Machine for pharmaceutical or biotechnological processes, assembly and method for realizing said machine

Abstract

The machine (1) for pharmaceutical or biotechnological processes comprises a structure (10) that defines a chamber (100) with a constant or decreasing horizontal section (A), movement means for moving materials and / or tools in the working space (100a), and ventilation means (2) with a treatment unit (221), inlets (21a, 21b) and outlets (25a, 25b). The first wall (13) advantageously comprises a first portion (131), a second portion (132) spaced apart from the first portion (131) and an inclined portion (133) with respect to the horizontal plane (H) extending upwards and downwards respectively, the inclined portion (133) adjoining the first portion (131) and the second portion (132) to define the chamber (100). The operating space (100a) extends at least partially above the angled portion (133) and / or within a volume disposed above the first portion (131) and in front of the angled portion (133).

Description

[Technical field]

[0001] The present invention relates to the technical field of handling materials in chambers with a controlled and / or classified and / or certified atmosphere in order to achieve one or more of the operations required in the life cycle of a pharmaceutical or biotechnological article, such as, for example, the handling of pharmaceutical or biotechnological materials, the handling, validation or pre-treatment of containers and their closures. [Background technology]

[0002] It is known in the related art to use a process chamber having a controlled atmosphere located within a containment structure, such as an isolation device or a Restricted-Access Barrier System (RABS).

[0003] Isolation devices are completely closed and sealed, so that they allow a complete isolation of the chamber. They offer a high level of protection against contaminants and are particularly useful for highly sensitive, hazardous and / or toxic materials. Furthermore, they allow extensive decontamination or cleaning processes, for example with hydrogen peroxide or other strong detoxifying agents. Typically, isolation devices are provided with a transparent wall to allow observation of the chamber from the outside environment, and that wall or another wall may be provided with gloves and / or doors to allow intervention inside the chamber.

[0004] Isolators are typically made of steel and are not intended for human entry. Isolators generally have the smallest possible volume relative to the needs of the process, even taking into account the fact that they are expensive to operate.

[0005] Typically, a RABS includes a containment wall that encloses the equipment but remains open to the white chamber. This containment wall may include a glove and / or a door to allow interaction with the work equipment. An air handling system may be integrated with that for the white chamber.

[0006] Using common terminology in the relevant technical field, the term "air" in this patent application is not limited to a particular mixture, but is defined as being equally identifiable as, for example, atmospheric air or nitrogen, but in describing the present invention, the more general term "fluid" is used.

[0007] In larger structures, such as RABS, the chamber may typically be accessed directly by humans or other machinery.

[0008] These processes are usually carried out inside clean rooms or clean areas, which are designed, maintained and controlled to prevent particle contamination of the items. As an example, the standard ISO 14644-1, as well as the European Code of Practice for Pharmaceutical Manufacturing and Quality Control, include a classification of clean rooms. Currently, in clean rooms, the atmosphere is controlled by injecting air that has been filtered, for example using HEPA filters.

[0009] Machines with a horizontal surface are known, which use the intake of air on both sides of this surface, or only on one side if a wall is attached. This air is used as a suspension transfer of any contaminants or particles from the clean zone towards the regeneration area. The machines often have hidden or turbulent areas, which prevent the formation of a single, substantially unidirectional flow. The horizontal surface also acts as a barrier and a deposition point for the contaminants or particles. Similarly, elements arranged inside the chamber change and impede the flow, at least locally reducing the effect of the flow. To eliminate these drawbacks, solutions of specific configurations are known. However, they do not adapt well when the system structure changes, for example when changing the station or the containment structure.

[0010] The disadvantages of machines with horizontal surfaces are partially eliminated by the machines illustrated in EP 3939896 and EP 3335844, which give examples of chambers with a controlled atmosphere inside the containment structure. Both chambers are served by an air flow in a top-to-bottom direction, which tends to limit / prevent particle deposition on the exposed surfaces of the process chamber. This air is generally filtered at both the inlet and outlet, and the flow is usually laminar or substantially laminar over at least a portion of it. Particle deposition is further limited by placing the robot on the wall, avoiding the use of a base. The term "wall" as used here and in the rest of this document, as used most broadly, refers to a vertically extending element.

[0011] However, the solutions described in EP 3939896 and EP 3335844 are not entirely satisfactory in that there continues to be a limited deposition of particles in the process chambers or, in any case, there is a tendency towards the use of more toxic substances and / or more stringent regulations.

[0012] Furthermore, all of the solutions described require special designs and implementations, making them difficult to design and / or manufacture, and customizable on time or at low cost. [Prior art documents] [Patent documents]

[0013] [Patent Document 1] European Patent Application Publication No. 3939896 [Patent Document 2] European Patent No. 3335844 Summary of the Invention [Problem to be solved by the invention]

[0014] The present invention is intended to obviate one or more of the disadvantages of the prior art solutions.

[0015] A first object of the invention is to provide a machine that facilitates the maintenance of chambers in the clean conditions required by pharmaceutical or biotechnological processes.

