Packaging for a drug container and / or a drug container holder and method for packaging a drug container and / or a drug container holder

Abstract

A packaging for a drug container and / or a drug container holder configured to receive a drug container, the packaging comprising a contact part configured to be connectable to or connected to the drug container and / or the drug container holder such that at least a distal end of the drug container and / or the drug container holder is covered by the contact part, wherein at least a portion of the contact part is removable to uncover the distal end.

Description

[0001] PAT25006-WO-PCT

[0002] Title

[0003] Packaging for a drug container and / or a drug container holder and method for packaging a drug container and / or a drug container holder

[0004] Background

[0005] Medical products, e.g. drug containers and / or drug container holders, are often packaged before leaving the production site to prevent damage or break and for keeping them clean during transport and storage. Conventional packagings may be disadvantageous for ecologic and economic reasons. For example, the packaging sizes might not always be appropriate for the user's needs, which potentially leads to waste of unused products / drugs when the expiration date is reached. Additionally, more packaging material than necessary for the user's needs has to be used.

[0006] Moreover, the conventional process of packaging drug containers and / or drug container holders often requires many steps, thereby creating high costs. Further, before administering the product, conventional packagings often require the user to perform a comparatively high number of steps for preparing the drug container for a drug delivery operation, e.g. an injection, which is inconvenient.

[0007] Hence, there is a need for an improved packaging for medical products such as drug containers and / or drug container holders.

[0008] Summary

[0009] The present disclosure relates to a packaging for a drug container and / or a drug container holder, e.g. a drug container and / or a drug container holder of a drug delivery device. Further, the disclosure relates to an arrangement comprising the packaging and a drug container and / or a drug container holder. Further, the disclosure relates to a kit comprising a drug container and a drive mechanism. Further, the disclosure relates to a drug delivery device comprising a drug container and a drive mechanism. Further, the disclosure relates to a method for packaging a drug container and / or a drug container holder.It is an object of the disclosure to provide an improved packaging for a drug container and / or a drug container holder.

[0010] The object is solved by the packaging according to claim 1 and the method according to claim 15. Further aspects and embodiments are described in the dependent claims.

[0011] According to an aspect of the disclosure, a packaging for a drug container and / or a drug container holder is provided. The drug container holder may be configured to receive a drug container therein. The packaging comprises a contact part configured to be connectable to or connected to the drug container and / or the drug container holder such that at least a distal end of the drug container and / or the drug container holder is covered by the contact part. For example, when connected to the drug container and / or the drug container holder, the contact part may be configured to cover at least a portion of the drug container, e.g. a septum, and / or at least a portion of the drug container holder, e.g. an attachment element of the drug container holder for connecting the drug container holder to a drug delivery device and / or a needle unit. The contact part is configured such that at least a portion thereof is removable, e.g. from the drug container and / or the drug container holder, to uncover the distal end of the drug container and / or the drug container holder. In one embodiment, the entire contact part may be configured to be removable from the drug container and / or the drug container holder to uncover the distal end.

[0012] Alternatively, the contact part may comprise a removable portion and a remaining portion. The removable portion may be configured to be removable, from a remainder of the contact part, e.g. from the remaining portion, to uncover the distal end of the drug container and / or the drug container holder. The remaining portion may be configured to remain connected to the drug container and / or the drug container holder, when the distal end is uncovered.

[0013] In one embodiment, the drug container may be one of a cartridge, a vial, a pouch or a syringe. The drug container may be deformable, e.g. flexible and / or collapsible, or non-deformable, e.g. rigid and / or non-collapsible. The drug container may contain a drug. The drug container may comprise a needle or may be configured to be connectable to a needle, e.g. via an attachment element. In one embodiment, the attachment element may comprise a thread or a Luer lock for connecting a needle unit with a needle thereto. The attachment element may be formed at the distal end of the drug container. A proximal end of the drug container may be configured to be connectable to or connected to a drive unit for expelling drug form the drug container, e.g. a drive unit of a drug delivery device. Alternatively, or additionally, the proximal end of the drug container may be configured to be connectable to or connected to a housing, e.g. a housing of adrug delivery device. The proximal end of the drug container may comprise a mounting section, which may comprise at least one of a thread, a snap element, a protrusion, a groove or other fixing means, for connecting the drug container to the drive unit and / or the housing.

[0014] In one embodiment, the drug container holder may be a dedicated drug container holder, configured such that the drug container holder may only be coupled to corresponding drug delivery devices, e.g. dedicated injection devices. In other words, the dedicated drug container holder and the drug delivery device each may comprise respective features for ensuring that no non-corresponding drug container holders or drug containers may be connected to, e.g. paired with, inserted in, or coupled to the drug delivery device, e.g. a drive mechanism thereof.

[0015] In one embodiment, the drug container holder, e.g. the distal end thereof, may comprise an attachment element, similar to the attachment element as described before for the drug container. A proximal end of the drug container holder may be configured to be connectable to or connected to a drive unit for expelling drug form a drug container, when the drug container is received in the drug container holder. For example, the drive unit may be a drive unit of a drug delivery device. Alternatively, or additionally, the proximal end of the drug container holder may be configured to be connectable to or connected to a housing, e.g. a housing of a drug delivery device. The proximal end of the drug container holder may comprise a mounting section, which may comprise at least one of a thread, a snap element, a protrusion, a groove or other fixing means, for connecting the drug container to the drive unit and / or the housing. The proximal end may be configured to haven an opening through which a drug container may be positioned in the drug container holder, e.g. in a distal direction. The distal end, e.g. an axial surface thereof which may point in the distal direction, may be configured to have an aperture such that, when a drug container is positioned in the drug container holder, a septum of the drug container is in line with a most distal point (edge) of the distal end of the drug container holder, or even extends beyond this point in the distal direction. Alternatively, the septum may be distal to the most distal point when the drug container is positioned in the drug container holder.

[0016] In one embodiment, the contact part may comprise a marking feature. The marking feature may be configured to impede, limit or hinder the connection of a needle to the drug container and / or the drug container holder, when the contact part, e.g. the removable portion, is connected to the drug container and / or the drug container holder. For example, the marking feature may be implemented on the removable portion of the contact part such that the removable portion has a sufficiently thick material for impeding the connection of a needle, as long as the removable portion is connected to the drug container and / or the drug container holder. Alternatively, or additionally, the marking feature may comprise a visual indication, e.g. a sign of a certain colorand / or a marking line on the contact part, e.g. on the removable feature, for warning a user (patient, health care professional, physician) that the distal end of the drug container and / or the drug container holder is covered. The marking feature may further be configured to indicate an amount of drug inside the drug container.

[0017] In one embodiment, the contact part may comprise a shrink element. The shrink element may be a shrink wrap or a shrink bag. The shrink element may be configured to reduce its dimensions, e.g. to shrink, when being subjected to heat. In other words, the shrink element may be configured to wrap, preferably tightly wrap, around a geometry, e.g. the distal end of the drug container and / or the drug container holder. In one embodiment, the remaining portion of the contact part may be a proximal portion of the shrink element, such that, when the shrink element is opened and the removable portion is removed, the remaining portion may remain connected to the drug container and / or the drug container holder.

[0018] For example, the shrink element may be made of a polymer, e.g. polyolefin, polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG) and / or polylactic acid (PLA). For example, the shrink element may be formed of Low-Density Polyethylene (LDPE), Linear Low-Density Polyethylene (LLDPE) or High-Density Polyethylene (HDPE). The material of the shrink element may be crosslinked or non-crosslinked. Alternatively, or additionally, the shrink element may be made of a material which is recyclable.

[0019] In some embodiments, the material of the shrink element may be biodegradable and / or of biologic origin. For example, the material of the shrink element may be based on PLA.

[0020] In some embodiments, the material of the shrink element may comprise a material similar to the material of the drug container holder. In other words, the material of the shrink element and the material of the drug container holder may be of the same group / family of materials. For example, the shrink element may comprise, e.g. be made of, PETG, while the drug container holder may comprise, e.g. be made of, PET.

