of the latter, requires a complete turning over of the container containing the bottles, then a lifting of the container. This turning over operation is generally complex to carry out, and there is a risk of impact of the bottles, likely to break them and / or generate problematic glass particles. In addition, this turning over operation is likely to lead to . the introduction into the bottles of foreign particles that may be present in the bottom of the container. Furthermore, when removing the covering film that seals the plastic container ("tub" or "tray") from 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 unloading of the bottles is done after removal of the flexible envelope and the upper part of the box. Typically, the bottles can then be extracted simultaneously from the lower part of the box, via the aforementioned lateral opening previously formed by removal or folding of the aforementioned removable or folding side wall, using a specific external tool forming a “U” shaped template introduced into the lower part of the box between the side walls and the bottles, via said upper opening, then moved laterally to drive and extract the bottles from the lower part of the box via said lateral opening.In addition to the fact that a tool specifically adapted to the dimensions of the lower part of the box is therefore necessary to unload the bottles, there is on the one hand a risk of damage and / or contamination of the bottles when introducing the external tool into the lower part of the box, and on the other hand, a risk of the bottles falling or being hit, rendering them unusable, when extracting the bottles from the side, the latter having to overcome a step several millimetres 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 are therefore intended to be discarded after unloading the bottles, use a significant mass of plastic, which is not without posing problems both economically and environmentally. Furthermore, the “nest and tub” and “tray” packaging systems (and derivatives), as defined in ISO 21882:2019, require the implementation of a packaging format specific to each format of bottles to be packaged. The development of packaging specific to a given format of bottles results in additional costs in the development and production phases of these packages, but also during the transport and unloading phases of the packaged bottles.

[0013] The objects assigned to the invention therefore aim to respond to the problems set out above and to propose in particular a new set of packaged containers, in particular empty and sterile containers, which allows 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 provide a new set of packaged containers allowing a practical, efficient and safe provision of containers. sterile for the purpose of filling the latter with a substance for pharmaceutical, medical or cosmetic use.

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

[0016] Another object of the invention is to propose a new set of packaged containers which are inexpensive to manufacture.

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

[0018] Other objects of the invention aim to propose a new method for 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 achieved by means of a set of packaged containers, comprising a package and a plurality of containers housed inside the package, said containers preferably being 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 in a main direction of extension of the container towards an opposite upper end of the container defining an access opening to an internal cavity of said container,said set of packaged containers being characterized in that said packaging comprises a rigid frame itself comprising an internal side wall which delimits a housing and which extends in an elevation direction from a first peripheral edge defining a first access opening to said housing to a second opposite peripheral edge defining a second access opening to said housing, said containers being arranged in said housing with their main extension directions oriented parallel to each other and to the elevation direction of the internal side wall of the frame, said packaging comprising a flexible envelope 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 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 bottom, from which a side wall of the container extends in a main direction of extension 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; - providing a frame comprising an internal side wall which delimits a housing and which extends in an elevation direction from a first peripheral edge defining a first access opening to said housing to a second opposite peripheral edge defining a second access opening to said housing; - arrangement of said containers in said housing with their main extension directions oriented parallel to each other and to the extension direction of the internal side wall of the frame; and - production of a flexible envelope 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.

[0021] Other features and advantages of the invention will appear and emerge in more detail on reading the description given below, with reference to the appended drawings, given solely as illustrative and non-limiting examples, among which:

[0022] [Fig-1] [Fig.l] illustrates, according to a schematic view, an example of a mode of rea lisation of a set of packaged containers according to the invention, which is capable of being obtained using the packaging method according to the invention. While the frame and the containers are illustrated in a side view, the flexible envelope is illustrated in sagittal side section. The different layers of the flexible envelope are illustrated arranged at a distance from each other only for the purpose of facilitating the reading of [Fig.l];

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

[0024] [Fig.3] [Fig.3] illustrates, in a schematic top view, an example of a frame which comprises the set of packaged containers of [Fig.l];

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

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

[0027] [Fig.6] [Fig.6] illustrates, in a schematic side view, the framework 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 [Fig.6];

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

[0030] [Fig.9] [Fig.9] illustrates, in a schematic top view, yet another example of a framework that can be included in a set of packaged containers conforming to the invention, in place of the frame of 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, in a schematic top view, yet another example of a frame that can be included in 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 exemplary embodiment of a set of packaged containers in accordance with the invention, which can be obtained using the packaging method in accordance with the invention;

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

[0037] The invention relates to a set 1 of packaged containers 2, or "unitary set of packaged containers", comprising a package 3 and a plurality of containers 2 housed inside the package 3, i.e. contained in the latter. An exemplary embodiment of such a set 1 of packaged containers 2 is illustrated as an example in [Fig.l] in a schematic manner. The containers 2 each have a lower end (first end) forming a bottom 21 (or a lower edge), from which a side wall 22 of the container 2 extends in a direction A-A' of main 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 the container 2. Advantageously, the bottom 21 allows the container 2, considered as such, to rest in a stable manner on a horizontal plane support by means of the bottom 21.As such, the bottom 21 of each of the containers 2 is advantageously flat, that is to say that it extends substantially in a plane (but not strictly necessary, insofar as the bottom 21 may possibly have a slight concavity), the direction A-A' of main extension of the container 2 being advantageously orthogonal to the plane of extension of the bottom 21 of the container 2. Preferably, the side wall 22 has a cylindrical shape, advantageously with a circular base. Preferably, the side wall 22 extends from the bottom 21 in a direction of extension which is parallel to the direction A-A' of main extension 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). As such, the side wall 22 of each container 2 therefore forms a body, the . container 2 comprising a shoulder 25 (flat or curved) and a neck 26 which extend the body towards the upper end of the container 2, the neck 26 defining the opening 23 for access to 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 of closing (not illustrated) said opening 23, such as a screw cap, a crimp cap, etc. However, the invention is not limited to containers 2 of the bottle type, the containers 2 being able to alternatively be pots, etc., depending on the intended application. Preferably, the containers 2 are substantially identical to each other. 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 (for example, a drug administrable by parenteral route), medical or cosmetic, or a substance for diagnostic use or even a biological fluid. Being advantageously intended to subsequently receive said substance, the containers 2 are advantageously empty, that is to say that their respective internal cavities 24 are empty. Furthermore, said containers 2 are advantageously open, their openings 23 being free and clear of any means of closure. Said containers 2 are therefore advantageously intended to each form a primary packaging for said substance to be contained.

[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” must be taken here in its conventional sense, and therefore designates a mineral glass, and preferably a silica glass. It may thus be a soda-lime glass (or “sodosilicocalcic”, 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, depending on the nature of the substance that the containers 2 are intended to contain. 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 the 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, the containers 2 may be made of plastic (for example high-density polyethylene (HDPE), polypropylene (PP), or even polyethylene terephthalate glycol (PETG)).

