Adapter for filling and subsequently closing pharmaceutical composition container, and container having adapter

Abstract

The present invention provides an adapter for filling and subsequently closing a container of a pharmaceutical composition, the adapter comprising: a housing having a first axis, the housing having a cavity having an opening coupleable with a port of the container; a closure element arranged in the cavity and displaceable from a first position to a second position in a direction along the first axis; a push rod arranged at least partially outside the cavity and movable by a user in a direction along the first axis to displace the closing element; the housing has an inlet port with an inlet port opening in communication with the cavity, at least a portion of the inlet port opening being located axially between the first position of the closure element and the opening when viewed along the first axis.

Description

Technical Field

[0001] The present disclosure relates to the filling of pharmaceutical containers. The present disclosure is particularly but not exclusively applicable to an adapter for filling and subsequently closing a pharmaceutical composition container, such as a flat pharmaceutical sachet made of plastic. Background Art

[0002] An exemplary pharmaceutical container is a flat pharmaceutical sachet made of one or more plastics, which exhibits excellent barrier properties and allows long-term storage like a glass vial. Such an exemplary pharmaceutical container may include three main parts: a film of one or more layers, which is welded to form a sachet; a port, which includes an interface and provides access to the interior of the sachet; and a closure, which is used to close the port.

[0003] US 8 763 798 B2 relates to a closure for filling and sealing a receiver containing a pharmaceutical fluid, and a method for filling and sealing a receiver with a pharmaceutical fluid. The closure used in the method includes a mounting part attachable to the receiver and a connector part connectable to a filling device. A closure body is disposed between the mounting part and the connector part, and a closure part for sealing the closure is located in the closure body. The closure part is slidable between a position for sealing the closure and a position for opening the closure. The closure is sealed tightly with a removable protective cap. The receiver is filled through the closure in a clean room. After filling, the closure is sealed by pressing the closure part into the closure.

[0004] Such pharmaceutical containers are typically developed to be filled at an automated filling station in a sterile environment in an industrial setting in order to minimize the risk of contamination. However, this can be inconvenient and involves undesirable logistics. Summary of the Invention

[0005] It is an object of the present invention to provide a filling tool that allows filling of a pharmaceutical container, and a pharmaceutical sachet designed to be filled by a practicing physician, nurse, or pharmacist in an industrial or clinical setting, such as a treatment room or pharmacy. This object is achieved by an adapter according to independent claim 1, a container having an adapter according to independent claim 11 or 12, or a combination according to claim 15. Preferred embodiments are defined in the independent claims.

[0006] According to a first aspect of the present disclosure, there is provided an adapter for filling and subsequently closing a pharmaceutical composition container, the adapter comprising:

[0007] a housing having a first axis, the housing having a cavity with a cavity opening capable of being coupled to a port of the container;

[0008] A closing element, which is arranged in the cavity and is capable of being displaced from a first position to a second position in a direction along the first axis;

[0009] A push rod, which is at least partially arranged outside the cavity and can be moved by a user in a direction along the first axis to displace the closing element;

[0010] The housing has an inlet port, which has an inlet port opening communicating with the cavity. When viewed along the first axis, at least a part of the inlet port opening is axially located between the first position of the closing element and the cavity opening.

[0011] According to a preferred aspect, the inlet port has an inlet port channel, and at least a part of the length of the inlet port channel is perpendicular to the first axis or inclined with respect to the first axis.

[0012] According to a preferred aspect, the adapter has two opposite sides along the first axis. One side is the side where the adapter can be connected to the port of the container, and the other side is the second side for being held and / or operated by the user.

[0013] According to a preferred aspect, the push rod has a substantially T-shaped cross-section along the first axis.

[0014] According to a preferred aspect, the adapter further includes a pierceable diaphragm in the inlet port channel.

[0015] According to a preferred aspect, the inlet port includes, at an end opposite to the cavity opening, one or more of a self-sealing elastic diaphragm, a needleless connector, a female Luer connector, a male Luer connector, a Luer access valve, a Luer activation device, or a combination thereof.

[0016] According to a preferred aspect, the inlet port is configured to cooperate with at least one of a male Luer connector, a female Luer connector, a vial adapter, a vial piercer, an IV set piercer, or a combination thereof.

[0017] According to a preferred aspect, the inlet port is configured to cooperate with at least one closing system delivery device or component.

[0018] According to a preferred aspect, the closing element is adapted to seal the port of the container.

[0019] According to a preferred aspect, the closing element is configured to remove substantially all of the drug from the cavity.

[0020] According to a preferred aspect, the closing element is configured to remove substantially all of the drug from the cavity after filling and displacement of the closing element.

[0021] According to a preferred aspect, the closure element is adapted to connect to the port of the container and to be released from the adapter when the adapter is removed from the container.

[0022] According to a preferred aspect, the closure element is a plunger for discharging fluid from the chamber.

[0023] According to a preferred aspect, the closure element is substantially an elastomeric material.

[0024] According to a preferred aspect, the closure element is a blend of a thermoplastic elastomer and an olefin polymer.

[0025] According to a preferred aspect, the chamber is made of an olefin polymer.

[0026] According to a preferred aspect, the adapter is configured such that one or more parts of the adapter or the housing are removed from the container after filling.

[0027] According to a preferred aspect, the adapter is configured such that one or more parts of the adapter or the housing are removed from the container after filling and displacement of the closure element.

[0028] According to a preferred aspect, the adapter housing has a protruding structure for being grasped by a user during use. The adapter housing may be generally elongated in the direction of the first axis, preferably generally cylindrical.

[0029] According to a preferred aspect, the push rod protrudes from the adapter housing (510) along the first axis at a side for being held and / or operated by a user.

[0030] According to a preferred aspect, the push rod protrudes from the adapter housing along the first axis at a side for being held and / or operated by a user.

[0031] According to a preferred aspect, the adapter housing has one or more connecting elements for connecting the adapter housing to the container housing. The one or more connecting elements may provide a releasable connection between the adapter housing and the container housing. The releasable connection may be a snap connection or a threaded connection.

[0032] According to a preferred aspect, the adapter housing has a second axis perpendicular to the first axis, and wherein the adapter housing has two opposing connecting elements for connecting the adapter housing to the container housing, along the second axis. The connecting elements may be flexible elements providing a releasable connection to the container housing. Each flexible element may be integral with the adapter housing at one of its ends, and the opposing flexible ends include locking features.

[0033] According to a preferred aspect, the locking feature is a flange that extends in a direction perpendicular to the plane defined by the first axis and the second axis and protrudes along the second axis, or the locking feature is a groove that extends in a direction perpendicular to the plane defined by the first axis and the second axis and is recessed along the second axis.

