A system for pharmaceutical, microbiological or biotechnological processes and a method for transferring objects and / or materials

Abstract

A system (1000, 1000') comprising an area (101) for housing pharmaceutical, microbiological or biotechnological processes, a chamber (1, 1a) comprising walls (11) which delimit a volume (V) and at least an opening (12a), between the volume (V) and the area (101), for passage of objects and / or material (A) between the volume (V) and the area (101) and / or vice versa, and a vehicle (2) which is movable internally of the area (101), configured to move objects and / or materials (A) from and / or to the chamber (1, 1a) and comprising a door (21) which is engageable at least in an opening of the at least an opening (12a) so as to separate the other area (101) from the volume (V). The system (1000, 1000') enables realising a method for transferring objects and / or materials (A) and a pharmaceutical, microbiological or biotechnological process comprising the method.

Description

[0001] A SYSTEM FOR PHARMACEUTICAL, MICROBIOLOGICAL OR BIOTECHNOLOGICAL PROCESSES AND A METHOD FOR TRANSFERRING OBJECTS AND / OR MATERIALS

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to the technical sector regarding systems for pharmaceutical processes or the like, for example microbiological or biotechnological processes, as well as to the technical sector relating to methods for transferring objects and / or materials in these contexts, the methods being an integral part of the pharmaceutical processes or the like. In greater detail the invention relates to the transfer of objects and / or materials between distinct spaces, among which at least one is a cleanroom.

[0004] DESCRIPTION OF THE PRIOR ART

[0005] It is known how systems for pharmaceutical processes or the like, with the aim of preventing contamination caused by inert particles and / or chemical and / or biological contaminants or risks to human health, must have structural characteristics and / or functional characteristics and / or operating procedures such as to define spaces with classified air and, possibly, spaces and / or equipment that are decontaminated. The classified air can be required to satisfy a class requirement demanded by a specific standard, for example class ISO 5 as defined by the ISO 14644-1 standard.

[0006] Commonly spaces with classified air are denoted by the term cleanrooms, although the term cleanroom is also used to indicate the system comprising one or more spaces having classified air. When it is desired to reach levels that are particularly stringent in terms of cleanliness and / or reduction of risks often use isolators or barrier systems with limited access, in the following also referred-to as RABS, an acronym for Restricted Access Barrier System.

[0007] RABS use a structure that surrounds the process apparatus and which is open towards the surrounding environment, typically again represented by a cleanroom. RABS can use the air handling means in the cleanroom that surrounds them or be provided with dedicate air handling means.

[0008] The isolators guarantee the sealing of the space with respect to the surrounding environment and comprise dedicated air handling means, thus offering a greater protection against contamination and risks to human health. Further, the completely closed and sealed arrangement facilitates the use of decontamination processes that are particularly effective and extended, such as for example the decontamination processes that use hydrogen peroxide.

[0009] Although the use of machinery and robots internally of isolators and RABS has been known for some time, they continue to comprise gloves and / or doors for allowing the intervention of personnel, if not during the main process, at least in the case of unforeseen events, and / or to allow transfer of objects and / or materials from or towards the cleanroom.

[0010] Patent application EP4166288A1 describes a further example of a cleanroom that is completely automated and not overseen, being closed in a prefabricated covering process; the system of EP4166288A1 is called an automated unmanned and gloveless cleanroom processing enclosure. Although the solution of EP4166288A1 enables obviating the presence of gloves and / or doors for the intervention of personnel, there is still the need to transfer objects and / or materials between distinct spaces. In general terms the distinct spaces for which a separation or barrier is included, with the aim of limiting or preventing contamination of at least one of the spaces. The separation or barrier is in general realised with one or more divider elements, frequently together, with a management of the air flows. The objects and / or materials to be transferred can be multiple, tendentially any element that is inherent to the process that is realised, for example: containers, being vials, bottles or ampoules, tubs or nests with containers, caps, lyophilization caps, tubs or nests with caps or lyophilization caps, ring-seals, syringes, accessories, disposable material and instruments, such as vibrators, grippers or plates for cell cultures.

[0011] It is known to subject the transfer between distinct spaces under control and management of decontamination with solutions that can be active or passive, often by a combination of a number of these solutions.

[0012] Two main technologies are known for the transfer of objects between distinct spaces: the access doors known as Rapid Transfer Ports or RTP, and the pass through chambers, are generally known as pass boxes, cleanroom pass throughs, clean transfer windows or transfer hatches. The pass through chambers, regardless of the specific term used, comprise a volume that is interposed between the distinct spaces.

[0013] Also known are pass through chambers provided with automatic opening and closing systems of the doors, generally commanded by an operator. An example is represented by an automatic door sold by the company Terra Universal and provided with an arm which has an end hinged to the frame and associated to a motor and the other end slidably hinged to the door.

[0014] Rapid Transfer Port technology does not guarantee the integrity of the classified space, due also to the high degree of involvement of the human operator, and is normally used for pre-sterilised materials.

[0015] In pass box technology, the volume enables limiting the risks of reciprocal contamination, for example with the possible use of interlocking devices which enable opening towards a single space at a time. Further, this technology can enable decontamination and / or washing of the objects in inlet and / or in outlet and can further limit the risks of reciprocal contamination in a case where the pass through chamber comprises one or more decontamination and / or washing devices. In this latter case, the pass through chamber is denominated, in technical jargon, active or dynamic, so as to distinguish it from the passive or static pass through chambers. Examples of decontamination and / or washing devices of known type comprise use of temperature, use of fluids, being for example washing water, water vapour, air, decontaminant gases, inert gases and detergents, use of depression and use of a decontamination unit with a radiation source, for example UVC, UV, a beam of accelerated electrons and pulsating light. The fluids can be dispensed and diffused in many ways and / or directions, for example in a downwards or upwards direction. Some of the chemical agents known to the expert in the sector comprise hydrogen peroxide, ozone, chlorine dioxide, ethylene oxide, propylene oxide and peracetic acid.

[0016] In both cited technologies, the transfer of the objects usually takes place with the direct involvement of the human operator, directly or through the use of gloves. In the case of pharmaceutical processes, but not only, the human presence constitutes a risk factor for contamination for the materials or process instruments, or a risk for the health of the personnel.

[0017] The solutions of patent EP3399018B1 and patent application US2016200461 A1 propose the implementation of the automation and / or robotisation in the transfer of objects and / or materials between spaces.

[0018] Patent EP3399018B1 describes an aeration method of an isolator system which comprises an isolator, an incubator a pass through chamber between the isolator and incubator and two doors to access the pass through chamber, respectively from the isolator and the incubator. According to the patent description the doors are manually moved by an operator through the use of gloves or might be moved by two robots respectively arranged in the isolator and the incubator.

[0019] Patent application US2016200461 A1 describes the transfer of bottles and caps in a sealed cleanroom owing to the use of an apparatus or a robot with an articulated arm which picks up, via a door, the bottles and the caps from a pre-chamber in which a decontamination process is included.

[0020] Although evidently there is a trend towards automation and / or robotisation of the transfer of objects between distinct areas, the existing solutions continue to replicate the structures and approaches that have to the present day characterised the manual systems. In this way there is the risk of still having the traditional limits and critical aspects and the resources inherent in automatic and / or robotic devices are not exploited and / or resources are used to adapt the functioning of the automatic and / or robotic devices to the manual methods.