[0021] In some embodiments, the material of the shrink element may have thermochromic characteristics. This may allow an indication that the shrink element and, potentially, the drug container and / or drug container holder has been exposed to heat. In other words, the shrink element may be configured to provide an indication, e.g. a visual indication, of a heat exposure of the drug, which may have changed the characteristics of the drug.In some embodiments, the shrink element may be configured to provide an ultraviolet (UV) protection for the drug container and / or the drug container holder, thereby protecting the drug from damage caused by UV radiation. For example, the shrink element may comprise an UV absorbing material and / or a protective layer configured to absorb UV radiation. Hence, additional protection elements, e.g. caps, may be omitted, which may reduce the number of components of a kit and / or a drug delivery device, e.g. the kit and / or the drug delivery device as described herein.

[0022] In one embodiment, the contact part may comprise a tape, e.g. a seal tape. In one embodiment, the tape may be configured to be attachable to or attached to an outer surface of the drug container and / or to an outer surface of the drug container holder, e.g. to a respective distal end or a respective attachment element. Alternatively, or additionally, the tape may be configured to be attachable to or attached to the septum. Attaching the tape may be realized via an adhesive, e.g. an adhesive applied between a seal portion of the tape and the component to which it is to be attached, e.g. the septum or the outer surface. The tape may comprise at least one of paper based materials, adhesives, and synthetic materials.

[0023] In one embodiment, the contact part may comprise a pouch. The pouch may comprise ribbed end portions. The end portions define opening elements (described below) of the pouch. The opening elements of the pouch may be configured to be closed and kept closed by an adhesive. Alternatively, or additionally, the end portions may be closed by welding, e.g. ultrasound welding. The pouch may be made of at least one of the following materials or combinations thereof, e.g. paper, pulp based materials, starch or other natural materials. The material may be biodegradable. Alternatively, or additionally, synthetic materials may be used.

[0024] In one embodiment, the contact part may comprise at least one compartment, In one embodiment, the pouch may comprise more than one compartment, e.g. at least 2 compartments, at least 5 compartments, at least 10 compartments, at least 15 compartments, at least 20 compartments, at least 25 compartments, and so on. For example, the number of compartments may be larger than 30, larger than 40, larger than 50, larger than 75, larger than 100, larger than 200 or even larger than 500. Each of the compartments may be configured to receive a drug container and / or a drug container holder. Each compartments may be connected to an adjacent compartment, e.g. via a ribbed portion, thereby forming a chain of compartments. The chain of compartments may be configured such that the connected compartments are separable from each other, e.g. one-by-one. The ribbed portions may comprise perforations or an embossing, thereby facilitating the separation of the compartments from each other.In one embodiment, the contact part may comprise at least one opening element configured to be opened by the user for uncovering at least the distal end of the drug container and / or the drug container holder. In specific, the opening element may be configured to be opened by the user such that the distal end may be exposed, e.g. by removing the contact part entirely or by removing at least the removable portion from the drug container and / or the drug container holder. In other words, the opening element may be configured to keep the contact part connected, e.g. by keeping the removable portion connected to the remaining portion, when the opening element is not opened. The opening element may be configured to be damaged by the user, during opening for uncovering the distal end. Hence, the opening element may define a break line for opening the contact part.

[0025] In one embodiment, the opening element may comprise a ribbed portion, e.g. perforation and / or an embossing. For example, the opening element may comprise a 360 degree perforation in a circumferential direction of the drug container. Alternatively, or additionally, the opening element may include an adhesive for keeping the opening element, and thereby the contact part, closed.

[0026] In one embodiment, the contact part may comprise an operation element, configured to be operable by a user for opening the contact part, e.g. the opening element. For example, the operation element may be configured to facilitate opening of the contact part and uncovering the septum, when being operated by the user, e.g. when being grabbed and operated, e.g. pulled away from and / or rotated relatively to the remainder of the contact part. Alternatively, or additionally, the operation element may be configured to be operated via a grab element, e.g. a clip or the like, configured to grab the operation element for operating it. For example, the grab element may be a cap clip. In other words, the operation element may be configured not to be in direct contact with the user, e.g. a user's hand, when being operated. In one embodiment, the operation element may comprise at least one of a flap, a flag, a hook, a loop, a protrusion, a recess and a strap, or combinations thereof, so that the operation element can be easily grabbed by the user for operating the operation element. In one embodiment, the operation element may be moved relative to the remainder of the contact part, e.g. the remaining portion, e.g. be rotated and / or be moved in an axial direction and / or be moved in a radial direction, thereby opening the contact part, e.g. separating the removable portion from the remaining portion. In other words, the opening element may be opened by the operation of the operation element, so that the removable portion may be removed from the contact part. Hence, the operation element may improve the handling of the packaging for uncovering the septum, e.g. before drug can be expelled from the drug container.In one embodiment, the contact part may comprise a label containing information (labeling data) regarding the drug container and / or the drug container holder and / or the drug inside the drug container. The label may be arranged on the remaining portion of the contact part, allowing the information to be available (e.g. readable) even after the contact part is opened. In one embodiment, the information may be printed on the contact part, e.g. on the remaining portion. In other words, the label may be a print only, without comprising a carrier material, so the labeling data may be printed directly on the contact part, e.g. on the shrink element or the pouch. Alternatively, or additionally, the label may comprise a carrier material, e.g. made of plastic or paper, which is configured to be connectable to or to be connected to the contact part, e.g. via an adhesive or via heat treatment. In one embodiment, the information may contain at least one of a drug name, an expiry date, a manufacturing date, information about characteristics of the drug and / or the manufacturer, and so on. Further, the label may contain a fill level indication, e.g. a scale, based on which the user can determine the amount of drug inside the drug container.

[0027] In one embodiment the label may comprise a tactile writing, e.g. a Braille writing. The tactile writing may be formed on an outer surface of the contact part, e.g. an outer surface of the shrink element. Alternatively, or additionally, the carrier material may comprise the tactile writing.

[0028] In one embodiment, the packaging may comprise a surrounding part configured to surround, envelope or enclose at least a portion of the contact part. For example, the surrounding part may be configured to form a space for receiving at least a portion of the contact part therein, e.g. the portion of the contact part which covers the distal end. In one embodiment, the surrounding part may be configured to receive the entire contact part therein. In one embodiment, the surrounding part may be configured to receive the contact part and the drug container therein. In another embodiment, the surrounding part may be configured to receive the contact part and the drug container holder therein, wherein the drug container holder may be equipped with a drug container. In other words, the space of the surrounding part may accommodate at least one object (unit, count) therein, wherein the object is at least a portion of one or more of the contact part, the drug container and the drug container holder. According to embodiments of the disclosure, the surrounding part may be configured to receive more than one object therein, e.g. at least 2 objects, at least 3 objects, at least 4 objects, at least 5 objects, at least 10 objects, at least 15 objects, at least 20 objects, at least 30 objects, at least 40 objects, at least 50 objects and so on.

[0029] In one embodiment, the surrounding part may comprise a box, a pouch, a bag, a wrap / film and / or other geometries suitable for surrounding at least a portion of an object. Depending onthe desired characteristics, the surrounding part may be made of different materials, e.g. wood, metal, paper, plastic, a biodegradable material, or one of the other materials mentioned herein.

[0030] In one embodiment, the surrounding part may comprise a supporting structure, e.g. an internal supporting structure, for supporting the objects received therein, e.g. the combination of the contact part with the drug container and / or the drug container holder, as described in this disclosure. The supporting structure may be an inlay for positioning the contact part within the surrounding part. The supporting structure may be made of one or more of the materials mentioned before with respect to other components of the packaging. Alternatively the surrounding part may be formed without supporting structures such that it allows for a flexible (non-fixed) distribution of the objects therein.

[0031] In one embodiment, the surrounding part may comprise a door for opening and closing the surrounding part. The door may be positioned on a surface of the surrounding part.

[0032] Alternatively, a surface as a whole may form the door of the surrounding part by being connected to another surface of the surrounding part, e.g. via a hinge. For example, the surface with the door may be a surface pointing in the axial direction (top or bottom loading surrounding part), or a surface pointing in a direction perpendicular thereto (side loading surrounding part).

[0033] In one embodiment, the packaging may comprise a connection element configured to connect the contact part and the surrounding part. The connection element may comprise a pin, a hook-and-loop structure, an adhesive tape and / or an adhesive, for example.

