Devices for transporting containers, apparatus for manufacturing pharmaceutical or biotechnology-related products, and methods thereof.

Abstract

A device (1) for transferring a group of containers (A) for pharmaceutical or biotechnological applications between chambers (11, 12) with controlled atmospheres, comprising a support structure (7), a support (2) configured to receive the containers (A) with exposed portions (B), a guide (3) configured to guide the support (2) and rotatably coupled to the support structure (7), a first rotation means (4) for the guide (3) and a movement means (5) for the support along the guide (3). The guide (3) rotates to place the exposed portions (B) of the containers (A) in one of the chambers (11, 12). The movement means (5) vary the distance (D) between the supports (2), preferably by means of a body (51). The body (51) is rotatably coupled to the guide (3) and comprises an outer surface (52) on which tracks (53, 54, 55, 56, 57, 58, 59, 60) are formed. Also described are an apparatus (100) and a method for producing a pharmaceutical or biotechnology related product.

Description

Technical Field

[0001] The present invention relates to a manufacturing process that requires a plurality of chambers with a controlled atmosphere, for example in the pharmaceutical or biotechnology industries, and more particularly to the transfer of containers between chambers.

[0002] More particularly, the present invention relates to a device for transferring containers, an apparatus for manufacturing pharmaceutical or biotechnology-related products, and a method thereof.

Background Art

[0003] In manufacturing processes, there is a recognized need to ensure a clear separation between adjacent chambers with a controlled, and in some cases, sterile atmosphere. This need is particularly recognized in the manufacture of pharmaceutical or biotechnology-related products, especially in the processes of filling and sealing containers. Examples of these processes are described in Patent Document 1.

[0004] Typically, such manufacturing is carried out inside a cleanroom or clean area designed, maintained, and controlled to prevent particulate contamination of the articles. For example, the standard ISO14644-1 and the European Good Manufacturing Practice include a classification of cleanrooms. The transfer of containers is even more important between chambers with different pharmaceutical environmental classifications.

[0005] Currently, in cleanrooms, atmosphere control is achieved by injecting filtered air, for example using HEPA filters. In the general terms of the technical field of reference, in the present application, the term "air" is not limited to a specific mixture, and for example, the mixture can be equally identified as ambient atmosphere or nitrogen.

[0006] Failure to clearly define the boundaries between chambers can have serious consequences. For example, qualitative risks to articles due to cross-contamination can cause harm to the end user or lead to a situation where the entire manufacturing lot has to be recalled.

[0007] The movement of containers between chambers is one of the most critical operations, especially for primary containers of pharmaceutical or biotechnology-related products, as transfer devices traverse the boundaries between chambers with the containers. In fact, conventional transfer devices such as belts, transporters, conveyors, rotating platforms, and trays move from one chamber to another. In addition, robotic systems enter adjacent chambers, at least with end effectors. The use of similar devices becomes particularly important for highly toxic substances or in more compact manufacturing lines where the spacing between components is narrow.

[0008] Therefore, the tendency to restrict the dimensions of manufacturing lines for pharmaceutical or biotechnology-related products can conflict with the need for greater flexibility in handling containers that may differ in shape, dimensions, and the arrangement of internal trays, crates, and other receiving containers. In fact, pre-processing and / or resizing operations must be completed to set up the manufacturing line, and / or at the beginning and end of the manufacturing line, which increases the risk of cross-contamination and the need to ensure adequate workspace.

[0009] Flexibility, small size, and clear separation between chambers are key elements in small-batch production lines. These manufacturing processes are often carried out inside isolators arranged to form a production line. An example of an isolator for automated production of pharmaceutical or biotechnology-related products is described in Patent Document 2. [Prior art documents] [Patent Documents]

[0010] [Patent Document 1] European Patent No. 1447328 [Patent Document 2] U.S. Patent Application Publication No. 2019 / 315004 [Overview of the project] [Problems that the invention aims to solve]

[0011] The first object of the present invention is to provide an apparatus that enables the movement of container groups for pharmaceutical or biotechnology applications between different chambers, thereby reducing or eliminating the risk of cross-contamination.

[0012] A second objective is to provide devices and apparatus for manufacturing pharmaceutical or biotechnology-related products. Considering the results obtained therefrom, these devices and apparatus can be compact and operated by a group of containers having different shapes and dimensions and different arrangements of containers.

[0013] A further objective is to provide a method for manufacturing pharmaceutical or biotechnology-related products that reduces or eliminates the risk of cross-contamination. [Means for solving the problem]

[0014] These and other objectives are achieved by a device for moving a group of containers for pharmaceutical or biotechnology applications as described in the claims, an apparatus for automated production of pharmaceutical or biotechnology-related products, and a method for manufacturing pharmaceutical or biotechnology-related products, as will become apparent to those skilled in the art through the following description.

