FR3088624A1 - STERILIZED PACKAGING, PARTICULARLY FOR THE PHARMACEUTICAL INDUSTRY - Google Patents

Abstract

The present invention relates to a package comprising: a tray, comprising an upper opening delimited by a periphery of the tray; a cover disposed on the upper opening so as to close the upper opening, characterized in that the cover comprises two parts, of which: - an edge film arranged on the periphery of the tray delimiting the upper opening, by direct contact with the periphery or by means of fixing, said border film being transparent to Ultra Violet radiation, - a central film: which is not in contact with the periphery of the tray delimiting the upper opening; surrounded by the border film; permeable to gases, the central film and the edge film being made of different respective materials and being fixed to each other along a fixing zone.

Description

"Packaging that can be sterilized, especially for the pharmaceutical industry"

Technical area

The present invention relates to a packaging, preferably a secondary packaging, ie a packaging which surrounds a material envelope in direct contact with a product.

The field of the invention is more particularly but not limited to that of packaging to be sterilized, preferably by e-beam or by chemical means.

State of the prior art

In a pharmaceutical medium, a tub is a tray made of rigid plastic material containing a rack filled with empty syringes or vials, and previously sterilized and depyrogenized. This tray is sealed with a film permeable to gases but impermeable to microorganisms. This allows a sterilization treatment by chemical means such as ethylene oxide after filling and sealing the tray.

This tray is packaged in one or even two protective pouch (s) comprising all or part of a surface which is also semipermeable for sterilization by chemical means after closing of the pouch (s).

These tubs, thus conditioned, are prepared by a supplier in the pharmaceutical industry, who no longer has to carry out in each filling line the heavy washing, drying, sterilization, depyrogenization operations of syringes or vials or cartridges or the like before they are placed. fill. It suffices to install one or two de-spotting stations upstream of the filling line, each being coupled with an airlock crossing of increasing level of protection.

Given the possible presence of germs on the outer envelope of the last bag, a new contamination of the outer surface of the tub, initially presumed to be sterile, is possible during the last removal.

-2In order to prevent the risk of this microbial contamination entering the sterile filling cabin, a final decontamination or sterilization operation is carried out on the tub in a specific tunnel, which then passes through an airlock and enters the sterile filling area .

The treatments currently used to carry out this decontamination respectively sterilization of the tubs are as follows: ragging with alcohol then compliance with an action time, sterilization tunnel by electron beam, automatic spraying of disinfectant product then application of a dwell time in a tunnel ... etc ...

These tubs can also be decontaminated by pulsed light.

The expected decontamination levels are typically 3 to 6 log on the reference germs or the wild germs encountered in the plant on the outside surface of the tub. To obtain this decontamination / sterilization efficiency, each external surface unit of the tub must be presented facing the emitter of pulsed light flashes, and receive the appropriate energy in the form of a number of flashes, subject to '' piloting of the process as a function of the germicidal efficiency sought.

Pulsed light being a sterilization / surface decontamination technology, it is subject to all the limitations linked to the geometry and in particular the shadow effects.

The object of the present invention is to improve the safety of aseptic packaging of such a tub or packaging.

Statement of the invention

This objective is achieved with packaging comprising:

- a tray, comprising an upper opening delimited by a periphery of the tray,

- a cover disposed on the upper opening so as to close the upper opening, characterized in that the cover comprises two parts, of which:

- a border film placed on the periphery of the tray delimiting the upper opening, by direct contact with the periphery or by

- 3 via fixing means, said border film being transparent to Ultra Violet radiation,

- a central film:

o which is not in contact with the periphery of the tray delimiting the upper opening o surrounded by the border film o gas permeable the central film and the border film being made of different respective materials and being fixed one to the other the other along a fixing area.

The central film preferably has:

- an air permeability of at least 360 mL / min, preferably at least 520 mL / min, preferably between 360 and 872 mL / min, preferably between 520 and 671 mL / min and / or

- a Gurley Hill porosity of at most 47 sec / 100cc, preferably at most 36 sec / 100cc, preferably between 5 and 47 sec / 100cc, preferably between 8 and 36 sec / 100cc.