[0034] In one embodiment, the connection element may establish a non-permanent, releasable connection between the contact part and the surrounding part, which may be opened without destroying the connection element. Alternatively, the connection element may be configured to implement a permanent connection between the contact part and the surrounding part, which can be opened only by destroying the connection element, e.g. by tearing apart the adhesive.

[0035] In one embodiment, the connection element may be configured such that the contact part is opened, when the object is separated from the surrounding part. For example, the connection element may be configured to open, e.g. remove or destroy, the opening element for opening the contact part, when the drug container holder and / or the drug container is moved relatively to the surrounding part, e.g. when the drug container holder is taken out of the surrounding part, which may be a box, a pouch, a bag or the like. When the contact part is a shrink element, the connection element may be configured to cause a separation of the removable portion fromremaining portion, when the drug container holder and / or the drug container is moved relatively to the surrounding part.

[0036] By way of example, the connection element may be an adhesive via which the operation element of a contact part, e.g. a proximal end portion of flap of a seal tape, is connected to the surrounding part, e.g. to an inner wall of a box or a pouch. Hence, when the drug container or the drug container holder is removed from the box, the adhesive causes the flap to remain connected to the box, thereby removing the seal tape from the distal end of the drug container and exposing the septum of the drug container. Without the connection element, two separate user action would be required for arriving at this point, i.e. removing the drug container from the box and removing the contact part from the drug container, e.g. removing the removable portion, for exposing the septum. Hence, the connection element may reduce the number of user actions required for preparing the drug container before delivery of the drug.

[0037] According to an aspect of the disclosure, an arrangement for a drug delivery device is provided. The arrangement, comprises a packaging, e.g. the packaging according to the present disclosure, and a drug container and / or a drug container holder for a drug container. The drug container holder may comprise the drug container. The packaging may be connected to the drug container and / or the drug container holder, e.g. via a contact part of a packaging as described in this disclosure. In other words, the contact part may be connected to the drug container and / or the drug container holder such that at least a distal end of the drug container and / or a distal end of the drug container holder is covered by the contact part.

[0038] In one embodiment, the contact part of the packaging of the arrangement is configured not to fully cover a proximal end of the drug container and / or a proximal end of the drug container holder. In other words, the proximal end of the drug container and / or the proximal end of the drug container holder may be outside of the contact part, when the contact part is connected to the drug container and / or the drug container holder.

[0039] In one embodiment, the drug container is filled with a drug. In one embodiment, the packaging and / or the drug container holder may be configured such that the drug container may be inserted into the drug container holder after the contact part is connected to the drug container holder. For example, the proximal end of the drug container holder may be configured to be opened such that a drug container may be positioned in the drug container holder via the proximal end, e.g. after the contact part is connected to the distal end of the drug container holder.According to an aspect of the disclosure, a kit is provided. The kit comprises a drive unit and a drug container. In one embodiment, the kit may comprise an arrangement including a drug container and / or a drug container holder and, optionally, a packaging, e.g. the arrangement as described in the present disclosure. The drive unit may be configured to expel drug from a drug container, when being operated by the user. According to an embodiment, the kit is configured such that the distal end of the drug container is uncovered before the drive unit is operated. In other words, the contact part of the packaging is opened before operation of the drive unit. The drive unit may be configured to be manually driven by a force of a user and / or it may be configured to be automatically driven by a force of a drive element, e.g. a spring or a motor, to expel drug from the drug container.

[0040] According to an aspect of the disclosure, a use of an arrangement for connecting a drug container and / or a drug container holder to a drive unit is provided. The arrangement may be an arrangement according to the disclosure. In one embodiment, the drive unit is a drive unit of a drug delivery device. The drive unit may be configured to expel drug from a drug container, e.g. a drug container of the arrangement, when being operated by the user. According to an embodiment, the distal end of the drug container is uncovered before the drive unit is operated.

[0041] According to an aspect of the disclosure, a drug delivery device is provided. The drug delivery device comprises a drug container with a drug and / or a drug container holder configured to receive a drug container therein. In one embodiment, the drug container holder may comprise the drug container. The drug delivery device further comprises a drive unit, e.g. the drive unit as described before. In one embodiment, the drug delivery device comprises a housing and / or an outlet element, e.g. an injection needle, for delivering drug from the drug container. The outlet element may be connected to the housing, the drug container and / or the drug container holder, either directly or via intermediate components, e.g. a needle unit.

[0042] In one embodiment, the drug delivery device may comprise a component of a packaging, e.g. a component of the packaging described in this disclosure. In one embodiment, the drug delivery device may comprise at least a portion of the contact part of the packaging, e.g. the remaining portion, which may include the label.

[0043] In one embodiment, the drug delivery device may comprise an arrangement and / or a kit according to the present disclosure.

[0044] According to an aspect of the disclosure, a method for packaging a drug container and / or a drug container holder is provided. The method comprises the step of connecting a contact part of apackaging to the drug container and / or the drug container holder such that at least a distal end of the drug container and / or a distal end of the drug container holder is covered by the contact part. The packaging may be a packaging as described in this disclosure.

[0045] In one embodiment, if the contact part comprises a shrink element, the shrink element may be placed to surround at least the distal end when packaging the drug container and / or the drug container holder. Afterwards, heat is applied to the shrink element for connecting the shrink element to the drug container and / or the drug container holder. For example, the shrink element may be heated up to a temperature of at least 15 degrees Celsius, e.g. at least 20 degrees Celsius, at least 25 degrees Celsius, at least 30 degrees Celsius, at least 40 degrees Celsius, at least 50 degrees Celsius, at least 60 degrees Celsius, at least 70 degrees Celsius, at least 80 degrees Celsius, at least 90 degrees Celsius, at least 100 degrees Celsius or even more. The shrink element may be configured to reduce its dimensions when subjected to heat, thereby shrinking onto the drug container and / or the drug container holder, e.g. onto the distal end.

[0046] In some embodiments, the temperature for heating up the shrink element may be determined based on the characteristics of the drug inside the drug container. Hence, negative effects on the drug, e.g. a change of its characteristics caused by high temperatures, may be minimized or even avoided. By way of example, when keeping the temperature below 30 degrees Celsius, e.g. at approximately 25 degrees Celsius or even lower, the characteristics of the drug may not be influenced by shrinking the shrink element onto the drug container and / or the drug container holder.

[0047] In one embodiment, the method may comprise the step of arranging the contact part in a surrounding part of the packaging. Additionally, the method may comprise the step of connecting the contact part to the surrounding part, e.g. via the connection element as described in this disclosure. For example, the contact part may be connected to the surrounding part via an adhesive. The adhesive may be configured to fix the operation element to an inner wall of the surrounding part.

[0048] The packaging according to the disclosure may require less packaging material as compared to conventional packagings for drug containers and / or drug container holders. For example, information leaflets, e.g. patient information leaflets, may be reduced in size or potentially even be omitted, if certain information is provided to the patient via the label. Further, the packaging materials may be more environmentally friendly as compared to a conventional packagings.Further, by placing a label on the contact part, similar surrounding parts may be used for different products, potentially saving packaging costs and ensuring that the correct product information is always attached to the product.

[0049] Further, the packaging or components thereof may be lighter and / or it may have smaller dimensions than conventional packagings, thereby reducing costs during transportation and storage, reducing waste and improving the user convenience. For example, when using surrounding parts of thin materials, e.g. surrounding parts other than boxes, the packaging may be lighter and deformable.

[0050] Further, by using the same or similar materials throughout the whole packaging, e.g. for the contact part and for the surrounding part, recycling of the packaging may be simplified for the user. For example, the step of correctly separating the packaging materials, may not be necessary and the packaging may be discarded as a whole without negatively impacting the recycling process.

[0051] Further, the packaging process may be simplified as the contact parts and / or arrangements can be placed inside the surrounding parts without a fixed orientation. In some embodiments, the surrounding part does not need to be assembled or erected before the contact parts and / or the arrangements may be placed therein.

[0052] The packaging may further provide a protection against damage and keep the distal end, e.g. for the septum and / or the attachment element, clean. This is particularly relevant before the drug container is used to deliver (expel) drug therefrom, e.g. during transport and / or storage of the drug container and / or the drug container holder having the drug container received therein.

[0053] The packaging may further enable a sale of units according to the user’s needs, thereby reducing waste, e.g. when units are sold from a chain of compartments according to the user’s needs, e.g. a prescription.