[0016] A second object of the present invention is to ensure high cleanliness in areas where contaminants or particles are typically more likely to accumulate.

[0017] It is an objective of some embodiments to have available space adjacent to the process station to accommodate the means for supplying energy or the means for supplying material.

[0018] Another objective in some embodiments is to facilitate the integration of venting means, as well as openings for the passage of material.

[0019] A non-secondary object of the present invention is to make the machine easy to build so that it can be quickly made available and / or quickly customizable, and preferably inexpensive. [Means for solving the problem]

[0020] These and other objects, which will become apparent to a person skilled in the art upon reading the following description, are achieved by a machine for pharmaceutical or biotechnological processes, an assembly, and a method for realizing the machine, according to the claims.

[0021] According to the teachings of this document, the machine comprises a structure, ventilation means and movement means.

[0022] The structure has an upper portion, a lower portion, and a wall therebetween with a first wall and a second wall opposite the first wall, the upper portion, the lower portion, and the wall defining a chamber.

[0023] The moving means for moving the material and / or the tools is configured to move the material and / or the tools in the working space inside the chamber.

[0024] The ventilation means comprises at least one fluid inlet inside the chamber above the working space, at least one fluid outlet from the chamber below the working space, and at least one fluid treatment unit suitable for pharmaceutical or biotechnological processes upstream of the at least one inlet. The ventilation means moves fluid from the at least one inlet to the at least one outlet.

[0025] The structure is configured such that the horizontal section of the chamber is constant or substantially constant or decreases descending from the at least one inlet to the at least one extraction port.

[0026] Advantageously, the first wall comprises a first portion, a second portion spaced horizontally from the first portion, and an inclined portion extending between the first and second portions, below the second portion and above the first portion and adjacent to the first and second portions to define the chamber.

[0027] The working space extends at least partly above the inclined portion and / or in a volume located above the first portion and in front of the inclined portion, at least in part this means that the working space also surrounds other areas.

[0028] The inclined portion is inclined relative to a horizontal plane, whereby the horizontal section of the chamber traversed by the fluid as it falls towards the first portion is reduced.

[0029] As exemplified below, the assembly comprises components, which are essential for carrying out a pharmaceutical or biotechnological process, and which can be linked with the remaining components to form the machine of the invention, as exemplified in the method.

[0030] Particular embodiments of the present invention, as defined in the claims, are described in the following sections of the specification with the aid of the accompanying figures. [Brief description of the drawings]

[0031] [Figure 1] FIG. 1 shows a front view of an embodiment of a machine for pharmaceutical or biotechnological processes according to the invention. [Diagram 2] FIG. 2 is a rear view of FIG. [Diagram 3] FIG. 1 is a cross-sectional view of an embodiment of a machine for pharmaceutical or biotechnological processes according to the invention, illustrating possible combinations of features according to the present disclosure. [Figure 4] FIG. 1 is a cross-sectional view of an embodiment of a machine for pharmaceutical or biotechnological processes according to the invention, illustrating possible combinations of features according to the present disclosure. [Diagram 5] FIG. 1 is a cross-sectional view of an embodiment of a machine for pharmaceutical or biotechnological processes according to the invention, illustrating possible combinations of features according to the present disclosure. [Figure 6]FIG. 1 is a cross-sectional view of an embodiment of a machine for pharmaceutical or biotechnological processes according to the invention, illustrating possible combinations of features according to the present disclosure. [Figure 7] FIG. 1 is a cross-sectional view of an embodiment of a machine for pharmaceutical or biotechnological processes according to the invention, illustrating possible combinations of features according to the present disclosure. [Figure 8] FIG. 1 is a cross-sectional view of an embodiment of a machine for pharmaceutical or biotechnological processes according to the invention, illustrating possible combinations of features according to the present disclosure. [Figure 9] FIG. 1 is a cross-sectional view of an embodiment of a machine for pharmaceutical or biotechnological processes according to the invention, illustrating possible combinations of features according to the present disclosure. [Figure 10] FIG. 1 is a front perspective view of an embodiment of an assembly according to the present invention. [Figure 11] 11 is a rear perspective view of an embodiment of an assembly according to the present invention substantially similar to the embodiment of FIG. 10; FIG. [Figure 12] 11 is a rear perspective view of an embodiment of an assembly according to the present invention substantially similar to the embodiment of FIG. 10; FIG. [Figure 13] FIG. 2 is a front view of another embodiment of a machine for pharmaceutical or biotechnological processes according to the invention, having another chamber, with trace lines of the cut surface in the following figures. [Figure 14] FIG. 14 is a cross-sectional view of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] With reference to the attached drawings, reference number 1 indicates a machine for pharmaceutical or biotechnological processes.

[0033] The embodiment of the machine (1) comprises a structure (10), means of movement for moving materials and / or tools, and means of ventilation (2).

