Transfer arrangement for the aseptic transfer of a pharmaceutical product, transfer system in question, use and procedure

Abstract

The invention relates to a transfer arrangement (2) for the aseptic transfer of a pharmaceutical agent from an isolator (4) into a container (6), comprising a coupling element (10) connectable to the container (6), a passage (12), and an actuable first closure means (14), which in an open position (O1) releases a passage (12) through the coupling element (10) and in a closed position (S1) blocks the passage (12) through the coupling element (10), and a funnel arrangement (16) with a connecting section (18) which is configured to be reversibly coupled to the coupling element (10), wherein the connecting section (18) has a second closure means (20) which in an open position (O2) releases a passage through the funnel arrangement (16) and in a closed position (S2) blocks a passage through the funnel arrangement (16). According to the invention, a compensator 8 that can be connected to the insulator 4 is proposed, wherein the funnel arrangement (16) can be inserted into the compensator (8) and, in the inserted state, is tightly, in particular hermetically, sealed with the compensator (8), in particular wherein the compensator (8) can be removed for sterilization.

Description

[0001] The invention relates to a transfer arrangement for the aseptic transfer of a pharmaceutical agent from an isolator into a container, comprising a coupling element connectable to the container, a passage, and an actuable first closure means which, in an open position, releases a passage through the coupling element and, in a closed position, blocks the passage through the coupling element, and a funnel arrangement with a connecting section which is configured to be reversibly coupled to the coupling element, wherein the connecting section has a second closure means which, in an open position, releases a passage through the funnel arrangement and, in a closed position, blocks a passage through the funnel arrangement.

[0002] Product-contacting means, within the meaning of the invention, contact of a means for transferring or storing a substance or a mixture of substances with a substance or mixture of substances that are to remain germ-free in the aseptic process.

[0003] The aseptic transfer of pharmaceutical products, for example between containers, is of paramount importance in the pharmaceutical industry, particularly in aseptic processes. A key objective is to ensure aseptic conditions before, during, and after the transfer process to prevent contamination. Boundary conditions governing the manufacture and processing of such products are defined in Good Manufacturing Practice (GMP) guidelines, such as those issued by the European Commission. In addition to ensuring aseptic conditions, protecting personnel from these substances is also a crucial consideration.

[0004] Product-contact parts must be sterilized during the manufacture of aseptic products. Decontamination with, for example, H₂O₂ is not a permitted method for sterilizing such product-contact parts according to current regulations. This necessitates an arrangement in which all product-contact parts must be interchangeable for sterilization, preferably in an autoclave.

[0005] Transfer devices of the type mentioned above are known from the prior art and are used to transfer substances, such as pharmaceuticals, between containers or the like. For this purpose, devices can be used in which both the coupling element and the connecting section of the funnel assembly have a closing mechanism. In a state where the coupling element and the connecting section of the funnel assembly are not coupled, the respective closing mechanisms can be moved into a closed position so that no material can escape from either the coupling element or the funnel assembly, nor is contamination a concern. After coupling the coupling element to the connecting section of the funnel assembly, the coupling elements can be opened, thus enabling material transfer through the transfer device. Sterile conditions are guaranteed at all times.

[0006] If pharmaceutical products are to be transferred from one container to another in accordance with GMP guidelines, it is standard practice to place the container from which the product is to be transferred into a cleanroom, also known as an isolator, and from there transfer it into a container that can be connected to the cleanroom.

[0007] Such isolators are usually stationary. Therefore, in systems known from the prior art, it is necessary to position a suitable container, into which the pharmaceutical agent is to be transferred from the isolator, precisely relative to the isolator in order to establish a corresponding coupling between a coupling element and, for example, a funnel arrangement connected to the isolator.

[0008] To achieve this, it is necessary to lift the container using a suitable lifting system. With container weights typically in the range of one ton or more, not only is precise handling of the lifting device required, but it has also occasionally been observed in practice that, due to positioning errors, the insulator is lifted in an undesirable manner, or the insulator and container are unintentionally decoupled.

[0009] In other systems known from the prior art, which have a compensator connected to the insulator, the coupling causes the compensator to stretch. In the event of material fatigue, this can lead to cracks forming in the stretched areas, potentially endangering operators or causing a reduction in the quality of the pharmaceutical product. Such a system is known, for example, from EP 3 524 365 B9. EP 3 971 095 A1 relates to a method and system for transferring materials using a transfer chamber. WO 2014 / 040 700 A1 discloses a valve device for the aseptic transport of materials.