[0015] According to the disclosure herein, the device comprises a support structure, a support, a guide, a first rotating means for the guide, and a moving means. The support comprises a support portion configured to accommodate a container having an exposed portion to be acquired by a container transport means. The guide is configured to guide the support and is rotatably coupled to the support structure to rotate between a first position and a second position. Furthermore, the guide positions the exposed portion of each container at least partially into one of two chambers having a controlled atmosphere, by receiving the support portion facing toward a first zone at the first position and a second zone at the second position. The moving means is advantageously configured to move the support along the guide such that the distance between the supports is varied according to the direction of the axis of rotation.

[0016] This apparatus is advantageously applicable to an apparatus having a first chamber having a first controlled atmosphere and a second chamber having a second controlled atmosphere. The technology of this disclosure also relates to a method for manufacturing pharmaceutical or biotechnology-related products, which includes a step of moving a container between chambers by the apparatus. [Brief explanation of the drawing]

[0017] Specific embodiments of the present invention will be revealed by the following description in accordance with the claims and with reference to the accompanying drawings. The accompanying drawings are as follows. [Figure 1] Figure 1 is a perspective view showing an observable end effector of a robotic system, illustrating an embodiment of a device for moving a group of containers for pharmaceutical or biotechnology applications according to the present invention. [Figure 2] Figure 2 is a perspective view of the embodiment shown in Figure 1, and is adaptable to different containers, not including some of the elements. [Figure 3] Figure 3 is a cross-sectional view of the embodiment shown in Figure 1, with respect to a plane passing through the axis of rotation. [Figure 4] Figure 4 is a side view of the continuous operating moments of the embodiment shown in Figure 1, and does not include some of the elements. [Figure 5] Figure 5 is a side view of the continuous operating moments of the embodiment shown in Figure 1 and does not include some of the elements. [Figure 6] Figure 6 is a side view of the continuous operating moments of the embodiment shown in Figure 1 and does not include some of the elements. [Figure 7] Figure 7 shows the operation sequence of the embodiment of Figure 1 from various viewpoints and, in some cases, does not include some of the elements. [Figure 8] Figure 8 shows the operation sequence of the embodiment of Figure 1 from various viewpoints and, in some cases, does not include some of the elements. [Figure 9] Figure 9 shows the operation sequence of the embodiment of Figure 1 from various viewpoints and, in some cases, does not include some of the elements. [Figure 10] Figure 10 shows the operation sequence of the embodiment of Figure 1 from various viewpoints and, in some cases, does not include some of the elements. [Figure 11] Figure 11 shows the operation sequence of the embodiment of Figure 1 from various viewpoints and, in some cases, does not include some of the elements. [Figure 12] Figure 12 shows the operation sequence of the embodiment of Figure 1 from various viewpoints and, in some cases, does not include some of the elements. [Figure 13] Figure 13 is a perspective view showing a further embodiment of the device according to the present invention. [Figure 14] Figure 14 is a perspective view showing an embodiment of the device according to the present invention. [Figure 15] Figure 15 is a cross-section showing the device of Figure 14 with respect to a plane passing through the threshold of the chamber. [Figure 16] Figure 16 is a perspective view showing a further embodiment of the device according to the present invention. [Figure 17] Figure 17 shows a further embodiment of the device according to the present invention in two consecutive operating moments, revealed from the end effector of each robotic system. [Figure 18]Figure 18 shows a further embodiment of the apparatus according to the present invention in two consecutive motion moments revealed from the end effector of each robot system. [Figure 19] Figure 19 shows a cross-sectional view of the device of Figure 17 with respect to a plane passing through the opening of the chamber, excluding some of the elements. [Figure 20] Figure 20 shows a cross-sectional view of the device in Figure 17, along with the acquisition position in Figure 20, which is different from the position in Figure 18, with respect to the plane passing through the opening of the chamber. [Figure 21] Figure 21 is a top-down cross-sectional view of the embodiment shown in Figure 1, and shows the end effector of the robot system observably, omitting some of its elements. [Figure 22] Figure 22 is a top-down cross-sectional view of the embodiment shown in Figure 1, and shows the end effector of the robot system observably, without including some of the elements. [Modes for carrying out the invention]

[0018] Referring to the attached drawings, reference numeral (1) indicates a device. The device moves a group of containers (A) for pharmaceutical or biotechnology applications between a first chamber (11) having a first controlled atmosphere and a second chamber (12) having a second controlled atmosphere, and a container (A) transport means (13, 14) operates in at least one of the first chamber (11) and the second chamber (12). Generally, the containers (A) are primary containers and are typically devices (1) of an apparatus (100) for the automated manufacturing of pharmaceutical or biotechnology-related products, with the first chamber (11) and the second chamber (12) connected by an opening (10), the size of which may be limited.

[0019] For example, container (A) may be a vial, bottle, syringe, or cartridge, or rarely, a combination thereof.

[0020] A controlled atmosphere chamber refers to a chamber that is controlled at least in terms of particles, as shown in, for example, ISO standard 14644-1. Generally, the first chamber (11) and the second chamber (12) are chambers having different air cleanliness properties.

[0021] One embodiment of this device (1) comprises a support structure (7), a support (2), a guide (3), a first rotating means (4), and a moving means (5).

