Method for protecting a tubular object

Abstract

The present invention relates to a method for protecting a tubular member. A method for protecting a tubular member (2) protruding from a container (3) containing a pharmaceutical fluid, the container being in particular a bottle, the method comprising the steps of: providing a container (3) filled with a pharmaceutical fluid, the tubular member (2) protruding from the container, providing a foam layer and / or foam body (4), surrounding the tubular member (2) with a housing (5), preferably the entire tubular member, such that the foam layer and / or foam body (4) is interposed between the tubular member (2) and the housing (5), while the body (6) of the container (3) remains outside the housing (5), attaching the housing (5) to the container (3), and freezing the container (3) and the housing (5) surrounding the tubular member (2). The present invention also relates to a protection device for a tubular member (2) protruding from a container (3) containing a pharmaceutical fluid, as well as related configurations and uses.

Description

Technical Field

[0001] The present invention relates to a method for protecting a tubular member protruding from a container (in particular a bottle) containing a pharmaceutical fluid and a protection device for a tubular member protruding from a container (in particular a bottle) containing a pharmaceutical fluid. Background Art

[0002] In the process of pharmaceutical production, especially in biopharmaceutical production, it is necessary to store and / or transport the fluids produced in (bio)pharmaceutical production in amounts far exceeding the individual patient doses. Since such amounts of pharmaceutical fluids represent very high value, in the pharmaceutical industry, extreme measures must be taken to protect not only the sterility of the pharmaceutical fluids but also the structural integrity of the devices used for storing, transporting, and further using the pharmaceutical fluids.

[0003] It should be mentioned that the container together with the pharmaceutical fluid is frozen for transportation and storage to prevent unwanted (bio)chemical processes and reactions during this period.

[0004] For example, a solution for protecting a container filled with a pharmaceutical fluid is disclosed in WO 2018129576 A1. Such solutions are very effective, especially for flexible containers, such as single-use bags.

[0005] However, there are also other more rigid containers, such as especially bottles, which are strong enough by themselves to ensure the structural integrity during transportation and storage. For such containers, the previously mentioned solutions are somewhat less suitable because they increase the size of the object to be transported or stored without bringing obvious benefits.

[0006] Containers such as bottles used in the pharmaceutical production process include tubes, connectors, etc., which are attached to the container to facilitate access to the container after transportation or storage, and they are crucial for maintaining the sterility of the pharmaceutical fluid. During the transportation and storage of the container, such tubes, connectors, and other accessories (collectively referred to as tubular members here) actually require additional protection, especially because the materials usually used to make tubular members become brittle when frozen. Summary of the Invention

[0007] Therefore, an object of the present invention is to provide a method and a protection device that allow easy protection of the tubular member during transportation and / or storage in a frozen state, especially without adding an unwanted volume to the object to be stored and / or transported.

[0008] Regarding the method, this object is achieved by the features of the present invention, wherein the method comprises the following steps:

[0009] - providing a container filled with a pharmaceutical fluid, from which a tubular member protrudes,

[0010] - Provide a foam layer and / or foam body,

[0011] - Surround the tubular member with a housing, preferably the entire tubular member, such that the foam layer and / or foam body is interposed between the tubular member and the housing, while the main body of the container remains outside the housing,

[0012] - Attach the housing to the container, and

[0013] - Freeze the container and the housing surrounding the tubular member.

[0014] Regarding the protection device, this object is achieved by the features of the present invention. The protection device includes: a housing that forms a chamber for surrounding the tubular member; and a foam layer and / or foam body, characterized in that the protection device includes an attachment element for attaching the housing to the container, so that the tubular member can preferably be completely arranged inside the housing.

[0015] Protection is also sought for a construction that includes

[0016] - A container, in particular a bottle, that contains a pharmaceutical fluid,

[0017] - A tubular member that protrudes from the container,

[0018] - A protection device according to the present invention that surrounds the tubular member and is attached to the container, and

[0019] - A foam layer and / or foam body that is interposed between the tubular member and the housing,

[0020] wherein the construction preferably exists in a frozen state.

[0021] Protection is also sought for the use of a protection device according to the present invention in a method according to the present invention.

[0022] According to the present invention, the freezing of the container together with the housing (and thus of course the fluid, the tubular member, and the foam layer and / or foam body) not only achieves the protection of the pharmaceutical fluid as described above, but also serves to harden the foam layer and / or foam body inside the housing. This hardening of the foam layer and / or foam body is advantageous because it fixes the tubular member, so the risk of mechanical damage (caused by impact or scratching, etc.) to the tubular member is greatly reduced and in most cases excluded. In this way, the tubular member is effectively and easily protected, while the volume of the main body of the container is not additionally increased.