[0034] The structure (10) has an upper portion (11), a lower portion (12) and walls (13, 14, 15, 16) therebetween, including a first wall (13) and a second wall (14) opposite the first wall (13).

[0035] The upper portion (11), the lower portion (12) and the walls (13, 14, 15, 16) define a chamber (100).

[0036] The moving means is configured to move materials and / or tools in the working space (100a) inside the chamber (100).

[0037] The ventilation means (2) comprises, inside the chamber (100), at least one fluid inlet (21a, 21b) above the working space (100a), at least one fluid extraction port (25a, 25b) below the working space (100a) for fluid from one of the chambers (100), and, upstream of the at least one inlet (21a, 21b), at least one fluid treatment unit (221) suitable for pharmaceutical or biotechnological processes.

[0038] The vent means (2) transfers fluid from at least one inlet (21a, 21b) to at least one outlet (25a, 25b).

[0039] The structure (10) is configured such that the horizontal section (A) of the chamber (100) is constant or substantially constant or decreases while descending from the at least one inlet (21a, 21b) to the at least one extraction port (25a, 25b).

[0040] The first wall (13) advantageously comprises a first portion (131), a second portion (132) spaced apart from the first portion (131) in relation to the horizontal direction (O), and an inclined portion (133) extending between the first portion (131) and the second portion (132) and adjacent to the first portion (131) and the second portion (132) below the second portion (132) and above the first portion (131) to define the chamber (100).

[0041] The operating space (100a) extends at least partially over the angled portion (133) and / or within a volume disposed above the first portion (131) and in front of the angled portion (133).

[0042] The inclined portion (133) is inclined with respect to the horizontal plane (H) so that the horizontal section (A) of the chamber (100) traversed by the fluid as it falls towards the first portion (131) is reduced.

[0043] The machine (1) of the invention avoids areas of stagnation of the fluid by lowering it towards at least one of the extraction openings (25a, 25b), promotes the acceleration of the fluid to prevent the deposition of contaminants or particles, and facilitates the suspension movement of the contaminants or particles. In particular, these advantages are evident around the inclined section (133) and the moving means, which often cause obstacles, hidden areas and / or sources of emission of contaminants or particles from the mechanical parts of the moving means. Similar advantages to those obtained for the moving means can also be obtained for any functional unit (99) of the process, which is generally located in the inclined section (133) and / or comes from the first section (131), as will be explained in more detail below.

[0044] Generally, materials and / or equipment are moved to accomplish one or more pharmaceutical or biotechnological processes.

[0045] Figures 6, 7 and 8 are examples of some operating spaces (100a) illustrating that the operating spaces (100a) do not necessarily correspond to the spaces reached by the moving means, but correspond to the spaces in which the materials and tools operate.

[0046] As an example, the operating space (100a) represented in FIG. 7 has, relative to the operating space (100a) represented in FIG. 8, a volume located above the first portion (131) and in front of the inclined portion (133), in other words a volume located between the inclined portion (133) and the second wall (14).

[0047] 6, 7 and 8, it can also be seen that the inclined portion (133) is below the operating space (100a), i.e., the operating space (100a) is above the inclined portion (133).

[0048] The operating space (100a) preferably extends at least partially over the inclined portion (133).

[0049] Minimal incremental variations in the horizontal section (A) of the chamber (100) do not affect the flow velocity and its ability to effectuate flotation, in that respect the horizontal section (A) can be substantially constant.

[0050] The first wall (13) and the second wall (14) preferably move towards each other below the inclined portion (133) and above the at least one extraction opening (25a, 25b).

[0051] The above mentioned effects lead to an increase in the flow velocity, which further promotes the suspension movement of the contaminants accumulated above and the cleaning of the associated space. Here, the moving means or parts of the functional unit (99) are often devices with fixed positions.

[0052] The immediate movement can be clearly defined by the position of the first wall (13) and / or the second wall (14).

[0053] The second wall (14) preferably has a part (not shown) at the height of the inclined portion (133), which is inclined to reduce the horizontal section (A).

[0054] The further restriction of the horizontal section (A) defined by the second wall (14) within the portion following the inclined portion (133) further facilitates increasing the velocity of the flow with the benefits mentioned above.

[0055] The second portion (132) preferably comprises an opening (130) for introducing or removing material into the chamber (100). Machines for pharmaceutical or biotechnological processes are usually provided with similar openings (130), which are often located in close proximity to the working space (100a).

[0056] The inclined portion (133) thus makes it possible to direct the flow surrounding the opening (130), as well as contaminants from the material that can pass through the opening (130), towards the at least one extraction opening (25a, 25b), while at the same time encouraging the avoidance of the accumulation of contaminants. In this way, a high level of cleanliness is maintained despite the presence of areas that are open or open to the external environment.

[0057] At least one extraction opening (25a, 25b) can be made in the first wall (13), as can be seen in Figure 8, or in the second wall (14), as shown by way of example in Figure 6, or in both, as shown by way of example in Figure 7. As a combination or alternative, at least one extraction opening (25a, 25b) can be made in the lower part (12). Positioning in the first wall (13) or in the second wall (14) is more convenient, especially if a filter (222) is arranged in the at least one extraction opening (25a, 25b).

