WO2025109637A1

WO2025109637A1 - Beta component for a transfer system, transfer system, sterile isolation area, aseptic filling apparatus and method for performing such filling

Info

Publication number: WO2025109637A1
Application number: PCT/IT2024/050236
Authority: WO
Inventors: Francesco DI CHIRO
Original assignee: IMA Industria Macchine Automatiche SpA
Current assignee: IMA Industria Macchine Automatiche SpA
Priority date: 2023-11-20
Filing date: 2024-11-18
Publication date: 2025-05-30
Anticipated expiration: 2026-05-20
Also published as: IT202300024525A1

Abstract

A beta component (24) of a transfer system (22), having a beta flange (26), an accommodating body (44) delimiting an accommodating space (36) and connected to said beta flange (26), a beta closure unit (30) removably connected to the beta flange (26) for opening and closing the accommodating space (36), the beta flange (26) and the beta closure unit (30) being configured to be coupled to an alpha flange (28) and an alpha closure unit (29) of an alpha port (27); the beta component (24) comprises: a positioning device (25) slidingly mounted to said beta flange (26) and having a proximal end (21) innermost in said accommodating space (36) and an opposite distal end (23), wherein the positioning device (25) is movable between a backward position, wherein the distal end (23) is inside said accommodating space (36), and a forward position wherein the distal end (23) can be positioned outside said accommodating space (36) when the beta closure unit (30) opens the accommodating space (36), a retaining support (50) having a back side (71) fixed to the distal end (23) of said positioning device (25) and a front side (72), opposite to the back side (71), wherein the front side is provided with a seat (70) for holding a respective filling needle (20).

Description

“BETA COMPONENT FOR A TRANSFER SYSTEM, TRANSFER SYSTEM, STERILE ISOLATION AREA, ASEPTIC FILLING APPARATUS AND METHOD FOR PERFOMING SUCH FILLING”

FIELD OF THE INVENTION

The embodiments described here concern a beta component for a transfer system for a sterile isolation area, a transfer system, a sterile isolation area, an aseptic filling apparatus and a method for performing such filling.

BACKGROUND OF THE INVENTION Systems for filling closable containers with a fluid product, in sterile conditions, free of germs and contamination, are known. These aseptic filling systems generally provide a sterile isolation area, closed to the outside, also known as an isolator. The sterile isolation area therefore forms a closed environment, with an atmosphere that meets specific requirements for cleanliness and absence of contamination.

The sterile isolation area is separated from an external operating area by a partition wall. The operating area, where operational personnel is present, is not a sterile environment.

Generally, there is a filling device in the sterile isolation area, to fill the aforementioned containers with a filling needle.

In this context, it is known that a Rapid Transfer Port (RTP) is an example of a transfer device or system used to safely transfer material from the operating area to the isolation area, preventing contamination of the material or the environment. An RTP consists of two fundamental parts: the alpha port, on the partition wall of the sterile isolation area, and the beta component, connected to the alpha port, which also includes an accommodating body, such as a rigid container or a flexible casing, to transfer the material.

In this context, in the past, the filling device or the components associated with the filling, for example the needles for the aseptic filling in the isolation area, have been managed and manipulated, for the purposes of replacement, upgrade, maintenance or other, by operating personnel using gloves. Generally, the operating personnel, wearing gloves, would mount the filling needle in a support of the filling device and then connect feed lines, such as flexible piping, from a product tank to the filling needle, usually by means of a pump that kept the product available for the purpose of filling.

In addition to the needle, or other components associated with the filling, it may be necessary to also introduce other objects into the isolation area.

However, more recently, there has been a strong tendency to look for new technical solutions that allow to manage and manipulate the filling device or the components associated with the filling, for example the filling needles or even other objects to be introduced, in order to replace them, update them, for maintenance or other purposes, without the operating personnel using gloves (so- called gloveless).

Some examples of known transfer and filling systems that offer attempts at gloveless technical solutions are described, for example, in EP 4 119 309 Al, EP 4 100 326 Al and EP 3 972 789 Al .

It is therefore desirable to provide technical solutions that allow for the possibility of introducing needles, filling components or even other necessary objects into the sterile isolation area safely and without contamination, and without the need for operating personnel to use gloves.

There is therefore the need to perfect a beta component for a transfer system for a sterile isolation area, a transfer system, a sterile isolation area, an aseptic filling apparatus and a method for performing such filling, which can overcome the disadvantages of the state of the art disclosed above.

The Applicant has devised, tested and embodied the present invention to overcome the shortcomings of the state of the art and to obtain these and other purposes and advantages.

SUMMARY OF THE INVENTION

The present invention is set forth and characterized in the independent claims, while the dependent claims describe other characteristics of the present invention or variants to the main inventive idea.

Some embodiments concern a beta component of a transfer system, having a beta flange, an accommodating body delimiting an accommodating space and connected to the beta flange, a beta closure unit removably connected to the beta flange for opening and closing the accommodating space. The beta flange and the beta closure unit are configured to be coupled to an alpha flange and an alpha closure unit of an alpha port.