[0023] According to the present invention, the foam layer and / or foam body is interposed between the tubular member and the housing. This means that at least part of the foam layer and / or foam body is arranged between the tubular member and the housing, such that the foam layer and / or foam body significantly reduces the contact area between the housing and the tubular member.

[0024] Of course, according to the present invention, more than one foam layer and / or foam body can be used. Hereinafter, the expression "foam layer and / or foam body" also means that more than one foam layer and / or foam body can be used, unless otherwise specified.

[0025] In a preferred embodiment, the foam layer and / or foam body completely surrounds the tubular member, thereby reducing or completely avoiding contact between the tubular member and the outer shell.

[0026] The body of the container can be understood as the part of the container that actually holds the pharmaceutical fluid. For example, if the container is a bottle, the collar for closing the opening of the bottle and, in some cases, the upper part of the neck of the bottle will not be part of the container body.

[0027] Generally speaking, in the context of the present invention, the collar is understood as such a part of the container where the openings for filling and emptying the container are located and the tubular member is attached to the container.

[0028] Preferably, the present invention is used for pharmaceutical liquids, especially biopharmaceutical liquids.

[0029] In the context of the present invention, the pharmaceutical fluid and liquid are either the drug itself or the fluid or liquid produced as a pre-product or intermediate product during the drug production process (similarly for biopharmaceutical fluids and liquids).

[0030] The outer shell according to the present invention can be advantageously manufactured by injection molding, for example, using a thermoplastic as the material of the outer shell.

[0031] As mentioned above, in the context of the present invention, the tubular member is understood as a tube connector (especially a sterile connector) attached to the container and used for filling and / or emptying the container preferably in a sterile manner. Such a tube is usually made of silicone or other materials that remain flexible for a long time.

[0032] The container, especially a bottle, can be made of, for example, thermoplastic, glass, and / or metal.

[0033] The foam layer and / or foam body can be, for example, polyethylene foam (especially high-density polyethylene). In particular, viscoelastic foam can be used.

[0034] Other advantageous embodiments are defined in the present invention.

[0035] Preferably, the method according to the present invention may further include transporting and / or storing the container and the outer shell surrounding the tubular member, thawing the container and the outer shell surrounding the tubular member, removing the outer shell and the foam layer and / or foam body, and removing the content of the container.

[0036] The housing may comprise two parts which are connected by a hinge, in particular an integrated hinge, such that the housing can be opened and closed.

[0037] In such embodiments, the two parts may be substantially shaped as half-shells such that a tubular body can be easily placed inside the housing.

[0038] In other conceivable embodiments, there may be a housing opening which can be placed on the tubular body without opening the housing, and the housing and / or the housing opening may be attached to the container and / or the opening of the container.

[0039] The integrated hinge is realized by a thin flexible part of the housing which allows the two parts of the housing to pivot relative to each other by the flexibility of the integrated hinge. Generally, the integrated hinge is made of plastic as the material, but conceivably, it can also be made of, for example, metal.

[0040] Furthermore, the attachment element may comprise two attachment element parts, one of which is arranged on each of the two parts of the housing, preferably such that closing the housing will simultaneously place the attachment element in the closed position.

[0041] In other words, in a preferred embodiment, the method steps of surrounding the tubular body with the housing and attaching the housing to the container can be simultaneously performed by closing the housing around a collar of the tubular body and the container such that the housing is attached to the container via a forced lock and / or a friction lock between the housing and the collar.

[0042] Forced lock is a type of lock in which the shape of different engaging elements (as opposed to the frictional force in a friction lock) prevents the housing from detaching from the container.

[0043] In a particularly preferred embodiment, the attachment element may comprise at least one engaging element which is configured to engage at least one recess and / or at least one protrusion of the container, and the at least one recess and / or at least one protrusion is preferably arranged on the collar of the opening of the container.

[0044] The housing may have a substantially cylindrical basic shape, the attachment element is arranged in a first base region of the substantially cylindrical basic shape, and a second base region of the substantially cylindrical basic shape is closed.

[0045] It is noted that it is not absolutely necessary to close the second base region of the substantially cylindrical basic shape. In some embodiments, if the second base region remains open, the positive effects of the present invention (i.e., easily and effectively protecting the tubular body) can also be achieved to a large extent.

[0046] In a preferred embodiment, the substantially cylindrical basic shape may of course be augmented with, for example, rounded edges, a closing element of the housing, a constriction, etc.

[0047] The first and / or second base regions of the substantially cylindrical base shape may particularly preferably be circular or elliptical regions. Of course, rectangular or other polygonal base regions may also be used.