[0054] The packaging may further reduce the number of steps to be performed by the user for preparing the drug container before drug can be delivered therefrom. For example, the packaging according to the disclosure allows for exposing the septum, when the drug container is removed from the surrounding part, so that no separate step of exposing the septum need to be performed. This increases convenience for the user.The foregoing has outlined rather broadly the features and technical advantages of embodiments of the present disclosure. Additional features and advantages of embodiments of the present disclosure will be described hereinafter, e.g. of the subject-matter of dependent claims. It should be appreciated by those skilled in the art that the conception and specific embodiments disclosed may be readily utilized as a basis for modifying or designing other structures or processes for realizing concepts which have the same or similar purposes as the concepts specifically discussed herein. It should also be recognized by those skilled in the art that equivalent constructions do not depart from the spirit and scope of the disclosure, such as defined in the appended claims.

[0055] The making and using of the presently preferred embodiments are discussed in detail below. It should be appreciated, however, that the present disclosure provides many applicable concepts that can be embodied in a wide variety of specific contexts. The specific embodiments discussed are merely illustrative of specific ways to make and use the disclosed concepts, and do not limit the scope of the claims.

[0056] Moreover, same reference numerals refer to same technical features if not stated otherwise. As far as "may" is used in this application it means the possibility of doing so as well as the actual technical implementation. The present concepts of the present disclosure will be described with respect to preferred embodiments below in a more specific context namely drug containers, drug delivery devices, especially drug delivery devices for humans or animals. The disclosed concepts may also be applied, however, to other situations and / or arrangements as well, e.g. for other containers, reservoirs, devices, injectors, spraying devices or inhalation devices.

[0057] Brief description of the drawings

[0058] For a more complete understanding of the presently disclosed concepts and the advantages thereof, reference is now made to the following description in conjunction with the accompanying drawings. The drawings are not drawn to scale. In the drawings the following is illustrated in:

[0059] Figure 1 A a schematic view of a drug container holder with a drug container received therein,

[0060] Figure 1 B a schematic view of a packaging according to an embodiment of the present disclosure,

[0061] Figure 2 a schematic view of a contact part according of a packaging to an embodiment of the present disclosure,Figure 3 a schematic view of a contact part according of a packaging to an embodiment of the present disclosure,

[0062] Figure 4 a schematic view of a contact part according of a packaging to an embodiment of the present disclosure,

[0063] Figure 5 a schematic view of a contact part according of a packaging to an embodiment of the present disclosure,

[0064] Figure 6 a schematic view of an arrangement according to an embodiment of the present disclosure,

[0065] Figure 7 a schematic view of an arrangement according to an embodiment of the present disclosure,

[0066] Figures 8A and 8B a schematic view of arrangements according to embodiments of the present disclosure,

[0067] Figure 9 a schematic view of an arrangement according to an embodiment of the present disclosure,

[0068] Figures 10A to 10C a schematic view of arrangements according to embodiments of the present disclosure including surrounding parts of packagings according to embodiments of the present disclosure,

[0069] Figures 11 A and 11 B a schematic view of arrangements according to embodiments of the present disclosure including surrounding parts of packagings according to embodiments of the present disclosure,

[0070] Figures 12A and 12B a schematic view of a kit according to an embodiment of the present disclosure,

[0071] Figure 13 a schematic view of a drug delivery device according to an embodiment of the present disclosure, and

[0072] Figure 14 steps of a method for packaging a drug container and / or a drug container holder according to an embodiment of the present disclosure.

[0073] Description of exemplary embodiments

[0074] As a general note, “distal” is used herein to specify directions (e.g. a distal direction D), ends or surfaces which are arranged at, face towards or point towards a dispensing end of the drug container or the drug container holder or the delivery device. On the other hand, “proximal” is used to specify directions (e.g. a proximal direction P), ends or surfaces which are arranged at, face away from or point away from the dispensing end and / or from the distal end of the drug container, the drug container holder or the drug delivery device or components thereof. The distal end may be the end closest to the dispensing end and / or furthest away from the proximal end and the proximal end may be the end furthest away from the dispensing end. A proximalsurface may face away from the distal end and / or towards the proximal end. A distal surface may face towards the distal end and / or away from the proximal end. The dispensing end may be the needle end where a needle is arranged or a needle or needle unit is or is to be mounted to the device, for example. The distal end may be an end that is closer to a needle compared to a proximal end. “Axial” may be used synonymously with “longitudinal” and may refer to a proximal-distal-direction.

[0075] In the following, several aspects and embodiments are exemplarily described in the context of a drug container holder 100 having a drug container 200 placed therein. However, it should be noted that all of these aspects and embodiments may be similarly applied to a drug container without drug container holder, or a drug container holder without a drug container positioned therein, if not explicitly indicated otherwise or impossible from a physical / technological perspective.

[0076] Certain embodiments in this disclosure are illustrated with respect to a drug delivery device, e.g. an injection device, e.g. an automatic or manual injection device, e.g. an autoinjector, a pen injector device, and / or a reconstitution device. The device may comprise an advanced needle cover used as an activation element or a dedicated activation element, e.g. a button or a sleeve.

[0077] Figure 1A illustrates a drug container holder 100 with a drug container 200 received therein. The drug container 200 contains a drug. The drug container holder 100 comprises a proximal end 102 and a distal end 101. The drug container 200 comprises a proximal end 202 and a distal end 201.

[0078] The distal end 101 of the drug container holder 100 comprises an attachment element 101a configured such that a needle unit or a needle, e.g. a needle 500, may be attached thereto, e.g. via a thread or a Luer lock. The proximal end 102 of the drug container holder 100 comprises a mounting section 102a via which a drive unit, e.g. a drive unit 300, for expelling drug from the drug container 200, may be connected to the drug container holder 100. The proximal end 102 may further be configured to be connectable to a housing, e.g. a housing 600 of a drug delivery device 700. As illustrated, the mounting section 102a may comprise a thread. However, other connection means (not illustrated) may be used, as well, e.g. a snap element, a protrusion, a groove / recess or other fixing means.

[0079] The proximal end 102 comprises an aperture (not illustrated) through which the drug container 200 may be positioned in the drug container holder 100 in a distal direction D. The distal end101 of the drug container holder 100 has an outlet aperture, e.g. for connecting the drug container 200 with an outside, e.g. via the needle 500.

[0080] In some embodiments (not illustrated), the distal end 101 may be configured such that, when a drug container 200 is positioned in the drug container holder 100, a septum 203 of the drug container 200 may be in line with a most distal point (edge) 101b of the distal end 101 of the drug container holder 100, or even extend beyond this edge 101b in the distal direction D.

[0081] Alternatively, as illustrated in figure 1, there may be a gap between the septum 203 and the most distal edge 101b such that the septum 203 is proximal to the most distal edge 101b. The drug container holder 100 may be a dedicated drug container holder and the drug container 200 may be a cartridge or a vial, as described in the foregoing.

[0082] In some embodiments, the drug container 200 may comprise an attachment element via which a needle and / or a needle unit may be connected to the distal end 201 of the drug container 200. For example, the attachment element may comprise a thread. The proximal end 202 of the drug container 200 may be configured to be connectable to a drive unit for expelling drug form the drug container, e.g. the drive unit 300. Alternatively, or additionally, the proximal end 202 of the drug container 200 may be configured to be connectable to or connected to a housing, e.g. the housing 600 of the drug delivery device 700.

[0083] According to embodiments of the present disclosure, the drug container 100 is filled with a drug. In some embodiments, a packaging (described below) and / or the drug container holder 100 may be configured such that the drug container 200 may be inserted into the drug container holder 100 after a contact part 20, 30, 40, 50 of the packaging is connected to the drug container holder 100. For example, the proximal end 102 of the drug container holder 100 may be configured to be opened such that a drug container 200 may be positioned in the drug container holder 100 via the proximal end 102, e.g. after the contact part 20 is connected to the distal end 101 of the drug container holder 100.

[0084] In some embodiments (not illustrated), the drug container 200 may be a syringe with a needle, Alternatively, the proximal end 202 of the drug container may comprise a mounting section (not illustrated), which may comprise at least one of a thread, a snap element, a protrusion, a groove or other fixing means, for connecting the drug container to the drug container holder 100 and / or the drive unit 300 and / or the housing 600.

