Patent ID: 12187490

DETAILED DESCRIPTION

General Description of the Packaging System

As shown inFIG.1, a packaging system100according to the present disclosure comprises a vessel10, a stack formed by a plurality of identical delivery trays20, each provided with receiving spaces21, stacked on top of one another parallel to the bottom10aof the vessel10, as well as a porous lid40placed on the opening of the vessel10to close it. The packaging system100can also comprise a cover30arranged on the top tray20″ of the stack. The vessel10containing the trays20, and closed by the porous lid40, is intended to be placed in at least one airtight bag (and generally two of these bags) in which the air has been evacuated in order to place the entire assembly under vacuum.

For the sake of clarity, it should be noted that, in the remainder of this description, the term “top tray20″” refers to the tray20of the stack located furthest from the bottom10aof the vessel10, and the term “bottom tray20′” refers to the tray located closest to the bottom10a.

Each of the trays20accommodates a plurality of medical items50stored individually in one of the receiving spaces21of the tray20without any contact being possible between them. The term “medical items50” denotes any type of item for medical use that must remain sterile and/or clean and free from any particulate contamination. In the examples described and shown, these are stoppers intended to close vials, but they could just as easily be any other type of medical item, such as syringes or vials. The shape and volume of the receiving spaces21will of course be adapted such that they can accommodate the medical item50in question. As will become apparent in the remainder of this description, stacking the trays20in the vessel10allows the receiving spaces21to be closed and allows the medical items50placed therein to be isolated in order to limit the risk of particulate contamination.

It should be noted in this respect that medical items50cannot be placed in the top tray20″ of the stack. In this case, this top tray20″ serves the sole purpose of closing the receiving spaces of the tray of the stack that is directly below it. As an alternative to this possibility, and as has already been mentioned, provision can be made to arrange a cover30on the top tray20″ of the stack in order to close the receiving spaces thereof. This cover30can take various forms, which will be presented in a later section of this description.

Description of the Vessel

The vessel10is a hollow packaging element intended to receive the trays20in which the medical items50are placed. The vessel10comprises an opening, a bottom10aand a peripheral wall10bthat delimits its general shape. The peripheral wall10bmay be provided with a shoulder that allows the vessel10to be handled, in particular, by automatic equipment. Advantageously, the vessel10has a parallelepipedal shape in order to optimize the space required for storing a given number of medical items50. The dimensions of the vessel10are chosen depending on the number of medical items50to be packaged. These dimensions may comply with a norm or a standard so as to facilitate use on an industrial scale. The vessel10may be formed from a plastics material, for example, polypropylene, amorphous polyethylene terephthalate or a styrenic polymer such as polystyrene.

In the illustrated example, the bottom10aof the vessel10is provided with bosses11allowing the bottom tray20′ to be wedged and/or centered, for example, by fitting these bosses on reliefs arranged on the lower surface of the tray20′. These reliefs can, for example, constitute caps, which will be described in detail in a later section of the present disclosure. The bottom tray20′ (as well as the entire stack of trays) is thus immobilized in the vessel10, the friction between the tray20′ and the vessel10is limited, and the generation of particles is thus prevented.

The bottom10aof the vessel10may optionally comprise altitude adjustment pads (not shown) on which the bottom tray20′ will rest. These pads make it possible to adjust the height of the stacks of trays20so that the top tray20″ (or the cover30, if present) is always flush with the level of the opening of the vessel10and of the sealing lid40, regardless of the unit height of the trays20; in fact, this unit height can vary depending on the size of the medical items50.

Description of the Delivery Trays

The stack of trays20ofFIG.1comprises a plurality of trays, all identical to each other, and an example of which in accordance with the present disclosure is shown inFIG.2. Each tray20comprises an upper face20aand a lower face20b.

The upper face20ais provided with a plurality of receiving spaces21each intended to receive a single medical item50in order to prevent any contact between two of the items50. The receiving spaces21are typically arranged in rows on the upper face of the tray20. A tray receiving space21has a bottom21a, formed from the upper face20aof the tray20, and an opening21bfor inserting the item50. Each receiving space21is delimited laterally by a partition22, perpendicular to the upper face20aof the tray20, which defines its shape. This can be any shape, for example, circular, hexagonal or rectangular, adjusted to the shape and/or to the size of the medical items50that the receiving space21is intended to accommodate. The partition22is solid, so as to laterally isolate each of the medical items50when they are arranged in the receiving spaces21.

The inner surface of the partition22, that is to say, the surface oriented toward the inside of the receiving space21, may be provided with at least one flexible lateral support element23, for example, a flexible lug23. This support element23makes it possible to retain the medical item50in the receiving space21and to limit its lateral movements. This reduces the possibilities of friction between the medical item50and the partition22as well as the risk of particle generation. The flexible nature of the lateral support elements23allows this receiving space21to be used for different dimensions of items50and thus allows the differences in dimensions to be taken into account that may exist even when these items are all identical to one another.