[0034] According to a preferred aspect, the push rod is embedded in the adapter housing such that the outermost end surface is flush with the surface of the adapter housing. The adapter housing may have a stepped structure such that the push rod can be displaced towards the container. The stepped structure may be a substantially U-shaped structure.

[0035] According to a preferred aspect, the inlet port includes a valve element for connecting the inlet port to a syringe. The syringe may be a needleless syringe.

[0036] According to another aspect of the present disclosure, there is provided a container for a pharmaceutical composition, the container having a separable and removable adapter for filling and subsequently closing the container, the adapter being defined as in any of the foregoing aspects, the container further comprising a medicament bag and a port configured to be removably connected to the adapter.

[0037] According to a preferred aspect, the medicament bag is a flexible medicament bag, preferably a flat flexible bag.

[0038] According to a preferred aspect, the container further comprises a container housing for accommodating the medicament bag. The port may be part of the medicament bag or part of the container housing.

[0039] According to a preferred aspect, the container housing includes one or more container connection elements that cooperate with the adapter connection elements. Each container connection element may include a locking feature. The locking feature may be a corresponding groove or flange.

[0040] According to another aspect of the present disclosure, there is provided a container for a flexible bag, the flexible bag having an internal space for accommodating a volume of liquid, the container comprising:

[0041] A container housing for accommodating the flexible bag;

[0042] An outlet port for communicating the internal space of the flexible bag with the exterior of the container; and

[0043] One or more container connection elements that cooperate with the connection elements of a flexible bag filling adapter.

[0044] According to a preferred aspect, each container connection element includes a locking feature.

[0045] According to a preferred aspect, the container housing has a container housing outer shell and a container housing lid.

[0046] According to a preferred aspect, the one or more container locking features include a housing locking feature and a lid locking feature.

[0047] According to a preferred aspect, the container connection element is formed as a recess in the circumferential walls of the container housing shell and the container housing lid. The locking feature may be formed as a ridge at the wall of the recess.

[0048] According to a preferred aspect, the container further includes an adapter for filling and subsequently closing the flexible bag in the container.

[0049] According to a preferred aspect, the adapter includes:

[0050] a housing having a cavity with a cavity opening that can be coupled to a port of the container;

[0051] a closing element disposed in the cavity;

[0052] a push rod at least partially disposed outside the cavity and movable by a user;

[0053] The housing has an inlet port with an inlet port opening that communicates with the cavity.

[0054] According to another aspect of the present disclosure, there is provided a combination of an adapter and a container frame for filling and subsequently closing a pharmaceutical composition container, the adapter including:

[0055] a housing having a first axis and having a cavity with a cavity opening;

[0056] a closing element disposed in the cavity and movable from a first position to a second position in a direction along the first axis;

[0057] a push rod at least partially disposed outside the cavity and movable by a user in a direction along the first axis to displace the closing element;

[0058] The housing has an inlet port with an inlet port opening that communicates with the cavity, and at least a portion of the inlet port opening is axially located between the first position of the closing element and the cavity opening when viewed along the first axis;

[0059] wherein the adapter housing has one or more connection elements for connecting the adapter housing to the container frame.

[0060] According to a preferred aspect, the one or more connection elements provide a releasable connection between the adapter housing and the container frame.

[0061] According to a preferred aspect, the releasable connection is a snap connection or a threaded connection.

[0062] One advantage of the present invention is that it allows for the filling of drug containers in a variety of scenarios, such as in an industrial or clinical setting. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] The present invention will be described with reference to the accompanying drawings, in which:

[0064] Figure 1 is a perspective view of a container with an adapter according to a first embodiment of the present invention.

[0065] Figure 2 is according to a first embodiment of the present invention Figure 1 of a front view of a container with an adapter.

[0066] Figure 3 shows a medicament bag of a container in communication with an adapter according to a first embodiment of the present invention.

[0067] Figure 4 shows a medicament bag of a container disengaged from an adapter according to a first embodiment of the present invention.

[0068] Figure 5 shows an adapter according to a first embodiment of the present invention.

[0069] Figure 6 shows an exploded perspective view of an adapter according to a first embodiment of the present invention.

[0070] Figure 7 shows a bottom perspective view of a housing of an adapter according to a first embodiment of the present invention.

[0071] Figure 8 shows a different exploded perspective view of an adapter according to a first embodiment of the present invention.

[0072] Figure 9 shows a top perspective view of a housing of an adapter according to a first embodiment of the present invention.

[0073] Figure 10 shows a cross-sectional perspective view of a housing of an adapter according to a first embodiment of the present invention.

[0074] Figure 11 shows a perspective view of different cross-sections of a housing of an adapter according to a first embodiment of the present invention.

[0075] Figure 12 shows a cross-section of an adapter according to a second embodiment of the present invention.

[0076] Figure 13Illustrates an adapter using the second embodiment of the present invention.

[0077] Figure 14 Illustrates additional steps of an adapter using the second embodiment of the present invention.

[0078] Figure 15 Illustrates details of a container according to an embodiment of the present invention.

[0079] Figure 16 Illustrates Figure 15 exploded perspective view of the container.

[0080] Figure 17 is an internal perspective view of the container housing shell. Detailed Description

[0081] Figure 1 is a perspective view of a container 300 with an adapter 100 according to the first embodiment of the present invention. Figure 1 Shows an adapter 100 releasably coupled to a container 300. The adapter 100 has an inlet port, and a syringe 400 is shown releasably connected to the adapter 100 at the inlet port. The container 300 has a container housing 320, and a medicament bag (not shown) is in the container housing 320. The medicament bag in the container 300 can be filled from the syringe 400 via the adapter 100.

[0082] Figure 1 Also shown are a push rod 140 of the adapter 100 and a connection element that releasably connects the adapter 100 to the housing 320 of the container 300. In Figure 1 can be seen the container connection element 340. This will be described in more detail below. It can also be seen that in this embodiment, the top surface of the push rod 140 is flush with the top surface of the adapter housing 110. However, the flush configuration is optional, and the top surface of the push rod 140 can also protrude from or be recessed relative to the top surface of the adapter housing 100. The function of the push rod 140 will be described in more detail below.

[0083] Figure 1A second aspect of the invention is also illustrated. The second aspect is a container 300 for a pharmaceutical composition, the container having a separable and removable adapter 100 for filling and subsequently closing a reservoir 300, both being pre-assembled. Thus, according to this aspect of the invention, the container 300 and the adapter 100 are provided pre-assembled as a kit set. A syringe 400 containing the pharmaceutical composition is provided separately, a medicament pouch is to be filled with the pharmaceutical composition, and the syringe is connected by the user to the adapter 100 of the pre-assembled kit. After the pharmaceutical composition has been filled into the medicament pouch and the medicament pouch has been closed, the syringe 400 is removed from the adapter 100, and the adapter 100 is detached or released from the container 300. Alternatively, the adapter 100 still connected to the syringe 400 is removed from the container 300.