[0022] Each support (2) comprises a support portion (21) configured to accommodate a container (A), the support portion (21) being configured to accommodate a container (A) having an exposed portion (B) exposed to the surrounding environment so as to be acquired by a means of transporting the container (A) (13, 14).

[0023] Guide (3) is configured to guide support (2), is rotatably coupled to support structure (7), and rotates between a first position and a second position with respect to a rotation axis (X). A first rotating means (4) is configured to rotate guide (3) between the first position and the second position with respect to the rotation axis (X). Generally, the first rotating means (4) allows for the full rotation of guide (3) and enables the determination of the first and second positions based on the geometric characteristics of the equipment and the specific needs of the production line. This is evident, for example, from the comparison of the acquired positions in Figure 18 and Figure 20.

[0024] The guide (3) accommodates the support (2) so that the support portion (21) is directed toward the first zone of the first position and the second zone of the second position, and positions at least partially the exposed portion (B) of each container in the first chamber (11) and the second chamber (12).

[0025] The moving means (5) is advantageously configured to move the support (2) along the guide (3) such that the distance (D) between the support bodies changes according to the direction of the axis of rotation (X).

[0026] The device (1) of the present invention makes it possible to reduce or eliminate the risk of cross-contamination during the passage of a container (A) between a first chamber (11) and a second chamber (12), and allows the transport means (13, 14) of the container (A) to take in or receive at least a portion of the exposed portion (B) of each container (A) into the chambers (11, 12) without interfering with the other chambers (12, 11).

[0027] Furthermore, the device (1) allows for variations in the distance (D) between containers (A) during transit between the first chamber (11) and the second chamber (12), providing high flexibility in situations where the risk of cross-contamination is reduced, and does not substantially affect the size of the production line or the machine in which the device (1) is installed. Thus, the production line or machine can process groups of containers (A) having distances (D) between them within a range of values. For example, as will be described in more detail below, with device (1), the production line can start and operate from nests with different pitches without changing the size of any of the chambers, simply by providing appropriate transport means (13) within the first chamber.

[0028] Figure 1 shows a preferred embodiment in which the guide (3) is linear, the guide direction is aligned with the direction of the axis of rotation (X), and the support (2) is maintained perpendicular to the guide (3). This configuration reflects a typical configuration of the container (A) in the gripping function of the transport means (13,14) and simplifies the interaction between the support (2) and the transport means (5).

[0029] The support portion (21) preferably includes a bowl or beaker-shaped component that supports and holds the container (A) while the guide (3) rotates. In the embodiment shown in the attached drawings, the beaker has dimensions suitable for the container (A) and is particularly interchangeable, as shown in Figures 1 to 3. In particular, the illustrated beaker has an inner diameter close to the outer diameter of the container (A) and is at a height that allows it to hold the exposed portion (B) of the container (A) in an exposed state.

[0030] In the figure, in the embodiment that includes an axisymmetric beaker with respect to the axis of symmetry and a linear guide (3), it can be seen that the support (2) has inlet openings all facing the same direction toward the bowl-shaped portion.

[0031] While the guide (3) can be adapted in various ways, considering the orientation and displacement requirements of the container (A), the guide (3) is preferably a linear guide, and more preferably configured to guide the support (2) according to the direction of the rotation axis (X). As a result, the container (A) can be easily removed from and grouped with respect to the support (2) arranged in this manner.

[0032] In the illustrated embodiment, the axis of rotation (X) is horizontal, but this is not strictly a necessary condition, as it can also be achieved, for example, by rotating the device (1) by 90 degrees, i.e., by making the axis of rotation (X) vertical.

[0033] The guide (3) is preferably rotated as much as possible to allow the placement or retrieval of containers (A) with different orientations. For example, in the operation sequences shown in Figures 4 to 6, the guide (3) is preferably able to position containers (A) at any angle to approximately 180 sexagesimal degrees available in each chamber (11, 12).

[0034] Figures 1, 21, and 22 show the calculation of the distance (D) between the axes of container (A). In the reference field, these distances (D) are generally identical and are indicated using the term "pitch." However, the distance (D) may be evaluated by referring to the outer surface of container (A) or based on other references.

[0035] The moving means (5) is preferably activated independently of the first rotating means (4) and is more preferably configured to move the support (2) to any position on the guide (3) which consists of a first position including an end position and a second position. In other words, it is more preferable that the moving means (5) is activated when the guide (3) has rotated to any position.

[0036] A similar device (1) offers high operational flexibility because it can move the containers (A) to positions or angles of different distances (D) in a variable sequence without mutual influence. In other words, for example, it is possible to change the pitch between the containers (A) and then rotate them, or vice versa, or to perform a pitch change between two rotations. The first and second positions may also be arbitrary. For example, referring to the description of the elements described below, the device (1) in Figure 1 may be able to change the distance (D) without a second rotating means (61) and by appropriately oriented the body (51). However, the change in distance is always the same between the first and second positions. Therefore, with respect to the variation in distance (D), it may be necessary to change the body (51) to obtain different changes in distance (D) or different first and second positions.

[0037] The moving means (5) is generally configured to move the supports (2) in such a way that the distance (D) between the supports (2) changes, taking into account the eventual presence of further supports (20) as described below.

