DEVICE FOR TRANSFERING CONTAINERS, APPARATUS FOR MANUFACTURING PHARMACEUTICAL OR BIOTECHNOLOGICAL PRODUCTS, AND METHOD 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 manufacturing processes, for example pharmaceutical or biotechnological, which require multiple chambers with controlled atmospheres, and in particular to the transfer of containers between the chambers.

[0002] More particularly, the present invention relates to devices for moving containers, apparatus for manufacturing pharmaceutical or biotechnology related products, and methods thereof. [Background technology]

[0003] There is a recognized need in manufacturing processes to reliably separate adjacent chambers having a controlled, and in some cases sterile, atmosphere. This need is particularly recognized in the manufacture of pharmaceutical or biotechnological products, and in particular in the container filling and sealing processes. Examples of these processes are described in US Pat. No. 5,399,633.

[0004] Typically, such manufacturing takes place inside clean rooms or clean areas that are designed, maintained, and controlled to prevent particulate contamination of the articles. For example, the standard ISO 14644-1 and the European Good Manufacturing Practice include classifications of clean rooms. The transfer of containers is even more critical between chambers with different pharmaceutical environment classifications.

[0005] Currently, in clean rooms, atmosphere control is achieved by injecting filtered air, for example using HEPA filters. In common parlance in the art to which reference is made, the term "air" in this application is not limited to a particular mixture, e.g., the mixture could equally be identified as ambient atmosphere or nitrogen.

[0006] Failure to clearly define the boundaries between chambers can have serious consequences, for example qualitative risks to goods due to cross-contamination, which can result in damage to the end user or even the necessity to recall the entire production lot.

[0007] The transfer of containers between chambers is one of the most important operations, especially for primary containers of pharmaceutical or biotechnological products, since the transfer device crosses the boundary between the chambers with the container. Indeed, conventional transfer devices such as belts, transporters, conveyors, rotating platforms, trays, etc. move from one chamber to another. In addition to this, robotic systems, at least with their end effectors, enter adjacent chambers. The use of similar devices becomes very important, especially for highly toxic substances and for more compact production lines with closer spacing between each component.

[0008] Thus, the trend to limit the dimensions of pharmaceutical or biotechnological production lines may conflict with the need for greater flexibility in the processing of containers that may differ in shape, size, and internal arrangement of trays, crates, or other receptacles. Indeed, pre-processing and / or resizing operations must be completed at the beginning and end of the production line to build the production line, which increases the risk of cross-contamination and the need to ensure adequate working space.

[0009] Flexibility, small size, and clear separation between chambers are key factors in small batch manufacturing lines. These manufacturing processes are often carried out inside isolators arranged to form a manufacturing line. An example of an isolator for the automated production of pharmaceutical or biotechnological products is described in US Pat. No. 5,399,633. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] European Patent No. 1447328 [Patent Document 2] US Patent Application Publication No. 2019 / 315004 Summary of the Invention [Problem to be solved by the invention]

[0011] A first object of the present invention is to provide an apparatus which allows transferring groups of containers for pharmaceutical or biotechnological applications between different chambers, reducing or eliminating the risk of cross-contamination.

[0012] A second objective is to provide devices and apparatus for the manufacture of pharmaceutical or biotechnological products, which, taking into account the results obtained, are compact and can be operated with a group of containers having different shapes and sizes and with different arrangements of containers.

[0013] A still further object is to provide a method for producing a pharmaceutical or biotechnology related product which reduces or eliminates the risk of cross-contamination. [Means for solving the problem]

[0014] These and other objects, as will become apparent to a person skilled in the art from the following description, are achieved by the device for moving a group of containers for pharmaceutical or biotechnological applications, by an apparatus for the automated production of pharmaceutical or biotechnological products and by a method for manufacturing a pharmaceutical or biotechnological product as claimed.