[0021] For example, replicating a transfer of the objects and / or materials alike to the manually operated transfer using gloves requires the use of a particularly advanced robot as the release and / or collection by the end effector of a robot is a delicate operation and requires special attention.

[0022] Again, for example, replicating the opening of the manual doors or automatic doors present in traditional pass through chambers prevents a reduction of operating spaces and dimensions, as well as requiring a coordination with respect to the movements of the automatic devices and / or robots. A reduction of operating spaces, in fact, i.e. the process chambers, can have a direct beneficial effect on the air handling means and / or on the decontaminating and / or washing means.

[0023] Further, the drawbacks delineated above also exist in the transfer of objects and / or materials towards and / or from spaces delimited internally of classified areas. For example, the described case history is reflected when a distinct process is included in a closed space or internal chamber, as occurs in relation to the capping apparatus in patent application US2016200461 A1 . A further example is represented by an autoclave or another sterilisation and / or decontamination and / or washing apparatus inserted internally of an isolator.

[0024] SUMMARY OF THE INVENTION

[0025] The present invention has the objective of obviating one or more of the drawbacks in the solutions of the prior art. A prime aim of the present invention is to provide a system for operating pharmaceutical, microbiological or biotechnological processes which simplifies the transfer of objects and / or materials towards or from areas predisposed to house pharmaceutical, microbiological or biotechnological processes.

[0026] A second aim is to provide a system and a method that limit the risk of contamination in the transfer of objects and / or materials.

[0027] A further aim, especially of some embodiments, is to improve the integration of the automatic solutions and / or robotic solutions in the cleanrooms so as to achieve advantages in realisational and / or functional terms and / or terms of control of the system and / or control of the contamination. In this way it is also possible to facilitate the improvement of the processes realisable in the system and / or the processes which use the method.

[0028] A still further aim is to enable, at least in some contexts, continuity of processes internally of the system during the course of the transfer of objects and / or materials. In this sense, the presence of a volume that can be confined by an operating area enables prosecution without interferences of the processes under way in that area; further, it can enable introduction into the area, via the volume, objects and / or materials useful for further carrying out of the processes.

[0029] These and other aims that will become clear to the expert in the sector from a reading of the description that follows are attained with a system for pharmaceutical, microbiological or biotechnological processes or a method for transferring objects and / or materials from and / or towards an area which is configured so as to house pharmaceutical, microbiological or biotechnological processes or a pharmaceutical, microbiological or biotechnological process according to the contents of the claims.

[0030] According to the teachings of the present description, the system comprises an area, a chamber and a vehicle.

[0031] The area is configured so as to house pharmaceutical, microbiological or biotechnological processes.

[0032] The chamber comprises walls which delimit a volume and at least an opening for passage of objects and / or materials between the volume and the area and / or vice versa.

[0033] The vehicle is movable internally of the area and is configured to move objects and / or materials from and / or to the chamber. The vehicle advantageously comprises a door which is engageable at least in an opening of the at least an opening so as to separate the area from the volume.

[0034] The system is preferably an isolator, a Restricted Access Barrier System, an automated unmanned and gloveless cleanroom processing enclosure or a cleanroom.

[0035] The method comprises steps of:

[0036] - providing a system such as the one described in the foregoing or according to an embodiment that is detailed in the following;

[0037] - engaging the door in the opening;

[0038] - transferring one or more objects and / or one or more materials from or to the vehicle after the door is engaged in the opening;

[0039] - disengaging the door from the opening;

[0040] - moving the one or more objects and / or the one or more materials internally of the area through the vehicle.

[0041] The method is preferably part of a pharmaceutical, microbiological or biotechnological process.

[0042] BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Specific embodiments of the invention will be described in the following part of the present description, according to what is set down in the claims and with the aid of the accompanying figures, in which: figure 1 is an axonometric view and of a first embodiment of a system for pharmaceutical, microbiological or biotechnological processes according to the invention; figure 2 is the same axonometric view as in figure 1 in a different operating condition of the system of figure 1 ; figure 3 is an axonometric view of an embodiment of a system for pharmaceutical, microbiological or biotechnological processes according to the invention; figure 4 is the same axonometric view as in figure 3 in a different operating condition of the system of figure 3; figure 5 is an axonometric view of a second embodiment of a system for pharmaceutical, microbiological or biotechnological processes according to the invention which differs from that of figure 3 due to the presence of a first door; figure 6 is the same axonometric view as in figure 5 in a different operating condition of the system of figure 5; figure 7 is a frontal axonometric view of the vehicle visible in figures from 1 to 5; figure 8 is an rear axonometric view of the vehicle visible in figures from 1 to 5; figure 9 is a frontal axonometric view of a further embodiment of the vehicle which differs from that of figure 7 due to the presence of a seal; figure 10 shows a schematic lateral view and of a third embodiment of a system for pharmaceutical, microbiological or biotechnological processes according to the invention which differs from that of figure 3 due to the presence of optional details and the presence of an outlet conduit; figure 11 shows a schematic lateral view of a still further embodiment of the vehicle; figure 12 shows a schematic lateral view of a fourth embodiment of a system for pharmaceutical, microbiological or biotechnological processes according to the invention which differs from that of figure 3 due to the presence of optional details and the presence of a second vehicle; figure 13 shows a schematic lateral view of a fifth embodiment of a system for pharmaceutical, microbiological or biotechnological processes according to the invention which differs from that of figure 12 due to a different support means of the second vehicle; figure 14 shows a schematic lateral view of an embodiment of a pass through chamber, different to the one of figures 10, 12 and 13; figure 15 shows a schematic lateral view of an embodiment of a pass through chamber, different to the one of figures 10, 12, 13 and 14; figure 16 illustrates a container complete with a cap in a relative position in which the cap does not close the mouth of the container; figures from 17 to 22 each show a schematic view from above of possible installations of pass through chambers in a system for pharmaceutical, microbiological or biotechnological processes according to the invention; figures 23 and 24 each show a schematic view from above of embodiments of a system for pharmaceutical, microbiological or biotechnological processes according to the invention; figure 25 is a perspective view of an embodiment of a system for pharmaceutical, microbiological or biotechnological processes according to the invention, in the form of automated unmanned and gloveless cleanroom processing enclosure denoting the outline of the cutting plane of the following figure; figure 26 is a section view of figure 25; figure 27 is an axonometric view of a sixth embodiment of a system for pharmaceutical, microbiological or biotechnological processes according to the invention which differs from that of figure 5 due to the door visible on the left; figure 28 is an axonometric view of a sixth embodiment of a system for pharmaceutical, microbiological or biotechnological processes according to the invention which differs from that of figure 3 due to the doors visible on the left; figure 29 shows a schematic lateral view of an embodiment of the chamber, different to the one of figure 1 ; figure 30 is a schematic view from above of an eighth embodiment of a system for pharmaceutical, microbiological or biotechnological processes according to the invention; figure 31 is an axonometric view of a ninth embodiment of a system for pharmaceutical, microbiological or biotechnological processes according to the invention which differs from that of figure 6 due to the presence of an opening on the first door; figure 32 is an axonometric view of a tenth embodiment of a system for pharmaceutical, microbiological or biotechnological processes according to the invention which differs from that of figure 1 due to the presence of a first door and an opening on the first door.