[0058] The extraction opening (25a) is preferably made in the second wall (14).

[0059] The extraction from the opposite side to the inwardly inclined inclined portion (133) not only facilitates flow direction but also allows a larger volume to be placed under the inclined portion (133), which is useful for device configurations, for example the means for supplying energy (6) and / or the means for supplying material (7) can be configured as a transfer means, which is useful for pharmaceutical or biotechnological processes carried out inside the chamber (100).

[0060] At least one extraction opening (25a, 25b) can be made in the first wall (13), but if realised in the second wall (14) it generally allows to provide a larger volume for the filter (222), which is particularly useful for increasing the volume of the chamber (100) and / or for connection to components of the vent means (2) arranged outside the second wall (14). This is advantageous in applications where it is difficult to define additional space beyond the space generally available for the vent means (2) above the upper part (11).

[0061] Assuming the same conditions, and referring to FIGS. 4 and 5, the chamber (100) of FIG. 4 requires a larger volume of filter (222) relative to the filter (222) of the chamber (100) of FIG.

[0062] The first wall (13) is preferably connected to the lower portion (12) with a chamfer and / or the second wall (14) is preferably connected to the lower portion (12) with a chamfer. The chamfer (R) is adapted to direct the flow towards the at least one extraction port (25a, 25b), thereby improving the floatation movement towards the outside of the chamber (100).

[0063] More preferably, due to the presence of an extraction opening (25a) realized in the second wall (14), the first wall (13) is connected to the lower part (12) with a chamfer, and due to the presence of an extraction opening (25b) realized in the first wall (13), the second wall (14) is connected to the lower part (12) with a chamfer.

[0064] As can be seen in Figures 3, 4, 6 and 8, the radius of curvature of the chamfer (R) is preferably such that the chamfer (R) points towards the at least one extraction port (25a, 25b).

[0065] The ventilation means (2) preferably comprises a filter (222), suitable for pharmaceutical or biotechnological processes, arranged at the extraction openings (25a, 25b) to clean the fluid from suspended contaminants or particles.

[0066] The ventilation means (2) preferably comprises a recirculation conduit (23), which connects at least one extraction port (25a, 25b) to at least one inlet (21a, 21b), as illustrated diagrammatically in Figures 4, 7 and 8. More preferably, the conduit (23) passes by the side of the second wall (14) instead of by the side of the first wall (13), as in known solutions.

[0067] The upper portion (11) typically houses at least one inlet (21a, 21b) and preferably the ventilation means (2) is configured such that the flow is laminar or substantially laminar in at least the first portion (F) and is directed perpendicular to the horizontal plane (H).

[0068] Laminar flow is often used in clean rooms due to its directional aspect. In the case of the machine (1) of the invention, it ensures a good suspension movement in the first part (F), which is usually free of obstacles, and a flow towards extraction.

[0069] Preferably, in particular in the case of laminar or substantially laminar flow, at least in the first part (F), the machine (1) comprises a separation wall (9) of the chamber (100), which wall (9) extends from the upper part (11) towards the lower part (12) to the height of the first part (131).

[0070] The separation wall (9) thus achieves a RABS-like configuration with a portion of the chamber (100) in which the moving means is set and where the inclined portion (133) and possibly also the opening (130) are present, are not subject to the effects of contaminants.

[0071] Preferably, especially in the case of laminar or substantially laminar flow, at least in the first portion (F), the at least one inlet (21a, 21b) extends or substantially extends across the entire horizontal section (A) of the chamber (100).

[0072] As can be seen especially in Figures 3 to 9, it is preferable for the flow to cover the entire horizontal section (A) to avoid the presence of areas where contaminants can accumulate.

[0073] In other words, at least one inlet (21a, 21b) preferably extends or substantially extends from the first wall (13) to the second wall (14), and more preferably from one of the walls (15, 16) adjacent to the first wall (13) and the second wall (14).

[0074] In particular in the case of laminar or substantially laminar flow, at least in the first portion (F), the first wall (13) and preferably both the second wall (14) have flat vertical portions (134, 141) that descend from the upper portion (11) and rest respectively in a vertical plane (Z). In this way, the areas of stagnation and possibly the laminar flow correct their direction without deviation.

[0075] Typically, but not necessarily, the walls (15, 16) adjacent to the first wall (13) and the second wall (14) are flat and vertical, i.e. they rest on a vertical plane as in Figure 14, although in other embodiments they can contribute to reducing the horizontal section (A).

[0076] The moving means may comprise a transport or conveyor, for example a conveyor belt, a mechanical arm, a robotic arm, and / or other known devices.

[0077] The moving means preferably comprises an arm (33). The machine (1) of the invention advantageously prevents the accumulation of contaminants and ensures floating movement even in the presence of the arm (33). The arm (33) can be a mechanical or robotic arm.