[0038] Various embodiments of the moving means (5) are possible, for example, they may be equipped with grab screws having double threads and appropriately coupled to each of the supports (2). The embodiments described below, in particular, ensure the exposure of surfaces that could cause cross-contamination and facilitate the positioning of seals that protect unexposed portions.

[0039] The guide (3) preferably has at least a through opening (31) for receiving the support (2), and each of the support (2) further has a guide portion (22) at the end opposite to the support portion (21). The guide portion (22) protrudes from at least the through opening (31) on the opposite side from which the support portion (21) is facing. For example, Figure 3 shows how the support portion (21) and the guide portion (22) face the opposite half-space with respect to a horizontal plane through which the guide (3) passes.

[0040] The moving means (5) comprises a body (51) positioned at least to the side of the through-opening (31) from which the guide portion (22) protrudes, and having an outer surface (52) formed thereon on which the tracks (53, 54, 55, 56, 57, 58, 59, 60) guide the guide portion (22). The guide portion (22) needs to protrude to engage with the tracks (53, 54, 55, 56, 57, 58, 59, 60). The support portion (21) may remain at least inside the through-opening (31), but in that case, the risk of cross-contamination generally increases.

[0041] The main body (51) is rotatably coupled to the guide (3) according to its respective axis of rotation (Y).

[0042] Each guide section (22) engages with its respective track (53, 54, 55, 56, 58, 59, 60), and at least some of the tracks (53, 54, 55, 56, 57, 58, 59, 60) are adapted to change the position of the guide section (22) along the direction of the rotation axis (Y) of the body (51) as the body (51) rotates relative to the guide (3).

[0043] In compact devices having surfaces exposed to fluids and, if possible, sterilization methods commonly used in pharmaceutical or biotechnology manufacturing lines, the distance (D) can be advantageously varied, achieving high operational flexibility.

[0044] Figures 9, 10, and 11 show the stereochemical configuration of the tracks (53, 54, 55, 56, 57, 58, 59, 60) in the illustrated embodiment. In particular, Figure 11 shows that the supports (2) are close to each other due to the positions of the guide portions (22) within the tracks (53, 54, 55, 56, 57, 58, 59, 60) that are close to each other toward these positions. More preferably, the tracks (53, 54, 55, 56, 57, 58, 59, 60) are formed as reliefs or grooves so as not to create areas that may hold contaminants. For example, Figure 3 shows a U-shaped groove.

[0045] The tracks (53, 54, 55, 56, 57, 58, 59, 60) can be adapted based on specific requirements. Generally, especially in the case of containers (2) arranged at a predetermined pitch, one of the tracks (53, 54, 55, 56, 57, 58, 59, 60) does not need to change the position of the guide portion (22) along the direction of the rotation axis (Y) of the main body (51), that is, it may have the same cross-section in each of the planes involved in the series of planes of the rotation axis (Y). For example, in the embodiment of Figure 1, the additional support (20) is housed in a seat (32) that only rotates and in which each track (57) does not change its position, and can actually be removed by appropriately adjusting the additional support (20).

[0046] The moving means (5) preferably further comprises a second rotating means (61) for rotating the main body (51) in order to independently achieve the rotation of the container (A) and the different distances (D) between the containers (A).

[0047] As already described in general, it is preferable that at least the through-opening (31) extends in accordance with the direction of the axis of rotation (X) so as to guide the support (2) along the same direction.

[0048] The rotation axis (Y) of the main body (51) preferably coincides with the rotation axis (X) of the guide (3), the first rotating means (4) includes a first axis (41), and the second rotating means (61) includes a second axis (62), more preferably the second axis (62) is partly located inside the first axis (41). Thus, the risk of cross-contamination is minimized, and simple control is made easier and the number of exposed elements is reduced. Figure 3 clearly illustrates the use of common seals to protect areas of the first axis (41) and second axis (62) that cannot be exposed and run, with the respective motors (43, 64), generally gear motors, and transmissions (42, 63).

[0049] The support (2) more preferably further comprises a connecting portion (23) between the support portion (21) and the guide portion (22), which is axially symmetric and configured to engage with at least the through-opening (31) in a manner that is movable, i.e., rotatable, with respect to its axis of symmetry. This rotation allows the connecting portion (23) to be reoriented at least within the through-opening (31), thereby facilitating exposure and, in some cases, sterilization of the connecting portion (23).

[0050] Generally, one or more containers (A) may not move along the guide (3). This may preferably occur with the central container (A), or, in the case of spaced containers, with respect to one of the two central containers.

[0051] Device (1) may comprise a further support (20) including each support portion (210) configured to accommodate a container (A) having an exposed portion (B), and as a result, the container (A) can be acquired by a transport means (13, 14). Guide (3) may comprise a seat (32) for receiving the further support (210). Various embodiments of support (2) may also be applied to the further support (20) so as not to require special pieces in other components. Thus, the further support (20) may comprise each guide portion (220) and each coupling portion (230).