[0044] DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] With reference to the appended figures, reference numerals 1000 and 1000’ denote a system for pharmaceutical, microbiological or biotechnological processes. As already evidenced in the description of the prior art, like processes require suitable spaces, generically known as cleanrooms.

[0046] The references are given to facilitate understanding of the invention but are not intended to limit the scope of protection thereof.

[0047] An embodiment of the system (1000, 1000’) comprises an area (101 ) which is configured to house pharmaceutical, microbiological or biotechnological processes, a chamber (1 , 1a) and a vehicle (2).

[0048] The chamber (1 , 1a) comprises walls (11 ) which delimit a volume (V) and at least an opening (12a) for passage of objects and / or materials (A) between the volume (V) and the area (101 ) and / or vice versa.

[0049] The vehicle (2) is movable internally of the area (101 ) and is configured to move objects and / or materials (A) from and / or to the chamber (1 , 1a).

[0050] The vehicle (2) advantageously comprises a door (21 ) which is engageable at least in an opening of the at least an opening (12a) so as to separate the area (101 ) from the volume (V).

[0051] According to the teachings of the invention, the door (21 ) borne by the vehicle (2) enables separating the area (101 ) from the volume (V) by means of the engagement thereof in an opening of the at least an opening (12a); owing to this characteristic simplifications and / or improvements are possible to the system (1000, 1000’) or to the process that is realised in the system (1000, 1000’). In the following, some of these obtainable possible advantages will be set out, the application thereof depending on the specific conditions of single applications. Among these are: the possibility of arranging a chamber (1 , 1a) not provided with a first door (13) and the possibility that the vehicle (2) picks up and / or releases objects and / or materials (A) with a separation between the volume (V) and the area (101 ) without the need for the vehicle (2) to move away from the chamber (1 , 1a).

[0052] The chamber (1 , 1a) can be open only towards the area (101 ), in this case denominated an internal chamber (1a) in the rest of this document, or can be a pass through chamber (1 ) which enables transfer towards another area (102).

[0053] The following part of the description will mainly make reference to the case of a pass through chamber (1 ), as it is evident that the internal chamber (1a) can in turn comprise the optional characteristics described in the following, when these are not in relation to the other area (102) or the at least another opening (12b) introduced below.

[0054] This also appears clearly from a comparison of figures 1 , 2, 29 and 30 respectively with figures 3, 4, 15 and 24; the former relative to an embodiment with an internal chamber (1a) and the latter relative to an embodiment with a pass through chamber (1 ). Figure 26 is also an example of how the two versions can coexit within a same system (1000, 1000’).

[0055] In the light of the above, and embodiment of the system (1000, 1000’) comprises an area (101 ) which is configured to house pharmaceutical, microbiological or biotechnological processes, a structure (100) which separates the area (101 ) from another area (102), a pass through chamber (1 ) and a vehicle (2).

[0056] The pass through chamber (1 ) is installed at a part of the structure (100) in order to enable transfer of objects and / or materials (A) between the area (101 ) and the other area (102) and / or vice versa. In other words, the pass through chamber (1 ) can enable transfer of objects and / or materials (A) in a direction, in the opposite direction or in both directions; common pass boxes do not have limitations on direction of travel.

[0057] The pass through chamber (1 ) comprises walls (11 ) which delimit a volume (V) and openings (12a, 12b), at least an opening (12a) for passage of objects and / or materials (A) between the volume (V) and the area (101 ) and / or vice versa and comprising at least another opening (12b) for passage of objects and / or materials (A) between the volume (V) and the other area (102) and / or vice versa.

[0058] The vehicle (2) is movable internally of the area (101 ) and is configured to move objects and / or materials (A) from and / or to the pass through chamber (1 ). In other words, the vehicle (2) comprises a frame (24) which is able to support at least an object and / or at least material, and means for moving the frame (24) in space, in particular in the area (101 ). In this way, for example, the vehicle (2) can serve a robot or another processing device internally of the area (101 ), operating as a slave.

[0059] The vehicle (2) advantageously comprises a door (21 ) which is engageable at least in an opening of the at least an opening (12a) so as to separate the area (101 ) from the volume (V).

[0060] According to the teachings of the invention, the door (21 ) borne by the vehicle (2) enables separating the area (101 ) from the volume (V) by means of the engagement thereof in an opening of the at least an opening (12a); owing to this characteristic simplifications and / or improvements are possible, to the system (1000, 1000’) or to the process that is realised in the system (1000, 1000’). In the following some of these obtainable possible advantages will be set out, the application thereof depending on the specific conditions of single applications.

[0061] An advantage is the possibility of arranging a pass through chamber (1 ) not provided with a first door (13). In a common case, represented by way of example in figures 5 and 6, the first door (13) is movable between a closed position (C), in which it is engaged in an opening of the at least an opening (12a), and an open position (O), in which it is in the area (101 ). As the first door (13) can be removed, it no longer constitutes an object in the area (101 ) in the open position (O) and the need to coordinate the opening and / or closure thereof with the process operated in the system (1000, 1000’), as well as the position of the vehicle (2) are not required.

[0062] Another advantage is given by the possibility that the vehicle (2) can pick up and / or release objects and / or materials (A) with a separation between the volume (V) and the area (101 ) without the need for the vehicle (2) to move away from the pass through chamber (1 ), as occurs in traditional pass through chambers, with the aim of enabling closure of a door. As it is no longer necessary to move the vehicle (2) away, there emerges a further advantage given by the possibility of avoiding, or partially avoiding, the pickup and / or release of the objects and / or materials (A) on a surface internally of the volume (V), for example on the shelf (16) visible in the pass through chamber (1 ) of figure 14. In fact, the objects and / or materials (A) internally of the volume (V) can be supported by the frame (24) of the vehicle (2), with a separation between the volume (V) and the area (101 ) operated due to the door (21 ) engaged by the at least an opening (12a).

[0063] As shown in figures from 1 to 4, the vehicle (2) makes available objects and / or materials (A) internally of the volume (V) and, at the same time, the door (21 ) is interposed between the volume (V) and the area (101 ). The above observations with respect to figures from 1 to 4 are also valid in the case where the pass through chamber (1 ), or the internal chamber (1a), is provided with a first door (13), as in the system (1000, 1000’) illustrated in figures 5 and 6. In this case, as can be observed in figure 6, it is further possible to engage the opening of the at least an opening (12a) also with the first door (13), enabling the operability of the pass through chamber (1 ) with the vehicle (2) moved away. With reference to figures from 3 to 6, it is possible to pick up and / or place objects and / or materials (A) through the door of the other area (102).

[0064] In a case in which the first door (13) is present, the seal to the fluids and / or the dust is usually guaranteed by a seal (4) of known type, for example of an inflatable type. The same applies to the further doors not associated to a vehicle visible in the appended figures. Both the first door (13) and the further doors can be for example automatically and / or manually openable.