In accordance with some embodiments, the beta component comprises a positioning device, slidingly mounted to the beta flange and having a proximal end innermost in the accommodating space and an opposite distal end. In accordance with some embodiments, the beta component further comprises a retaining support for at least one object, such as at least one filling needle for example, fixed to the positioning device.

In accordance with some embodiments, the positioning device is configured movable between a backward position, wherein the distal end is inside the accommodating space, and a forward position, wherein the distal end is positionable outside the accommodating space when the beta closure unit opens the accommodating space.

In accordance with some embodiments, in the backward position the retaining support is inside the accommodating space and in the forward position the retaining support is outside the accommodating space.

Furthermore, further aspects described here concern a transfer system, a sterile isolation area and an aseptic filling apparatus which include or provide to use a beta component as described here, as well as a method for performing such filling that provides to use or the presence of such beta component. DESCRIPTION OF THE DRAWINGS

These and other aspects, characteristics and advantages of the present invention will become apparent from the following description of some embodiments, given as a non-restrictive example with reference to the attached drawings wherein:

- fig. 1 is a schematic view of an aseptic filling apparatus including a beta component according to some embodiments described here;

- fig. 2 is a schematic view of an aseptic filling apparatus including a beta component according to further embodiments described here;

- fig. 3 is a perspective view of part of a transfer system including a beta component according to further embodiments described here; - fig. 4 is a partly sectioned top view of part of a transfer system including a beta component according to further embodiments described here;

- fig. 5 is a partly sectioned top view of part of a transfer system including a beta component according to further embodiments described here; - fig. 6 is a perspective view of a transfer system including a beta component according to further embodiments described here;

- fig. 7 is a lateral section of part of a transfer system including a beta component according to further embodiments described here; - fig. 8 is a lateral section of part of a transfer system including a beta component according to further embodiments described here.

We must clarify that the phraseology and terminology used in the present description, as well as the figures in the attached drawings also in relation as to how described, have the sole function of better illustrating and explaining the present invention, their purpose being to provide a non- limiting example of the invention itself, since the scope of protection is defined by the claims.

To facilitate comprehension, the same reference numbers have been used, where possible, to identify identical common elements in the drawings. It is understood that elements and characteristics of one embodiment can be conveniently combined or incorporated into other embodiments without further clarifications.

DESCRIPTION OF SOME EMBODIMENTS

Some embodiments described here, using figs, from 1 to 8, are applied for example in the context of transfer systems 22 used to transfer material in and out of sterile isolation areas 12, also called isolators, avoiding contamination. Such transfer systems 22 generally include two main components, an alpha port

27 and a beta component 24, which once coupled create a dual port system. Sometimes these transfer systems are also referred to with the acronym RTP.

In these transfer systems 22, the alpha port 27 includes an alpha flange 28 and an alpha closure unit 29. The alpha flange 28 is integrally fixed to a partition wall 16, or partitioning, of the sterile isolation area 12. In particular, the partition wall

16 has an aperture 13 and the alpha flange 28 is integrally mounted on the aperture 13. The alpha closure unit 29 is arranged movably, for example rotatably, on the alpha flange 26. It is generally similar to a door.

The alpha port 27 is usually provided with a safety mechanism, for example mechanical, which prevents the alpha closure unit 29 from opening in the absence of a beta component 24.

The beta component 24 comprises an accommodating space 36, delimited by an accommodating body 44, a beta flange 26 and a beta closure unit 30. The beta closure unit 30 is removably fixed to the beta flange 26, to open and close the accommodating space 36. It is generally similar to a lid that, for example, can be removed from the accommodating space 36.

The beta flange 26 and the beta closure unit 30 are configured to be coupled, by means of connection, to the alpha flange 28 and to the alpha closure unit 29 of the alpha port 27 of the transfer system 22. In particular, the beta closure unit 30 is connected to the alpha closure unit 29 so that both adhere to each other in a sealed manner with their respective external sides, and can only be moved together.

When connected, the beta closure unit 30 and the alpha closure unit 29 can only be opened together, and integrally form a closure unit 31 of the transfer system 22.

In the closed state, the alpha closure unit 29 forms the side of the closure unit 31 which faces toward the sterile isolation area 12, and the beta closure unit 30 forms the side of the closure unit 31 which faces away from the sterile isolation area 12, that is, facing toward the accommodating space 36. When it is open, the closure unit 31 moves, for example it rotates, in the sterile isolation area 12. The closure unit 31 is firmly clamped, guaranteeing that the sterile isolation area 12 is isolated from the external operating area 14.

The beta closure unit 30 coupled to the alpha closure unit 29 forms the closure unit 31 , and therefore closes the accommodating space 36 with respect to the sterile isolation area 12.

For example, the alpha closure unit 29 can be rotatably mounted on the alpha flange 28 using a hinge mechanism 49. The beta closure unit 30 is removable from the beta flange 26 so that, when coupled to the alpha closure unit 29, it follows its movement during opening. In possible implementations, the transfer system 22 can include a clamping mechanism 60. The clamping mechanism 60 can only be unlocked if the alpha closure unit 29 is coupled to the beta closure unit 30.

