Header bag for packaging at least one medical device

Abstract

The present disclosure relates to a header bag for packaging at least one medical device, comprising at least one sheet (10, 11) configured to be sealed to form an enclosure for the at least one medical device, the at least one sheet (10, 11) comprising at least an inner layer (10i, 11i) and an outer layer (10o, 11o), the inner layer and the outer layer being gas impermeable so that a vacuum can be created within a volume extending between the inner layer and the outer layer, and the header bag (1) further comprising a pressure sensor (15) disposed between the inner layer and the outer layer (10i, 10o) and an RFID tag configured to communicate with the pressure sensor.

Description

[Technical Field]

[0001] The present invention relates to a header bag for packaging at least one medical device, a package including such a header bag, and a process for packaging at least one medical device using such a header bag. [Background technology]

[0002] Medical devices may need to be transported from a first location to another location, for example, when a first portion of their processing occurs at the first location and a second portion of their processing occurs at the second location. For example, medical containers such as syringes may be manufactured at a first location and then filled with a pharmaceutical composition at a second location. They may then be sent to a third location for storage before delivery to a patient.

[0003] To that end, the bag may be used to package such medical devices for transport from one location to another, and in some cases, for storage at the end user's location.

[0004] In particular, the bag may be configured to maintain the sterility of the medical device, and to that end, the bag may be configured to provide a barrier to prevent foreign matter, such as contaminants including microorganisms, dust, plastics, or any particles emanating from the manufacturing and handling process, from entering the bag.

[0005] Furthermore, medical devices can be manufactured in a clean room, but a sterilization step can be carried out after packaging to destroy contamination. To that end, the bag can comprise walls that are porous to gas, in particular sterilizing gas (e.g., ethylene oxide), thus allowing said sterilizing gas to penetrate the bag and come into contact with the medical device.

[0006] Second, the integrity of the bag must be maintained until it is opened for use with the medical device, otherwise contamination of the medical device may occur, with potentially dangerous consequences for the patient.

[0007] During transport, the bag with the medical device is packed in a box intended to protect the medical device and the bag from mechanical constraints that could damage them, although it cannot be excluded that damage may occur within the bag, for example, in the event of contact with a sharp object.

[0008] Loss of pouch integrity may not be readily apparent, such as in the case of small tears in the bag wall, and therefore, even if the sterile bag is not obviously damaged, the medical device may become contaminated by the break.

[0009] To anticipate such contamination of medical devices, decontamination can be performed at the point of use, but such decontamination applied to all medical devices in the same box is expensive and time-consuming.

[0010] Therefore, it is desirable to perform such decontamination only on medical devices whose sterilization bags have been damaged.

[0011] There are whole package integrity loss indicators that can be placed in the bag and are configured to change color via a chemical reaction when the atmosphere within the bag changes.

[0012] However, such indicators can only detect loss of integrity if the bag is damaged, so detailed inspection of the bag is required.

[0013] Furthermore, such indicators cannot be used with bags that contain porous walls that allow for sterilization. In fact, due to such porous walls, the atmosphere inside and outside the bag is the same. Therefore, even if a breach occurs in the wall of the bag, the atmosphere inside the bag will not change and will not affect the color of the indicator. Summary of the Invention

[0014] It is an object of the present invention to provide a header bag that allows for easy detection of loss of integrity, whether or not the bag contains porous walls.

[0015] To that end, the present invention provides a header bag for packaging at least one medical device, comprising at least one sheet configured to be sealed to form an enclosure for the at least one medical device, the at least one sheet including at least an inner layer and an outer layer, the inner layer and the outer layer being impermeable to gas and capable of creating a vacuum in a volume extending between the inner layer and the outer layer, the header bag further comprising a pressure sensor disposed between the inner layer and the outer layer and an RFID tag configured to communicate with the pressure sensor, the RFID tag, for example, recording changes in pressure detected by the pressure sensor.

[0016] The vacuum created between the inner and outer layers of at least one sheet allows for the detection of loss of integrity of the header bag. Indeed, damage to at least one of the inner and outer layers results in loss of the vacuum between the layers. In particular, air or any other gas to which the damaged layer is exposed can penetrate between the layers. In some embodiments, the gas can be detected by a visual indicator, which may be sensitive to humidity, for example. In other embodiments, the gas can be detected by a pressure sensor associated with an RFID tag. In other embodiments, the gas can cause the inner and outer sheets to be separable from each other and can therefore be detected by pulling the layers apart to separate them.