[0015] According to the disclosure of the present specification, the device comprises a support structure, a support, a guide, a first rotation means of the guide, and a moving means. The supports each comprise a support configured to receive a container having an exposed portion to be picked up by the container transport means. The guide is configured to guide the support and is rotationally coupled to the support structure to rotate between a first position and a second position. Furthermore, the guide receives the opposing support toward a first zone in the first position and a second zone in the second position, thereby at least partially placing the exposed portion of each container in one of two chambers having a controlled atmosphere, respectively. The moving means is advantageously configured to move the support along the guide such that the distance between the supports varies depending on the direction of the rotation axis.

[0016] The apparatus is advantageously applied in an apparatus having a first chamber having a first controlled atmosphere and a second chamber having a second controlled atmosphere. The disclosed technology also relates to a method for manufacturing a pharmaceutical or biotechnology-related product, comprising a step for transferring a container between the chambers of the apparatus. [Brief description of the drawings]

[0017] Specific embodiments of the present invention will become apparent from the following description, as defined in the claims, and with reference to the accompanying drawings, in which: [Figure 1] FIG. 1 shows an embodiment of a device for transferring containers for pharmaceutical or biotechnological applications according to the invention in a perspective view with an end effector of a robotic system visible. [Diagram 2] FIG. 2 is a perspective view of the embodiment shown in FIG. 1, excluding some of the elements, to accommodate a different container. [Diagram 3] FIG. 3 is a cross-sectional view of the embodiment of FIG. 1 taken along a plane passing through the axis of rotation. [Figure 4] FIG. 4 is a side view of the operating moment sequence of the embodiment shown in FIG. 1, without including some of the elements. [Diagram 5] FIG. 5 is a side view of the sequential operating moments of the embodiment shown in FIG. 1, without including some of the elements. [Figure 6] FIG. 6 is a side view of the operating moment sequence of the embodiment shown in FIG. 1 without including some of the elements. [Figure 7] FIG. 7 illustrates the operational sequence of the embodiment of FIG. 1 from various perspectives, possibly without including some of the elements. [Figure 8] FIG. 8 illustrates the operational sequence of the embodiment of FIG. 1 from various perspectives, possibly without including some of the elements. [Figure 9] FIG. 9 illustrates the operational sequence of the embodiment of FIG. 1 from various perspectives, possibly without including some of the elements. [Figure 10] FIG. 10 illustrates the operational sequence of the embodiment of FIG. 1 from various perspectives, possibly without including some of the elements. [Figure 11] FIG. 11 illustrates the operational sequence of the embodiment of FIG. 1 from various perspectives, possibly without including some of the elements. [Figure 12] FIG. 12 illustrates the operational sequence of the embodiment of FIG. 1 from various perspectives, possibly without including some of the elements. [Figure 13] FIG. 13 is a perspective view of a further embodiment of a device according to the invention. [Figure 14] FIG. 14 is a perspective view showing an embodiment of an apparatus according to the present invention. [Figure 15] FIG. 15 is a cross-section of the device of FIG. 14 taken along a plane passing through the threshold of the chamber. [Figure 16] FIG. 16 is a perspective view of a further embodiment of an apparatus according to the invention. [Figure 17] FIG. 17 shows a further embodiment of the device according to the invention in two successive operating moments revealed from the end effector of the respective robot system. [Figure 18]FIG. 18 shows a further embodiment of the device according to the invention in two successive operating moments revealed from the end effector of the respective robot system. [Figure 19] FIG. 19 shows a cross-sectional view of the device of FIG. 17, without including some of the elements, with respect to a plane through the opening of the chamber. [Figure 20] FIG. 20 shows a cross-sectional view of the device of FIG. 17 with a different acquisition position for FIG. 20 than that of FIG. 18, relative to a plane passing through the opening of the chamber. [Figure 21] FIG. 21 is a cross-sectional top view of the embodiment shown in FIG. 1 with some of the elements omitted, allowing the end effector of the robotic system to be viewed. [Figure 22] FIG. 22 is a cross-sectional top view of the embodiment shown in FIG. 1 with some of the elements omitted, allowing the end effector of the robotic system to be seen. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] With reference to the attached drawings, the reference number (1) denotes a device for transferring a group of containers (A) for pharmaceutical or biotechnological applications between a first chamber (11) with a first controlled atmosphere and a second chamber (12) with a second controlled atmosphere, in at least one of the first chamber (11) and the second chamber (12) a transport means (13, 14) for the containers (A) is in operation. In general, the containers (A) are primary containers and are usually devices (1) of an apparatus (100) for the automated manufacture of pharmaceutical or biotechnological products, in which the first chamber (11) and the second chamber (12) are connected by an opening (10), the size of which may be limited.