[0052] More preferably, at least the through-opening (31) includes a first through-opening (311) and a second through-opening (312), each receiving at least a support (2), with a support seat (32) positioned between them. Thus, regardless of the distance (D) between the containers, the container (A) can be kept substantially centered relative to the guide (3).

[0053] The support members (2) and, optionally, additional support members (20) are preferably configured to be connected to one another and include connecting arms (241) that connect to each other to form part of an expandable pantograph. As shown in Figures 9 and 22, the continuous connecting arms (241) are rotatably connected to each other at their respective ends, and each support member (2) or additional support member (20) has only one connecting arm (241) if at an end, and two connecting arms otherwise. The connecting arms (241) advantageously rotate the support members (2) and additional support members (20) with displacement along the guide (3), thereby facilitating the exposure of all surfaces. Furthermore, the function of supporting or maintaining the position of the support member (2) is realized.

[0054] The support (2) preferably comprises a central portion (24). The central portion (24) is integrally formed with the connecting arm (241), coupled to the support portion (21) at a first end and to the guide portion (22) at the end opposite to the first end. Similarly, further support (20) may each comprise a central portion (240).

[0055] In a preferred modification, there is also an advantage in terms of mounting, where the guide portion (22) is a special screw that blocks the connecting portion (23) when engaging with the central portion (24). Referring to Figure 3 as an example, the connecting portion (23) is a two-part bush interposed between the central portion (24) and at least the through-opening (31). Referring again to Figure 3, the above device (1) uses a seal common in the art, thus allowing air to pass through and, in some cases, allowing sterilization of all areas that could cause cross-contamination, as these areas are within view and easily accessible.

[0056] Figures 7 to 12 specifically illustrate the operation sequence. -Preparation of container (A) Figure 7 - Arrangement of container (A) Figures 8 and 9 - First part of the rotation of the guide (3) and the main body (51) Figure 10 - End of rotation of guide (3) and main body (51) Figures 11 and 12

[0057] The device (1) may preferably be configured to perform different sequences. For example, in Figure 10, the main body (51) may not yet be rotating, or the container (A) may be prepared together with the support (2) arranged as in Figure 10.

[0058] The device (1) is preferably applicable inside a production line or machine for the automated production of pharmaceutical or biotechnology-related products. For this purpose, the support structure (7) includes a connecting portion (71) configured to be fixed to either the first chamber (11) or the second chamber (12), between them, or both. More preferably, the device (1) is installed at an existing threshold between the first chamber (11) and the second chamber (12). For this purpose, the device (1) may include a frame (72) and / or a separation wall (73), either alone or together, that defines an opening (10) for the passage of a container (A). Generally, it is preferable that the device (1) includes a frame (72) so that the seal is not compromised by the installation. Figures 19 and 20 show a separation wall (73) that defines an opening (10) and confines the device (1) inside the chambers (11,12). The same separation wall (73) is also shown in Figures 17 and 18, illustrating an example of a sequence that passes the gripping function of different robot systems, i.e., an example of placing device (1) inside a manufacturing line or machine.

[0059] Embodiments of an apparatus (100) for the automated manufacturing of pharmaceutical or biotechnology-related products according to the present invention include a first chamber (11) having a first controlled atmosphere, a second chamber (12) having a second controlled atmosphere, an opening (10) for passing a container (A) between the first chamber (11) and the second chamber (12), the aforementioned device (1), and a first transport means (13) and / or a second transport means (14).

[0060] Typically, the first chamber (11) and the second chamber (12) are provided as cleanrooms, for example, in accordance with ISO standard 14644-1, and more preferably, they have different pharmaceutical or biotechnological environmental classifications. For example, referring to the above standard, the first chamber (11) may be Class 3 and the second chamber (12) may be Class 2.

[0061] A first transport means (13) is located inside the first chamber (11) and is configured to transport container (A) so as to place or retrieve container (A) onto the support (2) of device (1). Similarly, a second transport means (14) is located inside the second chamber (12) and is configured to transport container (A) so as to place or retrieve container (A) onto the support (2) of device (1). An advantage of the present invention is found in that, for example, since container (A) is not retrieved in the second chamber (12), the transport means (13,14) are located on only one side.

[0062] The support structure (7) of the device (1) is advantageous in that the rotation axis (X) of the guide (3) is positioned at or near the opening (10), so that the rotation of the first rotating means (4) moves the support (2) from a first position facing the first chamber (11) to a second position facing the second chamber (12). This positions at least a portion of the exposed portion (B) of each container (A) in the first chamber (11) and the second chamber (12), respectively.

[0063] The above advantages are obtained as follows: It is preferable that the first transport means (13) and the second transport means (14) are configured so as not to enter the second chamber (12) and the first chamber (11), respectively, when placing or acquiring the container (A) on the support (2) of the device (1).

[0064] Generally, the transport means (13,14) include a robotic system not shown in Figures 14 to 16. The end effector of the robotic system is shown in other figures. An example of a robotic system is described in Patent Document 2.

[0065] The first transport means (13) of container (A) preferably comprises a first robot system located inside a first chamber (11), and the second transport means (14) of container (A) comprises a second robot system located inside a second chamber (12).