The alpha port 27 and the beta component 24 are connected, for example by means of bayonet locks, and when the locking is unlocked the closure unit 31 can be opened inside, that is, on the side of, the sterile isolation area 12. The opening can be manual or by motor, for example automatic through an automated opening mechanism, for example able to be actuated from the operating area 14.

Generally, a bio-decontamination cycle is initially carried out in the sterile isolation area 12, which creates a germ- free and contamination- free environment, and after the bio-decontamination cycle the beta component 24 is coupled to the alpha port 27 of the transfer system 22.

Some embodiments described here concern, in particular, a beta component 24 of a transfer system 22, having a beta flange 26, an accommodating body 44 that delimits an accommodating space 36 and is connected to the beta flange 26, a beta closure unit 30 removably connected to the beta flange 26 to open and close the accommodating space 36. As indicated above, the transfer system 22 can be, for example, an RTP system. The beta flange 26 and the beta closure unit 30 are configured to be coupled to an alpha flange 28 and to an alpha closure unit 29 of an alpha port 27 of the transfer system 22 as above.

Generally, the beta flange 26 lies on a lying plane P. When the beta flange 26 is coupled to the alpha flange 28, the lying plane P of the beta flange 26 is essentially parallel to the lying plane of the alpha flange 28 and, consequently, also to the lying plane of the aperture 13 provided in the partition wall 16.

According to some embodiments, the beta component 24 comprises a movable positioning device 25, fixed to the beta flange 26 and having a proximal end 21 innermost in the accommodating space 36 and a distal end 23 arranged toward the sterile isolation area 12.

The beta component 24 further comprises a retaining support 50 configured to hold at least one object, for example one or more filling needles, for example in a defined position and orientation.

In possible example embodiments, the retaining support 50 is configured to hold one object or a plurality of objects, for example two, three, four, five or even more than five.

Here and in the present disclosure, we will refer to a filling needle 20 as a possible example of an object held by the retaining support 50. The filling needle 20 is received in a seat 70 configured to receive the filling needle 20. In the example given here, the retaining support 50, in particular its front side 72, comprises two seats 70, each one configured to receive a respective filling needle 20.

The retaining support 50 is fixed to the positioning device 25. In particular, the retaining support 50 has a back side 71 fixed to the distal end 23 of the positioning device 25, and a front side 72 opposite the rear side 71 and facing toward the beta closure unit 30.

In addition, here and in the present description, the relative terms “proximal” and “distal”, when used to describe the positioning device 25 or parts thereof, are defined with reference to the perspective of the positioning device 25. Therefore “distal” refers to a direction of coupling to one or more objects, for example one or more filling needles 20, and “proximal” refers to an opposite direction, innermost in the accommodating body 44. Accordingly, the relative terms “proximal” and “distal”, when applied to other components, relate to the reference described above. Sometimes, in the present description, the term “back” may also be used with a meaning similar or comparable to “proximal”, and the term “front” may also be used with a meaning similar or comparable to “distal”.

The positioning device 25 is configured movable between a backward position (figs. 1, 4, 6, 7), wherein the distal end 23 is inside the accommodating space 36, and a forward position (figs. 2, 3, 5, 8), wherein the distal end 23 can be positioned outside the accommodating space 36 when the beta closure unit 30 opens the accommodating space 36, and vice versa.

Accordingly, in the backward position the retaining support 50 is inside the accommodating space 36 and in the forward position the retaining support 50 is outside the accommodating space 36.

In other words, in the backward position the positioning device 25 and the retaining support 50 connected thereto are completely inside the accommodating space 36, while in the forward position a part of the positioning device 25 and also the retaining support 50 connected thereto are outside the accommodating space 36, in particular they are in the sterile isolation area 12.

In this way, a filling needle 20, or more than one, held in the retaining support 50 can be moved, by means of the positioning device 25 fixed to the beta flange 26, into the sterile isolation area 12 by actuating the movement of the movable positioning device 25. This forward/backward movement, indicated by the arrow A with double direction in figs. 1, 2, 4, 5, 7, 8, can be achieved without the operating personnel using gloves to manipulate or position the filling needle 20 or other objects. According to one example, the positioning device 25 is configured movable in a predefined direction of movement F, which can be linear, for example. For example, the direction of movement F can be transverse, for example orthogonal, to the lying plane P of the beta flange 26. Consequently, after the closure unit 31 has been properly opened, the retaining support 50 can assume the forward position, thanks to the fact that the positioning device 25 is configured movable, and consequently the at least one filling needle 20 is moved outside the accommodating space 36, for example it is inside the sterile isolation area 12.

The position that the at least one filling needle 20 therefore takes in the sterile isolation area 12, outside the accommodating space 36, is advantageously a known position, stable, repeatable because achieved through a predefined movement of the positioning device 25 and, therefore, the at least one filling needle 20 is made available precisely and easily so that it can be picked up and repositioned, in general manipulated, by a manipulator 40 present there, for the purposes of continuing the filling operations.

Advantageously, thanks to the fact that the at least one filling needle 20 is made available in the sterile isolation area 12, outside the accommodating space 36, it is possible to use a manipulator 40 with a small number of degrees of freedom, since the movements to be performed are limited in number, because the at least one filling needle 20 is already suitably positioned in the sterile isolation area 12. For example, in this way, it is no longer necessary to go and remove the filling needle 20 from inside the accommodating space 36.