[0019] By way of example, the container (A) may be a vial, a bottle, a syringe, or a cartridge, or, more rarely, a combination thereof.

[0020] By controlled atmosphere chamber is meant a chamber that is controlled at least in terms of particles, for example as specified in ISO standard 14644-1. Generally, the first chamber (11) and the second chamber (12) are chambers with 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) has a support portion (21) configured to accommodate a container (A), the support portion (21) being configured to accommodate the container (A) having an exposed portion (B) exposed towards the surrounding environment so that the container (A) can be picked up by a transport means (13, 14) for the container (A).

[0023] The guide (3) is configured to guide the support (2) and is rotationally coupled to the support structure (7) and adapted to rotate about a rotation axis (X) between a first position and a second position. The first rotation means (4) is adapted to rotate the guide (3) about the rotation axis (X) between the first position and the second position. In general, the first rotation means (4) allows a complete rotation of the guide (3) and allows the first and second positions to be determined based on the geometric characteristics of the installation and the specific needs of the production line. This is evident, for example, from a comparison of the acquired positions in Fig. 18 and Fig. 20.

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

[0025] The displacement means (5) are advantageously configured to displace the supports (2) along the guide (3) so as to vary the distance (D) between the supports as a function of 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 in the passage of containers (A) between the first chamber (11) and the second chamber (12), and allows the transport means (13, 14) of the containers (A) to introduce or receive at least a portion of the exposed portion (B) of each container (A) inside the chamber (11, 12) without interfering with the other chamber (12, 11).

[0027] Furthermore, the device (1) allows to vary the distance (D) between the containers (A) during their passage between the first chamber (11) and the second chamber (12), thus offering high flexibility in situations where the risk of cross-contamination is reduced, without substantially affecting the size of the production line or the machine in which the device (1) is installed. Thus, the production line or the machine is capable of processing groups of containers (A) having a distance (D) between them within a range of values. For example, as will be explained in more detail below, with the device (1), a production line can be operated starting from nests of different pitches, providing only suitable transport means (13) in the first chamber, without size changes in all chambers.

[0028] In figure 1 a preferred embodiment is shown in which the guides (3) are linear, the guide direction is arranged according to the direction of the rotation axis (X) and the supports (2) are all kept perpendicular to the guides (3). This configuration reflects the typical configuration of containers (A) in the gripping functions of the transport means (13, 14) and simplifies the interaction between the supports (2) and the moving means (5).

[0029] The support (21) preferably comprises a bowl or beaker shaped component that supports and holds the container (A) during rotation of the guide (3). In the embodiment of the accompanying drawings, the beaker has a suitable size for the container (A) and is interchangeable, in particular as shown in Figures 1 to 3. In particular, the beaker shown has an inner diameter close to the outer diameter of the container (A) and is of a sufficient height to hold the exposed portion (B) of the container (A) exposed.

[0030] In the figure, it can be seen that in the embodiment with an axisymmetric beaker and straight guides (3) with respect to the axis of symmetry, the supports (2) all have their inflow parts pointing in the same direction towards the bowl-shaped part.

[0031] The guide (3) can be variously adapted, but considering the orientation and displacement needs of the containers (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), so that the containers (A) can be easily removed from and grouped with respect to the support (2) thus arranged.

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

[0033] The guide (3) preferably rotates as much as possible to allow placement or retrieval of container (A) at different orientations. For example, in the operational sequence shown in Figures 4-6, the guide (3) preferably allows placement of container (A) at any angle relative to the approximately 180 sexagesimal degrees available in each chamber (11, 12).

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

[0035] The moving means (5) is preferably actuated independently of the first rotating means (4), and more preferably configured to move the support (2) to any position of the guide (3) comprised between a first position and a second position including the end positions, i.e., the moving means (5) is more preferably actuated when the guide (3) is rotated to any position.