[0084] Figure 2 is of a container 300 according to a first embodiment of the invention having Figure 1 of the container 300 Figure 1 front view of the adapter 100. The front view of the adapter 100 is defined as the view showing the inlet port 150 (see Figure 4 ). Figure 2 Also shown is that the top surface or outermost end surface 141 of the plunger 140 is flush with the top surface 111 of the adapter housing 110. The adapter housing 110 has a first axis A and a second axis B perpendicular to the first axis. In Figure 2 the view, the first axis is the vertical axis and the second axis is the horizontal axis from left to right. These axes will be referred to below.

[0085] The adapter housing 110 has a connecting element 160 for releasably fixing the adapter housing 110 to the container housing 320. In the illustrated embodiment, there are two connecting elements 160 opposite each other, for example, in the sense that they can be operated in opposite directions, in the illustrated embodiment by pressing towards each other. Preferably, in the case where two connecting elements 160 are provided, they are symmetrically arranged relative to the inlet port leading into the medicament pouch. This symmetrical arrangement allows for a simple coupling of the adapter 100 of the container 300, since the user does not have to concern themselves with the correct orientation of the adapter 100 relative to the container 300.

[0086] In the illustrated embodiment, the adapter housing 110 is in a vertical plane (e.g., defined by axes A and B Figure 2has a generally rectangular cross-section in the plane of the figure). It may also have a generally rectangular cross-section in a horizontal plane (i.e., a plane perpendicular to axis A). Two connecting elements 160 are provided at the relatively smaller sides of the adapter housing 110. In the illustrated example, the container 300 also has a generally rectangular cross-section in both horizontal and vertical planes. However, alternative shapes are also contemplated by the present invention. For example, a square cross-section of the adapter 100 and / or the container 300 in the horizontal and / or vertical plane is also envisioned. As another example, the container 300 has an oval, semi-circular or even circular cross-section in the horizontal plane. The cross-section of the adapter 100 can be adapted to such a cross-section of the container 300, and thus in an alternative embodiment, the adapter 100 has a circular cross-section in the horizontal plane. In such an alternative embodiment, three connecting elements 160 can be provided, which are spaced 120° from each other around the vertical central axis and can be operated by the user with three fingers.

[0087] Each connecting element 160 has a locking feature 161 that engages with a mating locking feature 341 of the container connecting element 340, but other arrangements are also possible. The connecting element 160 is a flexible element that provides a releasable connection to the container housing 320. In the illustrated embodiment, each flexible element is integral with the adapter housing 110 at one of its ends, and the opposite flexible end includes the locking feature 161. The locking feature 161 is a flange that extends in a direction perpendicular to the plane defined by axes A and B and protrudes along axis B. Alternatively, the locking feature is a groove that extends in a direction perpendicular to the plane defined by axes A and B and is recessed along axis B. The locking feature 341 of the container 300 is a corresponding mating groove or flange.

[0088] Such mating locking features 161, 341 provide a releasable fixation of the adapter 100 to the container 300 along the first axis A. Alternatively, the locking features 161, 341 are shaped such that a sliding movement along the axis of the inlet port 150 (i.e., perpendicular to axis A) is required to couple the adapter 100 to the container 300. As another alternative, the connecting elements 160, 340 have a curved shape (curved around the first axis) or a helical shape such that the adapter 10 is connected to the container 300 by a rotational movement through a certain degree of rotation, causing the connecting elements 160, 340 to engage slidably. With this configuration, the connecting element 160 of the adapter 100 does not need to be flexible, but can be formed as a protrusion of the adapter housing 110.

[0089] Figure 3 A medicament pouch of a container 300 in fluid communication with an adapter 100 according to a first embodiment of the present invention is shown. In this figure, the container housing 320 is removed so that the medicament pouch 310 can be seen.

[0090] Figure 4 Shows the medicine pouch 310 of the container released from the adapter 100 according to the first embodiment of the present invention. In this figure, the container housing 320 is also not shown, and the adapter 100 is shown in a disconnected state, for example, before filling the medicine pouch 310 or before connecting the adapter to the container 300 after filling is completed. The medicine pouch 310 has a port 330 to which the adapter 100 can be coupled at a corresponding coupling element. In Figure 3 and Figure 4 , the push rod 140 is shown in its first position, for example, the initial position where the outer surface 141 is flush with the outer surface 111 of the adapter housing 110.

[0091] Figure 5 Shows the adapter 100 according to the first embodiment of the present invention. In this figure, the adapter 100 is shown in a state where the push rod 140 has been operated by the user. The push rod 140 has been displaced along the first axis towards the medicine pouch (not shown). This displacement requires the stepped structure of the adapter housing 110, which will be clearer below.

[0092] Figure 6 Shows an exploded perspective view of the adapter 100 according to the first embodiment of the present invention. Figure 6 Shows the adapter housing 110 having an adapter connection element 160 and an inlet port 150, and the adapter connection element has its flange 161. Figure 6 Also shows a part of the cavity 120 of the adapter housing 110, which opens towards the cavity opening 121 for fluid communication with the medicine pouch 310. Figure 6 Also shows the push rod 140 in more detail. The push rod 140 is at least partially disposed outside the cavity 120 and can be moved by the user in the direction along the first axis A to displace the closing element 130 within the cavity 120. The term "at least partially disposed outside the cavity" refers to Figure 1 the state shown, for example, when the push rod 140 is in its initial position. When moving the push rod 140 towards the medicine pouch to reach the state as shown in Figure 5 , the push rod moves into the cavity 120 to displace the closing element 130. Figure 6 Also shows the O-rings 144, 145 and the gasket 146. The O-rings 144, 145 are located on the push rod 140 and cooperate with the inner surface of the cavity 120 to provide a fluid-tight seal. This helps to ensure that when the medicine container 300 is closed, the drug composition is discharged from the cavity 120. The gasket 146 is located between the adapter 100 and the container 300 and helps to ensure a fluid-tight seal between the adapter 100 and the port 330 of the container 300.

[0093] In cross-section, the push rod 140 of this exemplary embodiment has a generally T-shape. The vertical portion of the T is formed by a generally cylindrical portion, and the horizontal portion is formed by a flat plate that forms the outer surface 141. Additionally, the push rod 140 may have opposing side elements 142 that extend parallel to the central vertical portion or rod such that the space formed by the push rod 140 is closed and guided by the adapter housing 110. As Figure 6 shown, one of the side elements may have a recess 143 that is shaped to mate with the shape of the inlet port 150 such that when the push rod 140 moves, it does not conflict with the inlet port 150.

