Patent Description:
Containers are used for various purposes. For example, a container can be used to store and transport several smaller containers or packaging units during an industrial process. Such packaging units can include vials, cartridges, ampoules, bottles, or pre-fillable syringes. In many industries, these different types of packaging units are collectively known as "primary packaging," i.e., the packaging that comes into direct contact with an end product. The end product may be a food product, a cosmetic product, or a pharmaceutical product. Thus, the container can serve as "secondary packaging," i.e., packaging that groups, protects, and labels the primary packaging.

Primary packaging can sometimes be sterilized while still inside the secondary packaging. Generally speaking, sterilization processes use heat, chemicals, or radiation to kill microorganisms, such as bacteria or fungi. Accordingly, containers that serve as secondary packaging can include features that allow sterilant to enter the container and come into contact with the primary packaging stored inside.

<CIT> describes a transport and packaging container, in which containers are accommodated without an additional supporting structure, i.e. directly. An upper segment is formed in the manner of a drawer having a bottom, two lateral side walls, and a rear side wall, both of which protrude at right angles from the bottom. Circular openings are formed in the side walls, which can be sterile sealed by a protective foil, such as a meshwork of synthetic fibers such as polypropylene fibers (PP) or a Tyvek® protective foil.

<CIT> describes a tub having a body able to contain a nest and medical containers, which has an inner shoulder for receiving the nest. The tub has an upper peripheral wall delineating an upper opening and including a peripheral outer flange leveled with this upper opening, for the sealing of the sealing cover. The tub is integrally formed by a single part of molded plastic material. The sealing cover is formed by a sheet of suitable heat sealable material, in particular by a sheet in Tyvek®, and is sealed on the upper peripheral wall or on the outer flange of the tub by heat welding.

<CIT> describes a vented rigid tray for gas sterilization having a synthetic polymer tray wall with exterior and interior surfaces, a base and upstanding sidewall, with a foraminous wall portion in the base and/or sidewall; filter media; a foraminous cap; and snap fit attachment means for the foraminous cap and tray wall where the filter media is held between the cap and foraminous wall portion.

<CIT> describes a package made of thermoplastic foil, for use in packing products of the medical and sterilizing industry. The package consists of a deep drawn cup-shaped part with external flanges around the rim. This is joined by hot sealing or welding to a transparent cover foil. The aperture in the bottom of the deep drawn part is closed by a foil of paper, cellulose or plastic fibers, which is joined to the part along the rim by hot sealing or welding. The fiber foil which permits a sterilization of the contents of the package thus does not impede the identification of the contacts which is important in emergencies. Its removal from the cover eliminates any recess where contaminants could collect.

<CIT> describes a medical package having a tub and a lid. The tub has a four-sided base with walls extending upwards therefrom; the walls terminate at a first flange which extends outwardly. From the first flange, four top walls extend upward and terminate at a second flange which extends outwardly. The tub is formed of a clear, ultraviolet light transmitting plastic. The lid has a gas permeable, microfiber central portion surrounded by a clear, ultraviolet light transmitting plastic film. The film has a high shear resistance and does not produce particulate matter during an opening procedure.

<CIT> describes a sterilizing container. In the sterilizing container for medical and surgical instruments comprising a box with a bottom part and a cover for sealing the bottom part in a germ-tight manner, the side walls of the bottom part of the box have openings covered on the outside with germ-tight but sterilization gas permeable filter layers which are held in position by retaining plates mounted on the side walls, the cover of the box being locked to the bottom part by a locking structure formed at one end of the box at which the cover and bottom part includes retaining structures receiving a safety tag which covers the locking structure when the cover is closed in such a way that the safety tag is firmly positioned in front of the locking structure and the locking structure is only accessible by destroying the safety tag.

The present invention aims to alleviate problems associated with known containers.

A container according to the present invention is set out in claim <NUM>. A method according to the present invention is set out in claim <NUM>. Further advantageous developments of the present invention are set out in the dependent claims.

According to the present invention, a container includes a body that includes a lower surface, an upper rim, and a plurality of side walls that extend between the lower surface and the upper rim, wherein the upper rim defines an opening to an interior space of the body, a flexible cover that covers the opening of the body and is bonded to the body along the upper rim, and gas-permeable material through which gas can enter and exit the interior space of the body. The upper rim of the body is spaced apart from any of the gas-permeable material, such that the cover can be peeled away from the upper rim to expose the opening while leaving the gas-permeable material intact.