[0066] As illustrated above, preferably, the axis of rotation (X) is located on a threshold between the first chamber (11) and the second chamber (12), for example, on a vertical plane that divides the threshold in half, although this is not necessarily the case.

[0067] The apparatus (100) preferably comprises a first ventilation and cleaning means, a second ventilation and cleaning means, and more preferably a deflection means.

[0068] The first ventilation and purification means is configured to purify the air and generate a first laminar flow (151) of air in the first chamber (11) toward at least the first outlet (152).

[0069] The second ventilation and purification means is configured to purify the air and generate a second laminar flow (161) of air in the second chamber (12) toward at least the second outlet (162).

[0070] In Figure 16, the arrows indicate the directions of the first laminar flow (151) and the second laminar flow (161). In a typical implementation, the first and second ventilation and cleaning means include a filter and, respectively, a first ventilation device (150) and a second ventilation device (160), the latter of which are shown in Figures 14 to 16.

[0071] The deflection means is configured to deflect a portion of the first laminar flow (151) from the second chamber (12) toward at least the second outlet (162).

[0072] The device (1) is positioned favorably with respect to the deflection means such that a portion exposed to the first laminar flow (151) is exposed to at least a portion of the first laminar flow (151) deflected toward the second outlet (162). The technology of the present disclosure can be applied to either of the isolator chambers (11,12) shown in Figure 16, where a pressure difference is generally generated that diverts a small portion of the laminar flow toward the other chamber (11,12).

[0073] The second chamber (12) is preferably positioned under reduced pressure relative to the first chamber (11), i.e., the first chamber (11) is in a positive pressure state. Specifically, according to common practice, the pressure difference is between 10 and 20 Pascals. Alternatively or in combination, the deflection means includes a separation wall (73), more preferably a separation wall (73) that also defines the opening (10). As shown in Figures 17 to 20, the separation wall (73) is positioned in the first chamber (11).

[0074] The apparatus (100) preferably comprises one or more isolators.

[0075] The present invention also relates to a method for producing pharmaceutical or biotechnology-related products, the method comprising, in one embodiment, the following steps: - A step of preparing an apparatus (100) comprising: a first chamber (11) having a first control atmosphere; a second chamber (12) having a second control atmosphere; an opening (10) between the first chamber (11) and the second chamber (12) through which a container (A) passes; a first transport means (13) for the container (A) equipped with a first robot system located inside the first chamber (11); a second transport means (14) for the container (A) equipped with a second robot system located inside the second chamber (12); and a support (2) equipped with a support portion (21). - A step of introducing container (A), preferably a primary container, into the first chamber (11). - A step of positioning the group of containers (A) introduced onto the support (2) by the first robotic system so as not to interfere with the second chamber (12). - A step of rotating the support (2) toward the second chamber (12) so that the exposed portion (B) of each container (A) can be acquired by the second robot system without interfering with the first chamber (11). - A step of acquiring a group of containers (A) from the support (2) by a second robotic system so as not to interfere with the first chamber (11). - A step of filling containers (A) with pharmaceutical or biotechnology-related materials. Here, each support (2) is configured to accommodate a container (A) having an exposed portion (B) such that the container (A) can be acquired by a transport means (13, 14) for the container (A), and can rotate relative to the opening (10) along a rotation axis (X), thereby allowing the support (2) to rotate between a first position facing the first chamber (11) and a second position facing the second chamber (12), and further positioning, at least partially, each exposed portion (B) of the container (A) in the first chamber (11) and the second chamber (12), respectively.

[0076] Generally, the robotic system of the device (100) is an anthropomorphic robot that includes a gripping function, such as pliers, configured for the container (A) in use.

[0077] Preferably, this method is applied using the apparatus (100) described above. In this case, the step of preparing the apparatus (100) according to the present invention is carried out, and the method includes the following steps. - A step of introducing container (A) into the first chamber (11). - The step of arranging the group of containers (A) introduced onto the support (2) by the first transport means (13) so as not to interfere with the second chamber (12). - A step of rotating the support (2) toward the second chamber (12) so that the exposed portion (B) of each container (A) can be acquired by the second transport means (14) without interfering with the first chamber (11). - A step of acquiring a group of containers (A) from the support (2) by a second transport means (14) so ​​as not to interfere with the first chamber (11). - A step of filling containers (A) with pharmaceutical or biotechnology-related materials.

[0078] Furthermore, in the process of rotating the support (2), it is also preferable to change the distance (D) between the containers (A) by moving the support parts (21) closer together or further apart from each other.

[0079] The containers (A) are typically arranged in multiple rows with the same pitch in each row, and more preferably, the distance (D) changes equally.

[0080] Generally, containers (A) are placed in a properly positioned manner within secondary containers such as drawers or trays. These secondary containers have appropriate storage compartments and serve to hold containers (A) in an aligned state. Syringes and bottles are usually supported by elements called "nests" and placed inside another element called a "tab." However, the dimensions and distances (D) of containers (A) frequently vary, often differing from batch to batch.

