A regulating valve for sealing process chambers

Abstract

Described is a regulating valve (25, 26, 27, 126), preferably for the seal of process chambers (2, 102), which comprises a wall (201 ) rotatable about an axis of rotation (R), between a blocked position and a position for passage of sterile elements (F, T), in the connecting path (81, 86) between a process chamber (2, 102) and a zone adjacent to it. The rotatable wall (201 ) has, on at least a relative first side (201a), a support (202, 212', 212") for at least one of the sterile elements (F, T) which extends in a direction normal to the axis of rotation (R), in such a way that, in the blocked position, the rotatable wall (201 ) is substantially normal to a feed direction (D) of the sterile elements (F, T) whilst, in the passage position, the rotatable wall (201 ) is parallel to the feed direction (D) and the support (202, 212', 212") acts as a connection between two portions of the path (81, 86).

Description

[0001] A regulating valve for sealing process chambers DESCRIPTION

[0002] Technical field

[0003] This invention relates to a regulating valve, preferably for the seal of process chambers which can be sterilised with superheated steam. The invention also relates to a container which can be sterilised by superheated steam which comprises this valve, as well as the method for transporting sterile elements such as bottles, vials, syringes and carpules or other sterile primary containers designed to contain, in aseptic fashion, pharmaceutical, biological and vaccine substances, towards the inside and outside of the sterilisable process chamber, as well as their sterile closures such as caps, rings or plungers or the joints of the previous items.

[0004] Background Art

[0005] The process of filling and finishing containers such as bottles, vials, syringes and carpules, known as “fill-finish”, is crucial in the production of drugs, especially for injectable ones. The main challenge is to maintain the sterility of the product during this delicate phase. Unlike terminal sterilisation, where the drug is treated in closed containers, the “aseptic fill-finish” involves the risk of losing sterility, since the drug is dispensed in open containers. For this reason, in order to ensure sterility, it is essential that the filling and finishing are carried out in specially designed environments to prevent contamination.

[0006] The national and international pharmaceutical guidelines establish strict requirements for the qualification and production of machinery used in this process. The production in an aseptic environment requires particular care, and the regulations require monitoring methods to ensure sterility and prevent particle and microbiological contamination during the filling and finishing of the containers.

[0007] The aseptic filling and finishing, known as “fill-finish”, currently occurs inside systems with redistricted access barriers (RABS) or isolators. These apparatuses create a confined environment for the filling and sealing of the containers, often integrating with automatic filling machines. The legislation imposes strict particle and microbiological requirements in these areas, with strict limits for non-viable particles both at rest and during the cycle and requiring a total absence of microbiological contamination.

[0008] The filling machines integrated into RABS or isolators must handle both parts in direct and indirect contact, adopting special measures to prevent contamination of the sterile product. The isolators can be closed or opened, with a mouse-hole for the extraction, designed to minimise the risk of contamination while performing fill-finish processes inside them. They incorporate ventilation chambers with HEPA filtration (high efficiency particulate air system) and HVAC systems (heating, ventilation and air conditioning) to maintain controlled environmental conditions.

[0009] These insulators, similar to small “white rooms”, are constructed with materials certified for aseptic areas, such as stainless steels or plastic, and are subject to a rigorous qualification. The air inside isolators is filtered to reduce the amount and size of the dispersed particulate, and decontamination systems, often based on vaporised hydrogen peroxide, are used before production to reduce microbiological charge. The meticulous design allows for effective cleaning and sanitising.

[0010] The current aseptic filling and finishing process, although advanced, has some critical aspects. The main technique used for reducing the microbiological charge is the hydrogen peroxide or vaporised hydrogen (VPHP or VHP) generator, which is considered essential for achieving the aseptic condition. However, this method is defined as “decontamination” and not “sterilisation” and shows significant limitations with respect to systems such as steam sterilisation, ionizing radiation, or chemical sterilisation with ethylene oxide (ETO).

[0011] The VHP develops a surface action, but has low penetration, strongly depends on the previous surface cleaning process and is difficult to control; in fact, even light films of accumulated residual substances can adversely affect the effectiveness of the process. In addition, VHP residues may compromise the pharmaceutical specialty; therefore, adequate removal of any residues from the indirect contact areas must also be ensured. This limitation makes VHP unsuitable for sterilising the parts in direct contact with pharmaceutical products and is commonly only accepted for the indirect contact surfaces in the filling and closing machines. As a result, these parts must be disassembled and steam sterilised separately, resulting in high production times and additional costs.