[0065] Many combinations are possible in terms of numbers of the at least an opening (12a) and use of respective doors and / or the door (21 ) and / or of doors of further vehicles similar or identical to the vehicle (2), some of these combinations being described in the following. One of these combinations, which can be particularly advantageous in some pharmaceutical, microbiological and / or biotechnological processes, includes at least a further pass through chamber (not illustrated but entirely alike to the pass through chamber (1 )) with a respective opening in which the door (21 ) can be engaged, similarly to what occurs with the at least an opening of the at least an opening (12a). The vehicle (2) can thus be used to transfer through the area (101 ) towards still another area towards which a further pass through chamber can be opened.

[0066] The openings (12a, 12b) are usually made on the walls (11 ), but an opening can also be made on a door which engages an opening realised on a wall (11 ), as illustrated in figures 31 and 32 and as described in the following.

[0067] The openings (12a, 12b) are preferably made on vertical portions of the walls (11 ).

[0068] Where the other area (102) is manually operated, or with different devices distinct from the second vehicle (3) subsequently introduced, each of the at least another opening (12b) is commonly provided with a respective door, possibly automatic, so as to guarantee the sealing of the volume (V).

[0069] The vehicle (2) can be made compact and in A simple way, especially in a case where the wall (21 ) is solidly constrained to the frame (24), especially in a case where the support means (22, 23, 26) are borne by the wall (21 ) and more especially in the case where some of the support means (22, 23, 26) are borne in a fixed way.

[0070] Regarding the above, the area (101 ) is typically a cleanroom. The other area (102) can also be a cleanroom and is so typically if it is part of the system (1000, 1000’).

[0071] As mentioned in the foregoing and as shown by way of example in figure 14, the pass through chamber (1 ) can comprise a shelf (16) which can be supported by a fixed structure or be movable by at least an actuator, for example by means of an electric cylinder or with a like system to the one used in the processing device of figures 15 and 29. More preferably, the shelf (16) can be orientable and / or rotatable about a vertical axis. The rotation of the shelf (16) enables the rotation of the objects and / or materials (A) in the volume (V).

[0072] The vehicle (2) preferably comprises support means (22, 23, 26) which support objects and / or materials (A) to be moved from and / or to the pass through chamber (1 ) in a transport volume (2V) which is arranged on a first side (21a) of the door (21 ) in such a way as to be in the volume (V) with the door (21 ) engaged in the opening (12a).

[0073] As illustrated in figures 23, 24 and 30, the support means (22, 23, 26) define a transport volume (2V) of the objects and / or materials (A) internally of the pass through chamber (1 ) or the internal chamber (1a), i.e. in the volume (V). The transport volume (2V) must be configured is such a way as to be able to cross the opening of the at least an opening (12a) that is to be engaged so as to have available the objects and / or materials (V) and maintain them in the volume (V) when the door (21 ) engages the opening.

[0074] As can be understood from the observation of figures 1 , 2, 3, 4 and 7 the first side (21a) of the door (21 ) functions as an internal wall of the pass through chamber (1 ) or of the internal chamber (1a) with the door (21 ) engaged in the opening (12a).

[0075] The support means (22, 23, 26) can comprise numerous devices and / or combinations of the devices. For example, figures 23, 24 and 30 illustrate a magnet (26), in figure 10 a tray (22) and in figure 11 a gripper (23). The presence of a tray (22) enables arranging an object and / or material in the volume (V) in a simple way which has previously been rested on the tray (22), possible for a subsequent pickup by another vehicle. A more detailed solution is illustrated in figures from 1 to 9. The support means (22, 23, 26) can also comprise, again with the possibility of combinations among them and with the examples illustrated above, one or more hooks, one or more gripping forks for gripping trays, one or more holes and one or more electromagnets.

[0076] Figure 11 shows by way of example how the gripper (23), as well as having prehensile fingers, can rotate, for example with respect to a horizontal axis, and could also translate or rotate with respect to other rotation axes.

[0077] Although in the appended figures the tray (22) is represented as being solidly constrained to the door (21 ), the vehicle (2) might comprise a sideshift or another device for moving the tray (22), for example for raising or lowering the tray (22) with respect to the door (21 ).

[0078] In the cases illustrated in figures 10 and 11 the tray (22) and the gripper (23) are inside the volume (V) with the door (21 ) engaged i.e. with reference to figure 10, with the vehicle (2) advanced towards the left by a distance equal to the distance between the door (21 ) and the opening of the at least an opening (12a).

[0079] According a particularly simple and effective embodiment:

[0080] - the vehicle (2) comprises a tray (22) which is borne by the door (21 ) on the first side (21a) and the tray (22) is configured in such a way as to be in the volume (V) with the door (21 ) engaged in the opening of the at least an opening (12a) and / or

[0081] - the vehicle (2) comprises a gripper (23) which is borne by the door (21 ) on the first side (21a) and the gripper (23) is configured in such a way as to be in the volume (V) with the door (21 ) engaged in the at least an opening (12a).

[0082] The presence of the tray (22) and / or the gripper (23), as well as other support means (22, 23, 26), internally of the volume (V) not only guarantees the support of the objects and / or materials (A), also preventing the contact thereof with other temporary rest or retaining surfaces, but it can also facilitate the carrying out of further operations in the volume (V) and / or the decontamination and / or the washing of the tray (22) or of the gripper (23).

[0083] As mentioned in the foregoing, through the at least another opening (12b), it is possible to pick up and / or place objects and / or materials (A) that the vehicle (2) has respectively released and / or must pick up. The passage of the objects and / or materials (A) through the at least another opening (12b) can take place manually by means of an operator or a robot, as known in the sector, or through a the second vehicle (3) alike to or identical to the vehicle (2).

[0084] The system (1000, 1000’) preferably comprises the other area (102) and a second vehicle (3). The second vehicle (3) is movable internally of the other area (102), is configured to move objects and / or materials (A) from and / or to the pass through chamber (1 ) and comprises a respective door (31 ) which is engageable in at least an opening of the at least another opening (12b) so as to separate the other area (102) from the volume (V).

[0085] In this case the above-described advantages can be provided in both sides, and the control and the repeatability of the process can be simpler, with also a reduction of the risks for the operators. Figures 12 and 13 illustrate how a plurality of variants is possible, for example by including a direct transfer between the vehicle (2) and the second vehicle (3), as in the case shown by way of example in figure 13, or an alternative access to the volume (V), as in the case shown by way of example in figure 12.

[0086] The second vehicle (3) can be realised in any one of the versions of the vehicle (2) described in the present description and for the second vehicle (3) the same considerations made for the vehicle (2) are valid. For example, it is possible to identify a respective first side (31a) also for the second vehicle (3), which can comprise a respective tray (32) and / or a respective gripper (33) and can have a respective frame (34), respective drive wheels (35) and a respective head (37). The engagement of the door (21 ) can be sufficient for some processes and, possibly, it might be integrated in a management of the air flows in proximity of the opening of the at least an opening (12a) engaged by the door (21 ). However in general it is preferable to guarantee the seal to the fluids and / or powder between the door (21 ) and the opening of the at least an opening (12a) engaged by the door (21 ).