The central film can be impermeable to microorganisms, preferably with LRV> 3 and / or a penetration of less than 1%.

the central film is preferably not transparent to UV, preferably with an optical transmission between 250nm and 300nm of less than 50%.

Edge film can have optical transmission between 250nm and 300nm greater than 70%

The edge film may have a burst strength greater than 670 kPa preferably greater than 900 kPa, and / or an impact resistance greater than 3400 J / m2 preferably greater than 4900 J / m2 and / or a resistance to the tear greater than 1.9 N, preferably greater than 2.7 N.

The border film can be:

impermeable to gases, preferably has an air permeability of less than 100 mL / min, and / or a Gurley Hill porosity of more than 50 sec / 100cc, and / or

- impermeable to microorganisms, preferably LRV> 3 and / or penetration less than 1%.

-4The fixing area can be:

impermeable to gases, preferably has an air permeability of less than 100 mL / min, and / or a Gurley Hill porosity of more than 50 sec / 100cc, and / or

- impermeable to microorganisms, preferably LRV> 3 and / or penetration less than 1%.

The tray preferably has an optical transmission, between 250nm and 300nm, of less than 50%.

The tray can be:

impermeable to gases, preferably has an air permeability of less than 100 mL / min, and / or a Gurley Hill porosity of more than 50 sec / 100cc, and / or

- impermeable to microorganisms, preferably LRV> 3 and / or penetration less than 1%.

In the fixing zone, the central film is preferably located between the border film and the tray. In other words, when the tray has its upper opening upwards (relative to its bottom), the central film is located below the border film.

The bonding force per unit area between the edge film and the tray is preferably less than the bonding force per unit area between the edge film and the central film.

The tray may include syringes, and / or cartridges and / or vials and / or cosmetic devices and / or other medical devices.

The tray can include:

- on the top, the upper opening delimited by the periphery of the tray,

- on the bottom, a bottom

- side walls connecting the bottom to the periphery of the upper opening, the side walls being preferably completely flat along a direction connecting the bottom to the upper opening, with the exception of a possible bend in connection between the bottom and the side walls and / or any

- 5 connecting bend between the side walls and the periphery of the upper opening.

According to another aspect of the invention, a method of using a packaging according to the invention is proposed, characterized in that it comprises the following successive steps:

- formation of the packaging by assembling the tray and the cover while the tray includes a content, and / or

- sterilization treatment by chemical means of the content through the central film, and / or

- packaging of the packaging in at least one protective pocket, on a packaging site, and / or

- sterilization by chemical means of the content through at least one bag, and / or

- transport of the packaging in its at least one pocket to a site remote from the packaging site, and / or

- extraction of the packaging from its at least one pocket on this remote site, and / or

- decontamination or sterilization of the packaging by Ultra Violet light (preferably comprising wavelengths between 200 nm and 300 nm, preferably between 250 nm and 300 nm) before separation of the cover and the tray.

Description of the figures and embodiments

Other advantages and particularities of the invention will appear on reading the detailed description of implementations and embodiments in no way limiting, and the following appended drawings:

FIG. 1 is a perspective view of a first embodiment of packaging according to the invention,

FIG. 2 is an enlargement of part A of FIG. 1,

FIG. 3 is a profile section view of part of the first embodiment of packaging according to the invention,

FIG. 4 is an enlargement of part B of FIG. 3,

FIG. 5 is a top view of the first embodiment of packaging according to the invention,

FIG. 6 illustrates the transmission of light as a function of the wavelength of this light for different materials 10 to 17. The abscissa axis is in nanometers and the ordinate axis is in percentage of transmission,

FIG. 7 is a perspective view of a second embodiment of packaging according to the invention, which is the preferred embodiment of the invention,

FIG. 8 is an enlargement of part C of FIG. 7,

FIG. 9 is a top view of the second embodiment of packaging according to the invention,

FIG. 10 is a side view of the second embodiment of packaging according to the invention,

- Figure 11 is a side sectional view of a part D of Figure 10 of the second embodiment of packaging according to the invention.