[0085] In some embodiments, the drug container holder 100 may be a dedicated container holder as described above.Figure 1B illustrates a packaging 1 for a drug container 200 and / or a drug container holder 100 according to the present disclosure. The packaging 1 comprises a contact part 20, 30, 40, 50. The contact part 20, 30, 40, 50 may be configured to be connectable to or connected to the drug container 200 and / or the drug container holder 100 such that at least a distal end 101, 201 of the drug container 100 and / or the drug container holder 200 is covered by the contact part 20, 30, 40, 50. At least a portion of the contact part 20, 30, 40, 50 is removable to uncover the distal end 101, 201. The packaging 1 may further comprise a surrounding part 60, 70 configured to surround at least a portion of the contact part 20, 30, 40, 50, e.g. receive the contact part 20, 30, 40, 50 therein.

[0086] Figures 2 to 5 illustrate embodiments of the packaging 1 for a drug container 200 and / or a drug container holder 100 according to the present disclosure.

[0087] The packaging 1 comprises a contact part 20, 30, 40, 50 configured to be connectable to the drug container 200 and the drug container holder 100 such that at least the distal end 201 of the drug container 200 and the distal end 102 of the drug container holder 100 are covered by the contact part 20, 30, 40, 50 (see Figures 6 to 11). As illustrated, the septum 203 and the attachment element 101a may be covered by the contact part 20, 30, 40, 50. The contact part 20, 30, 40, 50 is configured such that at least a portion thereof is removable from the drug container 200 and / or the drug container holder 100, to uncover the distal ends 101, 201.

[0088] Referring to Figures 3 to 5, the entire contact part 30, 40, 50 may be configured to be removable from the drug container 200 and the drug container holder 100 to uncover the distal ends 101, 201.

[0089] Referring to Figure 2, the illustrated contact part 20 comprises a shrink element, e.g. a shrink bag or shrink wrap. The contact part 20 comprises a removable portion 21b and a remaining portion 21a. The removable portion 21b is connected to the remaining portion 21a via an opening element 23, e.g. a perforation. The removable portion 21b is configured to be removable from the remaining portion 21a, when the opening element is opened, to uncover the distal end 201 of the drug container 200 and the distal end 101 of the drug container holder 100. The remaining portion 21a is configured to remain connected to the drug container 200 and / or the drug container holder 100, when the distal end 101, 201 is uncovered. The contact part 20 may comprise a marking feature 25. The marking feature 25 comprises a visual indication, e.g. a sign of a certain color and / or a marking line, for warning a user (patient, health care professional, physician) that the distal end 201 of the drug container 200 and / or the distal end 101 drug container holder 100 is covered.Alternatively, or additionally, the marking feature 25 may be configured to impede, limit or hinder the connection of a needle to the drug container 200 and / or the drug container holder 100, when the contact part 20, e.g. the removable portion 21b, is connected to the drug container 200 and / or the drug container holder 100. For example (not illustrated), the marking feature 25 may be implemented on the removable portion 21b such that the removable portion 21b has a sufficiently thick material for impeding the connection of a needle, as long as the removable portion 21b is connected to the drug container 200 and / or the drug container holder 100.

[0090] The contact part 20 may comprise a label 24 containing information (labeling data) regarding the drug container 200 and / or the drug container holder 100 and / or a drug inside the drug container 200. For example, the information may relate to a drug name, an expiry date, a manufacturing date, information about characteristics of the drug and / or the manufacturer, and so on. The label 24 may be arranged on the remaining portion 21a of the contact part 20, allowing the information to be available (e.g. readable) even after the contact part 20 is opened. For example, the label 24 may be printed on the remaining portion 21a of the shrink element 20. Alternatively, or additionally, the label 24 may comprise a carrier material as described above. The label 24 comprises a fill level indication, e.g. a scale, based on which the user can determine the amount of drug inside the drug container 200.

[0091] In some embodiments (not illustrated), the labeling information may be printed on the pouch 40, 50 or a label comprising a carrier material may be attached to the pouch 40, 50.

[0092] In some embodiments (not illustrated), the label 24 may comprise a tactile writing, e.g. a Braille writing. The tactile writing may be formed on an outer surface of the contact part, e.g. an outer surface of the shrink element. Alternatively, or additionally, the carrier material may comprise the tactile writing.

[0093] In some embodiments (not illustrated), the labeling information may be printed on the tape 30 or a label comprising a carrier material may be attached to the tape 30.

[0094] Referring again to Figure 2, the illustrated opening element 23 comprises a circumferential perforation between the remaining portion 21a and the removable portion 21b. The opening element 23 is configured to disconnect the removable portion 21b and the remaining portion 21a, when being opened. For example, when moving the removable portion 21b relative to the remaining portion 21a, the opening element 23 may be opened and destroyed thereby disconnecting the removable portion 21b and the remaining portion 21a. For inducing such arelative movement, the shrink element 20 may comprise an operation element 22, e.g. the illustrated flap, which can be grabbed by the user for opening the contact part 20. In this context, the flap 22, which is connected to the removable portion 21b, is moved relative to the remaining portion 21a, which causes a relative movement between the removable portion 21b and the remaining portion 21a, thereby opening the opening element 23. After disconnection and removal of the removable portion 21b from the remaining portion 21a, the contact part 20 is open and the distal ends 101, 201 are exposed.

[0095] In some embodiments, the operation element 22 may be configured to be operated via a grab element (not illustrated), as described above.

[0096] Exemplary materials for the shrink element are polymers, e.g. polyolefin, polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG) and / or polylactic acid (PLA). For example, the shrink element may be formed of Low-Density Polyethylene (LDPE), Linear Low-Density Polyethylene (LLDPE) or High-Density Polyethylene (HDPE). The material of the shrink element may be crosslinked or non-crosslinked, and it further may be recyclable.

[0097] In some embodiments, the material of the shrink element may be biodegradable and / or of biologic origin. For example, the material of the shrink element may be based on PLA.

[0098] In some embodiments, the material of the shrink element may comprise a material similar to the material of the drug container holder. In other words, the material of the shrink element and the material of the drug container holder may be of the same group / family of materials. For example, the shrink element may comprise, e.g. be made of, PETG, while the drug container holder may comprise, e.g. be made of, PET.

[0099] In some embodiments, the material of the shrink element may have thermochromic characteristics. This may allow an indication that the shrink element and, potentially, the drug container and / or drug container holder has been exposed to heat. In other words, the shrink element may be configured to provide an indication, e.g. a visual indication, of a heat exposure of the drug, which may have changed the characteristics of the drug.

[0100] In some embodiments, the shrink element may be configured to provide an ultraviolet (UV) protection for the drug container and / or the drug container holder, thereby protecting the drug from damage caused by UV radiation. For example, the shrink element may comprise an UV absorbing material and / or a protective layer configured to absorb UV radiation. Hence,additional protection elements, e.g. caps, may be omitted, which may reduce the number of components of a kit and / or a drug delivery device, e.g. the kit and / or the drug delivery device as described herein.

[0101] Figure 3 illustrates a contact part 30 comprising a tape, e.g. a seal tape, according to an embodiment of the present disclosure. The tape comprises a seal portion 31, configured to be attachable to or attached to the drug container 200, e.g. a septum 203 thereof. In this context, the opening element 33 may comprise an adhesive 33 between the seal portion 31 and the septum 203, for connecting the seal portion 31 to the septum 203. The tape 30 further comprises a flap 32 functioning as an operation element for opening the contact part 30, i.e. disconnecting the seal portion 31 from the septum 203. A proximal end portion 34 of the flap 32 may be configured to be connected to a surrounding part 60, 70, as described in detail below.

[0102] In some embodiment (not illustrated), the tape 30 may be configured to be attachable to an outer surface of the drug container 200 and / or to an outer surface of the drug container holder 100, e.g. to the distal end 201, 101 and / or the respective attachment element.

[0103] Figure 4 illustrates a contact part 40 according to an embodiment of the present disclosure. The contact part 40 comprises a pouch. An opening element 41 of the pouch 40 is designed as a ribbed portion 41, e.g. on both ends, which may be opened when an operation element 42, e.g. a flap 42, is moved relative to a surface of the pouch at which the flap 42 is connected to the pouch 40. The ribbed portion 41 is kept closed by an adhesive. The pouch 40 forms a compartment 40a for accommodating therein at least a portion of a drug container 200 and / or a drug container holder 100.