[0012] The transfer of sterilised parts inside the isolator, normally at a lower sterility level, involves the risk of losing the sterility during contact with air or handling. Complicated and risky methods, such as the use of “Rapid Transfer Port” (RTP) or the transfer and assembly by means of the isolator gloves, are used to maintain sterility, but are subject to residual contact risks, procedural errors and violations of the “first air” criterion in the aseptic area.

[0013] The situation becomes particularly critical for large components, such as vibrating cups and hoppers, which are sterilised in autoclaves, but because of the size they cannot be handled with gloves with the doors closed, thereby compromising the sterile safety. In conclusion, the current system represents a mitigated risk but not completely safe from the point of view of sterility.

[0014] Italian patent application No. 102023000024198, filed in the name of the same Applicant, describes a double-container system, both of which can be sterilised by superheated steam, which - by means of an automatic and autonomous process for sterilising the process instruments - greatly limits or eliminates the need for intervention by the operator during normal operation of the system, without a supporting autoclave or gloves, since there are no preparation operations in an aseptic condition.

[0015] Moreover, the above-mentioned system can be cleaned automatically, like conventional systems, such as freeze-dried devices, and guarantees an absolute safety of the sterility of the machine and all its parts inside the process chambers, making the filling and finishing step of the bottles, syringes and carpules extremely efficient, so much so that it is possible to achieve production speeds equal to the conventional filling systems.

[0016] However, using a common valve, during the passage of the bottles or other primary containers entering and leaving the process chamber, it would be necessary to request manual intervention by an operator for reassembling components in order to reconstitute the continuity of the guide path for the primary containers or their closures.

[0017] Moreover, with a traditional solution it would not be possible to minimise the air leaving the process chamber, generating a problem in controlling the pressure of the chamber and therefore in maintaining the requirement of overpressure of the aseptic zone.

[0018] In this way, there would be an increased risk of alteration of the sterile condition of the process chamber due to the presence of the flanges, the gloves and the manual assembly process, which in any case is difficult to check and monitor.

[0019] Summary of the Invention

[0020] The aim of the invention is to limit as much as possible the escape of the air from the chamber and eliminate the above-mentioned drawbacks, allowing the flow to be as constant as possible.

[0021] In the context of the above-mentioned aim, the invention also aims to guarantee a perfect and certain sterility of the machine and all its parts.

[0022] A further aim of the invention is to provide a container which can be sterilised by superheated steam which, whilst guaranteeing maximum quality and sterility, is also economically competitive.

[0023] Another aim of the valve according to this invention is to allow this movement, which is subjected to passing through areas under different conditions of temperature, pressure, saturation, etc., to be performed in a single closed environment, without the need for access from the outside during the operation of the process.

[0024] This purpose, as well as these and other aims which will become clearer below, are achieved by a regulating valve, preferably for the seal of process chambers, according to the invention, comprising the technical features described in one or more of the appended claims. The dependent claims correspond to possible different embodiments of the invention.

[0025] In particular, according to a first aspect, this invention relates to a regulating valve, preferably for the seal of process chambers, which comprises a wall rotatable about an axis of rotation, between a blocked position and a position for passage of primary sterile containers, or their closures, in the connecting path between a process chamber and one of the zones adjacent to it.

[0026] In other words, the valve intercepts the path of the sterile elements (bottles, syringes, carpules, caps for bottles, covers for syringes, etc.) entering and / or leaving process chambers.

[0027] The rotatable wall extends in a direction normal to an axis of rotation and has, on at least a relative first side, a supporting element for the aseptic product.

[0028] The term “zones adjacent” to the process chamber means those zones designed to be connected to the same process chamber by the valves for regulating the accesses.

[0029] In the blocked position, the rotatable wall is substantially normal to a feed direction of the sterile elements; in the transit position, on the other hand, it is parallel to the feed direction and the support connects between two portions of the path.

[0030] According to a first embodiment, which is used for moving bottles, syringes or carpules, the support comprises a shelf, which has a supporting surface for the primary sterile container.