[0036] The same device (1) offers high operational flexibility since the containers (A) can be moved to different distance (D) positions or angles in a variable sequence without mutual influence. In other words, it is possible, for example, to change the pitch between the containers (A) and then rotate them, or vice versa, or to perform the pitch change between two rotations. Also, the first position and the second position may be arbitrary. Also, for example, with reference to the description of the elements described below, the device (1) of FIG. 1 may not be provided with a second rotation means (61) and may be able to change the distance (D) by properly orienting the body (51). However, the change in distance is always the same between the first position and the second position. Therefore, with respect to the variation in distance (D), it may be necessary to change the body (51) to obtain a different change in distance (D) or different first and second positions.

[0037] The moving means (5) is generally configured to move the supports (2) taking into account the eventual presence of further supports (20) described below, thereby varying the distance (D) between the supports (2).

[0038] Various embodiments of the moving means (5) are possible, for example they may comprise grub screws with double threading, suitably coupled to each of the supports (2). The embodiment described below, inter alia, ensures the exposure of surfaces that may cause cross-contamination and facilitates the positioning of seals that protect the unexposed parts.

[0039] The guide (3) preferably comprises at least a through opening (31) for receiving the support (2), each of the supports (2) further comprising a guide portion (22) at an end opposite the support portion (21). The guide portion (22) projects from at least the through opening (31) on the opposite side to which the support portion (21) faces. For example, Figure 3 shows how the support portion (21) and the guide portion (22) face opposite half-spaces with respect to a horizontal plane passing from the guide (3).

[0040] The moving means (5) comprises a body (51) with an outer surface (52) arranged at least laterally of the through opening (31) from which the guide part (22) projects, on which tracks (53, 54, 55, 56, 57, 58, 59, 60) are formed to guide the guide part (22). The guide part (22) must project to engage with the tracks (53, 54, 55, 56, 57, 58, 59, 60). The support part (21) could remain at least inside the through opening (31), but in that case the risk of cross-contamination would generally be increased.

[0041] The body (51) is rotationally connected to the guide (3) according to a respective axis of rotation (Y).

[0042] Each guide portion (22) engages with a 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 portion (22) along the direction of the rotation axis (Y) of the body (51) during rotation of the body (51) relative to the guide (3).

[0043] In a compact device with surfaces exposed to fluids and, possibly, sterilization procedures typically used in pharmaceutical or biotechnological production lines, the distance (D) can be advantageously varied to achieve high operational flexibility.

[0044] Figures 9, 10 and 11 show the configuration of the tracks (53, 54, 55, 56, 57, 58, 59, 60) in the illustrated embodiment. In particular in Figure 11 it can be seen that the supports (2) are close to each other due to the position of the guides (22) in the tracks (53, 54, 55, 56, 57, 58, 59, 60) which are close to each other towards 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 retain 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 the specific requirements. In general, in particular for containers (2) arranged with a predefined pitch, one of the tracks (53, 54, 55, 56, 57, 58, 59, 60) may not change the position of the guide part (22) along the direction of the axis of rotation (Y) of the body (51), i.e. it may have the same cross section in each of the planes involved in the series of planes of the axis of rotation (Y). For example, in the embodiment of FIG. 1, the further support (20) is accommodated in a receiving seat (32) which only rotates and the respective track (57) does not change its position, and can actually be removed by appropriately adjusting the further support (20).

[0046] It is preferred that the moving means (5) further comprises a second rotating means (61) for rotating the main body (51) to independently realize the rotation of the containers (A) and different distances (D) between the containers (A).

[0047] As already generally stated, at least the through openings (31) preferably extend according to the direction of the rotation axis (X) so as to guide the support (2) along the same direction.

[0048] The axis of rotation (Y) of the body (51) preferably coincides with the axis of rotation (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), more preferably the second shaft (62) is partly inside the first shaft (41). Thus, the risk of cross-contamination is minimized, making it easier to implement simple controls and reduce the number of exposed elements. Figure 3 clearly shows the use of a common seal to protect the areas that cannot be kept exposed and running of the first shaft (41) and the second shaft (62) with their respective motors (43, 64), typically gear motors, and transmissions (42, 63).