The gas-permeable material includes an insert formed in the flexible cover, and the flexible cover includes a gas-impermeable material that encircles the insert.

According to one example, not covered by the present invention, the entire flexible cover may be formed of a gas-impermeable material.

According to the present invention, one of the plurality of side walls includes one or more apertures that extend through the side wall and that are covered by the gas-permeable material.

Preferably, a first side wall may include one or more first apertures that extend through the first side wall and are covered by the gas-permeable material, and a second side wall opposite the first side wall may include one or more second apertures that extend through the second side wall and are covered by the gas-permeable material.

Preferably, all of the side walls may include one or more apertures that are covered by the gas-permeable material.

According to the present invention, the lower surface includes one or more apertures that extend through the lower surface and that are covered by the gas-permeable material.

The one or more apertures in the lower surface are provided in addition to the apertures in the side wall(s).

Preferably, the one or more apertures in the lower surface may align with one or more gas-permeable inserts that are provided in the flexible cover.

Preferably, the container may also include a support tray that is arranged in the interior space of the body and includes an array of recesses, each recess configured to receive a vial, ampoule, cartridge, or syringe body. The support tray is sized to fit through the opening of the body.

According to the present invention, a method includes receiving a body that includes a lower surface, an upper rim, and a plurality of side walls that extend between the lower surface and the upper rim, wherein the upper rim defines an opening to an interior space of the body, and wherein one of the plurality of side walls includes one or more apertures that extend through the side wall and the lower surface includes one or more apertures that extend through the lower surface, and covering the one or more apertures with a gas-permeable material.

Preferably, covering the one or more apertures with a gas-permeable material can include bonding the gas-permeable material to an outer surface of the side wall. In other instances, covering the one or more apertures with a gas-permeable material includes attaching the gas-permeable material during an injection molding process to form the body. In other words, the gas-permeable material can be attached during the manufacturing process of the body or afterwards in a separate step.

According to the present invention, the method includes loading a plurality of primary packagings into the interior space. Preferably, loading of the plurality of primary packagings into the interior space includes loading a plurality of vials, ampoules, cartridges, or syringe bodies in corresponding recesses of a support tray. Preferably, the method can further include arranging the loaded support tray in the interior space of the body. According to the present invention, the method further includes bonding a flexible cover to the body along the upper rim of the body. According to the present invention, the flexible cover can include a gas-permeable insert encircled by a gas-impermeable material.

A flexible cover that includes a gas-permeable insert can be made in several ways. According to the present invention, the method includes receiving a flexible cover made of gas-impermeable material that is sized to cover the opening to the interior space of the body, forming an opening in the gas-impermeable material, covering the opening in the gas-impermeable material with a gas-permeable insert, and bonding a peripheral edge of the gas-impermeable material to the upper rim of the body. Preferably, the gas-permeable insert can be adhered to the gas-impermeable material using an adhesive. In some preferred cases, the gas-impermeable material is a first layer of gas-impermeable material, and the method may include arranging a second layer of gas-impermeable material over the gas-permeable insert, wherein the second layer of gas-impermeable material includes an opening aligned with the gas-permeable insert, and laminating the gas-permeable insert between the first and second layers of gas-impermeable material.

These and other embodiments described herein may provide one or more of the following benefits. Firstly, gas-permeable material may have a tendency to generate particles that can cling to and potentially contaminate the contents of the container. The container according to the disclosure may reduce the amount of gas-permeable material and, therefore, the potential to generate such particles. Secondly, gas-permeable material may be particularly prone to particle generation when manipulated in certain ways. By leaving any and all gas-permeable material intact, the container may further reduce unwanted particle generation. With the likelihood of particle generation reduced, the flexible cover may be removed more quickly. Finally, certain configurations of gas-permeable material in the container may improve the sterilization process by providing an entrance and exit for gaseous sterilant. When placed under vacuum pressure, the entrance and exit may improve the flow of sterilant through the container, and thus improve the efficiency of the sterilization process.