For example, a manipulator 40 with two degrees of freedom can be used, for example a single-axis mechanism, with two degrees of freedom, for example a rotation around an axis Y and a translation along the same axis Y (figs. 1, 2).

According to one example, the rotation can be around the axis Y and the translation can be along, or parallel to, the same axis Y, as indicated by the arrows R and V of figs. 1 and 2, respectively. For example, the axis can be a vertical axis.

According to another example embodiment, the manipulator 40 may have only one degree of freedom, that is, only one rotation around the axis Y. In this case, the manipulator 40 is favorably sized in height so as to be coordinated with the position of the at least one filling needle 20.

In possible example embodiments, the manipulator 40 can be a robotic device, for example a robotic arm.

According to another example, the manipulator 40 can be made as, or comprise, a movable part of a planar, electromagnetically driven motor, which are known in state of the art. For example, this movable part can be installed on a vertical wall, for example the partition wall 16, or on a horizontal plane, such as the floor of the sterile isolation area 12.

In all the embodiment examples as above, the manipulator 40 can be equipped with a manipulation head having, for example, retaining means 67 of any known type whatsoever, for example gripper means or suchlike. In accordance with some embodiments, the accommodating body 44 of the beta component 24 and delimiting the accommodating space 36 is removably connected to the beta flange 26.

For example, the accommodating body 44 can be formed by a flexible and sterilizable casing or pouch, or it can be formed by a dimensionally stable sterilizable container, made of stainless steel for example, and in the latter case it can typically be a rigid or at least partly rigid container (for example a so-called canister).

In the case of a flexible pouch or casing, when making the filling needle 20 advance by means of the positioning device 25, the flexible pouch or casing can be moved toward the transfer system 22, compressed or folded. In fact, when the at least one filling needle 20 is removed from the accommodating space 36 and made to advance into the sterile isolation area 12, if the accommodating body 44 is a flexible casing or pouch, it is compressed, since the flexible piping 43, described below, is pulled into the sterile isolation area 12. Alternatively, the accommodating body 44 can also be created as a bellows-shaped body. In the case of a flexible pouch or casing or bellows, therefore, it can be compressible, in particular in the direction of the beta flange 26, for example the direction of movement F, and possibly be configured to be variable in its extension but transversely rigid. In accordance with some embodiments, the positioning device 25 comprises a sliding slider assembly 33 having the distal end 23.

This sliding slider assembly 33 can be configured with a suitable mechanism able to implement a linear movement in the direction of movement F. For example, prismatic torque or rotary torque mechanisms can be used, such as a four bar linkage coupled by means of rotary torques.

For example, in the embodiments described using figs. 3, 4 and 5, the sliding slider assembly 33 can include one, two or more bars or rods 51, for example cylindrical in shape, which extend parallel to the direction of movement F. For example, there may be two bars or rods 51 arranged side by side.

In accordance with the embodiments described using the attached drawings and combinable with all the embodiments described here, the beta component 24 comprises a supporting and guiding member 37 fixed to the beta flange 26 and provided with guiding means 38 slidingly engaging the positioning device 25.

For example, in the embodiments described using figs. 3, 4, 5 the guiding means 38 are slidingly coupled to the sliding slider assembly 33, in particular the one, two or more bars or rods 51.

The guiding means 38 can be static with respect to the beta flange 26, while the positioning device 25, and in particular the sliding assembly 33, is movable with respect to the beta flange 26. Generally, the guiding means 38 are fixed, either directly (figs. 3, 4, 5) or indirectly (figs. 6, 7, 8), to the beta flange 26.

For example, in the embodiments described using figs. 3, 4 and 5, the guiding means 38 can slidingly engage the one, two or more bars or rods 51. The guiding means 38 can include one, two or more guiding bushings 63, for example two guiding bushings. The one, two or more guiding bushings 63 coupled to the one, two or more bars or rods 51 , respectively, can be an example of prismatic torques of the mechanism which is able to implement a linear movement in the direction of movement F.

In accordance with some embodiments, which can be combined with all the embodiments described here, the positioning device 25 is fixed to the beta flange 26 by means of fixing means 39. For example, the fixing means 39 can include a plurality of fixing tabs or other suitable fixing elements.

In accordance with some embodiments, which can be combined with all the embodiments described here, the supporting and guiding member 37 comprises both the guiding means 38 and also the fixing means 39. For example, the guiding means 38, or part thereof, can be fixed to the beta flange 26 by means of the fixing means 39. In the embodiments described using figs. 3, 4, 5, the supporting and guiding member 37 can include a mounting member 68 mating in shape with the beta flange 26, for example conformed as a crown or at least partly as a crown, and able to be applied to the latter in a stable manner, for example by means of the fixing means 39. The mounting member 68 can be connected to the guiding means 38, for example to the guiding bushings 63, whereby these are arranged in a manner coordinated with the respective bars or rods 51 as above.