[0094] Figure 6 Also shown is the stepped structure of the adapter housing 110. The stepped structure is a generally U-shaped structure. The stepped structure allows the push rod 140 to be displaced from an initial flush position (as Figure 1 shown) to the Figure 5 position shown. However, as described above, the flush configuration is a design option, and the push rod 140 may equally project upward from the surface 111 of the adapter housing 110. With this configuration, the stepped structure of the adapter housing 110 is not necessary, i.e., the upper surface 111 of the adapter housing is continuous.

[0095] Furthermore, Figure 6 shown is a valve element 170, such as a wipeable valve, for attaching or connecting or coupling a syringe, such as a needleless syringe.

[0096] Figure 7 Shown is a bottom perspective view of the housing 110 of the adapter 100 according to the first embodiment of the present invention. In the Figure 7 bottom view, the cavity 120 and its arrangement relative to the inlet port 150 are clearly seen.

[0097] Figure 8 Shown is a different exploded perspective view of the adapter 100 according to the first embodiment of the present invention. In this figure, the inlet port opening 151 can be seen. At the inlet port opening 151, the inlet port 150 is in fluid communication with the cavity 120 of the adapter housing 110.

[0098] Figure 9 Shown is a top perspective view of the housing of the adapter 100 according to the first embodiment of the present invention. Again, the cylindrical cavity 120 and the inlet port 150 are illustrated in this figure.

[0099] Figure 10A cross-sectional perspective view of the housing 110 of the adapter 100 according to a first embodiment of the present invention is shown. The cross-section is drawn in a plane formed by a first axis A and a third axis perpendicular to the first axis A and a second axis B. The cross-section shows an inlet port 150 having an inlet port channel 152 and an inlet port opening 151. In this embodiment, the axis of the inlet port channel 152 is perpendicular to the axis of the cavity 120.

[0100] The opening 151 enters the cavity 120 at a position along the first axis A that is between the closing element 130 in its first position (e.g., initial position) and the cavity opening 121. In other words, when viewed along the first axis A, the opening 151 is axially located between the first position of the closing element 130 and the cavity opening 121. The axial position of the opening 151 is preferably such that the closing element 130 does not overlap the opening 151 when in its initial position, and the closing element 130 also does not overlap the opening 151 in its final position. However, the present disclosure encompasses partial overlap of the closing element 130 with the opening 151 in one or both of these positions.

[0101] The cavity 120 has a portion with a slightly larger diameter towards the cavity opening 121. This facilitates mating with the port 330 of the medicament bag 310. The cavity 120 also has a portion with a slightly larger diameter towards the other end (e.g., the end opposite the end of the cavity opening 121) and on the side of the inlet port 150 remote from the cavity opening. This helps to hold the closing element 130 in place before the adapter 100 is used.

[0102] Figure 11 A perspective view of different cross-sections of the housing of the adapter according to a first embodiment of the present invention is shown. The cross-section is drawn in a plane formed by the first axis A and the second axis B. The opening 151 connecting the inlet port channel 152 to the cavity and the cavity opening 121 are seen.

[0103] Figure 12 A cross-section of the adapter 500 according to a second embodiment of the present invention is shown. In this embodiment, the adapter 500 has a different configuration.

[0104] The adapter 500 of this embodiment has a generally elongated housing 510 and is at least generally cylindrical in this preferred embodiment. The housing 510 defines a cavity 520 that has cavity openings 521 at the ends that face the medicament bag 310 or the medicament container 300, respectively, when the adapter 500 is in use. At the cavity opening 521, the housing 510 has a structure for mounting the adapter 500 to the container 300. In Figure 12In [the figure], adapter 500 is shown coupled to port 330 of medicament pouch 310 in container 300. Closing element 530 is located in cavity 520. Pusher 540 (which may be T-shaped in cross-section) is shown as being at least partially disposed outside (and at least partially within) cavity 520 and is movable by a user in a direction along first axis A to displace closing element 530 within cavity 520. Housing 510 has wings 560 for gripping by a user during use of adapter 500.

[0105] Housing 510 has an inlet port 550 with an inlet port opening 551 and an inlet port channel 552. In the illustrated embodiment, inlet port channel 552 is closed with a diaphragm 555.

[0106] Inlet port channel 552 is shown as being inclined relative to first axis A. For example, at least a portion of the length of inlet port channel 552 is inclined relative to first axis A (or second axis B). Thus, the axis of at least a portion of the length of inlet port channel 552 lies in the plane defined by axes A and B. In an alternative embodiment, the axis of at least a portion of the length of inlet port channel 552 may be further inclined relative to the plane defined by axes A and B. However, inlet port channel 552 may also be oriented perpendicular to first axis A, as shown in a first embodiment, i.e., along second axis B. In another alternative embodiment, inlet port channel 552 may be oriented perpendicular to first axis A and also inclined relative to the plane defined by axes A and B.

[0107] Opening 551 enters cavity 520 at a position along first axis A that is between closing element 530 in its first position (e.g., initial position) and cavity opening 521. In other words, when viewed along first axis A, opening 551 is axially located between the first position of closing element 530 and cavity opening 521. The axial position of opening 551 is preferably such that closing element 530 does not overlap opening 551 when in its initial position and closing element 530 also does not overlap opening 551 in its final position. However, the present disclosure encompasses partial overlap of closing element 530 with opening 551 in one or both of these positions.

[0108] As Figure 12As shown, after the main drug container is produced, the container 300 and the adapter 500 are (pre)-assembled for a pharmacy or clinic filling scenario. The assembly can be packaged as a single part. The adapter 500 includes a closure 530 required for a closed system. The adapter 500 is designed similar to a syringe, but instead of a plunger in the syringe, a closure element 530 in the adapter 500 is moved within the chamber 520 by a push rod 540. The connection of the inlet port 550 to the adapter chamber 520 allows filling of the drug container 300.

[0109] Figure 12 A septum 555 that can be pierced multiple times by a cannula is shown. The septum 555 is arranged in the inlet port channel 552 as a closure at the end of the inlet port 550 opposite the inlet port opening 551. Alternatively, a Luer connection or both, other non-Luer connections, or other suitable connectors can also be provided. For example, a cooperative connection can be provided for a closed system transfer device (CSTD) or its components to prevent the user from being exposed to the drug filled into the drug container using the device.

[0110] Figure 13 An example of using the adapter 500 of the second embodiment of the present invention is illustrated. The left-hand figure shows the (pre)-assembled adapter 500 and the drug container 300. The next usage stage is shown in the right-hand figure. It shows how the septum 555 is pierced by a filling syringe and how the medicament is transferred via the chamber 520 and through the chamber opening 521 into the medicament container 300 (the flow of the medicament is highlighted by two arrows). Once the medicament container 300 is filled, the syringe is removed by pulling out, unscrewing, etc. If needed, one or more additional components can be inserted into the container 300 in this way. Thus, if needed, the process can be repeated any number of times. For example, if a 50 ml syringe is used with the device and a 100 ml dose is required in the medicament bag, the described process can be repeated twice. Similarly, two 50 ml syringes can each be filled with a different drug (e.g., a biologic drug and saline) and each added to the bag in turn.