Certain embodiments and comparative examples will now be described, by way of example only, with reference to the accompanying drawings, in which:.

<FIG> shows a body <NUM> for a container <NUM> according to the present disclosure. The body <NUM> may be referred to as a "tub" and can be used as secondary packaging for primary packaging in the food, cosmetic, or pharmaceutical industries. Although the expression "primary packaging" can encompass vials, cartridges, ampoules, bottles, and syringes to name a few examples, the following description will refer to "vials" for all types of primary packaging.

The body <NUM> includes a lower surface <NUM>, an upper rim <NUM>, and side walls <NUM>, <NUM> that extend between the lower surface <NUM> and the upper rim <NUM>. The lower surface <NUM> can be a flat planar surface that rests on a table or worktop (not shown). As illustrated, the lower surface <NUM> has a rectangular shape with two long edges and two short edges. Accordingly, the side walls <NUM>, <NUM> include an opposing pair of long side walls <NUM> and an opposing pair of short side walls <NUM>. Referring to the coordinate axes shown in <FIG>, each long side wall <NUM> extends along the X-axis and a corresponding long edge of the lower surface <NUM>. Each short side wall <NUM> extends along the Y-axis and a corresponding short edge of the lower surface <NUM>. All four side walls <NUM>, <NUM> extend in the vertical direction, along the Z-axis, to connect the lower surface <NUM> and the upper rim <NUM>. Together, the lower surface <NUM> and the side walls <NUM>, <NUM> define an interior space <NUM> of the body <NUM> that can receive, e.g., a set of vials to be filled with a pharmaceutical product.

The upper rim <NUM> defines an opening <NUM> to the interior space <NUM> of the body <NUM>. As illustrated in <FIG>, the rim <NUM> can include a lip or flange <NUM> that encloses the opening <NUM> to the interior space <NUM>. The flange <NUM> can extend in a plane defined by the X-Y-axes, substantially orthogonally to the side walls <NUM>, <NUM>. As described below, the flange <NUM> can serve as a point of attachment for a cover (not shown in <FIG>).

The opening <NUM> can be sized to accommodate a support tray or "nest" that supports the primary packaging within the interior space <NUM> of the body <NUM> (not shown). The support tray can include an array of recesses that are each sized to receive a vial. The support tray can ensure that the vials are securely supported in an upright position and do not come into contact with one another. For example, an empty support tray can be inserted through the opening <NUM> of the interior space <NUM>. In some cases, a peripheral edge of the support tray can rest on an inner shoulder <NUM> that extends along some or all of the side walls <NUM>, <NUM>. Individual vials can be arranged in the respective openings of the support tray. In some cases, the vials are individually placed in the interior space <NUM> of the body <NUM> without any kind of support tray.

After the vials are loaded into the interior space of the body <NUM>, a flexible cover <NUM> is bonded to the body <NUM> along the upper rim <NUM>, as shown in <FIG>. For example, the flexible cover <NUM> can be heat sealed to the flange <NUM> of the rim along a peripheral seam <NUM>. The flexible cover <NUM> covers the opening <NUM> of the body <NUM> and thus isolates the interior space <NUM> defined by the body <NUM>. In other words, the flexible cover <NUM> seals the vials inside the body <NUM>. The sealed package or container <NUM> can be used to securely store and transport the vials. For example, the vials can be sterilized while inside of the container <NUM>.

During sterilization, several filled containers <NUM> can be loaded into a sterilization chamber that places the containers <NUM> under a vacuum. For example, the containers <NUM> and vials can be exposed to a gaseous chemical sterilant, such as ethylene oxide, nitrogen dioxide, or ozone. The sterilant can enter the container <NUM> through a gas-permeable material <NUM>, as depicted by the dashed arrows in <FIG>. In the present disclosure, the container <NUM> can include several, discrete pieces of gas-permeable material that are collectively referred to as "the gas-permeable material. " The gas-permeable material <NUM> is shown as a single sheet of material adhered to an outer surface of a long side wall <NUM>. The sheet of gas-permeable material <NUM> covers three windows or apertures <NUM> that are formed in and extend through the long side wall <NUM> (<FIG>). The combination of apertures <NUM> and gas-permeable material <NUM> allow the gaseous sterilant to enter and exit the interior space <NUM> of the body <NUM>, and thus, the container <NUM>.