[0078] The movement means also generally comprises a contact part (34) carried on each arm (33), which contacts material and / or tools inside the working space (100a).

[0079] The operating means may comprise a device supported by the walls (13, 14, 15, 16) and / or the top portion (11) and / or the inclined portion (133).

[0080] Typically, but not necessarily, a vehicle comprises multiple devices.

[0081] The movement means preferably comprises at least one robot (31, 32). More preferably, each robot (31, 32) comprises an arm (33) and a contact portion (34), and is configured to move the contact portion (34) within the working space (100a).

[0082] The locomotion means or at least one robot (31, 32) preferably comprises a part (35) which is connected or assembled to the first part (131) and / or the tilting part (133) so as to easily receive energy and / or material.

[0083] The machine (1) preferably comprises means (6) for supplying energy to the moving means and / or means (7) for supplying material to the moving means, arranged in the first part (131) or in the inclined part (133) on the opposite side of the chamber (100) so that they are adjacent to the working space (100a).

[0084] More preferably, the means for supplying energy (6) and / or the means for supplying material (7) are located below the inclined portion (133), inside the volume generally utilized for the passage of the air conduit in prior art solutions.

[0085] The machine (1) preferably comprises at least one functional group (99), which cooperates with the moving means to realize a pharmaceutical or biotechnological process.

[0086] At least one functional group (99) may comprise a metering system, an accumulation system, a container closure system, a ring sealing station, a liquid or powder dosing system, a container or cap placement area, a carousel, a centrifuge, or other devices commonly used in the pharmaceutical or biotechnological industry.

[0087] The angled portion (133) more preferably houses or supports at least one functional group (99) and / or the first portion (131) supports at least one functional group (99).

[0088] 6 and 7, the working space (100a) allows the movement means to act on the inclined portion (133) and on any functional unit (99) supported by the first portion (131). In limiting the working space (100a), the position of at least one functional group (99) involved in carrying out a pharmaceutical or biotechnological process is taken into account.

[0089] The ventilation means (2) preferably comprises at least one ventilation arrangement (24). One ventilation arrangement (24) is often placed on the top part (11), and other ventilation arrangements (24) can be introduced to manage the internal overpressure or underpressure inside the chamber (100), as well as the intake, the outward exhaust, and the recovery. For example, other ventilation arrangements (24) are placed on the side of the second wall (14) in Figures 3 to 9, allowing dynamic management of the regeneration and the internal pressure in the chamber (100).

[0090] At least one fluid treatment unit (221) preferably comprises a filter, more preferably a HEPA type filter for pharmaceutical or biotechnological processes.

[0091] The ventilation means (2) generally comprises a filter (222) for filtering the air at the outlet to the chamber (100), preferably a HEPA type filter for pharmaceutical or biotechnological processes.

[0092] The ventilation means (2) also comprises a filter (223) for filtering the air going to or coming from the outside, preferably a HEPA type filter for pharmaceutical or biotechnological processes.

[0093] The at least one fluid treatment unit (221) preferably comprises a fluid cooling and / or heating unit.

[0094] The means for supplying energy (6) may comprise an electrical cable, an electrical control unit, a conduit for pressurized fluid, or other device commonly used in the pharmaceutical, biotechnology, or robotics industries.

[0095] The means for supplying material (7) may comprise pipes for fluids such as water, air or nitrogen, or mechanical parts for openings and / or drawers and / or compartments, pumps, valves or other devices commonly used in the pharmaceutical or biotechnology industry. By way of example, in Fig. 10 the compartments leading to the chambers are partially visible in dotted lines and may lead to the chamber (100).

[0096] The materials may include containers or container parts, pharmaceutical products, biotechnological products, experimental products, or other materials used in pharmaceutical or biotechnological processes.

[0097] The tools may include, for example, pliers, measuring tools, pick-up devices, filling devices, or other tools used in pharmaceutical or biotechnological processes.

[0098] It also relates to an assembly (0) for manufacturing a machine (1) according to the present specification.

[0099] An embodiment of the assembly (0) is: - a wall portion for delimiting the chamber (100) comprising a first portion (131) and an inclined portion (133); - at least one separate wall (4); - a base (5) supporting the first part (131) and at least one further wall (4); - movement means for moving the materials and / or the tools, configured to move the materials and / or the tools in the working space (100a); - means for supplying energy to the moving means (6) and / or means for supplying material to the moving means (7), where: - the base (5), the first portion (131), the inclined portion (133) and the at least one further wall (4) delimit, but do not necessarily close, a volume (V) housing the means for supplying energy (6) and / or the means for supplying material (7); The inclined portion (133) is adjacent to the first portion (131) and rises from the first portion (131) in an oblique direction (D) relative to the horizontal plane (H).

[0100] The assembly (0) according to the invention facilitates the construction of a machine (1) since it comprises the essential components for realizing a pharmaceutical or biotechnological process in the chamber (100), with the advantages mentioned above.