[0111] Figure 14 Additional steps of using the adapter 500 of the second embodiment of the present invention are illustrated. Figure 14Illustrates the clogging and removal of the adapter 500 from the drug container. When all the drug ingredients are in the drug container 300, the pusher 540 of the adapter 500 is pressed. First, the closing element 530 acts as a plunger and pushes all the drug elements retained in the chamber 520 into the drug container 300. The user can push on the pusher 540 with the thumb and, at the same time, hold the two wings 560 with the index finger and middle finger to apply force on the pusher 540 (see the left-hand figure). At the end position (middle figure), the closing element 530 is connected to the port, which, for example, snaps in, and seals and closes the drug container 300. By further pressing the pusher 540 of the adapter (right-hand figure) until the pusher 540 touches the housing 510, the connection between the closing element 530 and the adapter 500 is released, and the adapter 500 can be removed from and discarded from the drug container 300. The closing element 530 is now arranged on the drug container 300. The right-hand figure shows that the adapter housing 510 has been lifted a certain distance from the drug container 300.

[0112] Figures 15 to 17 More particularly, the container 300 according to one aspect of the present invention is illustrated. The container 300 is adapted to receive the medicament bag 310. In the illustrated embodiment, the medicament bag 310 is flexible. The medicament bag 310 has an internal space for containing a volume of liquid. The container 300 includes a container housing 320 for receiving and, in the illustrated embodiment, supporting the medicament bag 310. The container 300 also has an inlet port (or corresponding outlet port) 343 for the port 330 for receiving or taking in the medicament bag 310 to communicate the internal space of the medicament bag 310 with the exterior of the container 300. The inlet port 343 is formed as a through hole. The container 300 has a container housing outer shell or container frame 322 and a container housing lid 321. When the lid 321 is connected to the outer shell or frame 322, an internal space for the medicament bag 310 is provided. However, the lid 321 is a preferred element, and the container 300 can receive the flexible bag 310 without being closed by the lid 321. The container housing lid 321 and the container housing outer shell 322 each have a peripheral wall 323, 324. The peripheral walls 323, 324 provide rigidity to the container housing 320.

[0113] The container 300 also has one or more container connection elements 340. The connection elements 340 are configured to cooperate with corresponding connection elements of a flexible bag filling adapter (such as the adapters 100, 500 of the present disclosure). In the illustrated embodiment, two connection elements 340 are provided. The two connection elements are preferably arranged one on each side of the inlet port 343.

[0114] Preferably, each container connection element 340 includes a locking feature 341. More preferably, one or more container locking features 341 include a housing locking feature 3411 and a lid locking feature 3412. In other words, when the container 300 has a lid and the container 300 is coupled to the adapters 100, 500, the adapters 100, 500 are coupled or connected to the container housing shell 322 and the container housing lid 321. This allows for a coupling direction along the axis of the port 343. For example, the locking features 3411 and 3412 on the lid and the housing provide a snap connection of the adapter to the container 300. Alternatively, the locking feature is provided only in the container housing shell 322 and not in the container housing lid 321. With this configuration, the adapters 100, 500 can be coupled to the container 300, for example, by a sliding movement perpendicular to the axis of the port 343.

[0115] In Figures 15 to 17 In the preferred embodiment shown, the container connection element 340 is formed as a recess in the circumferential walls 323, 324 of the container housing shell 322 and the container housing lid 321. The corresponding locking feature 341 is preferably formed as a ridge or flange at the wall of the recess. The ridge or flange can cooperate with a corresponding flange on the adapter connection element to releasably couple the two components together.

[0116] The adapters 100, 500, the adapter housings 110, 510, and the push rods 140, 540 can be made of one or more rigid plastic materials, such as polypropylene, polycarbonate, acrylonitrile butadiene styrene, polyamide, polystyrene, or combinations thereof. In some embodiments, portions of the adapter housings 110, 510 and the push rods 140, 540 can be overmolded on the side closest to the body of the container 300 with a soft compliant material, such as a thermoplastic elastomer or a thermoplastic polyurethane, to improve the comfort of the user of the device during filling of the container 300 or placement of the closure elements 130, 530.

[0117] The devices described herein can be used to treat and / or prevent one or more of many different types of diseases.

[0118] Exemplary diseases include, but are not limited to: rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia and / or dyslipidemia, cardiovascular disease, diabetes (e.g., type 1 or type 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behcet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, grafts, acute hypoglycemia, obesity, anaphylactic reactions, allergies, sickle cell disease, Alzheimer's disease, Parkinson's disease, Lewy body dementia, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity, cytokine release syndrome, immunodeficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation diseases (e.g., hemophilia, von Willebrand disease, factor V Leiden), and cancer.

[0119] Exemplary drug types that may be included in the delivery devices described herein include, but are not limited to: small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapy, radioisotopes and / or nuclear drugs, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptidomimetics, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogs, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapy, cell or gene therapy, oncolytic viruses or immunotherapies.

[0120] Exemplary drugs that may be included in the delivery devices described herein include, but are not limited to: immuno-oncology or bio-oncology agents such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T cell receptors, B cell receptors or costimulatory proteins.

[0121] Exemplary drugs that may be included in the delivery devices described herein include, but are not limited to, those that exhibit the proposed mechanism of action, such as: human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-1 (GLP-1) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, C1 esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death ligand 1 (PD-1 / PD-L1) inhibitors / modulators, B lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitors, T cell immunoglobulin and mucin domain 3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain protein (PVRIG) modulators, lymphocyte activation gene 3 (LAG3;Also known as cluster of differentiation 223 or CD223) antagonist, cluster of differentiation 276 (CD276 or B7-H3) antigen regulator, cluster of differentiation 47 (CD47) antagonist, cluster of differentiation 30 (CD30) regulator, cluster of differentiation 73 (CD73) regulator, cluster of differentiation 66 (CD66) regulator, cluster of differentiation w137 (CDw137) agonist, cluster of differentiation 158 (CD158) regulator, cluster of differentiation 27 (CD27) regulator, cluster of differentiation 58 (CD58) regulator, cluster of differentiation 80 (CD80) regulator, cluster of differentiation 33 (CD33) regulator, cluster of differentiation 159 (CD159 or NKG2) regulator, glucocorticoid-induced TNFR-related protein (GITR) regulator, killer cell immunoglobulin-like receptor (KIR) regulator, growth arrest-specific protein 6 (GAS6) / AXL pathway regulator, proliferation-inducing ligand (APRIL) receptor regulator, human leukocyte antigen (HLA) regulator, epidermal growth factor receptor (EGFR) regulator, B lymphocyte cell adhesion molecule regulator, cluster of differentiation w123 (CDw123) regulator, Erbb2 tyrosine kinase receptor regulator, endoglin regulator, mucin regulator, mesothelin regulator, hepatitis A virus cellular receptor 2 (HAVCR2) antagonist, cancer-testis antigen (CTA) regulator, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or OX40) regulator, adenosine receptor regulator, inducible T cell co-stimulator molecule (ICOS) regulator, cluster of differentiation 40 (CD40) regulator, tumor-infiltrating lymphocyte (TIL) therapy or T cell receptor (TCR) therapy.;