[0048] Naturally, the foam layer and / or foam body can be (pre-)arranged in the housing before use. Then, the operator can leave the foam layer and / or foam body in the housing and simultaneously surround the tubular body with the housing as well as the foam layer and / or foam body, or remove the foam layer and / or foam body and apply the foam layer and / or foam body before (at least partially) surrounding the tubular body with the housing (and the foam layer and / or foam body).

[0049] The protection device according to the invention can be equipped with a seal such that the protection device cannot be opened or at least is obvious when being pried open. Description of the Drawings

[0050] From the drawings and the accompanying description of the drawings, other details and advantages are obvious. The drawings show:

[0051] Figure 1 An embodiment showing the protection device according to the invention in an open configuration,

[0052] Figure 2 showing Figure 1 the embodiment having a foam body arranged inside,

[0053] Figure 3 showing Figure 1 the embodiment in a closed configuration,

[0054] Figure 4 showing the Figure 1 embodiment in a closed configuration equipped with a seal,

[0055] Figures 5 to 8 showing four depictions of an embodiment according to Figure 1 which visualize the method according to the invention,

[0056] Figure 9 and 10 showing two diagrams which show another embodiment of the protection device according to the invention. Detailed Description

[0057] Figure 1 An embodiment showing the protection device 1 according to the invention in an open state is shown. It includes a housing 5 which is divided into two parts 10 in the form of half-shells.

[0058] The housing has a substantially cylindrical base shape, and each of the two parts 10 forms half of the substantially cylindrical base shape.

[0059] Two parts 10 of the housing 5 are connected to each other via an integrated hinge 11, by means of which the operator can close the housing 5 (shown in the Figure 3 in the closed position).

[0060] An attachment element 9, which will be described further below, is arranged in a first base region of a substantially cylindrical base shape. A second base region of the substantially cylindrical base shape is enclosed (see Figure 3 ) when in the closed configuration, (at the top shown in Figure 1 ).

[0061] Furthermore, a constriction 17 of the housing 5 is located approximately in the middle between the first and second base regions along the substantially cylindrical base shape.

[0062] When the housing 5 is closed, an interior (generally designated by the reference numeral 8) forms a chamber in which a foam layer and / or foam body 4 as well as a tube 2 can be placed. Figure 2 An embodiment is shown in Figure 1 in which two foam bodies 4 are arranged in each of the two parts 10.

[0063] The attachment element 9 includes a joining element in the form of a recess 13, which engages with a projection 14 on a collar 7 of the container (see Figure 5 ). Not all of the joining elements are provided with reference numerals in order to avoid overloading the drawing.

[0064] The attachment element 9 is divided into two attachment element parts 12, which are located on each of the two parts 10 of the housing 5. Obviously, closing the housing 5 will also close the attachment element 9 in order to bring the attachment element 9 into engagement with the collar 7 (see Figure 6 and Figure 7 ).

[0065] As can be seen from Figure 1 and Figure 2 , there are several closing elements 16, which are used to hold the housing in the closed position. Again, not all of the closing elements are provided with reference numerals.

[0066] In Figure 3 it can also be seen that the substantially cylindrical base shape of the housing 5 is enclosed at the top (second base region of the substantially cylindrical base shape).

[0067] Figure 3 The closing element 16 in the closed configuration is also shown.

[0068] Figure 4 A protective device 1 equipped with a sealing member 18 is shown, which in the present exemplary embodiment includes a line and a tab extending around the constriction.

[0069] Thus, the constriction serves two purposes. First, it serves as a guide for the closure member, and second, it tightens the foam layer and / or foam body 4 within the outer shell 5, thereby further securing the tubular member 2 (see Figure 6 ).

[0070] Figures 5 to 8 FIG. shows how the protection device 1 is used to protect a tubular member 2 attached to a container 3, in this case the container is a bottle. First, a container 3, an outer shell 5 and two foam bodies 4 are provided ( Figure 5 ). Obviously, a single foam body 4 or one or more foam layers can also be used.

[0071] The container 3 includes a body 6 and a collar 7, and a protrusion 14 is provided on the collar (in this case a single protrusion 14, but embodiments of the present invention can also be used for containers 3 including any number of protrusions 14 or recesses 13). A tubular member 2 is attached to the top of the collar 7.

[0072] According to the present invention, the tubular member 2 is placed within the outer shell 5 together with the foam layer and / or foam body 4 ( Figure 6 ).

[0073] It is obvious that the foam layer and / or foam body 4 is / are interposed between the outer shell 5 and the tubular member 2, preferably such that the foam layer and / or foam body 4 completely surrounds the tubular member 2 (at least around the longitudinal axis of the tubular member, but preferably also at the top end portion of the tubular member).