Advantageously, the receiving spaces21are each provided with at least one stop24to prevent extensive contact between the medical item50and the bottom21aof the receiving space21. This stop24allows the friction surface with the bottom to be limited and reduces particle generation. The stop may be formed by fine ribs delimited on the bottom21aof the receiving space21, for example, three of these ribs, or by periodic supports, for example, three of these supports.

The lower face20bof the tray20has a plurality of caps25, the number of caps in this plurality typically being equal to the number of receiving spaces21arranged on the upper face20aof the tray20. The caps25are arranged on the lower face20bso as each to be in line with a receiving space21. The caps25here are delimited by walls26, similarly to the receiving spaces21, so as to have dimensions complementary to those of the receiving spaces21, so that when a first tray20is stacked on a second tray, identical to the first tray20, the caps25of the first tray20are able to close, for example, by interlocking, the receiving spaces of the second tray that they overhang (FIG.1). It is also conceivable that the walls26defining the caps25are perfectly aligned with the partitions22defining the receiving spaces21so that the receiving spaces are closed by placing, edge against edge, the walls26of a first tray20on the partitions22of a second tray20, directly under it in the stack: a receiving space21of the second tray20is then closed by abutment of the partition22of the receiving space21and of the wall26of the cap25, facing it, of the first tray20arranged on the second tray20(FIG.5). The wall26is solid, so as to laterally isolate each of the medical items50when they are arranged in the receiving spaces21closed by the caps25of the upper tray20.

Each cap25is also defined by a bottom25a, formed by the lower face20bof the associated tray20.

As already mentioned, the caps25of the bottom tray20′ of the stack can also allow this tray to be assembled by fitting on the bosses11of the bottom10aof the vessel10(FIG.1).

If the receiving spaces21are closed by fitting, the internal dimensions of the cap25are advantageously greater than the external dimensions of the receiving space21in order to locate the possible friction region between the receiving spaces21and the caps25on the outer surface of the partitions of the receiving spaces21, as is clearly visible inFIG.3. In other words, the walls26of the caps25surround the partitions22of the receiving spaces21from the outside and are in contact with the outer surface of the partitions22. This prevents particles from being generated inside the receiving spaces21during any friction of the walls26against the partitions22. Advantageously, slight lateral play will be provided, typically between 0.1 and 1 mm, between the walls26defining the caps25and the partitions22defining the receiving spaces21in order to prevent forcing the interlocking of the trays20during their stacking, which could make subsequent access to the medical items retained in a tray difficult.

According to a first variant, in particular, illustrated inFIGS.1and5, each receiving space21has a solid bottom21a, formed by the upper face20aof the tray20, and each cap25has a solid bottom25a, formed by the lower face20bof the tray20. When two trays20are stacked, the medical items50(for example, stoppers), arranged in the receiving spaces21of the underlying tray20, are completely isolated from each other and protected from potential particulate contamination generated during transport of the packaging system100or when the latter is opened.

According to a second variant, illustrated inFIGS.6A and6B, each receiving space21has a perforated bottom21a, and each cap25also has a perforated bottom25a, due to the presence of an orifice28in the tray20, centered on the bottom21aof each receiving space21. The orifice28associated with a receiving space21then has dimensions smaller than the dimensions of the medical item50that is intended to occupy the receiving space21, so that the outer upper part of the medical item50is able to close the orifice28. The lower part of the medical item50in turn is in contact with the bottom21aof the receiving space21.

This second variant is advantageous in that it limits the quantity of material used to manufacture a tray20. It is particularly suitable in the case of a medical item50in the form of a stopper51provided with a locking cap52, as shown inFIGS.6A and6B. The stopper51is usually made of an elastomeric material, having a head and a foot that is intended (in use) to be inserted into the neck of a vial. The locking cap52surrounds the stopper51and is intended (in use) to be gripped under the flange of the vial, when the foot of the stopper51is fully inserted into the neck: the locking cap52comprises retaining members able to be blocked under the collar in order to secure the stopper51on the vial. The locking cap52also comprises means ensuring the maintenance of the stopper51in the cap52during storage and transport in the packaging system100. Non-limiting examples of medical items50of this type can be found in documents EP2464577 or EP2464580.

The locking cap52of the medical item50may comprise a capsule52aforming the outer upper part of the medical item50. As illustrated inFIGS.6A and6B, it is this outer upper part52athat closes the orifice28and enables the medical items50of the same column (that is to say, directly above each other, in the stacked trays20) to be isolated from each other.