[0122] Exemplary drugs that may be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, rimegepant-vfrm, alirocumab, methotrexate, tocilizumab, interferon beta-1a, interferon beta-1b, peginterferon beta-1a, sumatriptan, darbepoetin alpha, belimumab, sarilumab, semaglutide, dupilumab, ritlecitinib, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tezepelumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immunoglobulins.

[0123] Exemplary drugs that may be included in the delivery devices described herein may also include, but are not limited to, cancer treatments such as: ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, deruxtecan, pertuzumab, trastuzumab-pertuzumab, alemtuzumab, margetuximab-cmkb, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, ibritumomab tiuxetan, isatuximab, mogamulizumab, pasireotide, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tanirixizumab, or margetuximab.

[0124] Exemplary drugs that may be included in the delivery devices described herein include any of the foregoing "generic" or biosimilar equivalents, and the foregoing molecular names should not be construed as limited to the "innovator" or "brand" versions of each, as in the non-limiting examples of the innovator agent adalimumab and biosimilars (such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz).

[0125] Exemplary drugs that may be included in the delivery devices described herein also include, but are not limited to, those for adjuvant or neoadjuvant chemotherapy, such as alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites or topoisomerase inhibitors, enzymes, retinoids, or corticosteroids. Exemplary chemotherapeutic drugs include, for example, but are not limited to 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.

[0126] Exemplary drugs that may be included in the delivery devices described herein also include, but are not limited to: pain relievers (e.g., acetaminophen), antipyretics, corticosteroids (e.g., hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, preservatives, anticoagulants, fibrinolytic agents (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombotic agents, or diluents such as sterile water for injection (SWFI), 0.9% sodium chloride injection, 0.45% sodium chloride injection, 5% dextrose injection, 5% dextrose and 0.45% sodium chloride mixture, lactated Ringer's injection, heparinized Ringer's flush, 100 U / mL heparinized Ringer's flush, or 5000 U / mL heparinized Ringer's flush.

[0127] Pharmaceutical formulations comprising any of the drugs described herein, including but not limited to, are also contemplated for use in the delivery devices described herein, such as pharmaceutical formulations comprising the drugs listed herein (or pharmaceutically acceptable salts thereof) and a pharmaceutically acceptable carrier. Such formulations may contain one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the sole active ingredient present, and may also contain dispersion enhancers (e.g., hyaluronidase of animal origin, human origin, or recombinant), concentration regulators or enhancers, stabilizers, buffers, or other excipients, administered alone or co-formulated.

[0128] Exemplary drugs that may be included in the delivery devices described herein include, but are not limited to, multi-agent treatment regimens such as AC, dose-dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, dose-dense CHOP, EPOCH, dose-dense adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7+3, 5+2, 7+4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VeIP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC or PE.

[0129] Various modifications to the described embodiments are possible and will be apparent to those skilled in the art without departing from the invention as defined by the appended claims.

[0130] The invention is further defined by the following clauses.

[0131] 1. An adapter (100, 500) for filling and subsequently closing a drug composition container (300), the adapter (100, 500) comprising:

[0132] A housing (110, 510) having a first axis (A), the housing (110, 510) having a cavity (120, 520) with a cavity opening (121, 521) that can be connected to a port of the container (300);

[0133] A closing element (130, 530) disposed in the cavity (120, 520) and displaceable from a first position to a second position in a direction along the first axis (A);

[0134] A push rod (140, 540) at least partially disposed outside the cavity (120,

[0135] 520) and displaceable by a user in a direction along the first axis (A)

[0136] to displace the closing element (130, 530);

[0137] The housing (110, 510) has an inlet port (150, 550) with an inlet port opening (151,

[0138] 551) in communication with the cavity (120, 520), and at least a portion of the inlet port opening (151, 551) is axially located between the first position of the closing element (130, 530) and the cavity opening (121, 521) when viewed along the first axis (A).

[0139] 2. The adapter (100, 500) according to clause 1, wherein the inlet port (150,

[0140] 550) has an inlet port channel (152, 552), and at least a portion of the length of the inlet port channel is perpendicular to the first axis (A) or inclined with respect to the first axis (A).

[0141] 3. The adapter (100, 500) according to clause 1 or 2, wherein the adapter (100, 500) has two opposite sides along the first axis (A), one side being the side where the adapter (100, 500) can be connected to a port (330) of the container (300), and the other side being a second side for holding and / or operating by the user.

[0142] 4. The adapter (100, 500) according to any one of the preceding clauses, wherein the push

[0143] rod (140, 540) has a substantially T-shaped cross-section along the first axis (A).

[0144] 5. The adapter (100, 500) according to any one of the preceding clauses, wherein the adapter (100, 500) further comprises a pierceable diaphragm (555) in the inlet port channel (152, 552).

[0145] 6. The adapter (100, 500) according to any one of the preceding clauses, wherein the inlet port (150, 550) comprises, at an end opposite to the cavity opening (151, 551), one or more of a self-sealing elastomeric diaphragm, a needleless connector, a female Luer connector, a male Luer connector, a Luer access valve, a Luer activation device, or a combination thereof.

[0146] piece, a Luer access valve, a Luer activation device, or a combination thereof.

[0147] 7. The adapter (100, 500) according to any one of the preceding clauses, wherein the inlet port (150, 550) is configured to cooperate with at least one of a male Luer connector, a female Luer connector, a vial adapter, a vial piercer, an IV set piercer, or a combination thereof.

[0148] 8. The adapter (100, 500) according to any one of the preceding clauses, wherein the inlet port (150, 550) is configured to cooperate with at least one closed system delivery device or component.

[0149] 9. The adapter (100, 500) according to any one of the preceding clauses, wherein the closure element (130, 530) is adapted to seal the port (330) of the container (300).

[0150] 10. The adapter (100, 500) according to any one of the preceding clauses, wherein the closure element (130) is configured to remove substantially all of the drug from the cavity (120).

[0151] 11. The adapter (100, 500) according to any one of the preceding clauses, wherein the closure element (130) is configured to remove substantially all of the drug from the cavity (120) after filling and displacement of the closure element (130, 530).