In accordance with some embodiments, the positioning device 25 can be configured to be actuated manually in order to pass from the backward position to the forward position, and vice versa (see for example figs. 3, 4, 5). For example, it can be pushed and, respectively, pulled by operating personnel, for example by acting at the proximal end 21. For this purpose, the positioning device 25 can include a hand-grip component, or handle, 61 for manual pushing/pulling, arranged at the back, that is, in the proximal position, meaning at the proximal end 21, and able to be gripped and handled by an operator in order to move the positioning device 25 in the direction of movement F between the backward position and the forward position. The hand-grip component 61 can be arranged at the back in the sliding slider assembly 33, for example associated with terminal proximal ends of the one, two or more bars or rods 51. In accordance with some embodiments, described using figs. 3, 4 and 5, the positioning device 25 comprises rear 52 and front 53 stopping means configured to cooperate with respective rear 54 and front 55 stopping portions of the supporting and guiding member 37, so as to halt the positioning device 25 in the backward position or in the forward position. In possible example embodiments, the rear stopping means 52 can be arranged in a proximal position on the sliding slider assembly 33, for example they can be stopping elements, such as plates or blocks, coupled at the back to the one, two or more bars or rods 51. For example, they can be placed adjacent to the hand-grip component, or handle, 61, downstream thereof in the direction of movement F. In possible example embodiments, the front stopping means 53 can be arranged in a distal position on the sliding slider assembly 33, for example they can be stopping elements defined by halting portions of the retaining support 50.

In some example embodiments, the rear 54 and front 55 stopping portions of the supporting and guiding member 37 can, in particular, be proximal and distal stopping portions of the guiding means 38, such as, for example, opposing portions of the guiding bushings 63 of the guiding means 38.

For example, the rear 52 and front 53 stopping means and the respective rear 54 and front 55 stopping portions can be configured not only to define a stop, that is, a halt in the two backward and forward positions identified above, but also to lock the positioning device 25 in the backward position or in the forward position. For this purpose, one of either the rear 52 or front 53 stopping means and one of either the rear 54 or front 55 stopping portions can comprise releasable coupling means, such as for example magnetic coupling means, or magnets, 35. For example, one or more magnets 35 can be comprised in the rear stopping means 52 and one or more magnets 35 can be comprised in the front stopping portions 55.

In accordance with other embodiments, the positioning device 25 can be configured to be actuated non-manually, that is, automatically or semi- automatically, for example mechanically and/or electrically and/or magnetically, to pass from the backward position to the forward position, and vice versa (see for example figs. 6, 7, 8).

In accordance with further embodiments, described using figs. 6, 7 and 8, the supporting and guiding member 37 comprises a rear plate 59 to which there is fixed a connecting bar 58 and possibly one, two or more supporting rods 57 which extend from the rear plate 59. The connecting bar 58 and the possible one, two or more supporting rods 57 can be fixed to the beta flange 26, for example by means of the fixing means 39. The rear plate 59 can be part of, or consist of, a back wall of the accommodating body 44. Furthermore, in some embodiments, described using figs. 6, 7 and 8, the guiding means 38 comprise a fixed sleeve 41, for example made as a hollow cylinder or similar tubular element, having a seat 65. The fixed sleeve 41 is, for example, fixed to the rear plate 59. In this case, therefore, the fixed sleeve 41 is indirectly fixed to the beta flange 26 through the fixing to the rear plate 59, which is in turn fixed to the beta flange 26 by means of at least the connecting bar 58 and possibly the one, two or more supporting rods 57.

Moreover, in the embodiments described using figs. 6, 7 and 8, the positioning device 25 comprises a movable body 42 to which the retaining support 50 is fixed at the front, at the respective distal end 23. The movable body 42 can be at least partly hollow, that is, have a suitable seat 64. The movable body 42 is configured to be slidingly coupled to the fixed sleeve 41, so that the latter acts as a guide. For example, the movable body 42 can be coupled telescopically with respect to the fixed body 41 , so that it can be moved in a guided manner in the desired direction of movement F.

In these embodiments, therefore, the sliding slider assembly 33 can include the movable body 42. In this case, the fixed sleeve 41 guides the movement of the movable body 42. For example, the movable body 42 can be positioned between two of the supporting rods 57 which, therefore, in this way can laterally enclose the movable body 42 and delimit a desired path along which the movable body 42 can be moved in a guided manner in the direction of movement F. In possible implementations, the actuation of the positioning device 25 can be, for example, mechanical. According to one example, elastic means 47 can be provided associated with the supporting and guiding member 37, configured to cooperate with the positioning device 25 and storing elastic energy in the backward position of the positioning device 25 (fig. 7). For example, the elastic means 47 can be arranged in the seat 65 of the fixed sleeve 41 and be able to expand in the seat 64 of the movable body 42. The elastic means 47, therefore, elastically stress against the movable body 42. For example, the elastic means 47 can be in a pre-loaded condition when the positioning device 25 is in the backward position.

This elastic energy is released in the transition from the backward position to the forward position, causing the positioning device 25, for example the movable body 42, to advance, and it is restored when the positioning device 25, for example the movable body 42, upon interacting with the beta closure unit 30, is drawn back to the backward position.