[0087] For this reason the pass through chamber (1 ) and / or the vehicle (2) preferably comprises a seal (4) for guaranteeing the seal between the door (21 ) and the opening (12a). In general it is simpler to use the seal (4) traditionally arranged on the opening of the pass through chambers of known type, as exemplified in the majority of the appended figures. However, as exemplified only in figure 9, the vehicle (2) might comprise a seal (4), preferably arranged on the lateral surface, or a perimeter surface, of the door (21 ) as can be observed in figure 9.

[0088] The first version has the advantage of being widely available, and the seal (4) can also be used both for the door (21 ) and for the first door (13), if present, or for doors of different vehicles.

[0089] The second version has the advantage of having the activation directly in the vehicle (2), limiting the need for controls and / or activations externally of the vehicle (2).

[0090] The seal (4), especially if of the inflatable type, can ensure the hermetic sealing of the volume (V).

[0091] In a case where the pass through chamber (1 ) comprises a seal (4) it is preferable for it to be inflatable so that in a first operating condition it enables the movement of the door (21 ) from or to the opening of the at least an opening (12a) provided with a seal (4) and in a second operating condition ensures the seal between the door (21 ) and the opening of the at least an opening (12a).

[0092] Likewise, in a case where the vehicle (2) comprises a seal (4), it is preferable for it to be inflatable so that in a first operating condition it enables the movement of the door (21 ) from or to the opening of the at least an opening (12a) and in a second operating condition it ensures the seal between the door (21 ) and the opening of the at least an opening (12a).

[0093] As mentioned above, with reference to figures 5 and 6, the pass through chamber (1 ) can comprise a first door (13) which is movable between an open position (0) in which the first door releases an opening of the at least an opening (12a) and enables the engagement of the door (21 ) and a closed position (C) in which the first door (13) engages the opening (12a) so as to separate the area (101 ) from the volume (V).

[0094] As illustrated in figures 31 and 32, alternatively or in addition to a first door (13) as described above, the pass through chamber (1 ) can comprise a first door (13) which is movable between an open position (0) in which the first door releases a further opening of the at least an opening (12a) towards the area and a closed position (C) in which the door engages the further opening of the at least an opening (12a) so as to separate the area (101 ) from the volume (V). Further, the door (21) is engageable in an opening of the at least an opening made on the first door (13). By way of example, this version enables arranging a first door (13) that is bigger, for example useful for transfer of objects and / or materials (A) during the course of the predisposing of the area (101 ) for the process, and an opening which cooperates with the door (21 ) of the vehicle (2) or enables the use of another vehicle with a larger door which is engageable in the further opening of the at least an opening (12a).

[0095] The first door (13) on the area (101 ) can clearly be present also in the case where the chamber (1 , 1a) is an internal chamber (1a): a first door (13), denoted by a broken line in figure 30, is an example of this possibility and figure 32 shows the case of figure 31 applied to an internal chamber (1a).

[0096] The appended figures clarify how the vehicle (2) is configured to move internally of the area (101 ) so as to move objects and / or materials (A) internally thereof. In other terms, the vehicle (2) comprises a frame (24) which is configured to support the door (21 ) and objects and / or materials (A). As shown by way of example in figure 26 the vehicle (2) is configured to move objects and / or materials (A) between a first position (P1 ) and a second position (P2) into the area (101 ) which, in the case of figure 26, is represented by the operating volume internally of an automated unmanned and gloveless cleanroom processing enclosure system such as the one described in application EP4166288A1 . Figure 26 illustrates how the vehicle (2) can operate as a slave as it can reach and be an auxiliary to the devices present in the area (101 ).

[0097] The expert in the sector is aware of numerous alternatives of vehicle (2), for example vehicles on rails or vehicles on wheels or remotely guided vehicles, automatically guided vehicles or autonomous vehicles.

[0098] The vehicle (2) preferably comprises a frame (24), which is configured to support the door (21 ) and objects and / or materials (A), and wheels (25), which are motorised or moved by one or more motors and which are connected to the frame (24) so as to move objects and / or materials (A) between a first position (P1 ) and a second position (P2) in the area (101 ), due to the rotation of the wheels (25) on the floor of the area (101 ).

[0099] According to a particularly simple configuration which also facilitates the management of the vehicle (2) and the interaction thereof with the opening of the at least an opening (12a) the door (21 ) is solidly constrained to the frame (24) of the vehicle (2), and / or is slab-shaped or substantially slab-shaped, for example possibly being a metal plate, or made of plastic or composite material. In a preferred embodiment the door (21 ) is conformed as the wall adjacent to the opening of the at least an opening (12a) to which it engages, and can even have a smaller thickness. In this way a continuous wall is created, with a possible interpositioning of the seal (4).

[0100] In a case in which the door (21 ) is solidly constrained to the vehicle (2) and slabshaped, it is preferable for it to have a vertical median plane (M), as illustrated by way of example in figures 11 and 13.

[0101] As is clear to the expert in the sector the door (21 ) it must be borne by the vehicle (2) so as to engage the opening (12a), for example guaranteeing the same height from the ground between the door (21 ) and the opening (12a).

[0102] Although the door (21 ) might be movable with respect to the frame (24) of the vehicle (2), a solidly-constrained door (21 ) simplifies the construction and the introduction of the support means (22, 23, 26) on the first side (21a), as well as limiting the number of activations and the controls thereof.

[0103] In a replication of the traditional closure of the pass through chamber of known type, the door (21 ) can be planar and vertical, with the consequent advantage of limiting the dust or particle deposits on the door (21 ) itself, tendentially also during the movement of the door (21 ) internally of the area (101 ).

[0104] The vehicle (2) is preferably a movable robot, typically a movable robot configured to operate in a cleanroom, or in a space having controlled contamination with classified air. As is known to the expert in the sector, in order to have available a cleanroom operating space internally of the system (1000, 1000’) air handling means (5) are typically present, schematically indicated in figure 25, and, possibly, decontaminating and / or washing means. Like air handling means (5) are of known type and like decontaminating and / or washing means are of known type and illustrated schematically in the preamble.

[0105] The air handling means (5) enable control of the area and the spaces of the system (1000, 1000’) in terms of control and management of decontamination, for example also including a negative or positive pressurisation between the area (101 ) and the volume (V) and, possibly, between the volume (V) and the other area (102). For example the transfer can take place from a non-controlled environment to a class ISO 5 ambience, as defined by the ISO 14644-1 standard. In other words, at least the area (101 ) is almost surely a classified environment.

[0106] Typically the air handling means (5) generate an air flow, with the term air indicating the fluid present in the space, the vertical laminar flow in the area (101 ). However some processes might use turbulent flows or even a laminar / horizontal directional flow. The air flow is generally treated with the use of filters suitable for the process that are realised internally of the system (1000, 1000’) at least towards the area (101 ) but often also towards the outside, especially for reasons relating to human safety. The area (101 ), as well as the machinery and equipment internally thereof, is also subject, generally, to a decontamination and / or washing process, for example using decontaminating and / or washing means described in the preamble hereto; typically at least at the end of the process setting.

[0107] The door (21 ) borne by the vehicle (2) can enable the process to take advantage of the presence of decontamination and / or washing devices (14i, 14o) and / or processing devices (15) in the pass through chamber (1 ).