Referring to <FIG> and <FIG>, each of the apertures <NUM> in the long side wall <NUM> are aligned along the Y-axis with a corresponding aperture <NUM> in the opposite long side wall <NUM>. The apertures <NUM> are also covered by a sheet of gas-permeable material <NUM> that allows gaseous sterilant to enter and exit the interior space <NUM> of the body <NUM>. When placed under a vacuum in the sterilization chamber, the opposing apertures <NUM>, <NUM> may create a pressure differential that induces a flow of gaseous sterilant (shown by the dashed arrows) through the interior space <NUM> of the body <NUM>. As illustrated, the opposing apertures <NUM>, <NUM> are aligned, i.e., fully overlap along the Y-axis to induce the paths represented by the dashed arrows. However, in some cases, the apertures may not be aligned along any of the coordinate axes shown in the Figures. For example, an aperture may be formed at one end of a first side wall, and a second aperture may be formed at an opposite end of an opposing side wall. The first and second apertures may form an entrance and exit for the gaseous sterilant through the interior space of the body and container.

In <FIG>, the opposing apertures <NUM>, <NUM> are formed in the long side walls <NUM>. However, the apertures may be formed elsewhere in the container <NUM>. For example, pairs of opposing apertures can be formed in both the long side walls <NUM> and the short side walls <NUM>. Further, the apertures <NUM>, <NUM> may not necessarily be formed in opposing pairs. In some cases, an aperture may be provided in one surface of the container <NUM> while the opposing surface is continuously formed, i.e., free from apertures.

The gas-permeable material <NUM> can include a gas-permeable foil, such as Tyvek®. Tyvek is a non-woven material formed of high-density polyethylene fibers that is permeable to gas and water vapor but not to liquids. Although <FIG> show a single continuous sheet of gas-permeable material <NUM> attached to each of the long side walls <NUM>, the gas-permeable material <NUM> can also be cut to size to cover individual apertures <NUM>, <NUM>. As described below in more detail, the gas-permeable material <NUM> can be applied to the body <NUM> when the body <NUM> is manufactured. Alternatively, the gas-permeable material <NUM> can be applied to the body <NUM> at a later time, for example, shortly before the vials are packaged in the container <NUM>.

Once the sterilization process is complete, the entire container <NUM> can be placed in a flexible or rigid bag to maintain sterility (not shown). When the time comes to use the sterile vials, the flexible cover <NUM> can be peeled from the flange <NUM>, as shown in <FIG>. For example, the flexible cover <NUM> can be peeled by breaking the bond between the flange <NUM> and the flexible cover <NUM> along the peripheral seam <NUM> shown, e.g., in <FIG>.

Peeling the flexible cover <NUM> away from the rim <NUM> and the flange <NUM> exposes the opening <NUM> to the interior space <NUM> of the body <NUM>. In accordance with the present disclosure, the upper rim <NUM> is spaced away from any of the gas-permeable material <NUM>, such that the flexible cover <NUM> can be peeled away from the upper rim <NUM> while leaving the gas-permeable material <NUM> intact. In this context, "spaced away" can include that neither the upper rim <NUM> nor the peripheral seam <NUM> comes into contact with any of the gas-permeable material <NUM> provided in the container <NUM>. Gas-permeable material <NUM> may generate particles when manipulated in certain ways. By leaving the gas-permeable material <NUM> intact as the flexible cover <NUM> is peeled from the upper rim <NUM>, the generation of particles can be reduced. Reduced particle generation reduces the exposure of the vials stored in the container <NUM> to such particles.

The upper rim <NUM> can be spaced away from the gas-permeable material <NUM> in a number of ways. According to one example, not covered by the present invention, the flexible cover <NUM> can be free from gas-permeable material, i.e., made of gas-impermeable material. In this case, the flexible material <NUM> may be located only on the side walls <NUM>, <NUM> or the lower surface <NUM> of the body and remain intact, namely attached to the body <NUM>, as the flexible cover <NUM> is peeled from the upper rim <NUM>. Examples of gas-impermeable materials that are suitable for the flexible cover <NUM> include rigid or semi-rigid plastic, a low-density polyethylene (LDPE) film, or a polyethylene film laminated with a polyethylene terephthalate film (PE/PET bi-layer film).