[0040] According to the invention, the packaging 3 of the set 1 of packaged containers 2 comprises a frame 31 (or “strapping” or even “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, in bending or even in 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 set 1 of containers 2 (in consideration of the nature / material of the latter, and the intended application for the latter).

[0041] Different examples of such a frame 31 are illustrated in the figures. For the sake of 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 the references in order 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 opposite the housing 312, extends in a direction B-B' (general) of elevation 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 respectively defines a second opening 314B for access to the housing 312.The frame 31 therefore 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 examples in the figures, the first and second openings 314A, 314B of the frame 31 which give access to the housing 312 of the latter are advantageously arranged opposite one another, and extend along a first and second opening plane respectively, which first and second opening planes are parallel to each other, the direction B-B' (general) of elevation being orthogonal to the first and second opening planes.

[0042] As illustrated by example in the figures, the frame 31 is typically annular, that is to say that it has a generally annular shape, which is preferably polygonal (more preferably with rounded corners), as in the examples illustrated in the figures, but which could alternatively be oval or circular. Preferably, as in the examples illustrated in the figures, said internal side wall 31 1A is closed on itself, so that it thus continuously delimits said housing 312 (closed frame 31). Advantageously, the frame 31 further comprises an external side wall 31 1B, opposite the internal side wall 31 1A, and therefore oriented opposite the outside of the frame 31. The frame 31 therefore advantageously comprises a side wall 315, preferably closed on itself, which defines said inner 31 IA and outer 31 IB side walls. 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 which open out of the inner 31 IA and outer 31 IB side walls, for example in order to reduce the weight of the frame 31.

[0043] According to a variant, the first and second openings 314A, 314B of the frame 31 have identical free sections. In this case, the internal 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 of direction parallel to said elevation direction B-B' of the internal side wall 31 IA (Figures 1, 3 to 8). According to another variant, the first and second openings 314A, 314B of the frame 31 have free sections that are different from each other. For example, the free section of the first opening 314A of the frame 31 is greater 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. transverse section, considered in a plane orthogonal to the direction B-B' of elevation of the internal lateral wall 31 IA) which is constant along the direction B-B' of elevation of the internal lateral wall 31 IA (FIGS. 1, 3 to 8). In this case, as envisaged 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 direction B-B' of elevation of the internal side wall 31 IA (figures 1, 3 to 8), due to the fact that the first and second openings 314A, 314B of the frame 31 have free sections that are different from each other and / or due to the fact that the internal side wall 31 IA of the frame 31 defines a zone of narrowing of the free section of the housing 312.

[0045] Preferably, the frame 31 has a rectangular external shape, and in particular a square shape, the (four) external angles of which 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 with 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, the (four) internal angles of which 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 with internal dimensions Dil x Di2 (the first and second internal dimensions Dil, Di2 being considered according to di . orthogonal sections between them). Thus, as in the examples illustrated in the figures, the frame 31 can advantageously have four sides, the side wall 315 of the frame 31 advantageously comprising four wall portions, defined by said internal 311A ​​and external 311B side walls, which extend generally parallel to each other two by two and which thus delimit said housing 312.

[0046] As visible in [Fig.l], the containers 2 are arranged in the housing 312 of the frame 31 with their main extension directions A-A' oriented parallel to each other and to the elevation direction B of the internal lateral wall 31 IA of the frame 31. The frame 31, and in particular the internal lateral wall 31 IA of the latter, therefore laterally surrounds the containers 2. 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 return, 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 envelope 32 which covers, that is to say which envelops, the frame 31 and the containers 2 to immobilize the latter relative to the frame 31 and which is in direct contact with the bottom 21 of the containers 2. The flexible envelope 32 therefore covers, preferably completely, the frame 31 and the containers 2 and keeps the containers 2 substantially immobile in position in the housing 312 of the frame 31. Advantageously, the flexible envelope 32 is closed. Typically, the flexible envelope 32 is formed from at least one flexible film, for example made of synthetic material. As will be detailed later, the flexible envelope 32 may be multi-layered, and for example formed from a plurality of layers 321, 322, 323, 324 of flexible envelope, preferably distinct and separable from one another, which are arranged to overlap one another.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 internal face 32A which is advantageously pressed on the one hand against the frame 31, and on the other hand against the containers 2 on either side of said 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 said containers 2 are thus immobilized in the packaging 3.

[0048] The packaging 3 is therefore in particular devoid of a frame bottom 31 or even of a tray separate from said frame 31, which would be interposed between the bottom 21 of the containers 2 and the flexible envelope 32, a portion (or “lower portion”) of the flexible envelope 32 which is arranged opposite the bottoms 21 of the containers 2 therefore forming a support against which the bottoms 21 of the containers 2 are in direct support. Another portion (or "upper portion") of the flexible envelope 32 which is arranged opposite the openings 23 of the containers 2 advantageously exerts in return, directly or indirectly, a force against the upper ends of the containers 2, so that the latter are therefore kept immobile in position relative to the frame 31 which surrounds them laterally. For example, the immobilization of the containers 2 by the flexible envelope 32 can be ensured by the fact that the enclosure formed by the flexible envelope 32 is placed under vacuum as will be seen in the following (that is to say at an internal pressure which is strictly lower than an external pressure of the atmosphere outside the flexible envelope 32), or even by the fact that the flexible envelope 32 is formed of at least one flexible heat-shrinkable plastic film which has been arranged and then thermally shrunk 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 having its own mechanical strength, and which therefore does not deform significantly under the weight of the containers 2.

[0049] The set 1 of packaged containers 2 according to the invention is thus of particularly simple and effective design. The combination of the frame 31 and the flexible envelope 32 ensures easy handling of the set 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 set 1 of packaged containers 2 according to the invention allows particularly simple and rapid unloading (unpacking) of the packaged containers 2. Indeed, the unloading of the containers 2 can then be carried out, after having placed the set 1 of packaged containers 2 on a substantially horizontal flat support (for example an unloading table) with the bottoms 21 of the containers 2 oriented in the direction of said flat support, - by cutting the flexible envelope 32, preferably following a cutting direction which laterally follows at least a portion of the external lateral wall 31 IA of the frame 31 (and advantageously at the level of a portion of said external lateral wall 31 IA from which a first portion 318A of the provided gripping member projects, as envisaged below), to thus provide in the flexible envelope 32 an opening of sufficient size to allow the frame 31 to pass through said opening, - then by gripping the frame 31 and extracting the latter from the cut-out flexible envelope 32, via said opening, by a relative sliding in translation of the frame 31 and the cut-out flexible envelope 32 (typically by keeping the frame 31 stationary relative to the support and by pulling on the cut-out flexible envelope 32), - then by extracting the containers 2 from the housing 312 of the frame 31, either via the first opening 314A of the frame 31 by lifting the frame 31 and moving the latter away from the containers 2 in an upward movement in a direction advantageously parallel to the direction A-A' of the containers 2, or via the second opening 314B of the frame 31 by raising the containers 2 relative to the frame 31 using a plate arranged under the bottoms 21 of the containers 2, of dimensions smaller than the respective dimensions of the housing 312 of the frame 31, and pushed into said housing 312 via the first opening 314A for access to the latter in an upward movement in a direction advantageously parallel to the direction A-A' of main extension of the containers 2.