[0010] Another challenge with such systems is that the compensator comes into contact with the pharmaceutical product and therefore requires complex sterilization while installed, which may be difficult or even impossible. Furthermore, with known systems, precise alignment of the container with the isolator is necessary to ensure a sealed connection.

[0011] Against this background, the invention was based on the objective of further developing a transfer arrangement of the type mentioned above in such a way as to eliminate the disadvantages found in the prior art as far as possible. In particular, a transfer arrangement was to be provided that is characterized by simplified operation and high integrity, and in addition, that at least the product-contacting parts can be sterilized in a simplified manner.

[0012] According to the invention, the problem is solved in a transfer arrangement of the type mentioned above by a compensator that can be connected to the insulator, wherein the funnel arrangement can be inserted into the compensator and, in the inserted state of the funnel arrangement, is tightly, in particular hermetically, sealed with the compensator, in particular wherein the compensator can be removed for sterilization.

[0013] The invention utilizes the fact that the compensator allows the funnel assembly connected to the container to be manually lowered, thereby coupling the connecting section of the funnel assembly to the coupling element attached to the container. This eliminates the need for a lifting system for the container and a corresponding control system with sensors. Simultaneously, the compensator compensates to a certain extent for alignment tolerances between the container and the insulator, particularly in a longitudinal direction.

[0014] According to one embodiment, the compensator is designed to compensate for alignment tolerances within a tolerance range in the direction of the compensator's longitudinal axis and in a direction orthogonal to it. This simplifies the positioning of the container under the insulator. Inaccuracies in the container's alignment can be compensated for by the arrangement according to the invention.

[0015] Furthermore, the transfer arrangement is designed in such a way that, during the coupling of the coupling element, which is connected to the container, and the funnel arrangement, the compensator is compressed, so that - compared to a stretching of the compensator - there is a lower risk of damage or cracking in the area of ​​the compensator, which has a positive effect on the overall integrity of the system.

[0016] Further advantages arise with regard to the sterilization of the transfer assembly components. The funnel assembly, together with the connecting section, can be removed from the isolator and sterilized in an autoclave. The coupling element, which connects to the container, is cleaned and sterilized inline along with the container. Sterilization while the coupling element and funnel assembly are connected is therefore unnecessary. Preferably, the compensator is connected to the isolator. The funnel assembly, which has been previously sterilized in an autoclave, can be appropriately packaged or sealed, inserted into the isolator, unpacked there, and then assembled in the compensator.

[0017] According to one embodiment, the coupling element has an actuating means which is coupled to the first locking means and is configured to move the first locking means into the open and / or closed position. In this way, the actuating means can move the first locking means of the coupling element into the respective open and closed positions.

[0018] According to one embodiment, the first closure means is designed as a first flap. According to another embodiment, the second closure means is designed as a second flap. Preferably, the flaps of the coupling element and the funnel assembly are arranged adjacent to each other in the coupled state and form a double flap. The coupled state is understood to be the state in which the coupling element and the connecting section of the funnel assembly are coupled to each other. In this coupled state, actuation of the actuating means causes the flaps to be moved together into the open position and / or the closed position. This means that by actuating the actuating means, both flaps, which form a double flap, are actuated together, i.e., moved together into the open position or the corresponding closed position.

[0019] According to one embodiment, the compensator has a section rigid along a longitudinal axis and a section compressible along the same longitudinal axis. This ensures that the compensator as a whole is compressible over a certain length, and the compressibility—as opposed to stretching—prevents the formation of cracks within the compressible section, thus avoiding any risk to the integrity of the transition assembly.

[0020] According to one embodiment, the compensator and / or the funnel arrangement have a sealing arrangement which hermetically seals the funnel arrangement against the compensator. This prevents a medium from penetrating into or escaping the insulator between the compensator and the funnel arrangement.

[0021] The invention has been described above with reference to a transfer arrangement. In a further aspect, the invention relates to a transfer system for the aseptic transfer of a pharmaceutical agent, comprising an isolator, a container, and a transfer arrangement for the aseptic transfer of a pharmaceutical agent from the isolator into the container. The invention solves the aforementioned problem with regard to the transfer system by designing the transfer arrangement according to one of the preceding embodiments.