Another way ,according to the invention, in which the upper rim is spaced away from the gas-permeable material <NUM> is show in <FIG>. More specifically, the gas-permeable material <NUM> provided in the container <NUM> can include an insert <NUM> formed in the flexible cover <NUM>'. The flexible cover <NUM>' also includes a gas-impermeable material <NUM> that encircles the insert <NUM>. In this instance, "encircles" may mean that the gas-impermeable material <NUM> surrounds a peripheral edge of the insert <NUM> while leaving the top and bottom surfaces of the insert <NUM> free for gas to travel through the insert <NUM>. Although the insert <NUM> is shown as having a circular shape, the insert <NUM> may also be square or rectangular in some instances. Accordingly, the expression "encircles" does not necessitate a circular insert <NUM>.

The insert <NUM> and the gas-impermeable material <NUM> are designed with a distance between a peripheral edge <NUM> of the insert <NUM> and a peripheral edge <NUM> of the flexible cover <NUM>' that allows the peripheral seam <NUM> (not shown) to be formed along the peripheral edge <NUM> of the flexible cover <NUM> without overlapping the insert <NUM> formed of gas-permeable material <NUM>. Due to the distance between the peripheral seam <NUM> and the insert <NUM>, the flexible cover <NUM>' can be peeled away from the upper rim to expose the opening while leaving the gas-permeable material <NUM> intact.

In some instances, the insert <NUM> in the flexible cover <NUM>' can be aligned with an aperture that is formed in the lower surface <NUM> of the body and covered by a further sheet of gas-permeable material <NUM>. For example, the insert <NUM> and the aperture can be aligned along the Z-axis shown in the figures. The insert <NUM> and the aperture in the lower surface <NUM> form an opposing pair of openings that induce flow of the gaseous sterilant similarly to the apertures <NUM>, <NUM> shown in <FIG>. Although the flexible cover <NUM>' is shown with a single insert <NUM>, multiple inserts can be formed across the surface of the flexible cover <NUM>' to evenly distribute the flow of gaseous sterilant and reduce regions of so-called "dead space" inside the container <NUM>. In such a case, each smaller insert is nonetheless encircled by the gas-impermeable material <NUM>.

<FIG> show two ways of making the flexible cover <NUM>' shown in <FIG>. In <FIG>, the flexible cover <NUM>' includes a gas-permeable insert <NUM> that is laminated between two layers of gas-impermeable material <NUM>. A hole <NUM> that corresponds to the insert <NUM> is cut in each of the layers of gas-impermeable material <NUM> and allows gaseous sterilant to pass through the insert <NUM>. In <FIG>, the flexible cover <NUM>' includes a single layer of gas-impermeable material <NUM>. The insert <NUM> is arranged to cover a hole <NUM> formed in the gas-impermeable material <NUM>. The insert <NUM> is bonded to the gas-impermeable material <NUM> along the peripheral edge <NUM> at a seam <NUM>. The seam <NUM> can include an adhesive that adheres the insert <NUM> to the gas-impermeable material <NUM>.

<FIG> and <FIG> show a further body <NUM>' for a container <NUM> according to the present disclosure. The body <NUM>' includes a lower surface <NUM>', an upper rim <NUM>', and two pairs of side walls <NUM>', <NUM>'. The body <NUM>' has substantially the same design as the body <NUM> of <FIG>. However, the body <NUM>' has a smaller height along the Z-axis and a longer length along the X-axis than the body <NUM>. Given this difference in dimensions, the long side walls <NUM>' are provided with six pairs of apertures <NUM>', <NUM>' that are covered by gas-permeable material <NUM> (<FIG>). Generally speaking, the greater size and/or the number of apertures, the shorter the duration of the sterilization cycles. To this end, the body <NUM>' of <FIG> and <FIG> can also be provided with one or more apertures in the lower surface <NUM>' or the short side walls <NUM>'. A flexible cover (not shown) that includes one or more inserts of gas-permeable material can be bonded to the upper rim <NUM>'.