[0108] The pass through chamber (1 ) preferably comprises a decontamination and / or washing device (14i, 14o) of known type for decontaminating and / or washing objects and / or materials (A), as well as parts of the vehicle (2) in the volume (V). As already illustrated in the introductory part, the expert in the sector is aware of numerous decontamination and / or washing devices (14i, 14o). The appended figures include an example of a device using fluids and which schematically include the inlet conduits (14i) and the outlet conduit (14o).

[0109] The pass through chamber (1 ) preferably comprises a processing device (15) for operating on objects and / or materials in the volume (V).

[0110] A first example of processing device (15) is represented by a depression system.

[0111] A second example of processing device (15) is represented by a freeze-dryer.

[0112] A third example of processing device (15) is schematically illustrated in figures 15 and 29 and comprises two movable plates, vertically utilisable for closing a container with a cap, i.e. for operating a process of closure of the objects (A) visible in figure 16. For example the single or combined movement of the two plates can be used for closing bottles and caps of the “press fit” type. The closure can take place in an inert atmosphere with the use of a depression system that creates the depression in the volume (V) before the introduction of the inert gas by the decontamination and / or washing device (14i, 14o) or by an appropriate processing device (15).

[0113] In general processing devices (15) comprise activations and a control unit of the activations which, in the case of the system (1000, 1000’), usually interacts with the control unit of the vehicle (2), for example waiting for the signal that the containers are in the volume (V), ready to be capped.

[0114] A fourth example of processing device (15) is represented by a ring-sealing station of known type.

[0115] A fifth example of processing device (15) is represented by a cooling device, for example a liquid nitrogen cooling device which can be used in a storing process which performs a cryogenic conservation.

[0116] The vehicle (2) typically comprises a respect control unit that, in general, interacts with a control unit of the system (1000, 1000’). The displacements necessary for collecting and / or depositing the objects and / or materials (A) in the area (101) and for depositing and / or collecting the objects and / or materials in the pass through chamber (1 ) are controlled by one or both the control units respectively of the vehicle (2) and the system (1000, 1000’).

[0117] The above-described system (1000, 1000’) can be an isolator, a Restricted Access Barrier System, an automated unmanned and gloveless cleanroom processing enclosure (1000’) or a cleanroom, being able to integrate the other area (102) or not. The other area (102) is not necessarily a part of the system (1000, 1000’), for example it might be the outside of an isolator or a cleanroom. As illustrated in the foregoing, the term cleanroom, often used for indicating the system, the terms used to indicate the other structures are commonly also used for indicating the systems, probably also because these solutions include, generally, a strong integration between the structure (100) and the devices housed by the structure (100), i.e. the air handling means (5), any decontaminating and / or washing means, if present, and the processing devices.

[0118] In figures from 3 to 6 the structure (100) is represented only partially, i.e. only a portion of the wall from which the pass through chamber (1 ) faces onto the area (101 ) is illustrated. According to the specific system, the structure (100) can seal the space (101 ), such as for example in an isolator or in the example of figure 26, or be partially open towards the outside. Clearly the structure (100) might be provided with other doors, for example doors RTP doors and / or gloves.

[0119] In schematic figures 10, from 12 to 15, from 17 to 24, 29 and 30 the structure is simplified with lines that divide spaces and, in this case too, the spaces might be completely closed or sealed or partially open towards the outside.

[0120] In the appended figures the vehicle (2), in the form of a movable robot, comprises at least a sensor, for example an optical sensor for a tv camera and / or an ultrasound sensor, which is arranged in the upper head-shaped part (27). The expert in the sector knows of numerous sensors, arrangements of the at least a sensor in the vehicle (2) and techniques for operating the vehicle (2) and, in particular, the movable robot.

[0121] The at least a sensor enables detecting the position of the vehicle (2) and / or the detecting of the objects and / or materials transported and / or the position thereof and, possibly, the orientation with respect to the frame (24).

[0122] By way of example, the control unit of the vehicle (2) can receive, from a sensor, information on the position of an object on the tray (22) so as to transmit the position of the object internally of the volume (V) once the door (21 ) is engaged in the opening (12a).

[0123] The teachings of the present description enable use of a control unit and / or at least a sensor and / or support means (22, 23, 26) that are less sophisticated as the vehicle (2) does not necessarily have to guarantee the precision of the positioning of the objects and / or materials (A) in the case that the vehicle (2) has to move away to allow for the closing of the first door (13).

[0124] Figure 17 shows how the pass through chamber (1 ) can have a plurality of openings towards an area while figure 18 shows how the pass through chamber (1 ) can have a plurality of openings towards each of the areas.

[0125] Figure 19 evidences the possibility of having a plurality of cascading pass through chambers (1 ) and how a plurality of alternative positions of the vertical wall of the structure (100) on the left are possible.

[0126] In figure 20 there are several flanked pass through chambers (1 ) between the area (101 ) and the other area (102).

[0127] Figure 21 enables observing how the pass through chamber (1 ) can be provided with a door towards one area and not towards the other area, whether the area (101 ) or the other area (102). The same option is equally possible in figure 24 while figure 23 also illustrates an opening of the at least another opening (12b) with no door, for example for engaging the respective door (31 ) of a second vehicle (3), not illustrated in the figure. Note how the door (21 ) might engage the opening (12a) on the right of figure 23 in a successive step; this might, for example, be useful for ensuring a certain arrangement of the objects and / or materials in the volume (V) and / or for facilitating the depositing and / or the collection towards one of the two openings of the at least another opening (12b).

[0128] Figure 22 shows a pass through chamber (1 ) with openings towards four areas, with each opening provided with an automatic door and, preferably, with interlocking systems of the opening of the doors.

[0129] The expert in the sector will understand how the appended figures illustrate only some of the possible combinations obtainable with the teachings included herein by varying the number of areas, the openings towards each area, the doors, the automatic doors, the number of pass through chambers (1 ), the arrangement of the pass through chamber (1 ) and the interlocking devices between two or more doors.

[0130] Like considerations can also be made in the case of a plurality of internal chambers (1a) arranged internally of the area (101 ).

[0131] The expert in the sector will also understand how the door of the at least another opening (12b) might open inwards or can open outwards or it can even be an RTP door, the acronym for Rapid Transfer Port. As shown by way of example in figure 27, the beta part of the RTP door provides the closure of one opening of the at least another opening (12b) through which the passage of objects and / or materials (A) can take place between the volume (V) and the other area (102) and / or vice versa. In this case the passage occurs after the coupling of the alpha part borne by a container to be secured to the RTP door. In the example case the transversal arrangement of the at least another opening (12b) makes access of the container secured to the RTP door more difficult by the vehicle (2). However, the expert in the sector will understand how the collecting of the container might take place by means of the gripper (23) described above or by other support means (22, 23, 26), especially in the case of opposing positions between two openings respectively of the at least another opening (12b) and the at least an opening (12a).

[0132] Figure 28 illustrates how also the at least another opening (12b) defined by the RTP door can be made on a door engageable in a further opening of the at least another opening (12b).

[0133] This is without taking account of the fact that the system (1000, 1000’) can be differentiated by the number of vehicles present, as well as the vehicle (2) and, possibly, the second vehicle (3) and any similar to the vehicle (2). For example figure 23 shows how the door of another vehicle can engage another opening of the at least an opening (12a). In this regard it is observed that, from an operating point of view, it is generally necessary for the volume (V) to be sealed, i.e. with all the openings (12a, 12b) being engaged, though this condition is not strictly necessary.