[0022] The transfer system utilizes the same advantages and preferred embodiments as the transfer arrangement according to the invention, and vice versa. In this regard, reference is made to the above explanations, and their content is incorporated herein.

[0023] In a further aspect, the invention relates to the use of a transfer arrangement according to one of the preceding embodiments for the aseptic transfer of a pharmaceutical agent from an isolator into a container. This use also takes advantage of the same benefits and preferred embodiments as the transfer arrangement and transfer system according to the invention, and vice versa. In this regard, reference is made to the above statements, and their content is incorporated herein.

[0024] In a further aspect, the invention relates to a method for the aseptic transfer of a pharmaceutical agent from an isolator into a container by means of a transfer arrangement according to one of the preceding embodiments. The invention solves the problem described above with regard to the method by comprising the following steps: sterilizing the funnel arrangement, in particular in an autoclave; cleaning and / or sterilizing the container and the coupling element coupled thereto; introducing the funnel arrangement into an isolator and inserting the funnel arrangement into the compensator; lowering the funnel arrangement and coupling the connecting section of the funnel arrangement to the coupling element; moving the first and second closure means into their respective open positions; and transferring a pharmaceutical agent from the isolator into the container.The method also takes advantage of the same benefits and preferred embodiments as the transfer arrangement, transfer system and use according to the invention, and vice versa.

[0025] The method according to the invention is based on the finding that the funnel assembly can first be sterilized separately, and only the container and the coupled coupling element need to be cleaned and sterilized inline. Subsequently, the funnel assembly can be introduced into the isolator, any outer packaging can be removed, and the funnel assembly can then be inserted into the compensator, with the funnel assembly and compensator being hermetically sealed from each other.

[0026] The funnel assembly can now be lowered with the assistance of the compensator, which compresses the compensator. This allows height differences between the container and the isolator to be overcome within certain limits. After coupling the connecting section of the funnel assembly to the coupling element, the closure devices can be moved to their respective open positions, and a pharmaceutical product can be transferred from the isolator into the container. This eliminates the need to sterilize the funnel assembly and coupling element while coupled, as well as the time-consuming process of lifting the container for coupling.

[0027] The method is further developed by manually lowering the funnel assembly, whereby the first flap of the coupling element and the second flap of the connecting section of the funnel assembly are coupled by this lowering action. In other words, the flaps thus form a double flap. According to one embodiment, the compensator is compressed by lowering the funnel assembly.

[0028] The process is further enhanced by performing the cleaning and / or sterilization of the container and the coupled coupling element using an inline process, in particular Clean-In-Place (CIP) sterilization or Sterilization-In-Place (SIP). The aforementioned sterilization methods have proven particularly suitable for the corresponding inline sterilization.

[0029] According to one embodiment, the method is further developed by the following steps: transferring the first and second closure means into the closed position after transferring the pharmaceutical agent from the isolator into the container, decoupling the connecting section of the funnel arrangement from the coupling element.

[0030] After the pharmaceutical agent has been transferred, both the funnel assembly and the coupling element are sealed by their respective closure devices, so that after decoupling and separating the components, the pharmaceutical agent is prevented from escaping from either the funnel assembly or the coupling element.

[0031] The invention is described in more detail below with reference to a preferred embodiment and the accompanying figures.

[0032] This shows: Fig. 1: an embodiment of a transfer system according to the invention in a decoupled state; Fig. 2: the embodiment of the transfer system according to the invention Fig. 1 in a coupled state; Fig. 3a-3h: the embodiment of the transfer system according to the invention. Fig. 1 and Fig. 2 in different operational positions, and Fig. 4: An embodiment of the method according to the invention in a representation as a block diagram.

[0033] Fig. Figure 1 shows a transfer system 100 for the aseptic transfer of a pharmaceutical product from an isolator 4 into a container 6. The transfer system 100 comprises the isolator 4 and the container 6, as well as a transfer arrangement 2 for transferring a pharmaceutical product from the isolator 4 into the container 6. The transfer arrangement 2 includes a coupling element 10 connectable to the container 6, a funnel arrangement 16, and a compensator 8 connected to the isolator 4.

[0034] The coupling element 10 has a passage 12. The coupling element 10 also has an actuable first locking means 14, which is located in the Fig. Figure 3c-h shows this in more detail. The first locking device 14, in an open position O1, releases a passage 12 through the coupling element 10. In a closed position S1, the first locking device 14 blocks the passage 12 through the coupling element 10.