These embodiments being in no way limitative, it will be possible in particular to consider variants of the invention comprising only a selection of characteristics described or illustrated subsequently isolated from the other characteristics described or illustrated (even if this selection is isolated within a sentence including these other characteristics), if this selection of characteristics is sufficient to confer a technical advantage or to differentiate the invention from the state of the prior art. This selection includes at least one characteristic, preferably functional, without structural details, and / or with only part of the structural details if this part only is sufficient to confer a technical advantage or to differentiate the invention from the state of the art. anterior.

We will first describe, with reference to Figures 1 to 6, a first embodiment of packaging 101 according to the invention.

Package 101 is secondary packaging.

- 7In this description, all standards or tests or standard methods are those or those according to their latest version available as of ¹ July 2018.

The package 101 comprises a tray 1, comprising an upper opening 2 delimited by a periphery 3 of the tray 1.

The tray 1 is typically made of injected polystyrene (PS). The packaging 101 comprises a cover 4 disposed or fixed on the upper opening 2 so as to close the upper opening 2. The cover 4 is horizontal or substantially horizontal.

Tray 1 includes:

- on the top, the upper opening 2 delimited by the periphery 3 of the tray 1,

- on the bottom, a bottom 5 preferably flat or substantially flat

- side walls 6 connecting the bottom 5 to the periphery 3 of the upper opening 2.

In this embodiment, the side walls 6 are not entirely flat along a direction connecting the bottom 5 to the upper opening 2, and include a step 9 located between:

- a connecting bend between the bottom 5 and the side walls 6 and

- A connecting bend between the side walls 6 and the periphery 3 of the upper opening 2.

The cover 4 comprises two parts including:

an edge film 41 (also called a frame or peripheral film) disposed or fixed on the periphery 3 of the tray 1, by direct contact with the periphery 3 or by means of fixing means 7, said border film 41 being transparent to Ultra Violet radiation,

- a central film 42:

o which is not in contact with the periphery 3 of the tray 1 o which is surrounded by the edge film 41 o which is permeable to gases in particular to air and to ethylene oxide.

The periphery 3 forms a fixing lip (typically for bonding or heat sealing) of the cover 4 (more precisely of the film 41) on the tray 1.

The central film 42 and the border film 41 are made of different respective materials and are fixed to each other along an attachment zone 44.

The central film 42 and the edge film 41 are fixed to each other by direct contact or by means of fixing means 43.

The packaging 101 comprises a fixing 7 (typically by gluing or heat sealing) between the border film 41 and the periphery 3.

The central film 42 has a permeability to air and / or to ethylene oxide (according to a method of Bendtsen, Standard ISO 5636-3) greater, preferably at least twice, than that of the border film 41.

The central film 42 has:

- a permeability to air and / or to ethylene oxide (according to a method of Bendtsen, Standard ISO 5636-3) of at least 360 ml / min preferably of at least 520 ml / min, preferably a permeability to air and / or to ethylene oxide (according to a method of Bendtsen, Standard ISO 5636-3) between 360 and 872 ml / min preferably between 520 and 671 ml / min and / or

- a Gurley Hill porosity (according to the Gurley Hill method, TAPPI T460 & ISO 5636-5 standards) of maximum 47 sec / 100cc, preferably maximum 36 sec / 100cc, preferably between 5 and 47 sec / 100cc, preferably between 8 and 36 sec / 100cc.

The central film 42 is impermeable to microorganisms, preferably with a Logarithmic Retention Value of Bacteria or LRV (for “Logarithmic bacteria Retention Value” in English), according to the standard test method ASTM F1608, greater than 3 and / or penetration , according to the standard test method ASTM F2638, less than 1%.