[0049] More preferably, the support (2) further comprises a coupling part (23) between the support part (21) and the guide part (22) that is axially symmetrical and configured to engage at least with the through opening (31) in a movable, i.e. rotatable, manner with respect to the axis of symmetry, said rotation allowing for orientation within at least the through opening (31) and thus facilitating exposure and possibly sterilization of the coupling part (23).

[0050] Generally, one or more containers (A) may not be moved along the guide (3), this may preferably happen for the central container (A) or for one of the two central containers in case of containers arranged at a pitch.

[0051] The device (1) may comprise a further support (20) comprising a respective support part (210) adapted to receive the container (A) having the exposed part (B) so that it can be taken up by the transport means (13, 14) of the container (A). The guide (3) may comprise a receiving seat (32) for receiving the further support (210). The various embodiments of the support (2) may also be applied to the further support (20) so that there is no need to manage special pieces in the other members. The further support (20) may thus comprise a respective guide part (220) and a respective coupling part (230).

[0052] More preferably, at least the through openings (31) include a first through opening (311) and a second through opening (312), each for receiving at least a support (2), between which the receiving seat (32) is arranged, so that the containers (A) can be kept substantially centered with respect to the guide (3), regardless of the distance (D) between the containers.

[0053] The support (2) and, possibly, the further support (20) are preferably configured to be connected to each other and comprise linking arms (241) which are connected to each other to form part of an extendable pantograph. As illustrated in figures 9 and 22, successive linking arms (241) are rotatably connected to each other at their respective ends, each support (2) or further support (20) comprising only one linking arm (241) if at an end, and two linking arms otherwise. The linking arms (241) advantageously rotate the support (2) and further support (20) with a displacement along the guide (3), thus facilitating the exposure of all surfaces. Furthermore, the function of supporting or maintaining the position of the support (2) is realized.

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

[0055] In a preferred variant, which is also advantageous in terms of mounting, the guide part (22) is a special screw that blocks the connecting part (23) when it engages with the central part (24). By way of example, with reference to FIG. 3, the connecting part (23) is a two-part bush, interposed between the central part (24) and at least the through opening (31). Referring again to FIG. 3, the device (1) described above uses seals common in the field, allowing the passage of air and, in some cases, allowing the sterilization of all areas that may cause cross-contamination, since these areas are in view and easily reachable.

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

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

[0058] The device (1) is preferably applicable inside a manufacturing line or machine for the automated production of pharmaceutical or biotechnological products. To this end, the support structure (7) comprises a connection (71) configured to be fixed to either, between, or both of the first chamber (11) and the second chamber (12). More preferably, the device (1) is installed at an existing threshold between the first chamber (11) and the second chamber (12). To this end, the device (1) may comprise, alone or together, a frame (72) and / or a separation wall (73) defining an opening (10) for the passage of the container (A). In general, the device (1) is preferably provided with a frame (72) so that the installation does not compromise the seal. Figures 19 and 20 show a separation wall (73) defining the opening (10) and enclosing the device (1) inside the chambers (11, 12). The same separation wall (73) is also shown in Figures 17 and 18, which show an example of a handover sequence to the gripping function of a different robotic system, i.e., placing the device (1) inside a production line or machine.

[0059] An embodiment of an apparatus (100) for the automated production of pharmaceutical or biotechnological products according to the invention comprises 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 clean rooms, for example according to ISO standard 14644-1, more preferably they have different medical or biotechnological environment classifications, for example, the first chamber (11) can be class 3 and the second chamber (12) can be class 2, with reference to said standard.

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

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

[0063] The above mentioned advantages are obtained in the following way: the first transport means (13) and the second transport means (14) are preferably configured not to enter the second chamber (12) and the first chamber (11), respectively, when placing or picking up the container (A) on the support (2) of the device (1).

[0064] Typically, the vehicles (13, 14) include a robot system (not shown in Figures 14 to 16). The end effector of the robot system is shown in other figures. An example of the robot system is described in US Pat. No. 5,399,633.