[0035] The funnel arrangement 16 has a connecting section 18. The connecting section 18 is designed to be reversibly coupled to the coupling element 10. In the Fig. In the state shown in Figure 1, the funnel arrangement 16 and the coupling element 10 are separated from each other, that is, not coupled. The connecting section 18 has a second closing means 20, which is also shown in the Fig. 3a-h is detailed. The second closing device 20, in an open position O2, allows passage through the funnel arrangement. The second closing device 20, in a closed position S2, blocks passage through the funnel arrangement 16. In the Fig. In the state shown in Figure 1, both the first locking means 14 and the second locking means 20 are in their respective closed positions S1 and S2.

[0036] The funnel assembly 16 is inserted into the compensator 8 and tightly, in particular hermetically, sealed with the funnel assembly 16. The coupling element 10 has an actuating means 36. The actuating means 36 is coupled to the first closing means 14 and is configured to move the first closing means 14 into the open position O1 and the closed position O2.

[0037] The compensator 8 has a section 30 that is rigid along a longitudinal axis 28 of the compensator 8 and a section 32 that is compressible along the longitudinal axis 28. Furthermore, the compensator 8 and the funnel arrangement 16 each have a sealing arrangement 34, 40. The sealing arrangements 34, 40 are designed to hermetically seal the funnel arrangement 16 against the compensator 8.

[0038] In the Fig. In the state shown in Figure 2, the compensator 8 is again connected to the insulator 4 and the coupling element 10 to the container 6. The funnel assembly 16, which is housed in the compensator 8, is coupled to the coupling element 10 via its connecting section 18. In this state, as shown in Figure 2, the compensator 8 is connected to the insulator 4 and the coupling element 10 is connected to the container 6. Fig. As detailed in Figures 3a-3h, a connection between isolator 4 and container 6 is established by opening the closure devices 14 and 20, allowing the pharmaceutical agent to be transferred from isolator 4 to container 6. For this purpose, the actuating device 36 was compared to the one described in the Fig. The state shown in 1 is pivoted about the longitudinal axis 28.

[0039] The Fig. Figures 3a-3h illustrate a typical procedure for the aseptic transfer of a pharmaceutical product from isolator 4 to container 6 using transfer arrangement 2. In the Fig. In the state shown in 3a, the compensator 8 is initially connected to the insulator 4. The compensator 8 is, as already shown in the Fig. 1 and Fig. 2 described, is designed to be compressible along its longitudinal axis 28. For this purpose, a compressible section 32 is provided, which is arranged adjacent to the rigid section 30. As with the upper area of ​​the Fig. As can be seen from Figure 3a, in this initial step the funnel assembly 16 has not yet been introduced into the isolator 4. As an example, the funnel assembly 16 is first sterilized externally using a sterilization device 38, for example, an autoclave. The funnel assembly 16 has a second closure 20 in the area of ​​the connecting section 18, which is designed as a second flap 24. For the purpose of sterilization, the second flap 24 is in the open position O2.

[0040] In the Fig. In the state shown in Figure 3b, the funnel assembly 16, including the connecting section 18, has now been inserted into the isolator 4. Optionally, the funnel assembly 16 can be packaged after sterilization, and the packaging removed after insertion into the isolator 4. The second flap 24 has now been moved to the closed position S2.

[0041] In the Fig. In the state shown in Figure 3c, the funnel assembly 16 was inserted into the compensator 8. The funnel assembly 16 is hermetically sealed with the compensator 8. The second sealing element 20, or the second flap 24, remains in the closed position S2. In the lower area of ​​the Fig. Figure 3c schematically indicates the container 6, which is connected to a coupling element 10. The coupling element 10 has the opening 12 and the closure means 14, which is designed as the first flap 22. In the Fig. In the state shown in 3c, coupling element 10 and funnel arrangement 16 are not coupled. Accordingly, the first flap 22 and the second flap 24 are also in their respective closed positions S1 and S2. The compensator 8, in particular the compressible section 32, is in a non-compressed or only slightly compressed state.