Consequently, unlike the embodiments described using figs. 3, 4, 5, in which there is a manual push to move the positioning device 25, for example using the hand-grip component 61, in the embodiments described using figs. 6, 7, 8 it is the opening of the beta closure unit 30 that causes the extension of the elastic means 47, which in turn push the movable body 42 and therefore move the positioning device 25 forward. For example, the elastic means 47 can be arranged with an axis of development coincident or parallel with the direction of movement F. As mentioned, for this purpose the arrangement of the elastic means 47 can be in the seat 65 of the fixed sleeve 41, so that they expand in the respective seat 64 of the movable body 42 (figs. 7, 8).

For example, the elastic means 47 can include a spring, which can typically be a mechanical spring or a gas spring. In the case of a spring, therefore, the elastic energy is stored when it is compressed and released when it is extended.

In some embodiments, for example in the case of a mechanical spring, a damping member (not shown) can be provided configured to damp the movement that the elastic means 47 impart to the movable body 42 in the passage toward the forward position, so as to control this advance and prevent it from being abrupt or excessively rapid.

Also in the embodiments described using figs. 6, 7 and 8, and which provide elastic means 47, suitable stopping means can be present, with a similar or comparable function to that described using figs. 3, 4 and 5. For example, a front stop of the positioning device 25, for example of the movable body 42, can be defined by the maximum extension of the elastic means 47 when they expand to determine the movement of the positioning device 25 into the forward position (fig. 8). Instead, a back stop can for example be defined by an abutment portion 66, for example a shoulder or step, provided on the guiding means 38, for example on the fixed sleeve 41. For example, a back end of the movable body 42 can be mating to abut against the abutment portion 66 on the fixed sleeve 41.

In accordance with further embodiments, the beta component 24 comprises a bumping or buffer member 45 arranged to cooperate with the beta closure unit 30.

In other words, the bumping or buffer member 45 is able to absorb shocks and possibly also to maintain the correct operating distance between the components. Advantageously, the bumping or buffer member 45 is configured to receive and possibly attenuate thrusts received from, or interactions with, the beta closure unit 30, which may for example occur in the passage of the positioning device 25 from the forward position to the backward position, for example when the closure unit 31 is closed and the beta closure unit 30 interferes against the positioning device 25 and/or the retaining support 50. The bumping or buffer member 45 can be arranged, for example, on the retaining support 50 or on the positioning device 25, for example on the distal end 23. For example, the bumping or buffer member 45 can include an element made of a material able to at least partly absorb shocks, for example plastic or elastic material, such as a block, cylinder, disc or similar element made of shock-absorbing material. Advantageously, moreover, the bumping or buffer member 45 can also be provided with the purpose of preventing friction, for example rubbing, between the beta closure unit 30 and the retaining support 50 that carries the filling needles 20, during the opening step of the beta closure unit 30 itself. For example, the bumping or buffer member 45 can act as an axial bearing to withstand the thrust of the beta closure unit 30.

In further embodiments, the actuation of the positioning device 25 can be carried out by means of an actuation element, for example electrical, electromechanical and/or magnetic. The actuation element can include a driving member, for example electrical, electromechanical and/or magnetic, configured to move the positioning device 25, for example the movable body 42, with respect to the fixed body 41 in the direction of movement F. The driving member can be made to operate by a power source, for example an electric current, or magnetic fields or a combination thereof. For example, the driving member can be one of either: an electric motor, an electromechanical motor, a magnetic motor, a piezoelectric actuator.

One or more position transducers, for example encoders, can optionally be provided to assist the actuation and/or the driving member in accurately reaching the forward position and the backward position.

According to further embodiments, there is also provided a sterile isolation area 12 with a partition wall 16 for separating it from a non-sterile operating area 14 (see figs. 1, 2, 3). The partition wall 16 has an aperture 13.

The partition wall 16 has an alpha port 27 of a transfer system 22 for introducing objects 24 from the operating area 14 to the sterile isolation area 12. The introduction occurs through the aperture 13. The transfer system 22 has a closure unit 31 formed by an alpha closure unit 29 and a beta closure unit 30. The closure unit 31 is configured to selectively clamp the aperture 13 and guarantee the sterility of the sterile isolation area 12 after it has been decontaminated.

In possible example embodiments, a filling device 18 can be arranged in the sterile isolation area 12, configured to fill closable containers 34 (figs. 1, 2) with a fluid product 32 by means of a filling needle 20.

In other example embodiments, the manipulator 40 can be used directly to fill the one or more closable containers 34. In this case, the filling device 18 may not be present, that is, the manipulator 40 may also act as a filling device 18. For example, the filling needle 20 can be connected to a flexible piping, or filling pipe, 43 that extends from the accommodating space 36, connecting, by means of a connector 48, to a storage tank 46 where the fluid product 32 is present. The flexible piping 43 can be connected to a pump 56, for example a peristaltic pump, which receives the fluid product 32 from the storage tank 46 and makes it available toward the filling needle 20.

The retaining support 50 comprises a support dedicated to the flexible piping 43 which is provided with an indentation 73 configured to hold the flexible piping 43 firmly in position.

In possible implementations, a beta component 24 according to embodiments described here is coupled to the alpha port 27.