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

[0066] As exemplified above, preferably, but not necessarily limited to, the axis of rotation (X) is located at the threshold between the first chamber (11) and the second chamber (12), e.g., on a vertical plane that divides the threshold in half.

[0067] The device (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 cleaning means is configured to clean the air and generate in the first chamber (11) a first laminar flow (151) of air from the first chamber (11) towards at least a first outlet (152).

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

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

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

[0072] The device (1) is advantageously 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 towards at least the second outlet (162). The techniques of the present disclosure may be applied to either of the isolator chambers (11, 12) shown in Figure 16, where typically a pressure differential is present that deflects a small portion of the laminar flow towards the other chamber (11, 12).

[0073] The second chamber (12) is preferably arranged under reduced pressure with respect to the first chamber (11), i.e. the first chamber (11) is arranged under positive pressure. In particular, according to common practice, the pressure difference is between 10 and 20 Pascals. Alternatively or in combination, the deflection means comprises a separation wall (73), more preferably also defining the opening (10). As shown in Figures 17 to 20, the separation wall (73) is arranged 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 a pharmaceutical or biotechnology-related product, which in one embodiment comprises the steps of: - providing an apparatus (100) comprising 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), a first means of transport (13) for the container (A) comprising a first robotic system arranged inside the first chamber (11), a second means of transport (14) for the container (A) comprising a second robotic system arranged inside the second chamber (12), and a support (2) comprising a support portion (21). - introducing a container (A), preferably a primary container, into the first chamber (11). - positioning the group of vessels (A) introduced by the first robotic system on the support (2) so as not to interfere with the second chamber (12). - rotating the support (2) towards the second chamber (12) so that the exposed portion (B) of each container (A) can be acquired by the second robotic system without interfering with the first chamber (11). - picking up the group of containers (A) from the support (2) by a second robotic system so as not to interfere with the first chamber (11). - filling the group of containers (A) with pharmaceutical or biotechnological material. Here, each support (2) is configured to accommodate a container (A) having an exposed portion (B) such that the container (A) can be picked up by a transport means (13, 14) for the container (A) and can be rotated relative to the opening (10) according to a rotation axis (X), thereby allowing the support (2) to rotate between a first position in which the support (2) faces towards the first chamber (11) and a second position in which the support (2) faces towards the second chamber (12), and further at least partially positioning each exposed portion (B) of the container (A) in the first chamber (11) and the second chamber (12), respectively.

[0076] In general, the robotic system of the apparatus (100) is an anthropomorphic robot that includes a gripping feature, such as pliers, configured for use with the container (A).

[0077] The method is preferably applied using the previously described device 100. In this case, a step of preparing the device 100 according to the invention is carried out and the method comprises the following steps: - introducing a container (A) into a first chamber (11). - positioning the group of containers (A) introduced by the first transport means (13) on the support (2) so as not to interfere with the second chamber (12). - rotating the support (2) towards the second chamber (12) so that an exposed portion (B) of each container (A) can be acquired by the second transport means (14) without interfering with the first chamber (11). - taking the group of containers (A) from the support (2) by a second transport means (14) so ​​as not to interfere with the first chamber (11). - filling the group of containers (A) with pharmaceutical or biotechnological material.

[0078] In the step of rotating the support (2), it is also preferable to change the distance (D) between the containers (A) by moving the supports (21) closer to or farther away from each other.

[0079] The containers (A) are typically arranged in a number of rows with the same pitch in each row, and more preferably the distances (D) vary equally.

[0080] Typically, containers (A) are placed in a suitable arrangement into a secondary container such as a drawer or tray. Such a secondary container has suitable accommodations and serves to keep containers (A) aligned. Syringes or bottles are usually supported by an element called a "nest" and placed inside another element called a "tub". However, the dimensions and distances (D) of containers (A) frequently vary and often differ from batch to batch.