[0017] In some embodiments, the header bag further comprises a porous wall sealed to the at least one sheet to form part of the enclosure.

[0018] The porous wall may be made from a nonwoven material comprising high density polyethylene fibers, coated cellulose fibers, and / or uncoated cellulose fibers.

[0019] In some embodiments, the header bag may include a single sheet configured to be folded and sealed onto itself to form the enclosure.

[0020] In other embodiments, the header bag may include at least two sheets configured to be sealed together to form an enclosure.

[0021] In some embodiments, the header bag may include an indicator disposed between the inner and outer layers, the indicator configured to change visual appearance when exposed to fluctuations in gas concentration, such as fluctuations in pressure or humidity.

[0022] In some embodiments, the header bag may include a pull tab attached to the outer layer.

[0023] The inner and outer layers of each sheet may comprise any of polyethylene, particularly low density linear polyethylene, polypropylene, and polyethylene terephthalate.

[0024] According to another aspect, the present invention provides packaging for at least one medical device comprising the header bag described above, wherein the at least one medical container is disposed within a sealed enclosure, and the volume between the inner and outer layers of each sheet is under vacuum.

[0025] According to another aspect, the present invention provides a process for packaging at least one medical device in such a header bag, said process comprising the steps (not necessarily performed in the following order): providing a header bag as described above, the header bag including at least one opening to allow placement of a medical device(s) therein; placing at least one medical container within the enclosure; Sealing the enclosure (closing the header bag), and creating a vacuum between the inner and outer layers of at least one sheet.

[0026] In some embodiments, a vacuum may be created in at least one sheet prior to providing the header bag.

[0027] In other embodiments, a vacuum may be created in the at least one sheet when sealing an enclosure containing at least one medical container. [Brief explanation of the drawings]

[0028] Additional features and advantages of the present invention are described below with reference to the accompanying drawings. [Figure 1] 1 is a schematic diagram of packaging according to a first embodiment; [Figure 2] FIG. 2 is a schematic view of a package according to a second embodiment. [Figure 3] 1 is a schematic diagram of a header bag according to a first embodiment. FIG. [Figure 4] FIG. 4 is an enlarged partial view of the header bag of FIG. 3. [Figure 5] 10 is a schematic diagram of a header bag according to a second embodiment including a visual indicator. [Figure 6A] 6 is a schematic diagram of a first visual embodiment of the indicator of FIG. 5. [Figure 6B] FIG. 6 is a schematic diagram of a second visual embodiment of the indicator of FIG. 5. [Figure 7] FIG. 10 is a schematic diagram of a header bag according to a third embodiment including a pressure sensor coupled to an RFID tag. [Figure 8] 1A-1C show top, bottom, and side views of a header bag according to one embodiment having two sheets configured to be sealed together. [Figure 9]1A-1C show top, bottom, and side views of a header bag according to one embodiment, configured with a single sheet sealed to itself. DETAILED DESCRIPTION OF THE INVENTION

[0029] The header bag comprises at least one sheet configured to be sealed to form an enclosure for one or more medical devices, such as medical containers.

[0030] The at least one sheet is made of two layers that are overlapped and sealed along their periphery to form a sheet: one layer, called the outer layer, defines the outer surface of the header bag and is exposed to the atmosphere surrounding the header bag, and the other layer, called the inner layer, defines the inner surface of the header bag and is exposed to the same atmosphere as the at least one medical device.

[0031] Sealing the layers can be accomplished by locally heating the area around the layers and applying mechanical pressure to promote welding of the two layers of material along a continuous line. Sealing the layers thus defines a sealed area where both the outer and inner layers are welded together. The layers can be made from the same polymeric material or compatible polymeric materials, i.e., polymers with different molecular structures that can still be welded to each other. In a preferred embodiment, at least one of the inner and outer layers can be made from polyethylene, particularly low-density linear polyethylene (LLDPE), polypropylene, and / or polyethylene terephthalate.

[0032] Both the inner and outer layers, as well as the continuous sealed area, are impermeable to gases such as oxygen, air, carbon dioxide, and / or water vapor, for example, air. Gas impermeable herein means a layer that has low permeability to gases such as air or oxygen. For example, low permeability to oxygen means a permeability of less than 1,000 cm3 / 25 μm / 24 h. The permeability may be measured using any device known to those skilled in the art, for example, a permeation oxygen analyzer (OxPerm, Ox-Tran 2.222) according to ASTM D3985 (Standard Test Method for Oxygen Gas Transmission Rate through Plastic Films and Sheets Using a Coulometric Sensor).