[0051] Thus, all of 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 the latter when they are unloaded manually by an operator. The frame 31 advantageously plays a dual role as a packaging element and as a tool for unloading the containers 2, so that it is therefore not necessary to use a complex external tool to unload the containers 2. It should be noted here that the rigid nature of the frame 31, in addition to contributing to reliable and effective immobilization of the containers 2 in the packaging 3, and to protection of the containers 2 against lateral impacts, also makes it easier to extract the containers 2 from the cut-out flexible envelope 32, since the frame 31 does not deform substantially when it is grasped and extracted from the cut-out flexible envelope 32.Moreover, in the absence of a bottom or packaging tray between the bottom 21 of the containers 2 and the flexible wrapper 32, only the thickness of the latter (or at least of at least one of the layers of the flexible wrapper 32) is likely to form a "step" to be overcome by the containers 2 when they are removed from the flexible wrapper 32. This step can thus 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 due to collisions between them and / or with the underlying flat support is particularly low. In addition, as explained further below, the design of the assembly 1 of packaged containers 2 advantageously allows a significant reduction in the mass of packaging material, especially in relation to the respective mass of the containers 2 concerned, 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 on the environmental level in terms of managing the waste generated when unloading the containers 2.

[0052] Advantageously, the frame 31 has predefined fixed dimensions, and therefore cannot be modified or adjusted. In particular, the housing 312 of the frame 31 therefore has predefined fixed dimensions, and therefore cannot be modified or adjusted. As such, the frame 31 advantageously forms a monolithic, single-piece part. 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 therefore of the set 1 of packaged containers 2.

[0053] Advantageously, said 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 more preferably between 150 mm and 220 mm, in order in particular to limit the size of the frame 31, and therefore of the set 1 of packaged containers 2, and to facilitate handling, transport and / or storage thereof. Such external dimensioning of the frame 31 also advantageously contributes to the robustness of the set 1 of packaged containers 2.Advantageously, said first and second minimum internal dimensions Dil, Di2 are each chosen to be between 120 mm and 420 mm, which makes it possible in particular to optimize the number of containers 2 contained in said assembly 1 (as a function of a nominal value of the external diameter of the body of the containers 2 and minimum and maximum dimensional tolerances), and therefore to give said assembly 1 a particularly economical appearance, while nevertheless 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 material, for example polycarbonate (PC) or polypropylene (PP), which makes it possible to obtain a good compromise between the mechanical strength of the frame 31 and its weight, and also makes it possible to ensure a relatively low manufacturing cost. Even more preferably, the frame 31 preferably forms a monolithic injection-molded or thermoformed part, which thus gives it a particularly smooth surface appearance, thus limiting the risk of abrasion of the internal side wall 31 1A of the frame 31 by friction against the containers 2, and therefore the risk of generation of foreign particles likely to be introduced into the containers 2.

[0055] Advantageously, the housing 312 of the frame 31 is dimensioned so that, the containers 2 being housed in the housing 312, the latter has a minimum useful section (considered in a plane orthogonal to the direction B-B' of elevation of the internal lateral wall 31 IA of the frame 31) having a void rate of between 1% and 80%, and preferably between 4% and 60%. Depending in particular on the external diameter of the number of containers 2, the void rate therefore corresponds to the portion of the total minimum useful section of the housing 312 of the frame 31 which is not occupied by the re containers 2. By “minimum useful section” is here advantageously meant the smallest useful section that the housing 312 has when it is empty of containers, considered in a plane orthogonal to the direction B-B' of elevation of the side wall internal 31 IA of the frame 31, and which therefore defines said first and second minimum internal dimensions Dil, Di2. Such a void rate 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 a portion of the containers 2 arranged in the housing 312 is in direct contact with at least a portion of the internal side wall 31 1A of the housing 312. This makes it possible in particular to further improve the holding of the containers 2 immobile relative to the frame 31 using the flexible envelope 32.

[0057] The frame 31, and in particular the internal side wall 31 IA of the latter, 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 said containers 2 respectively have along their direction A-A' of main extension (said total height h therefore corresponding to the distance between the lower end and the upper end of each container 2 along the direction A-A' of main extension of the latter). The containers 2 are advantageously each arranged in the housing 312 of the frame 31 with - their lower end positioned flush with the first opening 314A for access to the housing 312, i.e. inscribed in the first opening plane, or beyond the first opening 314A for access to the housing 312, and therefore outside the housing 312, and - their upper end positioned flush with the second opening 314B for access to the housing 312, i.e. inscribed in the second opening plane, or beyond the second opening 314B for access to the housing 312, and therefore outside the housing 312.