The positioning device 25 is initially in its backward position, contained in the accommodating space 36 of the beta component 24. Generally, the closure unit 31 is closed. The opening of the closure unit 31 enables the passage of the positioning device 25 from the backward position to the forward position, consequently moving the retaining support 50 within the sterile isolation area 12.

In other words, when the closure unit 31 , which is formed by the coupled alpha closure unit 29 and beta closure unit 30, is opened, the positioning device 25 can be activated, manually or not manually as indicated above, and thus the retaining support 50 is moved within the sterile isolation area 12. Therefore, in order to remove the at least one filling needle 20 being held, it is not necessary to intervene in the accommodating space 36 of the beta component 24. When the closure unit 31 is opened, it is moved, for example rotated, in the sterile isolation area 12, after which the positioning device 25 is actuated, making it advance, as indicated above. Because the retaining support 50 is arranged on the positioning device 25, it is also made to advance in the sterile isolation area 12 and, consequently, the at least one filling needle 20 is freely available, without any restrictions, in the sterile isolation area 12.

In further embodiments, a manipulator 40 can be provided, disposed in the sterile isolation area 12. It is configured to remove the at least one filling needle 20 held by the retaining support 50 when it is inside the sterile isolation area 12, by virtue of the forward position of the positioning device 25, and to reposition the at least one filling needle 20 in the retaining support 50. This repositioning can typically be performed after a filling operation has been completed.

Thanks to the fact that the at least one filling needle 20 is moved to a defined position within the sterile isolation area 12 through the movement of the positioning device 25, the manipulator 40 can pick up the filling needle 20 by carrying out a reduced number of movements and without the need to enter the accommodating space 36, as explained above.

As mentioned, a filling device 18 and the manipulator 40 could be present, or the manipulator 40 could be used directly for filling, thus acting as a filling device itself. In some further embodiments, the manipulator 40 itself may not be present, and instead be integrated in the filling device 18; in other words, the filling device 18 can be equipped with manipulation components able to perform the functions of the manipulator 40, in order to carry out the operations described here and according to the embodiments described here.

Furthermore, in some embodiments the filling device 18 can comprise a gripping device 19, able to support or hold a filling needle 20, so that it can be arranged to perform filling processes. The gripping device 19 can also be arranged in the filling device 18 in such a way as to be moved during the filling processes.

In accordance with further embodiments, a method for operating a filling apparatus 10 as described here can comprise coupling the beta component 24 to the alpha port 27 in the partition wall 16, the filling needle 20 being disposed in the accommodating space 36 of the beta component 24, held by the retaining support 50.

The method can also comprise performing a decontamination cycle in the sterile isolation area 12. This cycle can be carried out before and especially after connecting the beta component 24. The method can comprise opening the transfer system 22 toward the sterile isolation area 12 by opening the closure unit 31.

The method can comprise making the positioning device 25 advance from the backward position to the forward position, thereby moving the filling needle 20 held by the retaining support 50 within the sterile isolation area 12.

The method can comprise removing the filling needle 20 from the retaining support 50, using the manipulator 40. As mentioned, the latter can be an autonomous device or be integrated or combined with the filling device 18.

The method can then comprise filling a closable container 34 with the filling needle 20 within the filling apparatus 10.

For example, the method can comprise positioning the filling needle 20 in a filling device 18 by means of the manipulator 40 and thereby filling the container 34 within the filling apparatus 10.

For example, the method can subsequently comprise removing the filling needle 20 from the filling device 18 by means of the manipulator 40.

In another example, the method can instead comprise filling the container 34 within the filling apparatus 10, directly using the manipulator 40 that has picked up the filling needle 20.

The method can comprise repositioning the filling needle 20 in the retaining support 50 by means of the manipulator 40.

The method can comprise making the positioning device 25 move backward from the forward position to the backward position, thereby moving the filling needle 20 held by the retaining support 50 within the accommodating space 36.

When the filling needle 20 is positioned in the filling device 18 by means of the manipulator 40, the operation of filling a closable container 34 present in the sterile isolation area 12 with a fluid product 32 can be initiated, at the end of which the filling needle 20 can be removed from the filling device 18 and repositioned in the retaining support 50.

It is clear that modifications and/or additions of parts or steps may be made to the beta component for a transfer system for a sterile isolation area, transfer system, sterile isolation area, aseptic filling apparatus and method for performing such filling, as described heretofore, without departing from the field and scope of the present invention, as defined by the claims.

In the following claims, the sole purpose of the references in brackets is to facilitate their reading and they must not be considered as restrictive factors with regard to the field of protection defined by the claims.

Claims

1. A beta component (24) of a transfer system (22), having a beta flange (26), an accommodating body (44) delimiting an accommodating space (36) and connected to said beta flange (26), a beta closure unit (30) removably connected to the beta flange (26) for opening and closing the accommodating space (36), the beta flange (26) and the beta closure unit (30) being configured to be coupled to an alpha flange (28) and an alpha closure unit (29) of an alpha port (27), said beta component (24) comprising: a positioning device (25) slidingly mounted to said beta flange (26) and having a proximal end (21) innermost in said accommodating space (36) and an opposite distal end (23), said positioning device (25) being configured to be movable between a backward position, wherein said distal end (23) is inside said accommodating space (36), and a forward position wherein said distal end (23) is outside said accommodating space (36) when the beta closure unit (30) opens the accommodating space (36), characterized by further comprising: a retaining support (50) having a back side (71) fixed to the distal end (23) of said positioning device (25) and a front side (72), opposite to the back side (71), facing the beta closure unit (30), said front side (72) being provided with at least a needle seat (70) configured to hold a respective filling needle (20) at a position whereby the filling needle (20) is inside the accommodating space (36), when the positioning device (25) is in the backward position, and outside the accommodating space (36), when the positioning device (25) is in the forward position.