In particular, the stopper51of the medical item50, which constitutes the most sensitive part in terms of contamination, is completely isolated in the receiving space21of a tray20:by interlocking or abutment of the partition22of the receiving space21of the tray20with the facing wall26of the cap25of an upper tray,due to the closure of the perforated bottom25aof the cap25of the upper tray by the outer upper part52aof the locking cap52of the medical item50arranged in the receiving space21of the tray20, and potentially,due to the closure of the perforated bottom21aof the receiving space21by the outer upper part52aof the locking cap52of a medical item50arranged in a tray underlying the tray20.

In the particular case of the bottom tray20′, the closest to the bottom10aof the vessel10, the orifice28of the perforated bottom21aof the receiving spaces21of the tray20′ can be closed off by providing additional caps or seals at the bottom10aof the vessel10, or the orifices28can be left open.

According to a third variant, which mixes the first and second aforementioned variants, only part (at least one) of the receiving spaces21of a tray20may have a perforated bottom21a, the other part having a solid bottom21a.

Returning to the general description, it is advantageously possible to provide at least some of the caps25with a tray20of vertical support elements27(visible inFIG.3in the form of a flexible tab27), in order to maintain and limit the vertical movement of the medical items50arranged in the receiving spaces of the underlying tray. This reduces any friction associated with the movement of the medical item50within the receiving space21. Just like for the lateral support elements23, the flexible nature of the vertical support elements27allows a receiving space21to be used for different dimensions of items50and/or allows the variations in dimensions of these items to be taken into account.

Advantageously, the upper part of the receiving spaces21, that is to say, the upper end of the partitions22, is deformable. In the example ofFIG.3, the upper end of the partitions22has a pointed profile. The compressive forces exerted on the upper end of the partitions22during the stacking of the trays20lead to their deformation by crushing, which makes it possible to compensate for any defects in the flatness of the trays20. This ensures that all the receiving spaces of the trays are properly closed, in particular, during a subsequent vacuumization step of the vessel.

The trays may be made of a plastics material, for example, polypropylene or thermoplastic elastomer or polybutylene terephthalate (PBT).

Each tray20advantageously comprises a peripheral gripping rim20c, which may be located in the lateral extension of the upper20aand lower20bfaces, as illustrated inFIGS.1,2and3. Alternatively, as can be seen inFIGS.5,6A and6B, the peripheral gripping rim20ccan be located in the lateral extension of the upper end of the partitions22of the receiving spaces21.

Description of the Cover

The term “cover” is used to denote any element placed in the vessel10, on the top tray20″ of the stack, in order to close the receiving spaces thereof. This therefore avoids leaving this top tray20″ empty of any medical item50, as has been mentioned previously.

According to a first embodiment, illustrated byFIG.4A, the cover30may be a rigid plate30provided on its lower face with a plurality of caps32able to close the receiving spaces21of the bottom tray20′, for example, by interlocking. These caps32are therefore identical, in their shapes, dimensions and arrangements on the lower face of the plate30, to the caps25of the trays20. The rigid plate30and the caps32may be formed from the same material as that forming the trays20, and the plate may have similar dimensions.

In a variant of this embodiment, the plate may be composed of a plurality of individual strips30′ intended to cover and, respectively, close the rows of receiving spaces21of the top tray20″. These strips30′ can be secured to the porous lid40, for example, by welding, so that removing the lid40(when opening the packaging system100) naturally leads to opening the receiving spaces21of the top tray20″. In this embodiment in which the strips30′ are rigid, they are arranged, preferably, perpendicular to the direction of removal of the porous lid40in order to facilitate its removal.

According to a second embodiment, illustrated byFIG.4B, the cover30comprises a flexible plate or of a plurality of flexible strips30′, the lower face of which is provided with a cap32similar to those of the trays20. Like in the first embodiment, the strips30′ are configured to close a row of receiving spaces21of the top tray20″ of the stack. To impart or improve the flexible nature of a strip30′, the latter can be formed by relatively narrow bending regions33, interconnecting relatively wide support regions bearing the caps32.

The flexible strip30′ and the caps32may be formed by a flexible material, for example, based on thermoplastic elastomers.

This second embodiment is very particularly advantageous when the flexible plate30or the strips30′ are secured to the lid40that closes the vessel10. The receiving spaces21of the top tray20″ of the stack placed in this vessel are then opened when this lid is removed, and the medical items50stored in the receiving spaces21of the top tray20″ are immediately accessed. If the strips30′ are flexible enough, they can be arranged without any particular orientation with respect to the opening direction of the lid40.

According to a third embodiment, illustrated byFIG.4C, provision can also be made for the cover30to be implemented by a plurality of unitary caps30″, these caps being arranged, respectively, on the receiving spaces of the top tray20″ in order to close them. They can be soft or rigid caps.