[0058] Such a configuration advantageously contributes to a reliable immobilization of the containers 2 relative to the frame 31 by the flexible envelope 32 which covers the latter. 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 the latter are each arranged in the housing 312 of the frame 31 with - their lower end (and therefore their bottom 21) positioned flush with the first opening 314A for access to said housing 312, or beyond the first opening 314A for access 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 for 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%, more preferably at least equal to 30%, more preferably at least equal to 40%, more preferably at least equal to 50%, of the total height h of the containers 2, which advantageously contributes to firstly guaranteeing good immobilization of the containers 2 relative to the frame 31 using the flexible envelope 32, then to subsequently limiting the risk of containers 2 colliding, or even tipping, during 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 1B of the frame 31, extending between said first peripheral edge 313A and said opposite second peripheral edge 313B (and preferably again from the first peripheral edge 313A to the second peripheral edge 313B) in a direction preferably parallel to said elevation direction B-B' of the frame 31. Alternatively, or preferably in a complementary manner, the frame 31 preferably has at least one horizontal reinforcing rib 317, which projects from the external side wall 31 1B of the frame 31, preferably along the entire periphery of the latter, said horizontal reinforcing rib 317 being advantageously inscribed in a plane orthogonal to the elevation direction B-B' of the frame 31.Thus, the frame 31 can, for a limited quantity of material, nevertheless have excellent mechanical robustness, and in particular excellent rigidity. Advantageously, said 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 involuntary interaction with the containers 2, likely to damage and / or contaminate the latter (in particular in the case where the containers 2 are sterile), the frame 31 advantageously comprises a member for gripping the frame 31 which is arranged projecting from the external side wall 311B of the latter, and which is therefore advantageously distinct from the side wall 315 of the frame 31.Said gripping member is thus in particular designed and configured at least to allow the exercise, by its intermediary, of an external force either of keeping the frame 31 substantially immobile, or of traction against the frame 31, in particular during an operation of separating the frame 31 and the containers 2 from the flexible envelope 32 (or at least one of the layers 321-324 of flexible envelope 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 . external side wall projection 31 IB thus allows in particular a gripping of the frame 31 at a distance from the containers 2 arranged in the housing 312 of the latter, and advantageously by a lateral approach route, that is to say without having to place a gripping means, whether it is a human hand or a mechanical gripper (for example of the clamp type), above the upper end of the containers 2, and therefore their openings 23. Advantageously, the gripping member is integral with the external side wall 31 IB of the frame 31, so that the gripping member and the external side wall 31 IB therefore 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 its intermediary, of an external force which is either a force for holding the frame 31 stationary, or a tensile force against the frame 31 in a direction orthogonal to the direction B-B' of elevation of the internal lateral wall 31 1A of the frame 31, in particular during an operation of separating the frame 31 and the containers 2 from the flexible envelope 32 (or from at least one of the layers 321-324 of flexible envelope of the latter).For example, as in the embodiment illustrated in the figures, the first portion 318A of the gripping member may be formed by a (first) gripping tab, which therefore projects from the external lateral wall 311B 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 gripping tab therefore advantageously has sufficient dimensions to be able to be firmly grasped between the fingers of a hand or by a pair of pliers of a mechanical gripping means. The first portion 318A of the gripping member advantageously extends over at least part of the periphery of the external side wall 311B 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 moving 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 gripping member can 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 direction B-B' of elevation of the frame 31), in order to thus facilitate the gripping and manipulation of the frame 31 by means of the first portion 318A of gripping member.

[0063] As in the examples illustrated in the figures, said gripping member is in furthermore advantageously designed and configured to allow the exercise, by its intermediary, 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 from the housing 312 of the frame 31 by lifting the latter. In this respect, said gripping member preferably further comprises at least two gripping member portions 318B, 318C (second and third gripping member portions 318B, 318C), which are positioned diametrically opposite and which are designed and configured to allow the exercise, by their intermediary, of such an external upward traction force against the frame 31 in a direction having at least one component parallel to the elevation direction B-B' of the internal lateral 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, makes it possible to facilitate and make more reliable such an operation of extracting the containers 2 from the housing 312 of the frame 31 by lifting the latter, by limiting the risk of overturning the containers 2. For example, as in the embodiment illustrated in the figures, said second and third gripping member portions 318B, 318C may each be formed by a (second or third) gripping tab, which therefore projects from the external lateral wall 311B of the frame 31, and advantageously extends along a mean plane substantially orthogonal to the elevation direction B-B' of the frame 31. Said second and third gripping tabs therefore advantageously have sufficient dimensions to be able to be engaged, grasped, by fingers of one hand or by a mechanical means of grasping.Each of said second and third gripping tabs advantageously extends over at least part of the periphery of the external side wall 311B 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 gripping member portions 318B, 318C can advantageously each extend continuously along at least a third, preferably at least half, and more 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 thus facilitate gripping and handling of the frame 31 by means of said second and third gripping member portions 318B, 318C).Even more advantageously, said second and third portions 318B, 318C of the gripping member extend respectively, from the external side wall 311B of the frame 31 and away from the latter, over a substantially constant width L2, L3. When, as in the examples illustrated in the figures, the frame 31 is rec . tangular, the gripping member may advantageously comprise a pair of said second and third gripping member portions 318B, 318C, so that each of the four sides of the frame 31 is thus provided with a second or third gripping member portion 318B, 318C, which contributes to further facilitating gripping and handling of the frame 31. Preferably, the second and third gripping member portions 318B, 318C are of identical widths L2, L3. Preferably, in order to simplify the design and manufacture of the frame 31, one of said second and third gripping member portions 318B, 318C is merged with, or formed by, said first gripping member portion 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 may be formed by a gripping tab, as described above, which extends from the external 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 may each be formed by a gripping tab, as described above, which extends from the external 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 makes it possible to obtain good mechanical strength of the gripping tab(s), while maintaining a limited mass.

[0066] According to a variant, visible in figures 1 to 7, the first, second and third 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 member of the frame 31 may comprise at least one pair of second and third portions 318B, 318C of the gripping member, the second portion 318B of which is formed by the first portion 318A of the gripping member, the first portion 318A of the gripping member having a width L1 greater than, and for example twice greater than, the width L3 of the third portion 318C of the gripping member.This advantageously makes it easier to grip and manipulate the frame 31 by means of the first portion 318A of the gripping member, in particular during an operation of separating 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 allows in particular a reduction in the mass of the frame 31, without however negatively impacting the mechanical strength of the gripping member and / or of the horizontal reinforcing rib 317.Even more advantageously, when said first portion 318A of the gripping member forms a gripping tab, the or at least one of the through openings 319 is configured and dimensioned to allow the introduction of at least part of a finger of a human hand (possibly gloved) into the through opening(s) 319, in order to thus facilitate the exercise of said external force of holding stationary or traction against the frame 31 when unpacking the containers 2.

[0068] According to a variant, implemented in the exemplary embodiment illustrated in [Fig.l], the packaging 3 is devoid of an element for physically separating the containers 2 from each other in the housing 312 of the frame 31. Thus, the housing 312 of the frame 31 is therefore occupied only by the containers 2, which can be in contact with each other. According to another variant, not illustrated, the packaging 3 on the contrary comprises one or more elements for physically separating the containers 2 from each other in the housing 312 of the frame 31, to thus avoid direct contact between adjacent containers 2. The physical separating element(s) may, for example, form crosspieces defining cells each receiving one of the containers 2, the walls of said cells thus being interposed between the side walls 22 of adjacent containers 2.Preferably, the physical separation element(s) are integral with the frame 31, for example forming with the latter a monolithic, and therefore unique, part, which contributes in particular to facilitating the design of the packaging, as well as 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 the unloading of the latter. Preferably, the physical separation element(s) extend, in the direction B-B' of elevation 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 in said direction B-B' of elevation, so as to guarantee good immobilization of the containers 2 by the flexible envelope 32 relative to the frame 31.