[0031] Advantageously, on a second side of the rotatable wall, opposite the first side, there is a wing protruding from the plane in which the rotatable wall lies, for compensating relative to the bracket, which allows the reduction of the flow of air which passes from the inside to the outside of the container, and vice versa, when the valve is in the passage position.

[0032] According to a variant embodiment, used for transporting caps and covers for bottles, syringes or carpules, fastening elements are made which are positioned symmetrically relative to the axis of rotation, on both sides of the rotatable wall.

[0033] A further variant may also comprise fastening elements for caps and covers on only one side of the rotatable wall.

[0034] Another aspect of the invention relates to a container which can be sterilised by superheated steam and which comprises, on a load-bearing frame:

[0035] - an aseptic chamber, for containing sterile elements of primary containers, designed to be sterilised with saturated steam coming from a vaporisation duct;

[0036] - at least a first compensation chamber with compensated pressure, for housing the operational instruments of the container;

[0037] - a first partition hermetically interposed between the process chamber and the first compensation chamber; and

[0038] - accesses for connection between the process chamber and its adjacent zones, regulated when opening and closing by means of respective valves.

[0039] A distinctive feature of the container consists in the fact that each of the valves has a wall rotatable, about an axis of rotation, between a blocked position and a position for passage of the sterile elements of primary containers, during their connection path between the process chamber and one of the zones adjacent to it (that is, those zones designed to be connected to it by the above-mentioned accesses).

[0040] This rotatable wall comprises, on at least one relative side, a supporting element for a medical element, such as a bottle, a syringe or a carpule.

[0041] The rotatable wall extends in a direction normal to the axis of rotation, in such a way that, in the blocked position, it is substantially normal to the feed direction of the sterile elements; in the passage position, on the other hand, it is parallel to the feed direction in such a way that the support can connect two portions of the path.

[0042] The above-mentioned support may include a shelf equipped with a supporting surface for bottles, syringes or carpules, or fastening elements for caps or covers which seal the bottles, syringes or carpules.

[0043] In the first case, the rotatable wall has, on a second side opposite the first, a wing protruding from the plane on which the rotatable wall lies. The protruding wing is for compensating relative to the shelf and is designed to reduce the area of the passage section.

[0044] In the second case, the fastening elements are, on the other hand, positioned symmetrically on the two opposite sides, relative to the axis of rotation.

[0045] Preferably, the accesses are defined in the walls of the process chamber and comprise: an inlet opening for the bottles, syringes and carpules to be filled, regulated when opening and closing by an inlet valve; an access opening for the caps and the closing covers for bottles, syringes and carpules filled; and an outlet opening for the sealed bottles, syringes and carpules, positioned substantially on the opposite side of the process chamber relative to the axis of symmetry of the container.

[0046] The inlet opening is regulated when opening and closing by means of an inlet valve, the access opening is regulated when opening and closing by means of an access valve and the outlet opening is regulated when opening and closing by means of an outlet valve.

[0047] The path comprises a movement guide for transporting bottles, syringes or carpules between the inlet opening and the outlet opening, or includes a conveying track for the caps and the covers from the process chamber of a second container to the process chamber of the first container.

[0048] The Applicant has therefore developed a container which can be sterilised by superheated steam, for filling and finishing bottles, syringes and carpules, as well as for feeding caps for these bottles and covers for the syringes and carpules, without the use of isolators or similar means which force the operator to remove and refit the components or to intervene with gloves in the aseptic area. The container also allows the sterilisation of the instrumentation components, so as to ensure total disinfection and decontamination of all the parts.

[0049] Advantageously, in order to prevent that the pressure differential between the process chamber and the adjacent zones can cause damage to the apparatuses inside the container, a pressurising device is provided. The device is configured for bringing the internal pressure of the first compensation chamber between a standard pressure, corresponding to the external pressure, and an operating pressure, for compensating the pressure of the superheated steam inside the aseptic chamber.

[0050] Similarly, the container includes a second compensation chamber with compensated pressure, with inspection means for controlling the aseptic chamber, separated in a sealed fashion from this by a second partition.

[0051] Moreover, the second compensation chamber has an upper access to control the inside of the aseptic chamber, in such a way as to allow the operator to operate easily inside the process chamber.

[0052] Thanks to this compensation system, it is possible to keep the process chamber at extremely high pressures without damaging the instruments in the adjacent zones.