[0104] Figure 5 illustrates a contact part 50 according to an embodiment of the present disclosure. The contact part 50 comprises a pouch 50, similar to the pouch 40. However, the pouch 50 comprises more than one compartment 50a, 50b, 50c, 50d. The compartments 50a, 50b, 50c, 50d are connected via ribbed portions 51. The ribbed portions 51 may be closed by an additional adhesive. The operation element 52 is a flap, similar to the flap 42. However, the flap 52 is oriented perpendicularly to the ribbed portions 51. The ribbed portions 51 may comprise perforations or an embossing, thereby facilitating the separation of the compartments 50a, 50b, 50c, 50d from each other. The number of compartments is not limited to 4 or less, but may be larger than 4, as described above. By way of example, the pouch 50 may be made of paper, starch, and / or another material, which may be biodegradable.

[0105] In some embodiments, the pouches 40 and 50 may comprise synthetic materials.In some embodiments of the present disclosure (not illustrated), the contact parts 20, 30, 40, 50 may comprise other opening elements configured to be opened by the user for uncovering at least the distal end 201 of the drug container 200 and / or the distal end 101 of the drug container holder 100. For example, the opening elements may be configured to be damaged by the user, during opening for uncovering the distal ends 101, 201. In general, the opening elements of the present disclosure may be configured to define a break line for opening the contact parts 20, 30, 40, 50 to at least exposed the distal ends 101, 201.

[0106] In some embodiments of the present disclose (not illustrated), the operation elements 22, 32, 42, 52, 72 may be formed differently. For example, the operation elements 22, 32, 42, 52, 72 may comprise at least one of a flap, a flag, a hook, a loop, a protrusion, a recess and a strap, or combinations thereof. In general the operation element 22, 32, 42, 52, 72 may be formed to facilitate opening of the contact part 20, 30, 40, 50 and / or a surrounding part 70, for uncovering the septum 203, when being operated by the user, e.g. when the user induces a relative movement between the operation element 22, 32, 42, 52, 72 and the contact part 20, 30, 40, 50 and / or a surrounding part 70. Hence, the operation element 22, 32, 42, 52, 72 may improve the handling of the packaging 1 when uncovering the septum 203, e.g. before drug can be expelled from the drug container 200.

[0107] Figures 6 to 11 illustrate embodiments of arrangements 80a, 80b, 80c, 80d, 80e, 81a, 81b, 81c, 81 d, 81 d, 81e according to the present disclosure. In specific, figures 6 to 9 relate to embodiments of arrangements comprising a drug container holder 100 with a drug container 200 and a contact part 20, 30, 40, 50. The embodiments illustrated in figures 10 to 11 additionally comprise a surrounding part 60, 70 of a packaging 1, as described in the following. However, it should be noted that according to embodiments of the present disclosure, the drug container 200 or the drug container holder 100 may be omitted in each of the arrangements illustrated in figures 6 to 11.

[0108] As illustrated in figures 6 and 7, in some embodiments of arrangements 80a, 80b of the present disclosure, the contact part 20, 30 may be configured not to fully cover a proximal end 202 of the drug container 200 and / or a proximal end 102 of the drug container holder 100. In other words, the proximal ends 102, 202 may not overlap with the contact part 20, 30 in the axial direction, when the contact part 20, 30 is connected to the drug container 200 and / or the drug container holder 100.Referring to the arrangement 80c of figure 8A, the contact part 40 may be configured to accommodate the drug container holder 100 with the drug container 200 entirely therein. Two opening elements 41 may be formed at longitudinal ends of the contact part 40 and the operation element 42 may extend between the opening elements 41. Figure 8B relates to an arrangement 80d, in which the opening elements 41 are positioned laterally. The operation element 42 extends between the opening elements 41, e.g. such that its direction of extension crosses a longitudinal axis of the contact part 40. In some embodiments, the longitudinal axis of the contact part 40 may be perpendicular to the operation element 42.

[0109] Figure 9 illustrates an arrangement 80e in which the contact part 50 is a chain of compartments 50a, 50b, 50c, 50d, as described before. Each of the compartments 50a, 50b, 50c, 50d accommodates a drug container holder 100 with a drug container 200. An operation element 52 extends over the compartments 50a, 50b, 50c, 50d in a lateral direction thereof. The compartments 50a, 50b, 50c, 50d are connected via ribbed portions 51, as outlined in the foregoing.

[0110] Figure 10A illustrates an embodiment of an arrangement 81a according to the present disclosure, in which three drug container holders 100 with drug containers 200 are connected to three contact parts 40. The contact parts are illustrated as pouches 40. The pouches 40 are accommodated in a surrounding part 60, e.g. a box, with a capacity of three counts (units, objects). The box 60 may be a box as described in the foregoing, made of the materials mentioned in this disclosure.

[0111] Figure 10B illustrates an embodiment of an arrangement 81b according to the present disclosure, in which five drug container holders 100 with drug containers 200 are connected to five contact parts 20. The contact parts 20 are illustrated as shrink elements 20. The shrink elements 20 each comprise a removable portion 21b and a remaining portion 21a connected via an opening element 23. The shrink elements 20 are accommodated in a box 60 with a capacity of five counts. The box 60 may be a box as described in the foregoing, made of the materials mentioned in this disclosure.

[0112] Figure 10C illustrates an embodiment of an arrangement 81b according to the present disclosure. In this embodiment, the packaging 1 comprises a contact part 30 which is a tape, e.g. a seal tape, with a seal portion 31. The seal portion 31 is attached to the septum 203 of the drug container 200 via an adhesive 33, similar to the arrangement 80b illustrated in figure 7.Referring again to figure 10C, the packaging 1 comprises a surrounding part 60 implemented as a box. The tape 30 is connected to the box 60 via the connection element 61, which may be an adhesive 61. The adhesive 61 is disposed between a proximal end portion 34 of the flap 32 extending from the seal portion 31 and functioning as the operation element, and an inner wall 62 of the box 60, e.g. the bottom. The adhesive 61 may be configured to be stronger than the adhesive 33 such that, when the drug container holder 100 with the drug container 200 is removed from the box 60, the adhesive 33 is torn apart and seal portion 31 of the tape 30 is removed from the septum 203, thereby exposing the septum 203.

[0113] In general, the connection element 61 may be configured such that the contact part 20, 30, 40, 50 is opened, when at least a portion of the contact part 20, 30, 40, 50 is moved relatively to the surrounding part 60, 70. For example, the connection element 61 may be configured to open, e.g. remove or destroy, the opening element 23, 33 ,41, 51 for opening the contact part 20, 30, 40, 50, when the drug container holder 100 and / or the drug container 200 is moved relatively to the surrounding part 60, 70, e.g. when the drug container holder 100 is taken out of the box 60. When the contact part 20, 30, 40, 50 is a shrink element 20, the connection element 61 may be configured to cause a separation of the removable portion 21b from remaining portion 21a, when the drug container holder 100 and / or the drug container 200 is moved relatively to the surrounding part 60, 70.

[0114] In other embodiments (not illustrated), other connection elements may be used, e.g. a pin, a hook-and-loop structure and / or an adhesive tape. The connection element may be configured to create a non-permanent connection between the contact part and the surrounding part, which may be opened without destroying the connection element. Alternatively, the connection element may be configured to implement a permanent connection which can be opened only by destroying the connection element, e.g. by tearing apart the adhesive.

[0115] In some embodiment, the surrounding part may be different from a box 60, e.g. a pouch 70. Alternatively, or additionally, the surrounding part may comprise a bag, a wrap / film and / or other geometries suitable for surrounding at least a portion of an object. Depending on the desired characteristics, the surrounding part may be made of different materials, e.g. wood, metal, paper, plastic, a biodegradable material, or one of the other materials mentioned herein.

[0116] Figures 11A and 11 B illustrate embodiments of arrangements 81 d, 81 e in which the surrounding part 70 comprises a pouch 70. The illustrated pouches 70 have different dimensions reflecting their different capacities of 4 and 3 counts, respectively. The pouches 70 comprise ribbed portions 71 at their ends functioning as opening elements, similar to the ribbedportions 41, 51 described before. The pouches 70 further comprise operation elements 72, similar to the operation elements 22, 32, 42, 52 described before.