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

[0070] As in the examples illustrated in Figures 1 to 8, the frame 31 can advantageously have a transverse plane Pt, which is orthogonal to the direction B-B' of elevation of the internal lateral wall 31 IA of the frame 31, which preferentially forms a plane of symmetry of the frame 31. This contributes to further simplifying 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 may advantageously be designed and configured to be stacked in a stable manner, 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, in particular in a context of high-speed production on an industrial scale, by facilitating a step of providing a frame 31. This also makes it possible to facilitate a subsequent step of storing frames 31, by stacking frames 31 on top of each other, in the context 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 “stepped”) which allows - a fitting of a first part (or “lower part”) of the frame 31 which extends from the first peripheral edge 313A in the direction of the second peripheral edge 313B, on - and overlapping - a second part (or “upper part”) of another identical frame 31' which extends from the second peripheral edge 313B' in the direction of the first peripheral edge 313A' of this other frame 31', so that this part is arranged in the housing 312 of the frame 31, and - a fitting of a second part (or “upper part”) of the frame 31 which extends from the second peripheral edge 313B in the direction of the first peripheral edge 313A, in the housing 312” of another identical frame 31”, a first part (or “lower part”) of this other 31” frame,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 envelope 32, and in particular the internal face 32A of the latter, is in direct contact with the upper ends 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, said upper portion of the flexible envelope 32 therefore directly exerts a force against the upper ends of the containers 2 to immobilize the latter in the frame 31. Alternatively, the packaging 3 may comprise a flexible interlayer sheet, for example made of plastic, which is interposed between the internal face 32A of the flexible envelope 32 and the upper ends of the containers 2, thus covering the openings 23 of the latter, for example to limit a risk of introduction of foreign particles into the internal cavities 24 of the containers 2 during the unloading of the latter. In this case, the upper portion of the flexible envelope 32 therefore indirectly exerts a force against the upper ends of the containers 2 to immobilize the latter in the frame 31.

[0074] A portion (or “lateral portion”) of the flexible envelope 32, which is arranged opposite the external lateral wall 31 1B of the frame 31, is preferably in direct contact with the frame 31, and even more preferably along the entire external periphery of the frame 31. In other words, at least part of an internal face portion 32A defined by said lateral portion of the flexible envelope 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 therefore being advantageously devoid of a physical element, distinct and separable from the frame 31, which would be interposed between the frame 31 and said lateral portion of the flexible envelope 32.In addition to the fact that this contributes to simplifying the design and manufacture of the packaging 3 and more generally of the set 1 of packaged containers 2, this also makes it easier to unload the containers 2, by facilitating access to the frame 31 after opening the flexible envelope 32.

[0075] The flexible envelope 32 has a total thickness (i.e. all layers 321, 322, 323, 324 included where applicable) which is preferably between 50 μm and 800 μm, and even more preferably between 80 μm and 360 μm, which contributes to minimizing the “step” that the flexible envelope 32 is likely to form when unloading the containers 2, while still making it possible to reliably and robustly ensure the immobilization of the containers 2 in the frame 31 of the set 1 of packaged containers 2 before unloading.

[0076] According to a preferred variant, implemented in the exemplary embodiments illustrated in the figures, the containers 2 are sterile, that is to say that they are advantageously free of any viable microorganism. The set 1 of packaged containers 2 then constitutes a set 1 of packaged sterile containers 2. The containers 2 may, as such, have been subjected to a sterilization treatment. Advantageously, the term “sterile” is understood here and in what follows to mean a guaranteed level of sterility (or “Sterility Assurance Level” (SAL)) of 106. More preferably, the containers 2 are also apyrogenic, that is to say they are advantageously free of bacterial endotoxins. Said containers 2 may, as such, have been subjected to a depyrogenation treatment, typically in accordance with the requirements of the European and American pharmacopoeias in force. Thus, the set 1 of packaged containers 2 is particularly well suited to a pharmaceutical or medical application of the containers 2. Advantageously, the frame 31 is also sterile, as are any physical separation elements of the containers 2 and any flexible interlayer sheet, so as to avoid contamination of the containers 2 by one or other of the latter.

[0077] Advantageously, the internal cavities 24 of the containers 2 are free of foreign particles, and in particular of solid particles (glass particles, metal particles, etc.). Said containers 2 may, as such, 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) so-called internal layer 321, which defines a first enclosure in which the frame 31 and the containers 2 are housed, said first internal layer 321 being in direct contact with the bottom 21 of the containers 2, said first enclosure being sterile, and - at least one (first) so-called external layer 322, which covers said first internal layer 321 and defines a second enclosure containing said first enclosure, said first external layer 322 being impermeable to gases, said first and second enclosures being placed under vacuum.

[0079] An internal face of the first internal layer 321, therefore oriented opposite the frame 31 and the containers 2, therefore forms the aforementioned internal face 32A of the flexible envelope 32. The first internal layer 321 therefore constitutes the innermost layer of the flexible envelope 32. Advantageously, the first internal layer 321 forms a flexible envelope layer called a “sterile barrier”, capable of ensuring preservation of the sterile nature of said first enclosure that it defines and of its contents. The first external layer 322 advantageously forms a flexible envelope layer called a “protective” layer aimed at protecting the physical integrity of the first internal layer 321 against external attacks and / or contamination.

[0080] Preferably, the first outer layer 322 is separable from the first inner layer 321, so that it is possible to first separate 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), then to separate the first internal 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 envelope 32 and the frame 31 and containers 2 during the unloading of the containers 2 can be carried out sequentially, so as to limit a risk of contamination of the containers 2 by a contaminant which could be carried by the first external layer 322.

[0081] Said first and second enclosures being placed under vacuum, it is understood that at least said second enclosure (and preferably each of said first and second enclosures) is therefore closed. In addition, an internal face of the first external layer 322 is therefore thus pressed (possibly indirectly, as envisaged below) against an external face of the first internal layer 321.

[0082] Advantageously, as in the exemplary embodiment illustrated in [Fig.l], the flexible envelope 32 comprises a second inner layer 323, which covers said first inner layer 321, and which is interposed between the latter and said first outer layer 322. Distinct 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 external layer 322 may advantageously not be sterile, the sterile nature of the third enclosure defined by the second internal layer 323 guaranteeing sterility of the external face of the first internal layer 321. This thus advantageously allows final unloading of the containers 2 with a view to filling them under aseptic conditions.

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

[0084] Preferably, the first internal layer 321, as well as more preferably still said second internal layer 323, has(have) at least one portion which is permeable to gases, and therefore in particular to at least one sterilization gas (i.e. a gaseous fluid capable of causing sterilization of an element with which it is brought into contact, such as for example ethylene oxide or water vapor). The manufacture of the set 1 of packaged (sterile) containers 2 is thus facilitated, since it is thus 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 of the latter, and of the internal and external faces of the first internal layer 321, by introducing a sterilization gas into the first enclosure (and preferably into the third enclosure) via the portion(s) of internal layer permeable to gases. Then, the first internal layer 321, and even more preferably the second internal layer 323, can then be covered by the first internal layer 321, before the vacuum is created in the third enclosure, thus causing the first, second and third enclosures to be placed under a vacuum simultaneously.