[0053] Preferably, the process chamber is positioned between the first and the second compensation chamber along the vertical direction of extension of the container, coinciding substantially with the axis of symmetry of the container. Consequently, the first partition lies in a horizontal plane normal to this vertical direction.

[0054] Obviously, in an identical way to that seen in the first compensation chamber, the pressurising device of the second compensation chamber varies the internal pressure of the second compensation chamber between the standard pressure and the operating pressure.

[0055] According to a first embodiment, a first container is used for the sterile filling and finishing of bottles, syringes and carpules, which enter and leave in line from the container; for that purpose, inside it, there will be means for filling bottles, syringes or carpules.

[0056] In practice, the apparatuses for filling bottles, syringes or carpules are integrated inside this first container equipped with a process chamber and a first lower compensation chamber and a second upper compensation chamber. The first compensation chamber is basically a technical compartment, separated in a sealed fashion from the process chamber (where the sterile elements of primary containers are filled and sealed), but which is able to compensate for the pressure difference relative to the process chamber to prevent deformation of the bellows and a mechanical stress between the two compartments at higher pressures. In the same way, the second compensation chamber, where inspection means are preferably provided, is also equipped with a hermetic separation.

[0057] In this document, the terms “upper” and “lower” or “above” and “below” refer to the position of an element, or a part of it, relative to one of the horizontal planes on which the first or the second partition lies.

[0058] According to an alternative embodiment, the caps and the covers for the bottles, syringes or carpules are distributed in a second container. The process chamber of the second container is a chamber for feeding the caps, separated from a first and a second compensation chamber. The upper compensation chamber is provided with at least one transparent portion for inspecting the aseptic chamber, whilst the lower compensation chamber houses the cup vibration system. The caps are fed by a cap storage unit, upstream of the container, using a dosing valve system which, by means of a rotary butterfly, distributes the caps towards the process chamber of the first container in a controlled manner and suitable for the rate of feeding the vibrating cup.

[0059] Advantageously, the two containers are connected in an aseptic manner by a pipe intercepted by an opening and closing valve, in such a way that the caps or the covers are transported without problems of contamination between the two containers, that is to say, between the second container for distribution of the caps and the covers and the first container, that is to say, the container for sterile filling and finishing of bottles, syringes and carpules, where robotic hands will pick up the caps or the covers and seal the respective bottles, syringes and carpules.

[0060] The vaporisation duct of the process chamber of the container for the sterile filling and finishing of bottles, syringes and carpules is connected to a vaporisation device. The vaporisation device extends, inside the aseptic chamber, along a horizontal direction substantially normal to the vertical direction.

[0061] The second container for distributing the caps and the covers for the bottles, syringes or carpules preferably has the following accesses: an upper opening - regulated when opening and closing by means of an upper valve - for the entrance of caps falling towards a vibrating cup positioned in the aseptic chamber, and a lower opening - regulated when opening and closing by means of a lower valve - for transferring the caps leaving the vibrating cup towards the container for the sterile filling and finishing of bottles, syringes and carpules, which is also connected to the aseptic chamber.

[0062] The upper valve is a high containment valve of the traditional type.

[0063] Another aspect of the invention relates to a system of at least two aseptic containers under pressure, a first and a second container interconnected with each other by a pipe, wherein the first container is used for filling bottles, syringes, carpules and other sterile products, which must be filled and finished inside its own sterile process chamber, and the second container is used for the distribution of caps and sterile covers for the above- mentioned containers which will then be sent to the first container where the filling and closing will be performed.

[0064] In other words, the system comprises one or more sealed chambers in which it is possible to use superheated steam sterilising instead of VHP decontamination. In these process chambers, both the pressure and temperature can be raised in such a way as to make a true sterilisation possible, without compromising the filling automation and the instrumentation inside the chambers. In this way, the system can no longer be likened to a traditional isolator, but it is an environment which is able to withstand more than three absolute bars of pressure and at a temperature higher than that of sterilisation, as per the regulations.

[0065] The Applicant has in fact understood that a system configured in this way is a valid example for resolving the problems due to the limits of the VHP decontamination processes and the consequent procedures for introducing “autoclaved” parts, but it is also a good solution, with a low complexity, to allow old production sites to comply with the current guidelines.