[0074] In this example, the tubular member 2 includes three silicone tubes protruding from the container 3. The tubular member 2 may also include one or more sterile connectors and other accessory fittings.

[0075] Closing the outer shell 5 now causes the protrusion 14 to engage with the recess 13, such that the protection device 1 is attached to the container 3 and cannot be easily separated from the container (this is shown in Figure 7 ).

[0076] Of course, the positions of the protrusion 14 and the recess 13 can be interchanged, and the attachment of the outer shell 5 to the container 3 can be similarly achieved in this way.

[0077] Once the outer shell 5 is closed ( Figure 7 ), the tubular member 2 is safely protected within the foam layer and / or foam body 4 and the interior of the outer shell 5, while the body 6 of the container 3 remains free, i.e., outside the outer shell. In this way, the tubular member 2 is effectively and easily protected without increasing the volume of the container 3 itself.

[0078] Figure 9 and Figure 10 FIG. shows another embodiment of the protection device 1 according to the present invention, in its open and closed configurations respectively, the protection device having the same as that combined with Figure 1Similar functional elements described in the embodiments of

Claims

1. A method for protecting a tube (2) protruding from a container (3) containing a pharmaceutical fluid, the method comprising the steps of: - providing the container (3) filled with the pharmaceutical fluid, the tube (2) protruding from the container, - providing a foam layer and / or foam body (4), - surrounding the tube (2) with a housing (5) such that the foam layer and / or foam body (4) is interposed between the tube (2) and the housing (5), while the body (6) of the container (3) remains outside the housing (5), - attaching the housing (5) to the container (3), and - freezing the container (3) and the housing (5) surrounding the tube (2).

2. The method according to claim 1, wherein the method steps of surrounding the tube (2) with the housing (5) and attaching the housing (5) to the container (3) are carried out simultaneously by closing the housing (5) with a collar (7) surrounding the tube (2) and the container (3), such that the housing (5) is attached to the container (3) via a forced lock and / or friction lock between the housing (5) and the collar (7).

3. The method according to claim 1, wherein the method further comprises transporting and / or storing the container (3) and the housing (5) surrounding the tube (2), thawing the container (3) and the housing (5) surrounding the tube (2), removing the housing (5) and the foam layer and / or foam body (4), and removing the contents of the container (3).

4. The method according to any one of claims 1 to 3, wherein the container is a bottle.

5. The method according to any one of claims 1 to 3, wherein the entire tube is surrounded by a housing.

6. A construction, comprising a container (3) containing a pharmaceutical fluid, a tube (2) protruding from the container (3), a protection device (1) for a tube (2) protruding from a container (3) containing a pharmaceutical fluid, the protection device surrounding the tube (2) and attached to the container (3), and a foam layer and / or foam body (4) interposed between the tube (2) and the housing (5) of the protection device (1), The protection device (1) comprises a housing (5) which forms a chamber (8) for surrounding the tubular body (2) and a foam layer and / or foam body (4), while the body (6) of the container (3) is held outside the housing (5), characterized in that, the protection device (1) comprising an attachment element (9) for attaching the housing (5) to the container (3) such that the tube (2) can be arranged within the housing (5).

7. The construction according to claim 6, wherein the housing (5) comprises two parts (10) connected by a hinge (11) such that the housing (5) can be opened and closed.

8. The construction according to claim 7, wherein the two parts (10) are substantially shaped as half-shells.

9. The construction according to claim 7 or 8, wherein the attachment element (9) comprises two attachment element parts (12), one of which is arranged on each of the two parts (10) of the housing (5).

10. The construction according to any one of claims 6 to 8, wherein the attachment element (9) comprises at least one engaging element configured to engage at least one recess (13) and / or at least one protrusion (14) of the container (3).

11. The construction according to any one of claims 6 to 8, wherein the housing (5) has a substantially cylindrical base shape, the attachment element is arranged at a first base region of the substantially cylindrical base shape, and a second base region of the substantially cylindrical base shape is closed.

12. The construction according to any one of claims 6 to 8, wherein a foam layer and / or a foam body (4) is arranged in the housing.

13. The construction according to any one of claims 6 to 8, wherein the construction exists in a frozen state.

14. The construction according to claim 6, wherein the container is a bottle.

15. The construction according to claim 6, wherein the tubular member can be completely arranged within the housing.

16. The construction according to claim 7, wherein the hinge is an integrated hinge.

17. The construction according to claim 9, wherein closing the housing (5) simultaneously positions the attachment element (9) in a closed position.

18. The construction according to claim 10, wherein the at least one recess (13) and / or the at least one protrusion (14) is arranged on a collar (7) of an opening of the container (3).

19. Use of the construction according to any one of claims 6 to 18 in the method according to any one of claims 1 to 5.

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