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

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

[0087] Advantageously, the second outer layer 324 is impermeable to gases, and said fourth enclosure is placed under vacuum, so that an internal face of the second outer layer 324 is pressed, advantageously in direct contact, against the external face of the first outer layer 322. This makes it possible to further improve the reliability of the immobilization of the containers 2 in the frame 31, and to reinforce the rigidity and compactness of the set 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] Otherwise considered, 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 above that, while the first inner layer 321 (and where appropriate, the second inner layer 323) has (have) as its main role to guarantee the sterility of the packaged containers 2, the first outer layer 322 (and where appropriate, the second outer layer 324) therefore has (have) in particular the role of ensuring the immobilization of the packaged containers 2. It is further understood from the above that, in the case where the flexible envelope 32 comprises a plurality of layers 321-324 of flexible envelope each of the layers 321-324 of flexible envelope forms, as such, a flexible envelope.

[0090] Advantageously, the first internal layer 321, as well as preferably said second internal layer 323 if 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 from 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 the company DUPONT DE NEMOURS, which forms said gas-permeable portion.

[0091] Advantageously, the first external layer 322, as well as preferably the second external layer 324 where appropriate, is (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 even of several layers of polyethylene (PE) and ethylene vinyl alcohol (EVOH) with a total thickness advantageously between 70 μm and 120 μm.

[0092] By "under vacuum" or "placed under vacuum", it is advantageously meant that the internal pressure prevailing inside the enclosure(s) concerned is strictly lower than an external pressure of the atmosphere outside the flexible envelope 32. Preferably, the internal pressure, expressed as absolute pressure, is between 20 mbar and 100 mbar (i.e. between 2.106 Pa and 1.107 Pa). By "impermeable to gases", it is advantageously meant that the layer(s) concerned form(s) a barrier gas-tight, namely to "pure" gases or gas mixtures, and in particular to air and water vapor, and with the possible exception of hydrogen H2 and helium He. A gas-tight character advantageously induces a liquid-tight character.

[0093] Thanks to the particular design of the packaging 3 described above, and in the case where the frame 31 is made of plastic, the mass of plastic (excluding the flexible envelope) that the packaging 3 comprises ultimately turns out to be significantly lower than that of known packaging systems of the “tray” or “nest and tub” type. Indeed, it has been observed that, for 64 identical containers of the bottle type with a nominal capacity of 20 ml, the frame 31 can have a mass of 130 g, or 2.03 g of plastic per container. This typically represents a reduction of around 74% per container compared to a conventional “nest and tub” system, and of around 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 bottom 21, from which a side wall 22 of the container 2 extends in a direction A-A' of main 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 are advantageously in accordance with 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 advantageously applies mutatis mutandis to the containers 2 concerned by the method according to the invention.The method according to the invention advantageously constitutes a method for manufacturing a set 1 of packaged containers 2 in accordance with the invention, such as the latter has been described above. Thus, the description given above of the set 1 of packaged containers 2 advantageously applies mutatis mutandis to the method according to the invention, and reciprocally the description given below of the method according to the invention advantageously applies mutatis mutandis to the set 1 of packaged containers 2 according to the invention.

[0096] Preferably, the method for packaging containers 2 is an automated method, thus advantageously making it possible to manufacture a large number of sets 1 of packaged containers at a high rate. Thus, the steps of the method 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: supply of a plurality of said containers 2; - Step 2: providing a rigid frame 31 comprising an internal side wall 31 IA which delimits a housing 312 and which extends in an elevation direction B-B' from a first peripheral edge 313A defining a first opening 314A for access to said housing 312 to a second opposite peripheral edge 313B defining a second opening 314B for access to said housing 312; - Step 3: arrangement of the containers 2 in said housing 312 of the frame 31 with their main 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 inte generally, the frame 31 and the containers 2 to immobilize the latter relative to the frame 31, and which is in direct contact with the bottom 21 of the containers 2.

[0099] The method according to the invention thus makes it possible to package containers 2 in a simple, rapid and efficient manner, and to advantageously obtain, in a simple and efficient manner, a set 1 of packaged containers 2 in accordance with the invention, as described above, and thus having the various aforementioned advantages.

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

[0101] The frame 31 provided during Step 2 is advantageously in accordance with the description given above in connection with 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 provided during Step 2 of the method according to the invention. As mentioned previously, as in the examples illustrated in Figures 9 to 13, the frame 31 can be advantageously designed and configured to be stacked in a stable manner, for example by nesting, on at least one other identical frame 31 ([Fig. 11]). In this case, Step 2 advantageously comprises an operation of removing the frame 31 from a stack of frames 31 stacked on top of each other.

[0102] Advantageously, the frame 31 is manufactured upstream of Step 2, then is supplied during Step 2, under filtered laminar flow, typically obtained at least with a HEPA filter of grade H14 according to the EN 1822 standard and the ISO 14644 standard for the design, classification and testing of clean environments. In this way, it is not thus advantageously it is not necessary to wash the 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 in accordance with 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 angles of which are preferably rounded, chamfered, and defined by a first minimum internal dimension Di1 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 an element for physical separation 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 an element for physical separation of the containers 2 from each other in the housing 312).

[0104] Indeed, these seven specific dimensions of the housing 312 of the frame 31 advantageously make it possible to optimally frame a large number of the 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 the 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 containers 2 of the bottle type with a nominal external diameter of approximately 25.4 mm, 50.8 mm or 75.4 mm, and with a respective nominal capacity of 10 ml, 150 ml and 500 ml, it is advantageous to retain first and second minimum internal dimensions Dil, Di2 such that Dil = Di2 = 184 mm ± 2 mm. Indeed, it is then advantageously possible to package in the same frame 31 respectively 49, 9 or 4 identical containers 2, in the absence of a physical separation element of the containers 2 from each other.

[0106] For containers 2 of the bottle type with a nominal external diameter of approximately 22 mm, 32 mm or 49 mm, and with a respective nominal capacity of 5 ml, 20 ml and 100 ml, it is advantageous to retain first and second minimum internal dimensions Dil, Di2 such that Dil = Di2 = 203 mm ± 2 mm. Indeed, it is then advantageously possible to package in the same frame 31 respectively 64, 36 or 16 identical containers 2, in the absence of a physical separation element of the containers 2 from each other.

[0107] For containers 2 of the bottle type with a nominal external diameter of approximately 20.8 mm, 46 mm or 60.3 mm, and a respective nominal capacity of 5 ml, 50 ml and 250 ml, it is advantageous to retain first and second minimum internal dimensions Dil, Di2 such that Dil = Di2 = 198 mm ± 2 mm. Indeed, it is then advantageously possible to package in the same frame 31 respectively 81, 16 or 9 identical containers 2, in the absence of a physical separation element of the containers 2 between them.

[0108] According to a variant, Step 3 is carried out by arranging the containers 2 in the housing 312 of the frame 31 after the latter has been placed in a stable manner 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 opposite 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 motionless 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 relative to the containers 2.