[0134] The objects and / or materials (A) are tendentially any element that is inherent to the process that is realised internally of the system (1000, 1000’). Examples of objects and / or materials (A) transferable through the pass through chamber (1 ) are: containers, being vials, bottles or ampoules, tubs or nests with containers, caps, lyophilization caps, tubs or nests with caps or lyophilization caps, ring-seals, syringes, accessories, disposable material and instruments, such as vibrators, grippers or plates for cell cultures.

[0135] The invention also relates to a method for transferring objects and / or materials (A) from and / or towards an area (101 ) which is configured to house pharmaceutical, microbiological or biotechnological processes.

[0136] An embodiment of the method comprises steps of:

[0137] - providing a system (1000, 1000’) according to the present description;

[0138] - engaging the door (21 ) in an opening of the at least an opening (12a);

[0139] - releasing the door (21 ) from the opening (12a);

[0140] - transferring one or more objects and / or one or more materials from or to the vehicle (2) after the step of engaging the door (21 ) and before the step of releasing the door (21 ), i.e. with the door (21 ) engaged in the opening (12a);

[0141] - moving the one or more objects and / or the one or more materials internally of the area (101 ) through the vehicle (2), i.e. by means of the moving of the vehicle (2).

[0142] Once the system (1000, 1000’) has been supplied the sequence of the steps depends on the direction of transfer of the one or more objects and / or of the one or more materials from or towards the area (101 ). Where these are in the area (101 ), the vehicle (2) will move them, until engaging the door (21 ) for the transfer and thus will release the door (21 ), while where these are in the volume (V), the vehicle (2) will move the door (21 ), will disengage the door (21 ) following the transfer and thus will carry out the movement.

[0143] In the transfer of the one or more objects and / or of the one or more materials in a transfer direction the transfer of other one or more objects and / or one or more materials in the opposite transfer direction can take place.

[0144] The method attains the advantages described in the foregoing in terms of the system (1000, 1000’) enabling a simpler and effective management of the flows of objects and / or materials from and / or towards the area (101 ).

[0145] The above-described method can lead to time savings as it is not necessary to halt the vehicle (2) and close the opening (12a) as in the systems of the prior art.

[0146] The step of engaging the door (21 ) in an opening of the at least an opening (12a) comprises the step of moving the vehicle (2) and, preferably, the step of inflating a seal (4) so as to seal the volume (V). In the case of an inflatable seal (4), the step of releasing the door (21) from the opening (12a) comprises the step of deflating the seal (4).

[0147] The system (1000, 1000’) can be used for realising pharmaceutical, microbiological or biotechnological processes which include filling and / or capping and / or ring-sealing and / or freeze-drying and / or sampling and / or storing.

[0148] In the step of moving, the vehicle (2) preferably starts and / or reaches a filling station or a capping station or a ring-sealing station and / or a freeze-drying station.

[0149] The objects and / or materials (A) are preferably supported by the vehicle (2) during the whole displacement thereof from the pass through chamber (1 ) or from the internal chamber (1a) to the destination thereof in the area (101 ) or from the point of origin thereof in the area (101 ) to the pass through chamber (1 ) or the internal chamber (1a). In a case where the vehicle (2) is provided with wheels (25), the displacement typically takes place, or mostly takes place, i.e. without taking account of the displacement due to the support means (22, 23, 26), by means of the rotation of the wheels (25) on the floor of the area (101 ).

[0150] In a preferred embodiment of the method, the system (1000, 1000’) comprises another area (102) and a second vehicle (3). In this case, the pass through chamber (1 ) clearly comprises walls (11 ) which delimit a volume (V) and openings (12a, 12b), at least an opening (12a) for passage of objects and / or materials (A) between the volume (V) and the area (101 ) and / or vice versa and at least another opening (12b) for passage of objects and / or materials (A) between the volume (V) and the other area (102) and / or vice versa.

[0151] In further detail, in the step of providing a system (1000, 1000’), a system (1000, 1000’) is provided which comprises the other area (102) and a second vehicle (3) which is movable internally of the other area (102), which is configured to move objects and / or materials (A) from and / or to the pass through chamber (1 ) and which comprises a respective door (31 ) which is engageable in at least an opening of the at least another opening (12b) so as to separate the other area (102) from the volume (V). Also:

[0152] - the method comprises a step of engaging the respective door (31 ) in the other opening (12b);

[0153] - the method comprises the step of releasing the respective door (31 ) from the other opening (12b);

[0154] - in the step of transferring, the one or more objects and / or the one or more materials pass directly from the second vehicle (3) onto the vehicle (2) or from the vehicle (2) onto the second vehicle (3);

[0155] - the step of transferring takes place after the step of engaging the respective door (31 ) and before the step of releasing the respective door (31 ), i.e. with the respective door (31 ) engaged in the other opening (12b).

[0156] The preferred embodiment enables the direct transfer from the vehicle (2) to a second vehicle (3), as shown by way of example in figure 13: once the door (21 ) and the respective door (31 ) are engaged, it is possible to realise the transfer of the volume (V) of the pass through chamber (1 ), for example with the respective gripper (33) picking up a container arranged on the tray (22).

[0157] Regardless of the presence of a second vehicle (3), in a case where the pass through chamber (1 ) comprises a processing device (15) for operating on objects and / or materials in the volume (V), the method can comprise the step of processing the one or more objects and / or the one or more materials after the step of engaging the door (21 ) and before the step of releasing the door (21 ), i.e. with the door (21 ) engaged in the opening (12a). In a case in which a second vehicle (3) is present, the step of processing can place after the step of engaging the respective door (31 ) and before the step of releasing the respective door (31 ), i.e. with the respective door (31 ) engaged.

[0158] It is therefore possible to realise further operations during the transfer through the volume (V). Clearly, the internal chamber (1a) can comprise a processing device (15) for operating on objects and / or materials in the volume (V), with the method being able to comprise the step of processing the one or more objects and / or the one or more materials after the step of engaging the door (21 ) and before the step of releasing the door (21 ), i.e. with the door (21 ) engaged in the opening (12a).

[0159] By comparison, by way of example, with internal chambers for freeze-drying of known type, the movement of one or more objects and / or one or more materials from the vehicle (2) to a support in the internal chamber (1a) is avoided. However, the system (1000, 1000’) can also be configured to prevent awaiting the vehicle (2) for completion of the process carried out by the processing device (15), for example in a case comprising a first door (13).

[0160] In a preferred embodiment of the method, the system (1000, 1000’) comprises a further pass through chamber with a respective opening in which the door (21 ) can be engaged, the step of moving the vehicle (2) comprises a step of reaching the further pass through chamber and the method comprises the step of engaging the door (21 ) in the respective opening.

[0161] The method for transferring objects and / or materials (A) from and / or towards an area (101 ), illustrated in foregoing enables improvements in terms of working times and / or quality and / or control of contamination and / or the workability of the pharmaceutical, microbiological or biotechnological process.