[0152] 12. The adapter (100, 500) according to any one of the preceding clauses, wherein the closure element (130, 530) is adapted to connect to the port (330) of the container (300) and release from the adapter (100,

[0153] 500) when the adapter (100, 500) is removed from the container (300).

[0154] 13. The adapter (100, 500) according to any one of the preceding clauses, wherein the closing element (130) is a plunger for discharging fluid from the cavity (120).

[0155] 14. The adapter (100, 500) according to any one of the preceding clauses, wherein the closing element (130, 530) is substantially an elastomeric material.

[0156] 15. The adapter (100, 500) according to any one of the preceding clauses, wherein the closing element (130, 530) is a blend of a thermoplastic elastomer and an olefin polymer.

[0157] 16. The adapter (100, 500) according to any one of the preceding clauses, wherein the cavity (120, 520) is made of an olefin polymer.

[0158] 17. The adapter (100, 500) according to any one of the preceding clauses, wherein the adapter (100, 500) is configured such that one or more parts of the adapter (100, 500) or the housing (110, 510) are removed from the container (300) after filling.

[0159] 18. The adapter (100, 500) according to any one of the preceding clauses, wherein the adapter (100, 500) is configured such that one or more parts of the adapter (100, 500) or the housing (110, 510) are removed from the container (300) after filling and displacement of the closing element (130, 530).

[0160] 19. The adapter (500) according to any one of the preceding clauses, wherein the adapter housing (510) has a protruding structure (560) for being grasped by a user during use.

[0161] 20. The adapter (500) according to clause 19, wherein the adapter housing (510)

[0162] is generally elongated in the direction along the first axis (A), preferably generally cylindrical.

[0163] 21. The adapter (500) according to clause 19 or 20, wherein the push rod (540) protrudes from the adapter housing (510) along the first axis (A) at the side for being held and / or operated by a user.

[0164] 22. The adapter (100) according to any one of clauses 1 to 18, wherein the push rod (140) projects from the adapter housing (110) along the first axis (A) at the side for being held and / or operated by a user.

[0165] 23. The adapter (100) according to clause 22, wherein the adapter housing (110)

[0166] has one or more connecting elements (160) for connecting the adapter housing (110) to the container housing (320).

[0167] 24. The adapter (100) according to clause 23, wherein the one or more connecting elements (160) provide a releasable connection between the adapter housing (110) and the container housing (320).

[0168] 25. The adapter (100) according to clause 24, wherein the releasable connection is a snap connection or a threaded connection.

[0169] 26. The adapter (100) according to clause 23, 24 or 25, wherein the adapter housing (110) has a second axis (B) perpendicular to the first axis (A), and wherein the adapter housing (110) has two opposite connecting elements (160) for connecting the adapter housing (100) to the container housing (320) and opposite to each other along the second axis (B).

[0170] 27. The adapter (100) according to clause 26, wherein the connecting element (160) is a flexible element providing a releasable connection with the container housing (320).

[0171] 28. The adapter (100) according to clause 27, wherein each flexible element is integral with the adapter housing (110) at one of its ends, and the opposite flexible ends include locking features (161).

[0172] 29. The adapter (100) according to clause 28, wherein the locking feature (161) is a flange extending in a direction perpendicular to the plane defined by the first axis (A) and the second axis (B) and protruding along the second axis (B), or the locking feature is a groove extending in a direction perpendicular to the plane defined by the first axis (A) and the second axis (B) and recessed along the second axis (B).

[0173] 30. The adapter (100) according to any one of clauses 13 to 29, wherein the push rod (140) is embedded in the adapter housing (110) such that the outermost end surface (141) is flush with the surface (111) of the adapter housing (110).

[0174] 31. The adapter (100) according to clause 30, wherein the adapter housing (110)

[0175] has a stepped structure such that the push rod (140) can be displaced towards the container (300).

[0176] 32. The adapter (100) according to clause 31, wherein the stepped structure is a substantially U

[0177] -shaped structure.

[0178] 33. The adapter (100) according to any one of the preceding clauses, wherein the inlet port (150) includes a valve element (170) for connecting the inlet port (150) to a syringe (400).

[0179] 34. The adapter (100) according to clause 33, wherein the syringe (400) is a needleless syringe.

[0180] 35. A container (300) for a pharmaceutical composition, the container having a separable and removable adapter (100, 500) for filling and subsequently closing the container (300),

[0181] the adapter (100, 500) being defined as in any one of the preceding clauses, the container (300) further comprising:

[0182] a medicament bag (310), and

[0183] a port (330) configured for removably connecting to the adapter (100).

[0184] 36. The container (300) according to clause 35, wherein the medicament bag (310) is a flexible medicament bag, preferably a flat flexible bag.

[0185] 37. The container (300) according to clause 36, wherein the container (300) further comprises a container housing (320) for accommodating the medicament bag (310).

[0186] 38. The container (300) according to clause 37, wherein the port (330) is part of the medicament bag (310) or part of the container housing (320).

[0187] 39. The container (300) according to clause 37 or 38, wherein the container housing (320) includes one or more container connection elements (340) that cooperate with the adapter connection element (160).

[0188] 40. The container (300) according to clause 39, wherein each container connection element (340) includes a locking feature (341).

[0189] 41. The container (300) according to clause 40, wherein the locking feature (341) is a corresponding groove or flange.

[0190] 42. A container (300) for a flexible bag (310), the flexible bag having an internal space for containing a volume of liquid, the container (300) comprising:

[0191] An internal space for containing a volume of liquid, the container (300) comprising:

[0192] A container housing (320) for containing the flexible bag (310);

[0193] An outlet port (343) for communicating the internal space of the flexible bag (310) with the exterior of the container (300); and

[0194] One or more container connection elements (340) that cooperate with the connection element (160) of the flexible bag filling adapter (100).

[0195] 43. The container (300) according to clause 42, wherein each container connection element (340) includes a locking feature (341).

[0196] 44. The container (300) according to clause 42 or 43, wherein the container housing (300) has a container housing outer shell (322) and a container housing lid (321).

[0197] 45. The container (300) according to clause 44, wherein the one or more container locking

[0198] Features (341) include an outer shell locking feature (3411) and a lid locking feature (3412).

[0199] 46. The container (300) according to any one of clauses 42 to 45, wherein the container connection element (340) is formed as a recess in the circumferential walls (323, 324) of the container housing outer shell (322) and the container housing lid (321).

[0200] 47. The container (300) according to clause 46, wherein the locking feature (341) is formed as a ridge at the wall of the recess.

[0201] 48. The container (300) according to any one of clauses 42 to 47, the container further comprising an adapter (100, 500) for filling and subsequently closing the flexible bag (310) in the container (300).