[0101] The assembly (0) may for example be pre-checked or pre-sorted to build the machine (1) of the invention and then transported to another location for assembly with other parts of the structure.

[0102] The assembly (0) can be easily integrated into very different structures while ensuring a high level of cleanliness inside the chamber (100).

[0103] The assembly (0) is more easily transportable than the entire machine (1) and makes it easier to utilize means for transporting sensitive and fragile objects.

[0104] The wall portion preferably also comprises a second portion (132), more preferably an opening (130), as can be seen, for example, in Figure 10. This may be useful to further limit the sequence of motion and to maximize motion prior to obtaining a pre-assembled assembly (0).

[0105] The moving means preferably comprises a portion (35) connected or mated to the first portion (131) and / or the angled portion (133) so as to be on the opposite side of the volume (V) and so as to be easily energized or to receive material.

[0106] The assembly (0) preferably comprises a separation part (8) and the moving means comprises a first device and a second device.

[0107] The separation portion (8) is disposed on the inclined portion (133) between the first device and the second device, and has a first inclined surface (81) and a second inclined surface (82) facing opposite each other and extending toward the inclined portion (133) in the coupling direction (C) of the first device and the second device.

[0108] The separating portion (8) can interact with or house the walls (15, 16) so as to define the boundary of the chamber (100), thereby encouraging distance for the flow from the walls (15, 16) by the inclined surface, for the same reasons already adopted by the inclined portion (133). Similarly, this advantage is enhanced when the walls (15, 16) are provided with openings.

[0109] The invention also relates to a method for manufacturing the machine (1) according to this specification.

[0110] An embodiment of the method comprises: - providing an assembly (0) according to one of the embodiments described herein; - providing a part comprising an upper part (11), a lower part (12), walls (13, 14, 15, 16) and a second part (132) of the walls configured to form a structure (10) together with the parts of the walls, with the upper part (11), the lower part (12) and the walls (13, 14, 15, 16) defining a chamber (100); - providing a venting means (2) equipped with at least one fluid treatment unit (221), at least one inlet (21a, 21b) and at least one outlet (25a, 25b), suitable for pharmaceutical or biotechnological processes; - connecting the parts into an assembly (0) to obtain a first wall (13) with a first part (131), a second part (132) spaced apart from the first part (131) according to a horizontal direction (O) and an inclined part (133) adjacent to the second part (132) and extending between the first part (131) and the second part (132) and below the second part (132) and above the first part (131), as well as a horizontal section (A) of the chamber (100) that is constant or substantially constant or decreases going down from a set area of ​​at least one inlet (21 a, 21 b) to a set area of ​​at least one outlet (25 a, 25 b); - configuring the ventilation means (2) to have at least one fluid inlet (21a, 21b) above the working space (100a) and at least one outlet (25a, 25b) from the chamber (100) below the working space (100a) and to move fluid from the at least one inlet (21a, 21b) to the at least one outlet (25a, 25b), Includes.

[0111] The above-described method makes it possible to take advantage of having a generally pre-sorted and pre-assembled assembly (0) to create a chamber (100) that is particularly suited for the specific requirements of a pharmaceutical or biotechnological process. Thus, the machine (1) of the invention can be quickly available and / or quickly realized, as well as low-cost for one derived from zero design and manufacturing operations.

[0112] Furthermore, improvements to the assembly (0) can have a direct impact on all the machines (1) that are going to be built.

[0113] In the step of providing an assembly (0), the assembly is preferably provided with a separation part (8) and a moving means is preferably provided comprising the first device and the second device.

[0114] The separation portion (8) is disposed on the inclined portion (133) between the first device and the second device, and has a first inclined surface (81) and a second inclined surface (82) facing opposite each other and extending toward the inclined portion (133) in the coupling direction (C) of the first device and the second device.

[0115] Furthermore, in a step of connecting the parts to the assembly (0), the separating portion (8) is connected to the walls (13, 14, 15, 16) such that the walls (13, 14, 15, 16) extend between the first inclined surface (81) and the second inclined surface (82). The advantages indicated above are thus obtained.

[0116] The accompanying drawings may illustrate, by way of example, and may elaborate on the teachings presented above.

[0117] Figure 1 illustrates, for example but not necessarily, access for maintenance and inspection. Figure 2 illustrates several openings (130) and a visible wall with an RTP (Rapid Transfer Port) type opening.

[0118] The machine (1) of the invention can be equipped with further chambers: for example, starting from the assembly (0) of Fig. 10, a single chamber (100) is realised, or a chamber (100) and three further chambers in the case of Fig. 14.

[0119] The realized machine (1) may comprise three separate chambers, the external configuration of which may be that illustrated in FIG.

[0120] The assembly (0) illustrated below can be made using a "modular" approach ensuring one or multiple stations.

[0121] Referring to the machine (1) in FIG. 3, substantially four regions, or horizontal strips, of fluid velocity can be seen, namely, from the top: a first region reaching the inclined portion (133), a second region at the inclined portion (133), a third region below the inclined portion (133) reaching the inclined end of the second wall (14), and a fourth region further down.