[0109] Advantageously, the frame 31 is provided 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 by means of the second and third portions 318B, 318C of the gripping member of the frame 31, as described previously. This makes it possible to limit the risk of contact of an operator or a mechanical gripping means, handling the frame 31 during Step 2 and / or Step 3, with the internal side wall 31 IA of the frame 31 and / or with the containers 2, likely to damage or contaminate said internal side wall 31 IA and / or said containers 2.

[0110] Typically, Step 4 of manufacturing the flexible envelope 32 comprises providing at least one flexible film, for example made of synthetic material, and forming the flexible envelope 32 from said flexible film. Step 4 thus consists of manufacturing said flexible envelope 32, so that the latter covers, that is to say envelops, 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 set 1 of packaged containers 2 according to the invention, the flexible envelope 32 can be multi-layer, and for example formed from a plurality of layers 321, 322, 323, 324 of flexible envelope, preferably distinct and separable from one another, which are arranged to overlap one another.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. has an internal face 32A which is advantageously pressed on the one hand against the frame 31, and on the other hand 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 relative to the frame 31.

[0111] In view of the above, it is understood that the method according to the invention is therefore devoid of a step of providing a frame bottom 31 or even a tray separate from the frame 31, which would be intended to be interposed between the bottom 21 of the containers 2 and the flexible envelope 32, since at the end of Step 4, a portion (or “lower portion”) of said flexible envelope 32 which is arranged opposite the bottoms 21 of the containers 2 therefore forms a support against which the bottoms 21 of the containers 2 are in direct contact. Another portion (or “upper portion”) of the flexible envelope 32 which is arranged opposite the openings 23 of the containers 2 advantageously exerts in return, directly or indirectly, a force against the upper ends of the containers 2, so that the latter are therefore kept immobile in position relative to the frame 31 which surrounds them laterally.

[0112] For example, the immobilization of the containers 2 by the flexible envelope 32 can be ensured by a vacuum of the enclosure formed by the flexible envelope 32 as will be seen in the following (that is to say at an internal pressure which is strictly lower than an external pressure of the atmosphere outside the flexible envelope 32), or even by a thermal retraction around the frame 31 and the containers 2 of at least one flexible heat-shrinkable plastic film from which the flexible envelope 32 is formed in this case. Thus, Step 4 makes it possible to obtain a set 1 of packaged containers 2 which forms a compact and substantially rigid article, that is to say having a specific mechanical strength, and which therefore does not deform under the weight of the containers 2.The set 1 of packaged containers 2 obtained thus comprises a packaging 3 and a plurality of containers 2 housed inside the packaging, which packaging 3 comprises the rigid frame 31 and the flexible envelope 32 (but is on the other hand devoid of a frame base 31 or even 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 variant, the method according to the invention constitutes, more specifically, a method for manufacturing a set 1 of sterile packaged containers 2 (according to the definition of “sterile” already given previously), and in particular a set 1 of sterile packaged containers 2.

[0114] In this respect, Step 4 of manufacturing the flexible envelope 32 preferably comprises an operation of manufacturing at least a first internal layer 321 of the flexible envelope 32 which defines a first enclosure in which the frame 31 and the containers 2 are housed, the first internal layer 321 being in direct contact with the bottom 21 of the containers 2, said first internal layer 321 having at least one portion which is permeable to gases. Step E4 then advantageously comprises at least one operation of sterilizing said first enclosure defined by the first internal layer 321, by introducing a sterilizing gas into said first enclosure via said gas-permeable portion of the first internal layer 321. Then, Step E4 advantageously comprises an operation of manufacturing at least one first external layer 322, which covers said first internal layer 321, and which defines a second enclosure containing said first enclosure, said first external layer 322 being impermeable to gases.Subsequent to this operation, step E4 then advantageously comprises an operation of placing the first and second enclosures under vacuum, to thus press the first internal layer 321 and first external layer 322 against the frame 31 and the containers 2 and thereby ensure the immobilization of the latter relative 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 first separate the first outer layer 322 from the first inner layer 321 (typically after having opened the second enclosure, by cutting or tearing the first outer layer 322), then to subsequently 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 previously 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 previously 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 internal layer 323 of the flexible envelope 32, which covers the first internal layer 321 and which defines a third enclosure containing the first enclosure, the second internal layer 323 being distinct and separable from the first internal layer 321 and being interposed between the first internal layer 321 and the first external layer 322, the second internal layer 323 having at least one portion which is permeable to gases; - at least one operation of sterilizing the third enclosure by introducing a sterilizing gas into the third enclosure via said gas-permeable portion of the second internal layer 323; and - an operation to vacuum the first, second and third enclosures.

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

[0119] Preferably, Step 4 comprises an operation of closing the first enclosure, which is carried out before the operation of sterilizing the first enclosure, and where appropriate before the operation of manufacturing the second internal layer 323. Preferably, Step 4 comprises an operation of closing the third enclosure, which is carried out before the operation of sterilizing the third enclosure. It is further understood that Step 4 advantageously comprises an operation of closing the second enclosure, in a gas-tight manner, in order to maintain the latter under vacuum at the end of the operation of placing the second enclosure under vacuum.

[0120] It is possible to first carry out the sterilization operation of the first enclosure, then subsequently the sterilization operation of the third enclosure. However, it proves simpler and faster to carry out these two sterilization operations concomitantly, that is to say by introducing a treatment gas into the third enclosure, the treatment gas then also penetrating into the first enclosure via the gas-permeable portion of the first internal layer 321.Said gas-permeable portion of the first internal layer 321, as well as more advantageously still said gas-permeable portion of the second internal layer 323, is (are) preferably positioned opposite the openings 23 of the containers 2, so as to allow rapid and effective sterilization of the containers 2 using the sterilization gas, and therefore to facilitate and make reliable the implementation of the method, and thus the manufacture of the set 1 of packaged containers 2.

[0121] Preferably, the sterilizing gas or gases 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 from material(s) resistant to such sterilization with ethylene oxide (EtO) or steam. For sanitary and environmental reasons, it is even more preferable to choose steam sterilization. Typically, the operation or operations sterilization can be carried out by subjecting the containers 2 and the frame 31, wrapped in the first internal layer 321 and, where appropriate, the second internal layer 323, placed in an autoclave, to water vapor. In any case, the absence of a frame bottom 31, or a tray, or even a frame "roof" 31, greatly facilitates the diffusion and circulation of the sterilization gas(es) inside the first housing enclosure, in particular in and between the containers 2, which contributes to excellent reliability of the sterilization carried out, and therefore to the safety of the containers 2.