[0066] A fundamental feature of such a system is that the first and the second container are interconnected with each other by means of a pipe having the access valve or the lower valve, made as described above, interposed between the outlet opening of the process chamber of the first container and the lower opening of the process chamber of the second container.

[0067] Moreover, as the pressure and temperature can be increased in this system, it can be sterilised with superheated steam and suitable for the so-called “cleaning in place” (that is, in technical jargon, the process for cleaning the inside of a process apparatus without the removal or removal of parts of the apparatus, “CIP”), both hot and cold. And since it can be sterilised with saturated vapor, it is no longer necessary to decontaminate with VHP but, mainly, it is no longer necessary to insert and manage the parts in direct and indirect contact with the product, removing them and reassembling them in aseptic mode after the “autoclaving”.

[0068] A further protection is required for a method for sterilising a container for filling sterile containers for parenteral drugs which comprises the steps of:

[0069] - closing the accesses between the process chamber and zones adjacent to it by rotating the rotatable wall of the above-mentioned valves from the passage position to the blocked position, in such a way as to isolate the process chamber;

[0070] - changing the process chamber isolated in this way to a vacuum and, at the same time, changing the first compensation chamber to a vacuum (and, if necessary, also the second if it is provided);

[0071] - injecting saturated steam into the vacuum process chamber until the end of the validated sterilisation cycle has been performed. Advantageously, after having injected superheated steam into the vacuum process chamber, the process can again be carried out in a vacuum and then superheated steam can be injected again. This process may be repeated cyclically until the aseptic chamber is gradually and completely saturated.

[0072] Subsequently, in order to allow the transit into and out from the process chamber both of the sterile elements of primary containers and of an air flow (out from one or more of the accesses), the rotatable wall is again rotated to move it to the passage position.

[0073] In practice, during the washing or sterilisation step, the valves upstream and downstream of the guides for moving the bottles, syringes or carpules are closed and isolate the process chamber from the outside environment. Once the aseptic condition has been reached, the valves are opened and, thanks to an overpressure, the chamber maintains its sterility with a positive pressure gradient. The valves, by opening, put in communication the various zones of the container and allow the alignment of the guides for movement of the bottles, creating a single path for the bottle which will enter the filling chamber.

[0074] Detailed description

[0075] Further features and advantages of the invention are more apparent in the detailed description below, with reference to a preferred, non-limiting embodiment of the regulating valve, illustrated by way of example and without limiting the scope of the invention, with the aid of the accompanying drawings, in which:

[0076] Figure 1 shows a perspective view of a system 100 consisting of two containers 1 and 101 , which can be sterilised by superheated steam, for filling and closing bottles F to be closed by sterile caps T, for parenteral drugs, having sections designed to reproduce the inside of the process chamber 2, the inside of the second compensation chamber 105 and the inside of the pipe 14 or 1 14 for connecting between the process chambers 2 and 102 of the two containers 1 and 101 ; Figure 1 A shows a first enlargement 1 A of Figure 1 ;

[0077] Figure 1 B shows a second enlargement 1 B of Figure 1 ;

[0078] Figure 2 shows the system 100 of Figure 1 cross-sectioned with a plane passing through the vertical direction Z and normal relative to the plane XY; Figure 3 shows the second container 101 of the system 100 of Figure 1 , cross-sectioned with a further plane passing through the vertical direction Z and normal relative to the plane XY.

[0079] Figure 4 shows a perspective view of an inlet valve 27 in the passage position;

[0080] Figure 5 shows a perspective view of the inlet valve 25 (or a valve 27) in the blocked position;

[0081] Figures 6A and 6B show perspective views of an access valve 26 (or a lower valve 126) in the passage position and in the blocked position, respectively. The above-mentioned drawings show a preferred embodiment of a regulating valve, preferably for the seal of process chambers 2 and 102, according to the invention, which is identified in its entirety with the reference numerals 25, 26, 27 or 126, and which comprises a wall 201 which is rotatable, by means of an actuator 200, about an axis of rotation R, between a blocked position and a position for passage of aseptic products F and T in the connecting path 81 or 86 between a process chamber 2 or 102 and one of the zones adjacent to it.