The central film 42 is not transparent to UV.

The central film 42 has an optical transmission for each wavelength between 250nm and 300nm of less than 50%, preferably less than

- 930%. The film 42 therefore poses shadow problems during decontamination by light, typically by UV and / or pulsed light.

Film 42 is a semi-permeable film, since it is permeable to gases (in particular to air and to ethylene oxide) but impermeable to microorganisms.

The film 42 is typically made of non-woven high density polyethylene (HDPE) fibers.

The central film 42 preferably has a thickness of less than 200 µm.

The film 42 is flexible.

The film 42 does not cover any part of the periphery 3, and in particular no part of the upper walls of the tray 1, the upper walls being the walls of the tray 1 situated on the same side of the tray 1 as the upper opening 2 c ' i.e. opposite the bottom 5.

The film 42 is arranged to allow sterilization of the contents of the tray 1 by diffusion of a chemical disinfectant through the film 42 to the interior of the tray 1.

The central film 42 has an impact resistance:

- Mullen Burst burst strength according to ISO 2758 & ASTM D774 greater than 670 kPa, preferably greater than 900 kPa,

- Resistance (from Spencer Puncture) according to Standard ASTM D3420 greater than 3400 J / m2 preferably greater than 4900 J / m ²

- Tear resistance according to Standard (Elmendorf tear, MD) ASTM D1424 & EN 21974 greater than 1.9 N preferably greater than 2.7N

The border film 41 is disposed around the entire periphery 3 of the tray 1.

The border film 41 is said to be transparent to Ultra Violet radiation with respect to the central film 42.

The edge film 41 has an optical transmission for each wavelength between 250nm and 300nm (and even for each wavelength between 220nm and 300nm) greater,

- 10preference at least twice as high as that of the central film 42 at the same wavelength.

The border film 41 has an optical transmission:

- greater than 20% for each wavelength between 220nm and 300nm, and

- greater than 60%, preferably greater than 70%, for each wavelength between 250nm and 300nm.

The edge film 41 even has, towards the "visible", an optical transmission for each wavelength between 300 nm and 600 nm greater than 60%, preferably greater than 70%.

The film 41 has sufficient transmission in particular in the UVC and the visible to allow sterilization / decontamination in an acceptable time, of any surface that it covers (whether on the tray 1 or on the film 42).

The film 41 has at least the same mechanical properties as the semi-permeable film 42 in terms of impact and / or tear resistance.

The edge film 41 has an impact resistance:

- Mullen Burst burst strength according to ISO 2758 & ASTM D774 greater than 670 kPa, preferably greater than 900 kPa,

- Resistance (from Spencer Puncture) according to Standard ASTM D3420 greater than 3400 J / m2 preferably greater than 4900 J / m ²

- Tear resistance according to Standard (Elmendorf tear, MD) ASTM D1424 & EN 21974 greater than 1.9 N preferably greater than 2.7N

The edge film 41 is impermeable to gases, in particular to air and / or to ethylene oxide, and preferably has a permeability to air and / or to ethylene oxide of less than 100 ml. / min (according to a method of Bendtsen, Standard ISO 5636-3), and / or a porosity of Gurley Hill greater than 50 sec / 100cc (according to the method of Gurley Hill, Standards TAPPI T460 & ISO 5636-5),

The film 41 has at least the same resistance to humidity as the film 42.

The edge film 41 is impermeable to microorganisms, preferably with an LRV> 3 according to the standard test method ASTM

- 11 F1608, and / or a penetration less than 1% according to the standard test method ASTM F2638.

The film 41 can be of different possible materials. It is transparent to UV and is made of a material designed to be assembled by gluing or heat sealing to the tray (typically in PS) and to film 42 (typically in HDPE).

The film 41 is for example made of low density polyethylene (PELD), preferably laminated PELD.