[0033] In this way, a vacuum can be created within the volume extending between the layers during or after sealing of the sheet. For example, a vacuum can be created using a vacuum sealer, such as a MAGVAC™ machine, or by firmly applying the two layers together. When such a vacuum is created, the inner and outer layers adhere strongly to each other and cannot be separated even if an attempt is made to pull the layers apart. By vacuum, we mean a pressure of less than 400 mbar, or preferably less than 250 mbar, for example, a pressure between 50 mbar and 250 mbar.

[0034] In a preferred embodiment, the medical device comprises a medical container such as a syringe, eg, a pre-filled syringe, cartridge, or vial.

[0035] The medical device or devices may be enclosed directly within the header bag without any intermediate packaging, or they may be placed within intermediate packaging, such as a tub and / or nest, which is itself enclosed within the header bag.

[0036] Preferably, the header bag may include a wall that is porous to gases, particularly sterilizing gases (e.g., ethylene oxide). By porous, we mean that the wall's material, thickness, and permeability to gases are configured to allow sufficient sterilizing gas flow through the wall. In this way, at least one medical device enclosed within the header bag may be exposed to sterilizing gas that permeates through the porous wall into the sealed header bag. In preferred embodiments, the porous wall may be advantageously made of a nonwoven material made of high-density polyethylene (HDPE) fibers, such as Tyvek™, which is frequently used to perform the function of porous walls in sterilizable header bags. In some embodiments, the nonwoven material may include coated and / or uncoated cellulose fibers.

[0037] As opposed to a sheet, the porous wall may be formed of a single layer. The porous wall may be sealed to the header bag sheet by any means known to those skilled in the art, such as by thermal sealing. The porous wall may be sealed to the inner layer, the outer layer, or both layers forming the sheet.

[0038] However, the present invention is not limited to such embodiments and also covers header bags that are completely impervious to air and do not contain porous walls, which may be preferred, for example, when the medical device does not require sterilization after being placed in the header bag.

[0039] FIG. 1 shows an embodiment of a header bag 1 surrounding a bathtub 2 containing a medical container (not shown).

[0040] The header bag comprises two sheets 10, 11 sealed together.

[0041] Each sheet 10, 11 includes a respective inner layer 10i, 11i and an outer layer 10o, 11o.

[0042] Although a gap is represented between each inner layer and the respective outer layer to make it possible to distinguish between both layers, the inner and outer layers forming each sheet are in fact in contact with each other due to the vacuum created between them during or after the sealing of the sheets.

[0043] The header bag further comprises a porous wall 12 that is permeable to gases.

[0044] The porous wall is sealed to the sheets 10, 11, and it is the sheets 10, 11 themselves (the sealed area is designated by the reference S) that form the sealed enclosure of the bathtub 2.

[0045] A process for manufacturing such a header bag is described below with reference to FIG.

[0046] Instead of sealing two sheets together to form a header bag, it is also possible to fold a single sheet onto itself and then seal it along its perimeter (see FIG. 9 and corresponding description).

[0047] FIG. 2 shows another embodiment of a header bag.

[0048] This header bag is similar to the header bag of Figure 1 except that it does not include a porous wall.

[0049] The description of elements bearing the same reference numbers as in FIG. 1 remains applicable.

[0050] The double layer structure of each sheet forming the header bag and the vacuum within the sheets make it possible to detect any breaks in said sheets by applying the inner and outer layers to one another. Indeed, any break or hole in the inner and / or outer layer has the effect of releasing the vacuum between the layers and allowing the ingress of ambient gas (either from inside or outside the header bag) between the inner and outer layers.

[0051] This effect can be exploited in various ways to detect such corruption. Three embodiments of detection are described below.

[0052] According to a first embodiment, gas permeation between the inner and outer layers allows the layers to separate from one another, which is not possible when a vacuum is applied between the layers. For example, a user may pinch one of the layers (e.g., the outer layer) and pull it while maintaining the other layer (e.g., the inner layer) in a substantially fixed position. The user's ability to pull one of the layers, thereby separating it from the other layers, is evidence that the vacuum has been released and, therefore, that a break has occurred in at least one of the layers.