[0122] Although the opening (130) is depicted in FIG. 3, it may also be present in other embodiments as a connection (R).

[0123] 5 and 6, on the side of the first wall (13) opposite the chamber (100), there is a space in the machine (1), which may be used to place another white chamber or one with a controlled atmosphere, but also to return fluids towards at least one inlet (21a, 21b). The teachings of the present invention also make it possible to reduce the size of the machine (1) on the side of the first wall (13) opposite the chamber (100), with a higher cleaning efficiency at the opening (130).

[0124] In Fig. 10, although not necessarily, the base (5) comprises a platform extending from the first part (131) which facilitates the transport and management of the assembly (0) prior to realization of the machine (1) while protecting the area with the means of transport and possibly the functional unit (99).

[0125] In the same FIG. 10, as in the following FIGS. 11 and 12, it can be seen how easily it is possible to access the volume (V) and also the electric cable of the means for supplying energy (6).

[0126] As illustrated in Figures 11 and 12, the assembly (0) can easily be integrated with functional units (99), i.e. modules or devices commonly used in the pharmaceutical or biotechnological industries, greatly facilitating access during set-up, especially with regard to the set-up of the machine (1).

[0127] It should be understood that the above has been described as a non-limiting example, and any practical structural modifications are considered to fall within the scope of protection of the present technical solution, as claimed below.

Claims

1. A machine (1) for pharmaceutical or biotechnological processes, comprising: A structure (10) having an upper portion (11), a lower portion (12), and walls (13, 14, 15, 16) between said upper portion (11) and said lower portion (12), said walls (13, 14, 15, 16) including a first wall (13) and a second wall (14) opposite said first wall (13), said upper portion (11), said lower portion (12), and said walls (13, 14, 15, 16) defining a chamber (100); a means for moving materials and / or tools, configured to move materials and / or tools in a working space (100a) inside the chamber (100); and a ventilation means (2) comprising at least one fluid inlet (21 a, 21 b) inside said chamber (100) above an operating space (100 a), at least one fluid extraction port (25 a, 25 b) below said operating space (100 a) for fluids from said chamber (100), and at least one fluid treatment unit (221) suitable for pharmaceutical or biotechnological processes upstream of said at least one inlet (21 a, 21 b), for moving fluids from said at least one inlet (21 a, 21 b) to said at least one extraction port (25 a, 25 b); Equipped with the structure (10) is configured so that the horizontal section (A) of the chamber (100) is constant or substantially constant or decreases going down from the at least one inlet (21 a, 21 b) to the at least one outlet (25 a, 25 b), wherein the machine (1) the first wall (13) comprises a first portion (131), a second portion (132) spaced apart from the first portion (131) in the horizontal direction (O), and an inclined portion (133) extending between the first portion (131) and the second portion (132) and adjacent to the first portion (131) and the second portion (132) below the second portion (132) and above the first portion (131) to define the chamber (100); the working space (100a) extends at least partially above the inclined portion (133) and / or in a volume located above the first portion (131) and in front of the inclined portion (133); and the inclined portion (133) is inclined with respect to the horizontal plane (H), so that the horizontal section (A) of the chamber (100) traversed by the fluid as it falls towards the first portion (131) is reduced; A machine (1) characterized by:

2. 2. The machine of claim 1, wherein the first wall (13) and the second wall (14) approach each other below the inclined portion (133) and above the at least one extraction opening (25a, 25b).

3. 3. The machine (1) according to claim 1 or 2, wherein the second wall (14) has an inclined portion (not shown) so as to reduce the horizontal section (A) at the height of the inclined portion (133).

4. The machine (1) according to any one of claims 1 to 3, wherein the second part (132) comprises an opening (130) for introducing material into or removing material from the chamber (100).

5. 5. The machine (1) according to claim 4, wherein the working space (100a) extends at least partially over the inclined portion (133).

6. The machine (1) according to any one of claims 1 to 5, wherein an extraction opening (25a) is made in said second wall (14).

7. 7. The machine (1) according to any one of claims 1 to 6, wherein the at least one extraction opening (25a, 25b) is made in the first wall (13) and / or according to claim 6, wherein the second wall (14) and / or the first wall (13) are each connected to the lower part (12) with a chamfer, the chamfer (R) being adapted to direct the flow towards the at least one extraction opening (25a, 25b).

8. 8. The machine (1) according to any one of claims 1 to 7, wherein the ventilation means (2) comprise a filter (222) suitable for pharmaceutical or biotechnological processes, arranged in at least one extraction opening (25a, 25b).

9. 9. The machine (1) according to any one of claims 1 to 8, wherein the ventilation means (2) comprises a recirculation conduit (23) connecting at least one extraction inlet (25a, 25b) to at least one inlet (21a, 21b).