<FIG> is a schematic flowchart of a method <NUM> according to the present disclosure. The method <NUM> includes receiving <NUM> a body that includes a lower surface, an upper rim, and a plurality of side walls that extend between the lower surface and the upper rim, wherein the upper rim defines an opening to an interior space of the body, and wherein one of the plurality of side walls includes one or more apertures that extend through the side wall and/or the lower surface includes one or more apertures that extend through the lower surface. For instance, the body may be the body <NUM> shown in <FIG> or the body <NUM>' shown in <FIG>.

The method <NUM> further includes covering <NUM> the one or more apertures with a gas-permeable material, e.g., as shown in <FIG> and <FIG>. As described above, the gas-permeable material can include a gas-permeable foil, such as Tyvek®. In some instances, the method <NUM> begins with an injection molded body and attaches the gas-permeable material to the injection molded body. For example, the gas-permeable material can be cut to size and placed over the one or more of the apertures. A heat stamp can be applied to the gas-permeable material while an opposite surface of the injection molded body is held in place by a counter holder. Alternatively, the gas-permeable material can be bonded to an inner surface of the body, i.e., to a surface that faces the interior space of the body.

In yet a further alternative, covering <NUM> the one or more apertures with a gas-permeable material can take place at the same time the body is manufactured. For example, the body may be formed by injection molding, and the gas-permeable material can be attached to cover the one or more apertures during the injection molding process. Suitable processes for attaching the gas-permeable material in this way can include overmolding or insert molding.

The method <NUM> can optionally include loading <NUM> a plurality of vials, ampoules, cartridges, or syringe bodies in corresponding recesses of a support tray, arranging <NUM> the loaded support tray in the interior space of the body, and bonding <NUM> a flexible cover to the body along the upper rim of the body.

The flexible cover can be the flexible cover <NUM>, <NUM>' shown in <FIG> and <FIG>, for example. In some instances, bonding <NUM> the flexible cover to the body along the upper rim of the body can include receiving a flexible cover made of gas-impermeable material that is sized to cover the opening to the interior space of the body, forming an opening in the gas-impermeable material, covering the opening in the gas-impermeable material with a gas-permeable insert, and bonding a peripheral edge of the gas-impermeable material to the upper rim of the body. The flexible cover can be formed as shown in <FIG>. A second layer of gas-impermeable material can be arranged over the gas-permeable insert and the first layer of gas-impermeable material described above. The second layer of gas-impermeable material includes an opening aligned with the gas-permeable insert. The gas-permeable insert can then be laminated between the first and second layers of gas-impermeable material. Alternatively, the flexible cover can be formed as shown in <FIG> by adhering a peripheral edge of the gas-permeable insert to the gas-impermeable material using an adhesive.

Claim 1:
A container (<NUM>) comprising:
a body (<NUM>) that comprises a lower surface (<NUM>), an upper rim (<NUM>), and a plurality of side walls (<NUM>, <NUM>) that extend between the lower surface (<NUM>) and the upper rim (<NUM>), wherein the upper rim (<NUM>) defines an opening (<NUM>) to an interior space (<NUM>) of the body (<NUM>);
a flexible cover (<NUM>') that covers the opening (<NUM>) of the body (<NUM>) and is bonded to the body (<NUM>) along the upper rim (<NUM>); and
gas-permeable material (<NUM>) through which gas can enter and exit the interior space (<NUM>) of the body (<NUM>);
wherein the upper rim (<NUM>) of the body (<NUM>) is spaced apart from any of the gas-permeable material (<NUM>), such that the cover (<NUM>') can be peeled away from the upper rim (<NUM>) to expose the opening (<NUM>) while leaving the gas-permeable material (<NUM>) intact; and
wherein one of the plurality of side walls (<NUM>, <NUM>) comprises one or more apertures (<NUM>, <NUM>) that extend through the side wall (<NUM>, <NUM>) and that are covered by the gas-permeable material (<NUM>); wherein the flexible cover (<NUM>') comprises an insert (<NUM>) made of a gas-permeable material formed in the flexible cover (<NUM>'), wherein the flexible cover (<NUM>') comprises a gas-impermeable material (<NUM>) that encircles the insert (<NUM>); and
wherein the lower surface (<NUM>) comprises one or more apertures that extend through the lower surface (<NUM>) and that are covered by the gas-permeable material (<NUM>).