[0081] This method is particularly flexible, allowing for the management of containers (A) with different characteristics by replacing the support (21) to match the dimensions as needed and modifying the robotic system's end effector to match the dimensions and distance (D) of the container (A). Figures 1 and 2, and 21 and 22, show different end effectors for acquiring and positioning containers (A) of different dimensions. For similar reasons, the illustrated support (21) has different diameters.

[0082] For these reasons, in a preferred embodiment of this method, in the step of supplying containers (A), primary containers having predetermined dimensions are arranged in multiple rows of containers (A) in each row that are at the same distance (D) or at predetermined intervals. When supplying, this method further includes the following steps. - A step of preparing a first transport means (13), which is a collection unit, configured to collect a group of containers (A) having predetermined dimensions, and arranged in rows at predetermined intervals. - A step of preparing a support (2) for a support part (21) configured to accommodate a container (A) having predetermined dimensions. - A step of supplying a linear type guide (3) for guiding a support (2), and a moving means (5) for moving the support (2) along the guide (3) so as to change the distance (D) between the support bodies according to the direction of the axis of rotation (X).

[0083] In the process of arranging the container (A) group, containers (A) in the same row are advantageously arranged. In the process of rotating the support (2), the distance (D) between containers (A) changes equally by moving the support parts (21) closer to or further away from each other.

[0084] In the process of supplying containers (A), vials, bottles, syringes, or cartridges are preferably supplied, and each container (A) is provided with an inlet for introducing pharmaceutical or biotechnology-related materials. In the process of rotating the support (2), the containers are maintained with their inlets facing upwards in order to simplify the manufacturing process.

[0085] More preferably, in the step of rotating the support (2), the support (2) is rotated such that it forms an angle of equal magnitude with respect to the horizontal plane at the initial position and the final position, as shown in Figures 4 and 6.

[0086] This method, like apparatus (100), preferably includes a filling step or means for filling container (A) and / or a sealing step or means for sealing or capping. Other typical operations include washing, sterilization, and inspection.

[0087] The above is described as a non-limiting example, and any structural modification shall be deemed to fall within the scope of protection of the technical solution as described in the following claims.

Claims

1. An apparatus (100) for the automated production of pharmaceutical or biotechnology-related products, A first chamber (11) having a first control atmosphere, A second chamber (12) having a second control atmosphere, An opening (10) for passing a container (A) between the first chamber (11) and the second chamber (12), A device (1) for moving a group of containers (A) for pharmaceutical or biotechnology applications between the first chamber (11) and the second chamber (12), Equipped with, The aforementioned device (1) is Support structure (7), A support (2) is provided with support parts (21) configured to accommodate a container (A) having an exposed portion (B) so as to be acquired by the transport means (13, 14) of the container (A), A guide (3) configured to guide the support (2), which is rotatably coupled to the support structure (7) with respect to a rotation axis (X) so as to rotate between a first position and a second position, and which receives the support (2) such that the support portion (21) faces the first zone of the first position and the second zone of the second position, thereby at least partially positioned on the exposed portion (B) of each container (A) in the first chamber (11) and the second chamber (12), A first rotating means (4) is configured to rotate the guide (3) with respect to the rotation axis (X), A moving means (5) is configured to move the support (2) along the guide (3) so as to change the distance (D) between the support in the direction of the rotation axis (X), A first transport means (13) is disposed inside the first chamber (11) and configured to transport the container (A) so that it can be loaded onto and retrieved from the support (2) of the device (1), and / or a second transport means (14) is disposed inside the second chamber (12) and configured to transport the container (A) so that it can be loaded onto and retrieved from the support (2) of the device (1), Equipped with, The apparatus (100) is characterized in that the support structure (7) positions the rotation axis (X) of the guide (3) in or near the opening (10), so that when the first rotating means (4) rotates, the support (2) can be moved from a first position facing the first chamber (11) to a second position facing the second chamber (12), thereby positioning at least partially the exposed portion (B) of the container (A) in the first chamber (11) and the second chamber (12), respectively.

2. The moving means (5) is activated independently of the first rotating means (4) and is configured to move the support (2) to any position on the guide (3) between the first position and the second position, which includes the end position. The apparatus (100) according to claim 1, characterized in that...

3. The guide (3) is provided with at least one through-opening (31) for receiving the support (2), Each of the support members (2) further comprises a guide portion (22) at the end opposite to the support portion (21), the guide portion (22) protruding from the at least one through opening (31) on the opposite side of the support portion (21), The moving means (5) comprises a main body (51) rotatably coupled to the guide (3) according to each of the rotation axes (Y), and a second rotating means (61) configured to rotate the main body (51), The main body (51) is positioned on the side with the at least one through-opening (31) from which the guide portion (22) protrudes, and has an outer surface (52) formed so that the tracks (53, 54, 55, 56, 57, 58, 59, 60) guide the guide portion (22), Each of the guide portions (22) engages with the tracks (53, 54, 55, 56, 58, 59, 60), At least a portion of the aforementioned tracks (53, 54, 55, 56, 57, 58, 59, 60) are configured to change the position of the guide portion (22) along the direction of the rotation axis (Y) of the main body (51) when the main body (51) rotates relative to the guide (3). The apparatus (100) according to claim 1 or 2, characterized in that

4. The rotation axis (Y) of the main body (51) coincides with the rotation axis (X) of the guide (3), the first rotating means (4) comprises a first shaft (41), and the second rotating means (61) comprises a second shaft (62), the second shaft (62) having a portion inside the first shaft (41). The apparatus (100) according to claim 3, characterized in that...