As illustrated in FIG. 6, the film 41 can be:

- in low density polyethylene (LDPE): curve 11

- PCTFE (polychlorotrifluoroethylene): curves 14 and 15

- in poly-chloro-tri-fluoro-ethylene (PCTFE): curve 16

- Of fluorinated thermoplastic material (for example a polymer of tetrafluoroethylene and hexafluoropropylene): curves 12, 13 and 17 The edge film 41 preferably has a thickness less than 500 μm.

The film 41 is flexible.

However, in variants not illustrated, the film 41 is rigid and / or at least several millimeters thick.

The film 41 covers the entire periphery 3, and preferably all the upper walls of the container 1, the upper walls being the walls of the container 1 located on the same side of the container as the upper opening 2.

The film 41 forms a frame for the film 42.

The edge film 41 can be cut by a sharp object without dropping particles

The fixing means 43 and the fixing zone 44 are each: impermeable to gases in particular to air and / or to ethylene oxide, preferably to a permeability to air and / or to oxide ethylene less than 100 mL / min (according to a Bendtsen method, ISO Standard 5636-3), and / or a Gurley Hill porosity greater than 50 sec / 100cc (according to the Gurley Hill method, TAPPI T460 & ISO Standards 5636-5), and / or

- impermeable to microorganisms, preferably with an LRV> 3 according to the standard test method ASTM F1608, and / or a penetration less than 1% according to the standard test method ASTM F2638.

Thus, the assembly between the two components 41, 42 of the bi-material seal 4 is perfectly sealed against germs, in order to minimize the performance of the film 42 used industrially.

Similarly, the binding 7 is:

impermeable to gases in particular to air and / or to ethylene oxide, preferably to a permeability to air and / or to ethylene oxide of less than 100 ml / min (according to a method of Bendtsen, Standard ISO 5636-3), and / or a Gurley Hill porosity greater than 50 sec / 100cc (according to the Gurley Hill method, TAPPI Standards T460 & ISO 5636-5), and / or

- impermeable to microorganisms, preferably with an LRV> 3 according to the standard test method ASTM F1608, and / or a penetration less than 1% according to the standard test method ASTM F2638.

In the fixing zone 44, the central film 42 is located (along a vertical axis) between the border film 41 and the bottom 5 of the tray 1, but not between the border film 41 and the periphery 3. This reduces the gray areas and improves the possibilities of decontamination of the packaging 101.

In other words, when the tray 1 has its opening 2 upwards (relative to its bottom 5), the central film 42 is located below the border film 41.

The bonding force per unit area (of the bond 7) between the border film 41 and the tray (more precisely the periphery 3 of the tray 1) is less than the bonding force per unit area (of the bond 43 ) between the border film 41 and the central film 42. This makes it possible to have an assembly between the two components 41, 42 of the bi-material cover 4 which resists peeling of the cover 4.

Tray 1 is not transparent to UV.

- 13 Tray 1 has an optical transmission, between 250nm and 300nm, of less than 50%. It therefore poses shadow problems during decontamination by UV flash.

The tray 1 is rigid.

Tray 1 is:

impermeable to gases in particular to air and / or to ethylene oxide, preferably to a permeability to air and / or to ethylene oxide of less than 100 ml / min (according to a method of Bendtsen, Standard ISO 5636-3), and / or a Gurley Hill porosity greater than 50 sec / 100cc (according to the Gurley Hill method, TAPPI Standards T460 & ISO 5636-5), and / or

- impermeable to microorganisms, preferably with an LR.V> 3 according to the standard test method ASTM F1608, and / or a penetration less than 1% according to the standard test method ASTM F2638.

Thus, the bi-material cover 4 is fixed to the tray 1 on its periphery

3. The fixing between the cover 4 and the tray 1 is done at the transparent frame 41 of the cover. Thus, the upper part of the tray 3, under the cover 4, outside the weld or bonding bead 7 is located under a transparent frame 41. This zone 8 is then sterilizable / decontaminable by UV light and / or pulsed, by transmission of germicidal radiation through the material of the film 41. The fastener 7 can be sterilized / decontaminated by UV light and / or pulsed, by transmission of the germicidal radiation through the material of the film 41.