[0117] The surrounding parts 60, 70 as illustrated in figures 10 and 11 are formed without internal supporting structures, thereby allowing a flexible distribution of the objects therein. However, in some embodiments (not illustrated), the surrounding part may comprise a supporting structure, e.g. an internal supporting structure, for supporting the objects received therein. The supporting structure may be an inlay for positioning the contact part within the surrounding part. The supporting structure may be made of one or more of the materials mentioned before with respect to other components of the packaging 1.

[0118] According to embodiments of the disclosure (not illustrated), the surrounding part 60, 70 may be configured to have different capacities, e.g. at least 2 counts, at least 3 counts, at least 4 counts, at least 5 counts, at least 10 counts, at least 15 counts, at least 20 counts, at least 30 counts, at least 40 counts, at least 50 counts and so on.

[0119] According to some embodiments, the surrounding part 60 may comprise a door (not illustrated) for opening and closing the surrounding part 60. The door may be positioned on a surface of the surrounding part 60. In some embodiments, the surface as a whole may form the door of the surrounding part 60 by being connected to another surface of the surrounding part 60, e.g. via a hinge. For example, the surface with the door may be a surface pointing in the axial direction, or a surface pointing in a direction perpendicular thereto.

[0120] Figures 12A and 12B illustrate an embodiment of a kit 400 according to the present disclosure. The kit 400 comprises a drive unit 300 and an arrangement 80a, 80b, 80c, 80d, 80e, 81a ,81b, 81c, 81 d, 81 e including a packaging 1, a drug container 200 and a drug container holder 100.

[0121] The drive unit 300 is configured to expel drug from a drug container 200, when being operated by the user. The kit 400 is configured such that the distal end 201 of the drug container 200 is uncovered before the drive unit 300 is operated. In other words, the contact part 20 of the packaging 1, which is illustrated as a shrink element 20 in figures 12, is opened before operation of the drive unit 300. In specific, the removable portion 21b is removed from the remaining portion 21a by opening the perforation 23, e.g. by rotating the flap 22 relative to the drug container holder 100. As the remaining portion 21a of the shrink element 20 is shrunk to the drug container holder 100, it cannot follow the rotation of the flap 22. Hence, there is a shear stress in the perforation 23 causing a damage of the perforation, thereby disconnecting the removable portion 21b from the remaining portion 21a.Figure 12B illustrates the kit 400 after the removable portion 21b is removed from the drug container 200. The attachment element 101a of the drug container holder 100 and the septum 203 are uncovered and a needle, e.g. a needle 500, may be connected to the drug container 200, e.g. via connecting a needle unit to the attachment element 101a.

[0122] The drive unit 300 may be configured to be manually driven by a force of a user and / or it may be configured to be automatically driven by a force of a drive element, e.g. a spring or a motor, to expel drug from the drug container 200.

[0123] According to embodiments of the disclosure, a use of an arrangement for connecting a drug container 200 and / or a drug container holder 100 to a drive unit 300 is provided. The arrangement may be an arrangement 80a, 80b, 80c, 80d, 80e, 81a ,81b, 81c, 81 d, 81 e according to the disclosure. In one embodiment, the drive unit 300 is a drive unit of a drug delivery device. The drive unit 300 may be configured to expel drug from a drug container, e.g. a drug container 200 of the arrangement 80a, 80b, 80c, 80d, 80e, 81a ,81b, 81c, 81 d, 81 e, when being operated by the user. According to an embodiment, the distal end 201 of the drug container 200 is uncovered before the drive unit 300 is operated.

[0124] Figure 13 illustrates a drug delivery device 700 according to the present disclosure. The drug delivery device 700 comprises a drug container holder 100 with a drug container 200 containing a drug. The drug delivery device 700 further comprises the drive unit 300, a housing 600 and an outlet element 500, illustrated as an injection needle 500, for delivering drug from the drug container 200. The needle 500 may be connected to the housing 600, the drug container 200 and / or the drug container holder 100, either directly or via intermediate components, e.g. a needle unit (not illustrated).

[0125] In the illustrated embodiment, the drug delivery device 700 comprises parts of the packaging 1, e.g. the remaining portion 21a with the label 24.

[0126] Alternatively, or additionally, in some embodiments of the present disclosure, the drug delivery device 700 may comprise an arrangement 80a, 80b, 80c, 80d, 80e, 81a ,81b, 81c, 81 d, 81 e and / or a kit 400 according to the present disclosure.

[0127] Figure 14 illustrates steps of a method for packaging a drug container 200 and / or a drug container holder 100. The method comprises the step S101 of connecting a contact part 20, 30,that at least a distal end 201 of the drug container 200 and / or a distal end 101 of the drug container holder 100 is covered by the contact part 20, 30, 40, 50.

[0128] The method may further comprise the step S102 of arranging the contact part 20, 30, 40, 50 in a surrounding part 60, 70 of the packaging 1. Additionally, the method may comprise the step S103 of connecting the contact part 20, 30, 40, 50 to the surrounding part 60, 70 via a connection element 61 as described in this disclosure. For example, the contact part 20, 30, 40, 50 may be connected to the surrounding part 60, 70 via an adhesive 61. The adhesive 61 may fix the operation element 22, 32, 42, 52 to the surrounding part 60, 70, e.g. to an inner wall 62 of the surrounding part.

[0129] When connecting the contact part 20, 30, 40, 50 of the packaging 1 to the drug container 200 and / or to the drug container holder 100, the method may be designed to minimize or avoid negative effects on the drug inside the drug container. For example, a temperature for shrinking the shrink element 20 onto the drug container 200 and / or the drug container holder 100 may be determined based on the characteristics of the drug inside the drug container. For example, when keeping the temperature below a certain threshold, e.g. below 30 degrees Celsius, e.g. at around 25 degrees Celsius, negative effects on characteristics of the drug may be limited or avoided. On other words, the shrinking process may not negatively influence the drug. Further details regarding the method, e.g. other exemplary temperatures for the shrinking process, are described above.

[0130] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0131] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA andRNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0132] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about -4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0133] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders.

[0134] Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0135] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptidewhich has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0136] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0137] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0138] Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen,Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

[0139] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0140] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0141] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0142] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0143] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full-length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0144] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0145] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0146] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0147] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0148] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0149] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0150] Although embodiments of the present disclosure and their advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made therein without departing from the spirit and scope of the disclosure as defined by the appended claims. For example, it will be readily understood by those skilled in the art that many of the features, functions, processes and methods described herein may be varied while remaining within the scope of the present disclosure. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the system, process, manufacture, method or steps described in the present disclosure. As one of ordinary skill in the art will readily appreciate from the disclosure of the present disclosure, systems, processes, manufacture, methods or steps presently existing or to be developed later that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure. Accordingly, the appended claims are intended to include within their scope such systems, processes,methods or steps. The embodiments mentioned in the first part of the description may be combined with each other. The embodiments of the description of figures may also be combined with each other. Further, it is possible to combine embodiments mentioned in the first part of the description with examples of the second part of the description which relates to Figures 1A to 14.List of reference numbers