[0081] The method is particularly flexible and allows for the management of containers (A) with different characteristics by changing the size of the support (21) as required and by changing the end effector of the robotic system to suit the size and distance (D) of the container (A). Figures 1 and 2, and also Figures 21 and 22 show different end effectors for picking up and placing containers (A) of different sizes. For the same reason, the illustrated supports (21) have different diameters.

[0082] For these reasons, in a preferred embodiment of the method, in the step of supplying containers (A), primary containers having a predetermined dimension are arranged in a number of rows with the same distance (D) or a predetermined spacing between containers (A) in each row. When being supplied, the method further comprises the steps of: - providing a first transport means (13) which is a collecting part, configured to collect a group of containers (A) having predetermined dimensions and arranged in a row at predetermined intervals; - providing a support (2) for a support part (21) configured to receive a container (A) having predetermined dimensions; - providing a linear guide (3) for guiding the supports (2) and a moving means (5) for moving the supports (2) along the guide (3) so as to vary the distance (D) between the supports in accordance with the direction of the rotation axis (X).

[0083] In the step of arranging the groups of containers (A), the containers (A) in the same row are advantageously arranged. In the step of rotating the support (2), the distance (D) between the containers (A) is equally varied by moving the supports (21) closer or further away from each other.

[0084] In the step of providing the containers (A), preferably vials, bottles, syringes or cartridges are provided, each container (A) having an inlet for introducing a pharmaceutical or biotechnological material. In the step of rotating the support (2), the containers are maintained with the inlet facing upwards in order to simplify the manufacturing operation.

[0085] More preferably, in the step of rotating the support (2), the support (2) is rotated so as to form angles of equal magnitude with respect to the horizontal plane in the initial position and the final position, as shown in Figures 4 and 6.

[0086] The method preferably includes a step or means of filling and / or a step or means of sealing or capping of the container (A) as well as the device (100). Other typical operations correspond to cleaning, sterilization and inspection.

[0087] The above has been described as a non-limiting example, and any structural variations are deemed to fall within the protection scope of the present technical solution as set forth in the following claims.

Claims

1. An apparatus (100) for the automated production of a pharmaceutical or biotechnology related product, comprising: 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); A device (1) for transferring a group of containers (A) for pharmaceutical or biotechnological applications between said first chamber (11) and said second chamber (12), Equipped with The device (1) comprises: A support structure (7); supports (2) each having a support part (21) configured to receive a container (A) having an exposed part (B) so that the container (A) can be picked up by the transport means (13, 14) of the container (A); a guide (3) configured to guide the support (2), the guide (3) being rotatably coupled to the support structure (7) about a rotation axis (X) for rotation between a first position and a second position, and the guide (3) being at least partially positioned in the exposed portion (B) of each of the containers (A) in the first chamber (11) and the second chamber (12) by receiving the support (2) such that the support portion (21) faces toward a first zone in the first position and a second zone in the second position; a first rotation means (4) configured to rotate said guide (3) about said axis of rotation (X); a moving means (5) configured to move the supports (2) along the guide (3) so as to vary the distance (D) between the supports in the direction of the rotation axis (X); a first transport means (13) arranged inside the first chamber (11) and configured to transport a container (A) so as to load and pick up the container (A) located on the support (2) of the device (1); and / or a second transport means (14) arranged inside the second chamber (12) and configured to transport a container (A) so as to load and pick up the container (A) located on the support (2) of the device (1); Equipped with the support structure (7) positions the rotation axis (X) of the guide (3) at or near the opening (10), such that when the first rotating means (4) rotates, the support (2) can be moved from the first position in which the support (2) faces toward the first chamber (11) to the second position in which the support (2) faces toward the second chamber (12), and at least partially positions the exposed portion (B) of each of the containers (A) in the first chamber (11) and the second chamber (12), respectively; 1. An apparatus (100).

2. said moving means (5) being actuated independently of said first rotating means (4) and configured to move said support (2) to any position of said guide (3) between said first position and said second position, including an end position; 2. The device (100) of claim 1 .