2. Beta component (24) as in claim 1, characterized by comprising a supporting and guiding member (37) fixed to said beta flange (26) and provided with guiding means (38) slidingly engaging said positioning device (25).

3. Beta component (24) as in claim 2, characterized in that said positioning device (25) comprises rear (52) and front (53) stopping means configured to cooperate with respective rear (54) and front (55) stopping portions of said supporting and guiding member (37), so as to halt said positioning device (25) in said backward position and in said forward position, respectively, wherein said rear (54) and front (55) stopping portions are positioned preferably on opposite side of the supporting and guiding member (37).

4. Beta component (24) as in claim 3, characterized in that at least one of either said rear (52) or front (53) stopping means, and/or at least one of either said rear (54) or front (55) stopping portions comprise magnetic coupling means. 5. Beta component (24) as in any one of the preceding claims, characterized in that said positioning device (25) is configured to be mechanically and/or electrically and/or magnetically actuated, to be moved from said backward position to said forward position.

6. Beta component (24) as in any one of the preceding claims, characterized by comprising elastic means (47) associated with said supporting and guiding member

(37) and configured to cooperate with said positioning device (25) and storing elastic energy which is released when the positioning device (25) moves from said backward position to said forward position, causing an advance of said positioning device (25), said elastic energy being restored when said positioning device (25) is drawn back to said backward position.

7. Beta component (24) as in any one of preceding claims, characterized by comprising a bumping member (45) associated to said retaining support (50) to cooperate with said beta closure unit (30).

8. Beta component (24) as in any one of preceding claims, characterized in that the accommodating body (44) of the beta component (24) delimiting the accommodating space (36) is a bag made of a flexible material and in that the proximal end (21) is configured to be handled by a user to push or pull the positioning device (25) for moving the positioning device (25) between the backward position and the forward position. 9. Beta component (24) as in any one of preceding claims, characterized in that said at least one needle seat (70) protrudes from said front side (72) of the retaining support (50) toward said beta closure unit (30).

10. Beta component (24) as in any one of preceding claims, characterized in that said at least one needle seat (70) has a cylindrical shape vertically oriented to hold a respective filling needle (20) in vertical position.

11. Beta component (24) as in any one of preceding claims, characterized by further comprising a support, preferably on the retaining support (50), provided with at least an indentation (73) configured to retain a pipe (43) connected to a respective filling needle (20).

12. Beta component (24) as in any one of preceding claims, characterized in that the accommodating body (44) is provided with a connector (48) configured to connect an internal pipe (43), connected to a respective filling needle (20), to an external pipe connected to a storage tank (46) of the liquid product (32).

13. Transfer system (22) comprising an alpha port (27) and a beta component (24) as in any one of the claims 1 to 12.

14. Sterile isolation area (12) with a partition wall (16) which separates from a non- sterile operating area (14), the partition wall (16) having an alpha port (27) of a transfer system (22) for introducing objects from the operating area (14) to the sterile isolation area (12), the transfer system (22) having a closure unit (31) comprising an alpha closure unit (29) and a beta closure unit (30), characterized by comprising a beta component (24) as in any one of the claims 1 to 12 coupled to the alpha port (27), so that by opening the closure unit (31), the positioning device (25) is moved from said backward position to said forward position, consequently moving the retaining support (50) inside the sterile isolation area (12).

15. Filling apparatus (10) comprising a sterile isolation area (12) as in claim 14, wherein in the sterile isolation area (12) there is arranged a manipulator (40) configured to remove said filling needle (20) received in the respective needle seat

(70), when said positioning device (25) is in said forward position within the sterile isolation area (12), and to reposition said filling needle (20) in the respective needle seat (70).

16. Method for operating a filling apparatus (10) as in claim 15, characterized in that said method comprises:

- coupling the beta component (24) to the alpha port (27) on the partition wall (16), the filling needle (20) being accommodated in the needle seat (70);

- performing a decontamination cycle in the sterile isolation area (12);

- opening the transfer system (22) by opening the closing unit (31) toward the sterile isolation area (12);

- making the positioning device (25) advance from the backward position to the forward position, thereby moving the needle seat (70) holding the filling needle (20) within the sterile isolation area (12); - removing the filling needle (20) from the needle seat (70) by means of the manipulator (40);

- filling at least one closable container (34) with the filling needle (20);

- weighing the container (34); - repositioning the filling needle (20) in the needle seat (70) by means of the manipulator (40);

- moving back the positioning device (25) from the forward position to the backward position, thereby moving the needle seat (70) holding the filling needle (20) within the accommodating space (36).