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

[0123] Optionally, for the reasons set out above in connection with the set 1 of containers 2 packaged according to the invention, Step 4 may further comprise 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 and separable from the first outer layer 322. Advantageously, the second outer layer 324 is impermeable to gases, and Step 4 then comprises an operation of placing said fourth enclosure under vacuum (followed therefore by an operation of closing, in a gas-impermeable manner, said fourth enclosure). Alternatively, the second outer layer 324 could be formed by a flexible heat-shrinkable plastic film, and Step 4 could then comprise an operation of thermal shrinking the second outer layer 324 around the second enclosure.

[0124] Preferably, said first internal layer 321, as well as preferentially said second internal layer 322 where appropriate, is (are each) formed by a flexible plastic bag provided with an opening which gives access to the inside of the bag and which 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 bag. For example of the “Steribag” type, said (or each of said) bag(s) may be formed from 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 the company DUPONT DE NEMOURS, which forms said gas-permeable portion. Advantageously, the bag(s) are provided and implemented under H14 level filtered laminar flow, 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 in an ISO 7 atmosphere (according to the ISO 14644-1:2015 standard), 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 bag provided with an opening which gives access to the interior of the bag and which 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 bag.For example of the “Steribag” type, and preferably colorless and transparent, said (or each of said) pouch(es) may be for example formed from several layers of polyethylene and polyamide with a total thickness advantageously between 70 μm and 120 μm, or even from several layers of polyethylene (PE) and ethylene vinyl alcohol (EVOH) with a total thickness advantageously between 70 μm and 120 μm.

[0126] Preferably, said pocket(s) are arranged relative to the frame 31 during Step 4 so that the welded opening of the or each of the pockets extends longitudinally opposite a portion of the external lateral wall 31 1A of the frame 31 from which the aforementioned first portion 318A of the gripping member of the frame 31 projects.

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

[0128] Preferably, said method is devoid of steps of supplying and placing a flexible interlayer sheet, for example made of plastic, interposed between the internal 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, said upper portion of the flexible envelope 32 therefore directly exerts an effort against the upper ends of the containers 2 to immobilize the latter in the frame 31.

[0129] Alternatively, the packaging method may instead comprise: - a step of providing a flexible intermediate sheet, for example made of plastic, preferably 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 intermediate sheet to cover the openings 23 of the containers 2.

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

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

[0132] Preferably, the method comprises a step of depyrogenation of the containers 2, in order to obtain apyrogenic containers 2, i.e. free from bacterial endotoxins. Advantageously, said depyrogenation step is carried out before Step 3 (i.e. only said containers 2 are subjected to it), which makes it possible to use for the frame 31 and for the flexible envelope 32 materials which are not necessarily resistant to the temperature conditions necessary for depyrogenation, and which are therefore less expensive. Typically carried out in accordance with the requirements of the European and American pharmacopoeias in force, the depyrogenation step can be carried out for example by passing the containers 2 through a depyrogenation tunnel in which the containers 2 are subjected to a dry heat flow at a predefined temperature and for a predefined treatment duration.

[0133] Optionally, the packaging method may comprise 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 above only to facilitate understanding of the invention. These terms do not imply as such any notion of order or importance of the elements that they designate, nor any limiting technical character by particular, and could therefore possibly be omitted.

Claims

Claims

1. Set (1) of packaged containers (2), comprising a package (3) and a plurality of containers (2) housed inside 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 bottom (21), from which a side wall (22) of the container (2) extends in a direction (A-A') of main extension 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 set (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 (313A) defining a first opening (314A) for access to said housing (312) to a second opposite peripheral edge (313B) defining a second opening (314B) for access to said housing (312), said containers (2) being arranged in said housing (312) with their main extension directions (A-A') 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 envelope (32) which covers the frame (31) and the containers (2) for immobilize the latter relative 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, in which said flexible envelope (32) comprises - at least a first internal layer (321), which defines a first enclosure in which the frame (31) and the containers (2) are housed, said first internal layer (321) being in direct contact with the bottom (21) of the containers (2), said first enclosure being sterile, and - at least a 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 outer layer (322) preferably being separable of said first internal layer (321), said first and second enclosures being placed under vacuum.

3. Assembly (1) according to the preceding claim, in which the first internal layer (321) has at least one portion which is permeable to gases, 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 interposed 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, in which the second internal layer (323) has at least one portion which is permeable to gases, and which is preferably positioned opposite the openings (23) of the containers (2).

6. Assembly (1) according to any one of the preceding claims, in which 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 exertion of an external force either of keeping the frame (31) stationary, or of traction 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 allow the exertion 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 lateral wall (311 A) of the frame (31), one of said second and third gripping member portions (318B, 318C) being preferentially merged, or formed by, said first gripping member portion (318A).

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

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

10. An assembly (1) according to any preceding claim, wherein the frame (31) is made of plastic, for example polycarbonate or polypropylene, the frame (31) preferably forming a monolithic injection-molded or thermoformed part.

11. Assembly (1) according to any one of the preceding claims, in which said packaging (3) is devoid of an element for physical separation 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 elements for physically separating the containers from each other in the housing (312) of said frame (31).

13. 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 bottom (21), from which a side wall (22) of the container (2) extends in a direction (A-A') of main extension 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: providing a plurality of said containers (2); - providing a frame (31) comprising an internal side wall (311 A) which delimits a housing (312) and which extends in an elevation direction (B-B') from a first peripheral edge (313A) defining a first opening (314A) for access to said housing (312) to a second opposite peripheral edge (313B) defining a second opening (314B) for access to said housing (312); - arrangement of the containers (2) in the housing (312) with their main 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 - manufacturing a flexible envelope (32) which covers the frame (31) and the containers (2) to immobilize the latter relative to the frame (31), and which is in direct contact with the bottom (21) of said containers (2).

14. Method according to the preceding claim, in which 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) which are each chosen to be between 120 mm and 420 mm, and more preferably 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.

15. A method according to any one of claims 13 and 14, wherein the step of manufacturing the flexible envelope (32) comprises: - an operation of manufacturing at least a 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); - an operation of sterilizing said first enclosure by introducing a sterilizing gas into said first enclosure via said portion permeable to gas, or by ionizing irradiation; - an operation of manufacturing at least a first external layer (322), which covers said first internal layer (321), and which defines a second enclosure containing said first enclosure, said first external layer (322) being impermeable to gases; and - an operation of placing said first and second enclosures under vacuum.

16. Method according to the preceding claim, in which the step of manufacturing the flexible envelope (32) comprises: - an operation of manufacturing at least a second internal layer (323) of said flexible envelope (32), which covers said first internal layer (321) and defines a third enclosure containing said first enclosure, said second internal layer (323) being distinct and separable from said first internal layer (321) and being interposed between said first internal layer (321) and said first external layer (322), said second internal 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); - an operation of sterilizing said third enclosure by introducing a sterilizing gas into said third enclosure via the gas-permeable portion of the second internal layer (323), or by ionizing irradiation; and - an operation of placing said first, second and third enclosures under vacuum.

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