The two films 41, 42 constituting the cover 4 are sealed (typically by the fixing 43 by gluing or by heat welding), so that the transparent frame 41 is found above the central surface 42 made of semi material -permeable, when the cover 4 is fixed on the tray 1. This design has the advantage of not creating any shadow area on the part of the cover 4 in contact with the outside.

Each part of the cover 4 in contact with the outside can be sterilized / decontaminated by pulsed light.

Tray 1 typically contains as content:

- one or more syringes and / or

- one or more bottles and / or

- one or more cartridges and / or

- one or more cosmetic device (s), and / or

- one or more other packaging (s) pretreated (s) and ready (s) for filling, preferably sterilized and / or depyrogenized.

A method according to the invention for using the packaging 101 comprises in this order all or part of the following successive steps:

- Formation or closing of the packaging 101 by assembling the tray 1 and the lid 4 while the tray comprises a content (typically comprising one or more syringes and / or one or more vials or other) ...), this content preferably being previously sterilized and / or depyrogenized,

- sterilization treatment by chemical means (typically ethylene oxide) of the content through the film 42

packaging of the packaging 101 in one or even two protective pouch (s), each pouch preferably comprising all or part of a surface which is also semi-permeable (permeability to gases but not to the microorganism as defined for the film 42) , on a packaging site

- sterilization by chemical means of the contents through the pocket (s) after closing of the pocket (s), preferably on this packaging site

transport of the packaging 101 in its pocket (s) to a site remote from the packaging site, preferably several kilometers away,

- extraction of the packaging 101 from the pocket (s), preferably on this remote site

- decontamination or sterilization (preferably on this remote site) of the packaging 101 by Ultra Violet light (comprising wavelengths between 250 and 300 nm) and / or pulsed, this decontamination or sterilization preferably amounting to at minus 3, 4, 5 or 6 log on germs on the outer surface of the package 101

- separation of the cover 4 and the tray 1, preferably on this remote site

- filling the content (typically syringe (s) and / or vial (s) and / or cartridge) with a product (typically a pharmaceutical or cosmetic product), preferably at this remote site.

The pocket (s) can be generalized by "at least one pocket".

Compared to the state of the art for which a zone, lying between a perimeter of a tray and an opaque operculum to UV outside of a bonding bead, is not accessible to the decontamination light, the invention has the advantage of making it possible to sterilize / decontaminate also the fixing bead 7 and / or the zone 8 located between the film 41 and the periphery 3 outside (relative to the center of the tray 1) of the fixing 7, taking into account that this zone 8 can be recontaminated during the process for removing the bag (s). Then, the germs which may be at this location are likely to recontaminate the contents of the tray 1 when the cover 4 is detached from the tray 1 and it passes over the content placed in the tray 1 or more generally end up in the aseptic packaging area if the cover is detached by cutting.

It is noted that the upper face 3 of the tray 1 comes from a fold of the lateral faces 6 towards the outside of the tray 1.

We will now describe, with reference to FIGS. 7 to 11, a second embodiment of packaging 102 according to the invention. This embodiment will only be described for its differences from the first embodiment 101.

In this embodiment, the side walls 6 are completely flat or completely smooth along a direction connecting the bottom 5 to the upper opening 2, with the exception of a possible single curvature or bend or bend or rounded angle of connection between the bottom 5 and the side walls 6 and / or of a possible single curvature or bend or bend or bend or rounded angle between the side walls 6 and the periphery 3 of the upper opening 2.

March 9 is therefore absent.

The upper face 3 of the tray 1 comes from a fold of the side faces 6 towards the inside of the tray 1.

Of course, the invention is not limited to the examples which have just been described and numerous modifications can be made to these examples without departing from the scope of the invention.