[0082] The rotatable wall 201 has, on at least a relative first side 201 a, a support 202 or 212' and 212" for supporting a sterile element F and T. Moreover, the rotatable wall 201 extends in a direction normal to the axis of rotation R in such a way that, in the blocked position (illustrated more clearly in Figures 5 and 6B), it is substantially normal to a feed direction D of the sterile elements F and T (Figures 1 A and 1 B), whilst in the passage position (Figures 4 and 6A) it is parallel to the feed direction D; in this position, the support 202 or 212' and 212" is for connecting between two portions of the path 81 or 86.

[0083] In particular, the paths 81 and 86 are the relative trajectories drawn respectively by the movement guide 81 for the bottles F and by the transport track 86 for the caps T. For this reason, these paths also include the stretches of the guide 81 , upstream and downstream of the container 1 , that is to say, upstream and downstream of the valves 25 and 27.

[0084] The rotatable wall 201 is mounted on the wall of the chamber 2 or on the duct 14 (1 14) by means of a frame 207, the innermost circumference of which defines the diameter of the opening 21 , 22 or 23.

[0085] The process chamber 2 or 102, which contains the sterile elements to be processed (bottles F of the container 1 or caps T of the container 101 ) is hermetically separated from the first compensation chamber 3 or 103 by means of a first partition 4 or 104 and, from the second compensation chamber 5 or 105, by means of a second partition 6 or 106. All the partitions 4, 6, 104 or 106 are tightly sealed (Figures 2 and 3).

[0086] As already indicated, the process chamber 2 or 102 has accesses which allow the connection with the adjacent zones, regulated when opening and closing by means of respective valves 25, 26, 27, 125 and 126.

[0087] As illustrated in Figure 4, the support is a shelf 202 which has a supporting surface 202a for the bottles F.

[0088] According to this embodiment, the rotating wall 201 has, on a second side 201 b opposite the first side 201 a, a wing 203 which protrudes from the plane in which the wall 201 lies, to compensate for the imbalance caused by the bracket 202 during the rotation of the wall 201 about the axis R and reduce the area available for the flow of air (Figure 5).

[0089] The bottles F which come from a storage unit area and are transported towards a storage area along the path 81 along the feed direction D are first intercepted by the valve 25 and 27 which regulates the connection of a process chamber 2 with the adjacent outer zones.

[0090] The portion of path, which is interrupted due to the presence of the valve 25 or 27, is missing a part at the valve 25 or 27. The missing portion is replaced by the bracket 202 when the rotatable wall 201 is rotated in the passage position. Vice versa, in the blocked position of the wall 201 , the flow of the bottles F along the direction D is forced to interrupt.

[0091] According to the example embodiment of Figures 6A and 6B, on the other hand, the support comprises fastening elements 212’ and 212” for the caps T, positioned symmetrically on the first side 201 a and on a second side 201 b opposite the first side 201 a, relative to the axis of rotation R.

[0092] Even if the operating principle is the same along the path 86, intercepted by the valve 26 (126), the feed direction D comprises transporting the caps T in pairs.

[0093] The container 1 or 101 , which can be sterilised by superheated steam, is preferably used for filling bottles, syringes and carpules F and closing them by caps T or other covers; it comprises, on a load-bearing frame 15 or 1 15, a process chamber 2 or 102 for containing the apparatuses to be sterilized, which can be sterilised by superheated steam using a vaporisation duct 20 or 120.

[0094] There are also two compensation chambers 3 and 5 or 103 and 105: a first compensation chamber 3 or 103 for housing the instrumentation 10 or 1 10 and a second compensation chamber 5 or 105. In order to the process chamber 2 or 102 from the compensation chambers 3 and 5 or 103 and 105, respectively, there is a first partition 4 or 104, hermetically interposed between the process chamber 2 or 102 and the first compensation chamber 3 or 103, and a second partition 6 or 106, hermetically interposed between the process chamber 2 or 102 and the second compensation chamber 5 or 105. The container 1 or 101 has accesses 21 and / or 22 and / or 23 and / or 121 and / or 123 for the connection between the process chamber 2 or 102 and the zones adjacent to it, designed to be connected with the process chamber 2 or 102 and regulated when the opening and closing by means of respective valves 25 and / or 26 and / or 27 and / or 126. Each of these valves 25 and / or 26 and / or 27 and / or 126 has a wall 201 rotatable about an axis of rotation R, between a blocked position and a position for passage of sterile elements F or T in the connecting path 81 or 86 between the process chamber 2 or 102 and one of the zones adjacent to it.