[0202] 49. The container according to clause 48, wherein the adapter (100, 500) comprises:

[0203] A housing (110, 510) having a cavity (120, 520), the cavity having a cavity opening (121, 521) capable of being coupled to a port of the container (300);

[0204] A closing element (130, 530) arranged in the cavity (120,

[0205] 520);

[0206] A push rod (140, 540) at least partially arranged outside the cavity (120,

[0207] 520) and movable by a user;

[0208] The housing (110, 510) has an inlet port (150, 550), the inlet port having an inlet port opening (151, 551) in communication with the cavity (120, 520).

[0209] 50. A combination of an adapter (100, 500) and a container frame (322) for filling and subsequently closing a pharmaceutical composition container (300), the adapter (100,

[0210] 500) comprising:

[0211] A housing (110, 510) having a first axis (A), the housing (110,

[0212] 510) having a cavity (120, 520), the cavity having a cavity opening (121, 521);

[0213] A closing element (130, 530) arranged in the cavity (120,

[0214] 520) and movable from a first position to a second position in a direction along the first axis (A);

[0215] Position;

[0216] Pusher (140, 540), said pusher being at least partially arranged outside said chamber (120,

[0217] 520) and being movable by a user in a direction along said first axis (A)

[0218] to displace said closing element (130, 530);

[0219] Said housing (110, 510) has an inlet port (150, 550), said inlet port having an inlet port opening (151,

[0220] 551) that communicates with said chamber (120, 520), and when viewed along said first axis, at least a part of said inlet port opening (151,

[0221] 551) is axially located between said first position of said closing element (130, 530) and said chamber opening (121, 521);

[0222] wherein said adapter housing (110) has one or more connecting elements (160) for connecting said adapter housing (110) to said container frame (322).

[0223] 51. The adapter (100) according to clause 50, wherein said one or more connecting elements (160) provide a releasable connection between said adapter housing (110) and said container frame (322).

[0224] 52. The adapter (100) according to clause 51, wherein said releasable connection is a snap connection or a threaded connection.

[0225] ​

Claims

1. An adapter (100, 500) for filling and subsequently closing a container (300) of a pharmaceutical composition, the adapter (100, 500) comprising: A housing (110, 510) having a first axis (A), the housing (110, 510) having a cavity (120, 520) with a cavity opening (121, 521) capable of being coupled to a port of the container (300); A closure element (130, 530) disposed in the cavity (120, 520) and capable of being displaced from a first position to a second position in a direction along the first axis (A); A push rod (140, 540) at least partially disposed outside the cavity (120, 520) and capable of being moved by a user in a direction along the first axis (A) to displace the closure element (130, 530); The housing (110, 510) has an inlet port (150, 550) having an inlet port opening (151, 551) in communication with the cavity (120, 520), and at least a portion of the inlet port opening (151, 551) is axially located between the first position of the closure element (130, 530) and the cavity opening (121, 521) when viewed along the first axis (A).

2. The adapter (100, 500) according to claim 1, wherein the inlet port (150, 550) has an inlet port channel (152, 552), at least a part of the length of the inlet port channel being perpendicular to the first axis (A) or inclined with respect to the first axis (A).

3. The adapter (100, 500) according to claim 1 or 2, wherein the adapter (100, 500) has two opposite sides along the first axis (A), one side being the side where the adapter (100, 500) can be connected to the port (330) of the container (300), and the other side being a second side for being held and / or operated by a user.

4. The adapter (100, 500) according to any one of the preceding claims, wherein the closing element (130, 530) is adapted to seal the port (330) of the container (300).

5. The adapter (100, 500) according to any one of the preceding claims, wherein the closing element (130, 530) is adapted to connect to the port (330) of the container (300) and to be released from the adapter (100, 500) when the adapter (100, 500) is removed from the container (300).

6. The adapter (100, 500) according to any one of the preceding claims, wherein the closing element (130) is a plunger for discharging fluid from the cavity (120).

7. The adapter (500) according to any one of the preceding claims, wherein the adapter housing (510) has a protruding structure (560) for being grasped by a user during use.

8. The adapter (100) according to any one of claims 1 to 6, wherein the push rod (140) protrudes from the adapter housing (110) along the first axis (A) at the side for being held and / or operated by a user.

9. The adapter (100) according to claim 8, wherein the adapter housing (110) has one or more connecting elements (160) for connecting the adapter housing (110) to the container housing (320).

10. The adapter (100) according to any one of claims 13 to 20, wherein the push rod (140) is embedded in the adapter housing (110) such that the outermost end surface (141) is flush with the surface (111) of the adapter housing (110).

11. A container (300) for a pharmaceutical composition, the container having a separable and removable adapter (100, 500) for filling and subsequently closing the container (300), The adapter (100, 500) being defined as in any one of the foregoing claims, and the container (300) further comprising: A medicament bag (310), and A port (330) configured for removably connecting to the adapter (100).

12. A container (300) for a flexible bag (310), the flexible bag having an internal space for accommodating a volume of liquid, the container (300) comprising: A container housing (320) for accommodating the flexible bag (310); An outlet port (343) for communicating the interior space of the flexible bag (310) with the exterior of the container (300); and One or more container connection elements (340) that cooperate with the connection element (160) of the flexible bag filling adapter (100).

13. The container (300) according to claim 12, the container further comprising an adapter (100, 500) for filling and subsequently closing the flexible bag (310) in the container (300).

14. The container according to claim 13, wherein the adapter (100, 500) comprises: A housing (110, 510) having a cavity (120, 520) with a cavity opening (121, 521) capable of being coupled to a port of the container (300); A closure element (130, 530) disposed in the cavity (120, 520); A push rod (140, 540) at least partially disposed outside the cavity (120, 520) and capable of being moved by a user; The housing (110, 510) has an inlet port (150, 550) having an inlet port opening (151, 551) in communication with the cavity (120, 520).

15. A combination of an adapter (100, 500) and a container frame (322) for filling and subsequently closing a pharmaceutical composition container (300), the adapter (100, 500) comprising: A housing (110, 510) having a first axis (A), the housing (110, 510) having a cavity (120, 520) with a cavity opening (121, 521); A closure element (130, 530) disposed in the cavity (120, 520) and capable of being displaced from a first position to a second position in a direction along the first axis (A); Push rods (140, 540), said push rods being at least partially arranged outside said cavities (120, 520) and being movable by a user in a direction along said first axis (A) to displace said closing elements (130, 530); Said housings (110, 510) have inlet ports (150, 550), said inlet ports having inlet port openings (151, 551) that communicate with said cavities (120, 520), and at least a part of said inlet port openings (151, 551) is axially located between said first position of said closing elements (130, 530) and said cavity openings (121, 521) when viewed along said first axis; wherein said adapter housing (110) has one or more connecting elements (160) for connecting said adapter housing (110) to said container frame (322).

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