[0162] The invention also relates to a like pharmaceutical, microbiological or biotechnological process which comprises the method of the present description. As mentioned in the foregoing, the pharmaceutical, microbiological or biotechnological process can comprise steps of picking up containers and / or placing containers and / or filling containers and / or closing containers (capping and / or ring-sealing) and / or carrying out sampling and or storage of products and or material and / or freeze-drying products and / or materials.

[0163] It is understood that the above has been described by way of non-limiting example and that any constructional variants are considered to fall within the protective scope of the present technical solution, as claimed in the following.

Claims

CLAIMS1 ) A system (1000, 1000’) for pharmaceutical, microbiological or biotechnological processes, comprising:- an area (101 ) which is configured so as to house pharmaceutical, microbiological or biotechnological processes;- a chamber (1 , 1a) which comprises walls (11 ) which delimit a volume (V) and at least an opening (12a) for passage of objects and / or materials (A) between the volume (V) and the area (101 ) and / or vice versa;- a vehicle (2) which is movable internally of the area (101 ) and which is configured to move objects and / or materials (A) from and / or to the chamber (1 , 1a); characterised in that the vehicle (2) comprises a door (21 ) which is engageable at least in an opening of the at least an opening (12a) so as to separate the area (101 ) from the volume (V).2) The system (1000, 1000’) of claim 1 , wherein the vehicle (2) comprises support means (22, 23, 26) which support objects and / or materials (A) to be moved from and / or to the chamber (1 , 1a) in a transport volume (2V) which is arranged on a first side (21a) of the door (21 ) in such a way as to be in the volume (V) with the door (21 ) engaged in the opening (12a).3) The system (1000, 1000’) of claim 2, wherein:- the vehicle (2) comprises a tray (22) which is borne by the door (21 ) on the first side (21a) and wherein the tray (22) is configured in such a way as to be in the volume (V) with the door (21 ) engaged in the opening (12a) and / or- the vehicle (2) comprises a gripper (23) which is borne by the door (21 ) on the first side (21a) and wherein the gripper (23) is configured in such a way as to be in the volume (V) with the door (21 ) engaged in the opening (12a).4) The system (1000, 1000’) of any one of claims 1 to 3 wherein the chamber (1 , 1a) and / or the vehicle (2) comprises a seal (4) for guaranteeing the seal between the door (21 ) and the opening (12a).5) The system (1000, 1000’) of claim 4, wherein the chamber (1 , 1a) comprises an inflatable seal (4) which in a first operating condition enables the movement of the door (21 ) from or to the opening (12a) and in a second operating condition ensures the seal between the door (21 ) and the opening (12a).6) The system (1000, 1000’) of any one of claims 1 to 5, wherein the chamber (1 , 1a) comprises a first door (13) which is movable between an open position (O) in which the first door (13) releases an opening of the at least an opening (12a) and enables the engagement of the door (21 ) and a closed position (C) in which the first door (13) engages the opening (12a) so as to separate the area (101 ) from the volume (V).7) The system (1000, 1000’) of any one of claims 1 to 5, wherein the chamber (1 , 1a) comprises a first door (13) which is movable between an open position (O) in which the first door (13) releases a further opening of the at least an opening (12a) towards the area and a closed position (C) in which the first door (13) engages the further opening of the at least an opening (12a) so as to separate the area (101 ) from the volume (V) and in which the door (21 ) is engageable in an opening (12a) made on the first door (13).8) The system (1000, 1000’) of any one of claims 1 to 7, wherein the vehicle (2) comprises a frame (24), which is configured to support the door (21) and objects and / or materials (A), and wheels (25), which are motorised or moved by one or more motors and which are connected to the frame (24) so as to move objects and / or materials (A) between a first position (P1 ) and a second position (P2) in the area (101 ).9) The system (1000, 1000’) of claim 8, wherein the door (21 ) is solidly constrained to the frame (24), is slab-shaped or substantially slab-shaped and has a vertical median plane (M).10) The system (1000, 1000’) of any one of claims 1 to 9, wherein the vehicle (2) is a movable robot configured so as to operate in a clean room.11 ) The system (1000, 1000’) of claim 10, comprising air handling means (5) which generate a vertical laminar flow in the area (101 ).12) The system (1000, 1000’) of any one of claims 1 to 11 , wherein the chamber (1 , 1a) comprises a decontamination and / or washing device (14i, 14o) for decontaminating objects and / or materials (A) and / or parts of the vehicle (2) in the volume (V).13) The system (1000, 1000’) of any one of claims 1 to 12, wherein the chamber (1 , 1a) comprises a processing device (15) for operating on objects and / or materials in the volume (V).14) The system (1000, 1000’) of any one of claims 1 to 13 comprising a structure (100) which separates the area (101 ) from another area (102) wherein;- the chamber (1 , 1a) is a pass through chamber (1 ) which is installed at a part of thestructure (100) in order to enable transfer of objects and / or materials (A) between the area (101 ) and the other area (102) and / or vice versa;- the pass through chamber (1 ) comprises openings (12a, 12b), comprising said at least an opening (12a) for passage of objects and / or materials (A) between the volume (V) and the area (101 ) and / or vice versa and comprising at least another opening (12b) for passage of objects and / or materials (A) between the volume (V) and the other area (102) and / or vice versa.15) The system (1000, 1000’) of claim 14 comprising the other area (102) and a second vehicle (3) which is movable internally of the other area (102), which is configured to move objects and / or materials (A) from and / or to the pass through chamber (1 ) and which comprises a respective door (31 ) which is engageable in at least an opening of the at least another opening (12b) so as to separate the other area (102) from the volume (V).16) An isolator, Restricted Access Barrier System, automated unmanned and gloveless cleanroom processing enclosure (1000’) or cleanroom according to one of claims 1 to 15.17) A method for transferring objects and / or materials (A) from and / or towards an area (101 ) which is configured so as to house pharmaceutical, microbiological or biotechnological processes comprising steps of:- providing a system (1000, 1000’) according to any one of claims 1 to 16;- engaging the door (21 ) in the opening (12a);- releasing the door (21 ) from the opening (12a);- transferring one or more objects and / or one or more materials from or to the vehicle (2) after the step of engaging the door (21 ) in the opening (12a) and before the step of releasing the door (21 ) from the opening (12a);- moving the one or more objects and / or the one or more materials internally of the area (101 ) through the vehicle (2).18) The method of claim 17, wherein:- in the step of providing a system (1000, 1000’), the system (1000, 1000’) of claim 15 is provided;- the method comprises steps of engaging the respective door (31 ) in the other opening (12b) and releasing the respective door (31 ) from the other opening (12b);- in the step of transferring, the one or more objects and / or the one or more materials pass directly from the second vehicle (3) onto the vehicle (2) or from the vehicle (2) onto the second vehicle (3);- the step of transferring takes place after the step of engaging the respective door (31 ) and before the step of releasing the respective door (31 ).19) The method of claim 17 or 18, wherein in the step of providing a system (1000, 1000’) a system wherein the chamber (1 , 1a) comprises a processing device (15) for operating on objects and / or materials in the volume (V) is provided and wherein the method comprises the step of processing the one or more objects and / or the one or more materials after the door (21 ) is engaged in the opening (12a).20) A pharmaceutical, microbiological or biotechnological process comprising the method according to one of claims 17 to 19.

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