[0095] According to a first variant, the rotatable wall 201 has, on a single side of it, a support 202 for bottles F. The support 202 extends in a direction normal to the axis of rotation R, therefore moving along the entire side of the wall 201. In this case, on the second side 201 b, opposite the first side 201 a of the rotatable shelf 201 , there is a wing 203 protruding from the plane in which the rotatable wall 201 lies, for compensating relative to the shelf 202 which reduces the area available for the passage of air.

[0096] Alternatively, the rotatable wall 201 has, on both sides, a support 212’ and 212”, that is to say, fastening elements 212’ and 212”, for the caps T; the fastening elements 212’ and 212” are positioned symmetrically on the first side 201 a and on a second side 201 b opposite the first side 201 a, relative to the axis of rotation R. In this case, too, the fastening elements (supports) 212’ and 212” extend along the direction normal to the axis of rotation R (Figure 6A).

[0097] In this way, both with the single support 202 and with the double supports 212’ and 212”, in the blocked position, the rotatable wall 201 is substantially normal to a feed direction D of the sterile elements F and T, whilst in the passage position, it is parallel to the feed direction D and the support 202 or 212’ and 212” is for connecting between two portions of the path 81 or 86, respectively.

[0098] Basically, there is a system 100 consisting of two containers 1 and 101 used, respectively, for filling and finishing bottles F in an aseptic manner and for distributing the closing caps T for bottles F for parenteral drugs. The two containers 1 and 101 are connected to each other by a pipe 14 (or 1 14) which has the access valve 26 (or the lower valve 126) interposed between an access opening 22 of the process chamber 2 and a lower opening 123 of the process chamber 102.

[0099] In this regard, the accesses 21 , 22 and 23, defined in the walls of the process chamber 2 are: an inlet opening 21 for the bottles F to be filled, regulated when opening and closing by means of an inlet valve 25, an access opening 22 for the caps T for closing the filled bottles F, regulated when opening and closing by means of an access valve 26 and an outlet opening 23 for the sealed bottles F, positioned substantially on the opposite side of the process chamber 2 relative to the axis of symmetry of the container 1 , regulated when opening and closing by means of an outlet valve 27.

[0100] According to the example described, the two valves 26 and 126 coincide, as well as - obviously - the two pipes 14 and 1 14: the pipe 14, also denoted by the numeral 1 14, is simply the set of two half-pipes (14 and 114), relative to the containers 1 and 101 , which start from the respective process chambers 2 and 102 and are connected or divided by the valve 26 (coinciding with the valve 126).

[0101] As described in Italian patent application No. 102023000024198, the bottles F are filled in the process chamber 2 of a first container 1 and the caps T are positioned. In the container 1 , the accesses are defined in the vertical walls of the process chamber 2, or rather in the circular vertical wall which delimits the chamber 2.

[0102] In the process chamber 2, the bottles F transit by means of a movement guide 81 by which the bottles F enter and leave. The continuous movement of the guide allows the filling of the bottles F in succession and, then, the positioning of the caps T on the filled bottles; on the other side, the caps T, coming from the second process chamber 102 of a second container 101 , enter inside the chamber 2 by means of a transport track 86.

[0103] Basically, the path of the bottles F between the inlet opening 21 and the outlet opening 23 is implemented by the movement guide 81 , whilst the path of the caps T between the process chamber 102 and the process chamber 2 is made replaceable by the transport track 86.

[0104] Figure 1 shows that, if the valves 25 and 27 are positioned on the corresponding openings 21 and 23, the access valve 26 is, on the other hand, mounted in the middle portion of a pipe 14 which connects the first container 1 with a second container 101 , generally similar on the basis of the inventive concept expressed here, which has the purpose of allowing the distribution of the caps T for closing the bottles F.

[0105] Therefore, both of the paths 81 and 86 are without a part at the openings 21 and 23 (or valves 25 and 27) in the walls of the process chamber 2 and at the valve 26 (126) in the pipe 14 (1 14).

[0106] In detail, the movement guide 81 is formed by a pair of helical screws 81 .

[0107] It is important to emphasise that each of the valves 25 and 27 comprises a wall 201 rotatable about an axis of rotation R, between a blocked position and a position for passage of the bottles F along the path 81 , that is to say, along the movement guide 81 , for connecting between the process chamber 2 and the zones adjacent to it.