[0151] P proximal direction

[0152] D distal direction

[0153] 1 packaging

[0154] 20 shrink element

[0155] 21a remaining portion

[0156] 21b removable portion

[0157] 22 operation element

[0158] 23 perforation

[0159] 24 label

[0160] 25 marking feature

[0161] 30 tape

[0162] 31 seal portion

[0163] 32 operation element

[0164] 33 adhesive

[0165] 34 proximal end portion

[0166] 40 pouch

[0167] 40a compartment

[0168] 41 ribbed portion

[0169] 42 operation element

[0170] 50 pouch with multiple compartments 50a compartment

[0171] 50b compartment

[0172] 50c compartment

[0173] 50d compartment

[0174] 51 ribbed portion

[0175] 52 operation element

[0176] 60 box

[0177] 61 connection element

[0178] 62 inner wall

[0179] 70 pouch

[0180] 71 ribbed portion

[0181] 72 operation element

[0182] 80a arrangement

[0183] 80b arrangement80c arrangement

[0184] 80d arrangement

[0185] 80e arrangement

[0186] 81a arrangement

[0187] 81b arrangement

[0188] 81c arrangement

[0189] 81 d arrangement

[0190] 81 e arrangement

[0191] 100 drug container holder

[0192] 101 distal end of drug container holder

[0193] 101a attachment element

[0194] 101b most distal edge

[0195] 102 proximal end of drug container holder

[0196] 102a mounting section

[0197] 200 drug container

[0198] 201 distal end of drug container

[0199] 202 proximal end of drug container

[0200] 203 septum

[0201] 300 drive unit

[0202] 400 kit

[0203] 500 injection needle

[0204] 600 housing

[0205] 700 drug delivery device

[0206] 5101 connecting contact part

[0207] 5102 arranging contact part

[0208] 5103 connecting contact part and surrounding part

Claims

35PAT25006-WO-PCTClaims1. A packaging (1) for a drug container (200) and / or a drug container holder (100) configured to receive a drug container (200), the packaging (1) comprising:a contact part (20, 30, 40, 50) configured to be connectable to or connected to the drug container (200) and / or the drug container holder (100) such that at least a distal end (101, 201) of the drug container (200) and / or the drug container holder (100) is covered by the contact part (20, 30, 40, 50),wherein at least a portion of the contact part (20, 30, 40, 50) is removable to uncover the distal end (101, 201).

2. The packaging (1) of claim 1, wherein the contact part (20, 30, 40, 50) is configured to cover at least a part of a septum (203) of the distal end (101, 201).

3. The packaging (1) of any one of the preceding claims, wherein the contact part (20, 30, 40, 50) comprises one of a shrink element (20), a tape (30) and a pouch (40, 50).

4. The packaging (1) of any one of the preceding claims, wherein the contact part (50) comprises at least two compartments (50a, 50b, 50c, 50d), each of them being configured to receive a drug container (200) and / or a drug container holder (100), and wherein the compartments (50a, 50b, 50c, 50d) are connected to each other.

5. The packaging (1) of any one of the preceding claims, wherein the contact part (20, 30, 40, 50) comprises an opening element (23, 33, 41, 51) configured to be opened by a user for uncovering at least the distal end (101, 201) of the drug container (200) and / or the drug container holder (100).

6. The packaging (1) of claim 5, wherein the contact part (20) comprises a remaining portion (21a) configured to remain connected to the drug container (200) and / or the drug container holder (100), when the opening element (23) is opened.

7. The packaging (1) of any one of the preceding claims, wherein the contact part (20, 30, 40, 50) comprises an operation element (22, 32, 42, 52), configured to be operable by the user for opening the contact part (20, 30, 40, 50).

368. The packaging (1) of any one of the preceding claims, wherein the contact part (20) comprises a label (24) containing information regarding the drug container (200) and / or the drug container holder (100) and / or a drug inside the drug container (200), wherein the label (24) is arranged on the remaining portion (21a).

9. The packaging (1) of any one of the preceding claims, further comprising a surrounding part (60, 70) configured to surround at least a portion of the contact part (20, 30, 40, 50).

10. The packaging (1) of claim 9, further comprising a connection element (61) configured to connect the contact part (20, 30, 40, 50) and the surrounding part (60, 70) and to open the contact part (20, 30, 40, 50), when at least a portion of the contact part (20, 30, 40, 50) is moved relatively to the surrounding part (60, 70).

11. The packaging (1) of claim 9 or 10, wherein the surrounding part (60, 70) is formed without supporting structures, thereby allowing a flexible distribution of objects therein.

12. The packaging (1) of any one of claims 9 to 11 , wherein the contact part (20, 30, 40, 50) is a pouch (40, 50), and wherein the surrounding part (60, 70) is a pouch (70), a bag, or a wrap.

13. The packaging (1) of any one of claims 3 to 12, wherein the pouch (40, 50) is made of at least one of the following materials or combinations thereof: paper, pulp based materials, and / or starch.

14. The packaging (1) of any one of claims 9 to 13, wherein the surrounding part (60, 70) is made of at least one of the following materials: a biodegradable material, paper, pulp based materials, and / or starch.

15. The packaging (1) of any one of claims 4 to 14, wherein the at least two compartments (50a, 50b, 50c, 50d) are connected via a ribbed portion (41, 51, 71), wherein the ribbed portion (41, 51, 71) is configured to connect two adjacent compartments to each other, thereby forming a chain of compartments (50a, 50b, 50c, 50d).

16. The packaging (1) of claim 15, wherein the ribbed portion (41, 51, 71) comprises a perforation (23) or an embossing.

17. The packaging (1) of claim 15 or 16, wherein the compartments (50a, 50b, 50c, 50d) are separable from each other in a one-by-one manner.

18. The packaging (1) of any one of claims 8 to 17, wherein the label (24) is printed on the contact part (20, 30, 40, 50).

19. The packaging (1) of claim 18, wherein the contact part (20, 30, 40, 50) is a shrink element (20) or a pouch (40, 50).

20. The packaging (1) of any one of claims 7 to 19, wherein the operation element (22, 32, 42, 52) is configured to be movable relative to the remaining portion (21a) such that the contact part (20, 30, 40, 50) is opened by a rotation of the operation element (22, 32, 42, 52) relative to the remaining portion (21a).

21. The packaging (1) of any one of claims 6 to 20, wherein contact part (20) comprises a removable portion (21b), configured to be removable from the remaining portion (21a), when the opening element (23, 33, 41, 51) is opened.

22. The packaging (1) of claim 21, wherein contact part (20) comprises a marking feature (25) configured to impede, limit or hinder the connection of a needle to the drug container (200) and / or the drug container holder (100), when the removable portion (21b), is connected to the drug container (200) and / or the drug container holder (100).

23. An arrangement (80a, 80b, 80c, 80d, 80e, 81a, 81b, 81c, 81 d, 81e) for a drug delivery device comprising:a drug container (200) or a drug container holder (100) with a drug container (200); and the packaging (1) according to any one of the preceding claims,wherein the contact part (20, 30, 40, 50) is connected to the drug container (200) and / or the drug container holder (100) such that at least a distal end (201) of the drug container (200) and / or a distal end (101) of the drug container holder (100) is covered by the contact part (20, 30, 40, 50).

24. The arrangement of claim 23, wherein the contact part (20, 30, 40, 50) is configured not to cover a proximal end (202) of the drug container (200) and / or a proximal end (102) the drug container holder (100).

25. The arrangement of claim 23 or 24, wherein the drug container (200) is filled with a drug.

26. Use of the arrangement according claim 25 for connecting the drug container (200) and / or the drug container holder (100) to a drive unit (300),wherein the drive unit (300) is configured to expel drug from the drug container (200) of the arrangement, when being operated by the user,wherein the distal end (201) of the drug container (200) is uncovered before the drive unit (300) is operated.

27. A packaging (1) for a drug container (200) and / or a drug container holder (100) configured to receive a drug container (200), the packaging (1) comprising:a contact part (20, 30, 40, 50) configured to be connectable to or connected to the drug container (200) and / or the drug container holder (100) such that at least a distal end (101, 201) of the drug container (200) and / or the drug container holder (100) is covered by the contact part (20, 30, 40, 50),wherein at least a portion of the contact part (20, 30, 40, 50) is removable to uncover the distal end (101, 201),wherein the contact part (20, 30, 40, 50) comprises at least two compartments (50a, 50b, 50c, 50d), each of them being configured to receive a drug container (200) and / or a drug container holder (100),wherein the compartments (50a, 50b, 50c, 50d) are connected via a ribbed portion (41, 51, 71),wherein the ribbed portion (41, 51, 71) is configured to connect two adjacent compartments to each other, thereby forming a chain of compartments (50a, 50b, 50c, 50d).

28. Method for packaging a drug container (200) and / or a drug container holder (100), the method comprising the step of:i) connecting (S101) a contact part (20, 30, 40, 50) of a packaging (1) to the drug container (200) and / or to the drug container holder (100) such that at least a distal end (101, 201) of the drug container (200) and / or the drug container holder (100) is covered by the contact part (20, 30, 40, 50), and, optionally,ii) arranging (S102) the contact part (20, 30, 40, 50) in a surrounding part (60, 70) of the packaging (1).

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