3. The guide (3) comprises at least one through opening (31) for receiving the support (2), Each of the supports (2) further includes a guide portion (22) at an end opposite to the support portion (21), the guide portion (22) protruding from the at least one through opening (31) on the opposite side to the support portion (21); the moving means (5) comprises a 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 body (51), the body (51) is arranged on a side of the at least one through opening (31) from which the guide portion (22) projects, and has an outer surface (52) on which tracks (53, 54, 55, 56, 57, 58, 59, 60) are formed to guide the guide portion (22); Each of the guide portions (22) engages with a corresponding one of the tracks (53, 54, 55, 56, 58, 59, 60); At least some of the 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).

3. Apparatus (100) according to claim 1 or 2, characterized in that

4. the rotation axis (Y) of the body (51) coincides with the rotation axis (X) of the guide (3), the first rotating means (4) comprises a first axis (41), the second rotating means (61) comprises a second axis (62), and the second axis (62) corresponds to a part of the inside of the first axis (41); 4. The device (100) according to claim 3 .

5. said at least one through opening (31) extends in the direction of said axis of rotation (X) to guide said support (2) along said 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) and thereby be rotatable about the symmetric axis.

5. Apparatus (100) according to claim 3 or 4, characterized in that

6. A further support (20), said further supports (20) each comprise a support part (210) configured to receive a container (A) having an exposed part (B) so as to be picked up by said transport means (13, 14) of said container (A), The guide (3) includes a receiving seat (32) for receiving the support portion (210), 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) being arranged therebetween; An 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) according to claim 6, the further support (20) comprises a connecting arm (241), which configured to couple together and, when coupled together, form part of an expandable pantograph; 7. Apparatus (100) according to claim 5 or 6, characterized in that

8. the support (21) comprises a portion having the shape of a bowl or beaker for supporting and holding the container (A) when the guide (3) rotates; An apparatus (100) according to any one of the preceding claims, characterized in that

9. a first ventilation and cleaning means for cleaning air in the first chamber (11) and generating a first laminar flow of air (151) from the first chamber (11) towards at least one first outlet (152); second ventilation and cleaning means for cleaning the air in the second chamber (12) and generating a second laminar flow of air (161) from the second chamber (12) towards at least one second outlet (162); deflection means for deflecting a portion of the first laminar flow (151) from the second chamber (12) towards the at least one second outlet (162); Further equipped with the device (1) is positioned with respect to the deflection means such that a portion of the device (1) exposed to the first laminar flow (151) is exposed to a portion of the first laminar flow (151) that is deflected towards the at least one second outlet (162), An apparatus (100) according to any one of the preceding claims, characterized in that

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

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

12. 1. A method for producing a pharmaceutical or biotechnology related product, comprising: Providing a device (100) according to any one of claims 1 to 11; Introducing a container (A) into said first chamber (11); positioning the group of containers (A) introduced by the first transport means (13) on the support (2) so as not to interfere with the second chamber (12); rotating said support (2) towards said second chamber (12) so as to allow said exposed portion (B) of each container (A) to be picked up by said second transport means (14) without interfering with said first chamber (11); taking said group of containers (A) from said support (2) by said second transport means (14) so ​​as not to interfere with said first chamber (11); filling said group of containers (A) with pharmaceutical or biotechnological material; Equipped with A method comprising:

13. In the step of introducing the containers (A), primary containers having a predetermined size are arranged and fed in a number of rows with the same distance (D) or a predetermined spacing between the containers (A) in each row, the method comprising: providing said first transport means (13) as a collecting section, arranged in a row at said predetermined intervals, configured to collect said groups of containers (A) having said predetermined dimensions; providing said support (2) of a support part (21) configured to receive a container (A) having said predetermined dimensions; providing a linear guide (3) for guiding the supports (2) and a moving means (5) for moving the supports (2) along the guide (3) so as to change the distance (D) between the supports in the direction of the rotation axis (X); Further equipped with In the step 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) is equally changed by moving the supports (21) closer to or farther from each other.

13. The method according to claim 12.

14. In the step of introducing the container (A), a vial, a bottle, a syringe or a cartridge is provided, each of the containers (A) having an inlet for introducing a pharmaceutical or biotechnological material; 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 equal angles with respect to a horizontal plane in the initial position and the final position.

14. The method according to claim 12 or 13.

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