Claims (15)

REVEN DICATIONS 1. Package (101, 102) comprising: - a tray (1), comprising an upper opening (2) 5 delimited by a periphery (3) of the tray, - a cover (4) disposed on the upper opening so as to close the upper opening, characterized in that the cover comprises two parts, of which: - an edge film (41) disposed around the periphery of the tray 10 delimiting the upper opening, by direct contact with the periphery or by means of fixing means (7), said edge film being transparent to Ultra Violet radiation, - a central film (42): o who is not in contact with the perimeter of the demarcating tray 15 the upper opening o surrounded by the border film o gas permeable the central film and the border film being made of different respective materials and being fixed to each other along a fixing zone 20 ( 44). 2. Packaging according to claim 1, characterized in that the central film (42) has an air permeability of at least 360 ml / min and / or 25 a porosity of Gurley Hill of maximum 47 sec / 100cc. 3. Packaging according to claim lou 2, characterized in that the central film (42) is impermeable to microorganisms, preferably with a higher log retention value of bacteria. 30 to 3 and / or penetration less than 1%. 4. Packaging according to any one of the preceding claims, characterized in that the central film (42) is not transparent to - 18UV, preferably with an optical transmission between 250nm and 300nm less than 50%. 5. Packaging according to any one of the preceding claims, characterized in that the border film (41) has an optical transmission between 250nm and 300nm greater than 70% 6. Packaging according to any one of the preceding claims, characterized in that the border film (41) has a burst strength greater than 670 kPa. 7. Packaging according to any one of the preceding claims, characterized in that the border film (41) is: impermeable to gases, preferably has an air permeability of less than 100 mL / min, and / or a Gurley Hill porosity of more than 50 sec / 100cc, and / or - impermeable to microorganisms, preferably a Logarithmic Retention Value of Bacteria greater than 3 and / or a penetration less than 1%. 8. Packaging according to any one of the preceding claims, characterized in that the tray (1) has an optical transmission, between 250nm and 300nm, less than 50%. 9. Packaging according to any one of the preceding claims, characterized in that the tray (1) is: - impermeable to gases, preferably has an air permeability of less than 100 mL / min, and / or a Gurley Hill porosity of more than 50 sec / 100cc, and / or - impermeable to microorganisms, preferably a Logarithmic Retention Value of Bacteria greater than 3 and / or a penetration less than 1%. 10. Packaging according to any one of the preceding claims, characterized in that, when the tray (1) has its upper opening (2) upwards, the central film (42) is located below the border film (41 ). VS 11. Packaging according to any one of the preceding claims, characterized in that the bonding force per unit area between the edge film (41) and the tray (1,3) is less than the bonding force per unit surface between the border film (41) and the film 10 central (42). 12. Packaging according to any one of the preceding claims, characterized in that the tray (1) comprises syringes, 15 and / or cartridges and / or vials and / or cosmetic devices. 13. Packaging according to any one of the preceding claims, characterized in that the tray (1) comprises: 20 - on the top, the upper opening (2) delimited by the periphery (3) of the tray, - on the bottom, a bottom (5) - side walls (6) connecting the bottom to the periphery of the upper opening, The side walls being entirely flat along a direction connecting the bottom to the upper opening, with the exception of a possible connection bend between the bottom and the side walls and / or a possible connection bend between the side walls and the periphery of the upper opening. 14. Method of using a packaging according to any one of the preceding claims, characterized in that it comprises the following successive steps: - Formation of the packaging (101, 102) by assembling the container (1) and the cover (4) while the container includes a content - sterilization treatment by chemical means of the content through the central film (42) 5 - packaging of the packaging (101, 102) in at least one protective pocket, on a packaging site - chemical sterilization of the contents through at least one bag - transport of the packaging (101, 102) in its at least one pocket 10 to a site distant from the packaging site, - extraction of the packaging (101, 102) from its at least one pocket on this remote site - decontamination or sterilization of the packaging (101, 102) by Ultra Violet light before separation of the cover (4) and the 15 tray (1).