[0053] To facilitate this method of detecting damage, a pull tab may be provided on the outer layer. For example, the pull tab may be bonded to the outer layer. Typically, the pull tab may be adhered to the outer layer via an adhesive layer provided on the pull tab. Alternatively, the pull tab may also be thermally sealed to the outer layer. In this way, a user may grasp the pull tab (which is easier than pinching the outer layer) and pull it to attempt to separate the outer layer from the inner layer.

[0054] In some embodiments, the inner layer can be adhered to the intermediate packaging using, for example, an adhesive patch such as double-sided tape. In this way, the inner layer can remain secured to the medical device or intermediate packaging, which allows the outer layer to be more easily separated from the inner layer if gas is introduced between the layers due to breakage.

[0055] 3 and 4 show a header bag according to a first embodiment.

[0056] The header bag 1 may or may not include a porous wall. The header bag may be formed from one of multiple double-layer sheets, as described above. Only one sheet, including an inner layer 10i and an outer layer 10o, is depicted in FIG. 3.

[0057] A medical device (not shown) is placed in the bath 2, although in an alternative embodiment, one or more medical devices may be placed directly in the header bag.

[0058] The inner layer 10i is adhered to the bottom of the tub with double sided tape 17.

[0059] The pull tab 13 is adhered to the outer layer 10o.

[0060] As best seen in Figure 4, which is an enlarged view of a portion of the outer layer 10o near the pull tab 13, the pull tab may be formed of two tapes 13a, 13b, with one end 130a, 130b of the tapes bonded to the outer layer 10o and opposite ends 131a, 131b of the tapes 13a, 130b bonded to each other. The bonding may be direct, in which case the tapes 13a, 13b have adhesive surfaces. Alternatively, the bond may be made via an adhesive or any other type of bonding.

[0061] The user can then grasp the joined ends 131a, 131b and pull the outer layer in the direction of the arrow.

[0062] Preferably, the pull tab 13 is located substantially on the side of the sheet opposite the area that is adhered to the bathtub 2. In this way, the inner layer 10i can be held securely to the bathtub while the user pulls the pull tab 13.

[0063] If the header bag contains two or more double layer sheets, each sheet may be provided with a pull tab so that breaks in each sheet can be detected.

[0064] According to a second embodiment, the penetration of gas between the inner and outer layers can be detected by an indicator sensitive to at least one property of the gas located between the inner and outer layers.

[0065] For example, the indicator may be sensitive to variations in gas concentration, such as humidity fluctuations, or to variations in pressure. The indicator is configured to change a visual aspect (e.g., color) in response to said property of the gas. Advantageously, said indicator is reversible, meaning that the change in visual aspect is reversible.

[0066] For example, the indicator may have a first color that is retained as long as a vacuum is maintained between the inner and outer layers and changes when the indicator is exposed to air that penetrates through a breach in at least one of the layers. Typically, indicators commercialized by OLIKROM may be used.

[0067] To allow the user to see this change in visual aspect of the indicator, the outer and / or inner layers may be transparent or translucent, particularly in the case of the low density polyethylene layer described above.

[0068] 5 and 6A-6B show a header bag according to the second embodiment.

[0069] The header bag 1 is formed from two double layer sheets 10, 11. In the illustrated embodiment, the header bag 1 also includes a porous wall 12, although this is optional.

[0070] Each sheet includes an indicator 14 disposed between the inner and outer layers forming the respective sheet. When the header bag is formed, a vacuum is applied between the inner and outer layers, isolating the indicator from the surrounding environment due to the fact that the layers are impermeable to air. Each indicator may have a central portion and a peripheral portion. The vacuum may be created with a vacuum sealer equipped with a vacuum nozzle and a bi-active seal bar, such as a MAGVAC™ machine.

[0071] As shown in FIG. 6A, a central portion 141 of the indicator has a first color, which may be the same as the color of the surrounding portions.

[0072] When a hole H is punctured in the sheet 10, air from outside the header bag penetrates between the inner and outer layers of the sheet, thereby exposing the corresponding indicator 14 to the humidity contained in said air.

[0073] Thus, as shown in Figure 6B, the central portion 141 of the indicator changes color, while the peripheral portion 140 can remain the same color.

[0074] A user may observe the color of each indicator through the inner and / or outer layer and then detect whether a color change has occurred.

[0075] Of course, this embodiment is also applicable where the header bag is formed from only one double layer sheet, in which case only one indicator is required.