5. The at least one through opening (31) extends in the direction of the rotation axis (X) to guide the support (2) along that direction, The support (2) further comprises a connecting portion (23) between the support portion (21) and the guide portion (22), the connecting portion (23) being axially symmetric and configured to engage with the at least one through opening (31), thereby being rotatable about its axis of symmetry. The apparatus (100) according to claim 3 or 4, characterized in that...

6. Further support (20) is provided, Each of the further supports (20) comprises a support portion (210) configured to accommodate a container (A) having an exposed portion (B) so as to be acquired by the transport means (13, 14) of the container (A), The guide (3) is provided with a receiving seat (32) for receiving the further support (20), The at least one through-opening (31) has a first through-opening (311) and a second through-opening (312), each through-opening receiving at least one support (2), and the receiving seat (32) is positioned between them. The moving means (5) is configured such that the further support (20) does not move along the guide (3). The apparatus (100) according to any one of claims 3 to 5, characterized in that

7. In the case of the support (2) and the device (1) described in claim 6, the further support (20) comprises connecting arms (241), the connecting arms (241) are configured to connect with each other, and by connecting with each other, form part of an expandable pantograph. The apparatus (100) according to claim 5 or 6, characterized in that...

8. The support portion (21) includes a bowl or beaker-shaped portion for supporting and holding the container (A) when the guide (3) rotates. The apparatus (100) according to any one of claims 1 to 7, characterized in that

9. In the first chamber (11), a first ventilation and cleaning means is provided for purifying the air and generating a first laminar flow (151) of air directed from the first chamber (11) toward at least one first outlet (152), In the second chamber (12), a second ventilation and cleaning means is provided for purifying the air and generating a second laminar flow (161) of air directed from the second chamber (12) toward at least one second outlet (162), A deflection means for deflecting a portion of the first laminar flow (151) toward at least one second outlet (162), Furthermore, The device (1) is positioned relative to the deflection means such that the portion exposed to the first laminar flow (151) is exposed to a portion of the first laminar flow (151) that is deflected toward the at least one second outlet (162). The apparatus (100) according to any one of claims 1 to 8, characterized in that

10. The first transport means (13) and the second transport means (14) are configured so as not to interfere with the second chamber (12) and the first chamber (11) respectively when loading or retrieving a container (A) on the support (2) of the device (1). The apparatus (100) according to any one of claims 1 to 9, characterized in that

11. The first transport means (13) of the container (A) comprises a first robot system located inside the first chamber (11), and the second transport means (14) of the container (A) comprises a second robot system located inside the second chamber (12). The apparatus (100) according to any one of claims 1 to 10, characterized in that

12. A method for manufacturing pharmaceutical or biotechnology-related products, A step of preparing the apparatus (100) according to any one of claims 1 to 11, The process involves introducing container (A) into the first chamber (11), The steps include arranging the group of containers (A) introduced onto the support (2) by the first transport means (13) so as not to interfere with the second chamber (12), The process involves rotating the support (2) toward the second chamber (12) so that the exposed portion (B) of each container (A) can be acquired by the second transport means (14) without interfering with the first chamber (11), A step of acquiring the group of containers (A) from the support (2) by the second transport means (14) so ​​as not to interfere with the first chamber (11), A step of filling the aforementioned container group (A) with pharmaceutical or biotechnology-related materials, Equipped with, A method characterized by the following features.

13. In the process of introducing container (A), when primary containers having predetermined dimensions are arranged in multiple rows of containers (A) in each row at the same distance (D) or predetermined intervals, and supplied, this method A step of preparing the first transport means (13), which is a collection unit, configured to collect the group of containers (A) having the predetermined dimensions, and arranged in rows at predetermined intervals, A step of preparing the support (2) of the support part (21) configured to accommodate the container (A) having the predetermined dimensions, A step of supplying a linear type guide (3) for guiding the support (2), and a moving means (5) for moving the support (2) along the guide (3) so as to change the distance (D) between the supports in the direction of the rotation axis (X), Furthermore, In the process of arranging the group of containers (A), containers (A) in the same row are arranged. In the step of rotating the support (2), the distance (D) between the containers (A) changes equally by moving the support parts (21) closer together or further apart from each other. The method according to claim 12, characterized in that

14. In the process of introducing container (A), a vial, bottle, syringe, or cartridge is supplied, and each of the containers (A) is equipped with an inlet for introducing pharmaceutical or biotechnology-related materials. In the step of rotating the support (2), the container is held so that the inlet faces upward, and the support (2) is rotated so that it forms an equal angle with respect to the horizontal plane at the initial and final positions. The method according to claim 12 or 13, characterized in that...

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