10. 10. The machine (1) according to any one of claims 1 to 9, wherein the upper part (11) houses at least one of the inlets (21a, 21b) and the ventilation means (2) are configured such that the flow is laminar or substantially laminar in at least the first part (F) and is directed perpendicular to a horizontal plane (H).

11. 11. The machine (1) according to claim 10, further comprising a separating wall (9) of the chamber (100), the separating wall (9) extending from the upper part (11) towards the lower part (12) to the height of the first part (131).

12. The machine (1) according to any one of the preceding claims, wherein at least one of the inlets (21a, 21b) extends over the entire horizontal section (A) of the chamber (100) or substantially the entire horizontal section (A).

13. 13. The machine (1) according to any one of claims 1 to 12, wherein both the first wall (13) and the second wall (14) have flat vertical portions (134, 141) which descend from the upper portion (11) and rest in a respective vertical plane (Z).

14. Machine (1) according to any one of the preceding claims, wherein the walls (15, 16) adjacent to the first wall (13) and the second wall (14) are flat and vertical.

15. Machine (1) according to any one of the preceding claims, wherein said movement means comprises a part (35) connected to or associated with said first part (131) and / or said inclined part (133).

16. Machine (1) according to any one of the preceding claims, wherein said means of movement comprise at least one robot (31, 32).

17. 17. The machine (1) according to any one of claims 1 to 16, comprising means (6) for supplying energy to the moving means and / or means (7) for supplying material to the moving means, the means (7) being arranged in the first part (131) or in the inclined part (133) on the side facing the chamber (100).

18. 18. Machine (1) according to claim 17, wherein the means (6) for supplying energy and / or the means (7) for supplying material are located below the inclined portion (133).

19. Machine (1) according to any one of the preceding claims, comprising at least one functional group (99) which, in cooperation with said means of movement, realizes a pharmaceutical or biotechnological process.

20. 20. Machine (1) according to claim 19, wherein said inclined portion (133) houses or supports at least one functional group (99).

21. 21. Machine (1) according to claim 19 or 20, wherein said first part (131) supports at least one functional group (99).

22. An assembly (0) for realising a machine (1) according to any one of claims 1 to 21, comprising: a wall portion for delimiting the chamber (100) comprising a first portion (131) and an inclined portion (133); at least one further wall (4); a base (5) supporting said first portion (131) and at least one further wall (4); a moving means for moving the material and / or the tool, configured to move the material and / or the tool in the working space (100a); and means (6) for supplying energy to said moving means and / or means (7) for supplying material to said moving means; Equipped with where: said base (5), said first portion (131), said inclined portion (133) and at least one further wall (4) delimit a volume (V) containing said means for supplying energy (6) and / or said means for supplying material (7); The assembly (0) wherein said inclined portion (133) is adjacent to said first portion (131) and rises from said first portion (131) in an oblique direction (D) relative to a horizontal plane (H).

23. A separating part (8) is provided, the moving means comprises a first device and a second device; The separating portion (8) is disposed on the inclined portion (133) between the first device and the second device, and has a first inclined surface (81) and a second inclined surface (82) facing opposite to each other and widening toward the inclined portion (133) in the coupling direction (C) of the first device and the second device. Assembly (0) according to claim 22.

24. A method for implementing a machine (1) according to any one of claims 1 to 21, comprising: Providing an assembly (0) according to claim 22 or 23, providing a part comprising an upper part (11), a lower part (12), walls (13, 14, 15, 16), and a second part (132) of the walls, which together with said upper part (11), said lower part (12) and said walls (13, 14, 15, 16) define a chamber (100) and are configured to form a structure (10) together with said wall parts; Providing a venting means (2) suitable for pharmaceutical or biotechnological processes, comprising at least one fluid treatment unit (221), at least one inlet (21a, 21b) and at least one outlet (25a, 25b), connecting said parts to said assembly (0) to achieve a first wall (13) comprising a first part (131), a second part (132) spaced apart from said first part (131) according to a horizontal direction (O), and an inclined part (133) adjacent to said second part (132) and extending between said first part (131) and said second part (132), below said second part (132) and above said first part (131), as well as to achieve a structure (10) having a horizontal section (A) of the chamber (100) that is constant or substantially constant or decreases downward from the set area of ​​at least one inlet (21 a, 21 b) to the set area of ​​at least one outlet (25 a, 25 b); configuring said venting means (2) to have at least one fluid inlet (21 a, 21 b) located above the working space (100 a) and at least one fluid extraction port (25 a, 25 b) from said chamber (100) below said working space (100 a), and to move fluid from said at least one inlet (21 a, 21 b) to said at least one extraction port (25 a, 25 b); A method comprising:

25. 25. The method according to claim 24, wherein in the step of providing an assembly (0), an assembly (0) according to claim 23 is provided, and in the step of connecting the parts to the assembly (0), a separating portion (8) is connected to the wall (13, 14, 15, 16) such that the wall (13, 14, 15, 16) extends between a first inclined surface (81) and a second inclined surface (82).

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