[0076] However, it may be decided to place two or more indicators located at different positions on a single sheet, for example to increase the chances of detecting damage over the entire surface of the sheet.

[0077] According to a third embodiment, gas permeation between the inner and outer layers can be detected by a pressure sensor disposed between the inner and outer layers. A radio frequency identification (RFID) tag is also disposed between the inner and outer layers. The RFID tag is configured to communicate with the pressure sensor and record changes in pressure between the inner and outer layers detected by the pressure sensor.

[0078] The data recorded on the RFID tag can be read by an RFID reader 16 outside the header bag. Thus, a user can use the RFID reader to obtain information about the pressure between the inner and outer layers of the sheet to determine whether a break in the sheet has occurred.

[0079] FIG. 7 shows a header bag according to the third embodiment.

[0080] The header bag 1 is formed from two double layer sheets 10, 11. In the illustrated embodiment, the header bag 1 also includes a porous wall 12, although this is optional.

[0081] Each sheet includes a pressure sensor 15 associated with an RFID tag located between the inner and outer layers forming the respective sheet. Typically, sensors commercialized by ASYGN, such as the ASX321x sensor, may be used. Once the header bag is formed, a vacuum is applied between the inner and outer layers, and the pressure sensor can measure an initial pressure corresponding to the vacuum.

[0082] When a hole H is created in sheet 10, air from outside the header bag penetrates between the inner and outer layers of this sheet. As a result, the corresponding pressure between the inner and outer layers increases, and the pressure sensor measures a new pressure that is greater than the initial pressure. The measured pressure is recorded in the memory of the RFID tag.

[0083] When a user brings an RFID reader 16 toward the header bag, the RFID reader can read the data recorded on the RFID tag, based on which the user can determine that a pressure increase has occurred and infer that a break has occurred in the corresponding sheet.

[0084] Of course, this embodiment is also applicable if the header bag is formed from only one double layer sheet, in which case one sensor and RFID tag may be required.

[0085] To provide an additional means for detecting breakage, a pull tab may be provided on the outer layer, as previously described with respect to the first embodiment.

[0086] More generally, two or more of the above embodiments may be combined, where this is technically feasible.

[0087] The manufacture of header bags primarily involves providing inner and outer layers with appropriate dimensions to form respective sheets, overlapping the inner and outer layers to form the sheet, and sealing the volume. The sealing can be achieved, for example, by locally heating at least one of the inner and outer layers and applying pressure to create a mechanical bond between the layers. Sealing can also be achieved using an adhesive locally applied to the inner layer, the outer layer, or both the inner and outer layers. The seal is continuous along the periphery of the sheet to create an airtight volume between the inner and outer layers.

[0088] A vacuum may be created in the volume during or after the sealing. In particular, a vacuum between the inner and outer layers is preferably created when the two inner and outer layers are sealed together. Alternatively, the vacuum may be created at a later stage in the packaging process when the header bag is sealed to close the enclosure after at least one medical device has been placed inside the bag.

[0089] The sheet can then be sealed to itself or to another similar sheet to form an enclosure for the medical container. If appropriate, at least one sheet is further sealed to a porous wall. To this end, the materials of the sheet(s) and the porous wall must be compatible to enable such a seal. For example, the sheet(s) and the porous wall can be made of the same type of polymer so that they can be welded together. In particular, a polyethylene layer and a polyethylene nonwoven fabric can be sealed together.

[0090] FIG. 8 shows top, bottom, and side views (from top to bottom) of a header bag according to one embodiment having two sheets and a porous wall configured to be sealed together.

[0091] The top of the header bag comprises a first sheet 10 formed from an inner layer 10i and an outer layer 10o (see side view) and a porous wall 12, each having a rectangular shape. The porous walls are sealed to the first sheet 10 along a common longitudinal side. The inner and outer layers 10i, 10o are sealed together along the other three sides of the sheet 10. A vacuum can be created between the inner layer 10i and the outer layer 10o during or after sealing the layers. The sealed area is designated by the reference S.

[0092] The bottom of the header bag comprises a second sheet 11 formed from an inner layer 11i and an outer layer 11o (see side view). The second sheet has a rectangular shape substantially identical to the shape of the assembly of the first sheet 10 and porous wall 12. The inner and outer layers 11i, 11o are sealed along four sides of the sheet 11. A vacuum can be created between the inner layer 11i and the outer layer 11o during or after sealing the layers.