[0042] In the Fig. In the state shown in Figure 3d, the funnel assembly 16 was lowered towards the coupling element 10, and a coupling between the coupling element 10 and the funnel assembly 16 was established. This is accompanied by a compression of the compensator 8, which is evident from the corresponding compression of the compressible section 32. The flaps 22, 24 of the coupling element 10 and the funnel assembly 16 are arranged adjacent to each other in the coupled state and form a double flap 26. Actuation of the actuating means 36 in the state shown in Figure 3d Fig. The coupled state shown in 3d causes flaps 22 and 24 to be moved together into the open position O1, O2 and the closed position S1, S2. Fig. 3d the first flap 22 and the second flap 24 are unchanged in their respective closed positions S1, S2.

[0043] In the Fig. The state shown in 3e is the coupling element 10 as also in Fig. 3d is coupled with the funnel arrangement 16. However, by actuating the actuating means 36, the flaps 22, 24 were moved into the respective open positions O1, O2, so that a connection between isolator 4 and container 6 is established and a pharmaceutical agent can be transferred aseptically from the isolator 4 into the container 6.

[0044] After the pharmaceutical agent has been transferred, the double flap 26 can be closed by actuating the actuating device 36 and in the Fig. In the state shown in Figure 3g, the coupling element 10 is decoupled from the funnel assembly 16. This also separates the first flap 22 from the second flap 24, so that the first flap 22 now closes the coupling element 10 and the second flap 24 closes the connecting section 18 of the funnel assembly 16. The unwanted leakage of the pharmaceutical agent is thus prevented.

[0045] In the Fig. In the state shown in Figure 3h, the funnel arrangement 16 was removed from the compensator 8, can be ejected from the insulator 4 and, as shown in Fig. 3a shown above, must be sterilized.

[0046] Fig.Figure 4 shows an exemplary block diagram of a method 200 for the aseptic transfer of a pharmaceutical agent from the isolator 4 into the container 6 using the transfer arrangement 2.Method 200 comprises the following steps: sterilizing 202 the funnel assembly 16, in particular in an autoclave; cleaning and / or sterilizing 204 the container 6 and the coupling element 10 coupled to it; inserting 206 the funnel assembly 16 into an isolator 4 and placing the funnel assembly 16 into the compensator 8; lowering 208 the funnel assembly 16 and coupling 210 the connecting section 18 of the funnel assembly 16 with the coupling element 10; transferring 212 the first and second closure means 14, 20 into their respective open positions O1, O2; transferring 216 a pharmaceutical agent from the isolator 4 into the container 6; and transferring 216 the first and second closure means 14, 20 into the closed positions S1, S2 after transferring the pharmaceutical agent from the isolator 4 into the container 6, decoupling 218 of the connecting section 18 of the funnel arrangement 16 from the coupling element 10.

[0047] The lowering 208 of the funnel assembly 16 can be performed manually, whereby the first flap 22 of the coupling element 10 and the second flap 24 of the connecting section 18 of the funnel assembly 16 are coupled by lowering 208 and coupling the funnel assembly 16 with the coupling element 10. The compensator 8 is compressed by the lowering 208 of the funnel assembly 16. The cleaning and / or sterilization 204 of the container 6 and the coupling element 10 coupled to it can be carried out by means of an inline process, in particular by means of clean-in-place (CIP) sterilization or sterilization-in-place (SIP). Reference symbol list 2. Transfer order 4 Insulator 6 containers 8 compensator 10 coupling element 12. Passage of the coupling element 14 first sealing agent 16 Funnel arrangement 18 Connecting section of the funnel arrangement 20 second sealing agent 22 first flap 24 second flap 26 Double flap 28 Longitudinal axis of the compensator 30 rigid section 32 compressible section 34 Sealing arrangement of the compensator 36 Actuating means of the coupling element 38 Sterilization unit 40 Sealing arrangement of the funnel arrangement 100 transfer system 200 procedures 202 Sterilizing the funnel assembly 204 Cleaning and / or sterilizing the container and coupling element 206 Inserting the funnel assembly into an insulator 208 Lowering the funnel arrangement 210 Coupling the connecting section with the coupling element 212 Transferring the first and second sealing devices into the open position 214 Transferring a pharmaceutical product from an isolator into the container 216 Moving the first and second locking devices into the closed position 218 Decoupling the connecting section from the coupling element O1 Opening of the first sealing agent S1 Closing position of the first locking device O2 Opening of the first sealing agent S2 Closing position of the first locking device