Description of the Lid

The porous lid40is intended to be sealed, for example, by means of plastic welding, on the upper edges of the peripheral wall10bof the vessel10, once the vessel has been filled with the trays20carrying the medical items50and optionally the cover. The porous lid is intended to keep the medical items50clean and to prevent particles from entering the vessel10. The air porosity of the lid40makes it possible to extract the air from the vessel during a subsequent vacuumization step. It may be, for example, made of TYVEK®, a material commonly used in the pharmaceutical industry.

When provision is made to place a cover30in the vessel on the top tray20″ of the stack, as has already been mentioned with reference to the two embodiments of this cover30, the porous lid can also be sealed, for example, by welding, to this cover30simultaneously with its sealing on the upper edges of the peripheral wall10bof the vessel10.

To allow this, the elements of the packaging system100are dimensioned so that the exposed surface of the cover30(whichever embodiment is chosen), when the latter is placed on the top tray20″ of the stack of trays, is flush with the upper edge of the wall of the vessel10.

Description of the Packaging Method

In order to minimize contamination by particles and in order to preserve the possible sterility of the medical items50, the various steps described below are carried out, preferably, in a controlled environment.

A first tray20′, the bottom tray20′ of the stack, is arranged on the bottom10aof the vessel10so as to align and fit the caps25of the lower face21aof the first tray20′ with the bosses11of the bottom10aof vessel10(if present). Medical items50are then, or were previously, placed in the receiving spaces21of the first tray20′.

Then, a second tray20is arranged on the first tray20′. The caps25arranged on the lower face of the second tray close the receiving spaces21of the first tray20′. Medical items50are arranged in each receiving space21of the second tray20before or after this operation. This is repeated as many times as there are trays20to be placed in the vessel10and until the last tray20″ is placed, forming the top tray20″ of the stack.

In the event that no cover30is provided, the last tray20″ is kept empty, that is to say, without placing medical items in its receiving spaces21.

Otherwise, a cover30is placed on the upper face20aof the top tray20″ of the stack in order to close its receiving spaces21, in which the medical items have been placed beforehand. As has already been mentioned, this cover can be formed by a plate provided with caps, which is therefore arranged integrally on the top tray20″. It may be, alternatively, a plurality of flexible or rigid strips30′ bearing caps, and placed in rows on the top tray20″ so as to close the receiving spaces21, or else unitary caps30″ arranged on each receiving space21. Optionally, a combination of these options can be used to close the receiving spaces21of the top tray20″.

The porous lid40is then arranged on the top tray20″ or on the cover30, then secured to the upper edges of the wall10bof the vessel10, as well as possibly to the flexible plate30or to the strips30′ and/or unitary caps30″ when these are present.

In a following step, the vessel10, the opening of which has been closed by the porous lid40, is placed in at least one airtight bag (and, preferably, two bags for safety reasons), and the vacuumization is carried out in this bag before it is hermetically sealed. The vacuumization of the assembly allows the various components of the assembly100to be blocked vertically, and therefore allows each receiving space21to be closed individually. Any defects in the flatness of the trays20and of the cover30are compensated for by the deformable nature of the partitions22of the receiving spaces21and by the relative flexibility of the trays20. The vacuumization also makes it possible to horizontally block the various components of the assembly100by deforming the peripheral wall10bof the vessel10in order to press it against the edge of the trays20. The vacuumization therefore makes it possible to limit the friction between the various elements of the assembly100and thus the generation of particles by friction by blocking the vertical and horizontal movement of the elements.

Opening the Packaging System

To open the packaging system and access the medical items packaged therein, the vessel10containing the stack of trays20is first of all taken out of the bag. The lid40is then removed to expose the cover30, when the latter is present. The cover30is extracted from the vessel, for example, using a suction cup when the latter is in the form of a rigid plate, to expose the receiving spaces21of the top tray20″. When it is in the form of rigid or flexible strips sealed to the lid40, opening this lid naturally leads to removing the caps from the receiving spaces21, without any additional operation. The medical items50can then be picked up individually or row by row, manually and/or automatically by a machine. Once the top tray20″ has been emptied of its medical items50, the latter is also removed to expose the receiving spaces21and the medical items50of the underlying tray20. These operations are repeated until all the medical items50stored in the vessel10have been removed.

Of course, the present disclosure is not limited to the embodiments described and it is possible to add variants without departing from the scope of the invention as defined by the claims.

Although a single type of receiving space delimited by partitions has been described here, other shapes or configurations could be envisaged. The receiving spaces can, for example, be arranged in cells to optimize the space in the vessel, the inner surface of a partition of one receiving space forming the outer surface of a partition of another receiving space. The receiving spaces could equally well correspond to a recess formed in a tray or be a combination of recesses and partitions.

Finally, although here is put forward a fitting of the caps on the receiving spaces carried out from the outside to locate the possible friction region on the outer surface of the receiving spaces, it is, of course, possible to have the reverse. In this case, the external dimensions of the cap25are smaller than the internal dimensions of the receiving space21so that the fitting of the cap25takes place from the inside.