[0093] The header bag can then be assembled by laminating the first sheet 10 and porous wall 12 assembly to the second sheet 11 .

[0094] The superposed sheets are then sealed on three sides, which can be done using the same technical means as used to seal the individual sheets.

[0095] A fourth side remains open to allow the medical container or intermediate packaging to be inserted into the enclosure. In the illustrated embodiment (see side view), the opposite side of porous wall 12 remains open. Said side can be sealed after the medical container is placed in the header bag.

[0096] The porous wall 12 is optional. If the header bag is not intended to be sterilized, the porous wall may be omitted and the header bag may be formed from first and second sheets 10, 11 having similar dimensions.

[0097] FIG. 9 shows top, bottom, and side views of a header bag according to one embodiment, configured as a single sheet that is folded and sealed to itself.

[0098] The header bag comprises a sheet 10 that is folded upon itself to form both the top and bottom of the header bag. The sheet 10 includes an inner layer 10i and an outer layer 10o (see side view). More precisely, the top of the header bag is formed from a portion of the sheet 10 and a porous wall 12, each of which has a rectangular shape. The bottom of the header bag is formed from the remaining portion of the sheet 10.

[0099] The porous wall 12 is sealed to the first sheet 10 along its common longitudinal side. The inner and outer layers 10i, 10o are sealed together along the other three sides of the sheet 10. As a result, the volume between layers 10i and 10o extends from the top to the bottom of the header bag. A vacuum can be created between the inner layer 10i and the outer layer 10o during or after the sealing of the layers.

[0100] The header bag can then be assembled by folding sheet 10 to form a top and bottom and sealing two sides of the folded sheet. In contrast to the previous embodiment, the third side (left side in FIG. 9) does not require a seal, as it is formed by folding sheet 10.

[0101] The fourth side remains open to allow the medical container or intermediate packaging to be inserted into the enclosure. In the illustrated embodiment (see side view), the opposite side of the fold remains open. Said side can be sealed after the medical container is placed in the header bag.

Claims

1. 1. A header bag (1) for packaging at least one medical device, comprising: at least one sheet (10, 11) configured to be sealed to form an enclosure for the at least one medical device, the at least one sheet (10, 11) comprising at least an inner layer (10i, 11i) and an outer layer (10o, 11o), the inner layer and the outer layer being impermeable to gas so that a vacuum can be created in a volume extending between the inner layer and the outer layer; and a pressure sensor (15) disposed between the inner layer and the outer layer (10i, 10o), and an RFID tag configured to communicate with the pressure sensor.

2. 2. A header bag according to claim 1, further comprising a porous wall (12) sealed to said at least one sheet (10, 11) to form part of said enclosure.

3. 3. The header bag of claim 2, wherein the porous wall (12) is made of a nonwoven material comprising high density polyethylene fibers, coated cellulose fibers, and / or uncoated cellulose fibers.

4. 4. A header bag according to any one of claims 1 to 3, comprising a single sheet (10) configured to be folded and sealed onto itself to form the enclosure.

5. 4. A header bag according to any one of claims 1 to 3, comprising two sheets (10, 11) adapted to be sealed together to form the enclosure.

6. 6. The header bag of claim 1, further comprising an indicator disposed between the inner and outer layers, the indicator configured to change visual appearance when exposed to a change in gas concentration, such as a pressure or humidity change.

7. 7. A header bag according to any one of claims 1 to 6, further comprising a pull tab (13) attached to the outer layer (10o, 11o).

8. 8. The header bag of claim 1, wherein the inner and outer layers of each sheet comprise any of the following materials: polyethylene, polypropylene, and / or polyethylene terephthalate.

9. 9. A packaging for at least one medical container comprising a header bag (1) according to any one of claims 1 to 8, wherein the at least one medical container is placed in the sealed enclosure, and the volume between the inner and outer layers of each sheet is under vacuum.

10. 1. A process for packaging at least one medical container, comprising: Providing a header bag (1) according to any one of claims 1 to 8; placing at least one medical container within the enclosure; sealing the enclosure; forming a vacuum between the inner and outer layers of the at least one sheet.

11. The process of claim 10 , wherein the vacuum is formed in the at least one sheet prior to providing the header bag.

12. 11. The process of claim 10, wherein the vacuum is created in the at least one sheet when sealing the enclosure containing the at least one medical container.

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