Claims

[1] Transfer arrangement (2) for the aseptic transfer of a pharmaceutical product from an isolator (4) into a container (6), with - a coupling element (10) connectable to the container (6), with a passage (12) and an actuable first closing means (14), which in an open position (O1) releases a passage (12) through the coupling element (10) and in a closed position (S1) blocks the passage (12) through the coupling element (10), and - a funnel arrangement (16) with a connecting section (18) which is designed to be reversibly coupled to the coupling element (10), wherein the connecting section (18) has a second closing means (20) which in an open position (O2) releases a passage through the funnel arrangement (16) and in a closed position (S2) blocks a passage through the funnel arrangement (16), characterized bya compensator (8) that can be connected to the insulator (4), wherein the funnel arrangement (16) can be inserted into the compensator (8) and, in the inserted state, is tightly sealed with the compensator (8) by the funnel arrangement (16). [2] Transfer arrangement (2) according to claim 1, wherein the coupling element (10) has an actuating means (36) which is coupled to the first locking means (14) and is configured to transfer the first locking means (14) into the open position (O1) and / or the closed position (O2). [3] Transfer arrangement (2) according to claim 1 or 2, wherein the first closure means (14) is designed as the first flap (22) and the second closure means (20) is designed as the second flap (24). [4] Transfer arrangement (2) according to claim 3, wherein the flaps (22, 24) of the coupling element (10) and the funnel arrangement (16) are arranged adjacent to each other in the coupled state and form a double flap (26). [5] Transfer arrangement (2) according to claim 4, wherein actuation of the actuating means (36) in the coupled state causes the flaps (22, 24) to be transferred together into the open position (O1, O2) and / or the closed position (S1, S2). [6] Transfer arrangement (2) according to one of the preceding claims, wherein the compensator (8) has a section rigid along a longitudinal axis (28) of the compensator (8) and a section (32) compressible along the longitudinal axis (28). [7] Transfer arrangement (2) according to one of the preceding claims, wherein the compensator (8) and / or the funnel arrangement (16) has a sealing arrangement (34, 40) which hermetically seals the funnel arrangement (16) against the compensator (8). [8] Transfer arrangement (2) according to one of the preceding claims, wherein the compensator (8) is configured to compensate for alignment tolerances in a tolerance range in the direction of the longitudinal axis (28) of the compensator (8) and / or in a direction orthogonal thereto. [9] Transfer system (100) for the aseptic transfer of a pharmaceutical product, with - an insulator (4), - a container (6), and - a transfer arrangement (2) for the aseptic transfer of a pharmaceutical agent from the isolator (4) into the container (6), wherein the transfer arrangement (2) is configured according to one of the preceding claims. [10] Use of a transfer arrangement (2) according to one of the preceding claims for aseptically transferring a pharmaceutical agent from an isolator (4) into a container (6). [11] Method (200) for aseptically transferring a pharmaceutical agent from an isolator (4) into a container (6) using a transfer arrangement (2) according to one of the preceding claims, wherein the method (200) comprises the steps: - Sterilizing (202) the funnel assembly (16), - Cleaning and / or sterilizing (204) the container (6) and the coupling element (10) connected to it, - Insertion (206) of the funnel arrangement (16) into an insulator (4) and insertion of the funnel arrangement (16) into the compensator (8), - Lowering (208) the funnel assembly (16) and coupling (210) the connecting section (18) of the funnel assembly (16) with the coupling element (10), - Transferring (212) the first and second closure means (14, 20) into their respective opening positions (O1, O2) and transferring a pharmaceutical product from the isolator (4) into the container (6). [12] Method (200) according to claim 11, wherein the lowering (208) of the funnel arrangement (16) is carried out manually and wherein the first flap (22) of the coupling element (10) and the second flap (24) of the connecting section (18) of the funnel arrangement (16) are coupled by the lowering (208). [13] Method (200) according to claim 11 of 12, wherein the compensator (8) is compressed by lowering (208) the funnel arrangement (16). [14] Method (200) according to one of claims 11 to 13, wherein the cleaning and / or sterilization (204) of the container (6) and the coupling element (10) coupled thereto is carried out by means of an inline method. [15] Method (200) according to any one of claims 11 to 14, comprising the further steps: - Transferring (216) the first and second closure means (14, 20) into the closed position (S1, S2) after transferring the pharmaceutical product from the isolator (4) into the container (6), - Decoupling (218) of the connecting section (18) of the funnel arrangement (16) from the coupling element (10).

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