[0108] The rotatable wall 201 has, on at least one relative side, a shelf 202 for supporting the bottles F, which extends along a direction normal to the axis of rotation R, in such a way that, in the blocked position, the rotatable wall 201 is substantially normal to a feed direction D of the bottles (from the storage unit area to the storage area) and, in the passage position, the wall 201 is parallel to the feed direction D with the shelf connecting the two portions of the movement guide 81 interrupted at the openings 21 and 23, that is, at the valves 25 and 27.

[0109] For reasons of equilibrium and for reducing the air flows during the rotation of the wall 201 about the axis R, on a second side 201 b opposite the first side 201 a of the wall 201 , there is a wing 203 protruding from the plane in which it lies.

[0110] On the other hand, the caps T are carried inside the process chamber 2 by means of a transport track 86 which runs inside the pipe 14 and which connects the two containers 1 and 101 .

[0111] The valve 26 (which coincides with 126) also includes a wall 201 rotatable about an axis of rotation R, between a blocked position and a position for passage of the caps T on the path 86, that is to say, along the conveying track 86, for connection between the two process chambers 2 and 102.

[0112] The rotatable wall 201 in this case has two fastening elements 212’ and 212” for as many caps T, positioned symmetrically on the first side 201 a and on a second side 201 b opposite the first side 201 a, relative to the axis of rotation R.

[0113] The fastening elements 212’ and 212” extend along a direction normal to the axis of rotation R, in such a way that, in the blocked position, the rotatable wall 201 is substantially normal to the feed direction D of the caps T (which goes from the second process chamber 102 to the first process chamber 2, inside the pipe 14 or 1 14); whilst in the passage position, the rotatable wall 201 is parallel to the feed direction D and the fastening elements 212’ and 212” connect the two portions of the transport track 86 interrupted at the valve 26 (126).

[0114] Inside the process chamber 2 there is a filling head 82 which supports needles 83 for injecting the fluid selected for filling the bottles F, of per se known type. Also mounted inside the process chamber 2 are robotic hands 84, also of per se known type, which pick up the caps T to be positioned on the bottles F and position the caps T on the filled bottles F, in such a way as to seal them.

[0115] With reference to Figure 3, the container 101 , used to dispense the caps T to the container 1 , by means of the transport track 86, has two accesses: an upper opening 121 and a lower opening 123.

[0116] The inlet opening 121 is for the caps T falling towards a vibrating cup 108, of per se known type, positioned in the process chamber 102.

[0117] The lower opening 123 is defined by the intersection of the cylindrical wall of the pipe 14 (1 14) with the other cylindrical wall of the process chamber 102, and allows the distribution of the caps T, coming out from the vibrating cup 108, towards the first container 1 .

[0118] Each of the mouths 121 and 123 is regulated when opening and closing, respectively, by an upper valve 125 (which is not of the type according to the invention) and a lower valve 126 (coinciding with the access valve 26). More in detail, the transport track 86 collects the caps T downstream of the vibrating cup 108 and through the pipe 14 (1 14) in which the track 86 is installed, facilitating the guided sliding up to the access opening 22 (if the lower valve 126, that is to say, 26 allows it) of the first container 1 .

[0119] As mentioned above regarding the configuration of the container 101 , since the storage unit 112 for caps is positioned above the process chamber 102, the caps T enter into the chamber 102, through the neck 102a, by gravity, feeding the vibrating cup 108 below.

[0120] In use, the two containers 1 and 101 , interconnected by the pipe 14 (1 14) regulated by the access valve 26 (that is, by the lower valve 126), are positioned in such a way that the first container 1 has the process chamber 2 positioned below the process chamber 102, in such a way as to favour the lowering of the caps T on the transport track 86. For this reason, the legs 15 of the container 1 are shorter than the legs 1 15 of the container 101 .

[0121] The valves 25, 26 and 27 are moved to the blocked position by rotating, thanks to the actuator 200, the wall 201 about the axis R, so as to be able to isolate the process chambers 2 and 102 of the containers 1 and 101 from the zones adjacent to them; the chambers 2 and 102, isolated in this way, are initially changed to a vacuum.

[0122] Saturated steam is then injected in the process chambers 2 and 102 to perform the validated sterilisation cycle.

[0123] In order to allow the transit into and out of the process chamber 2 and / or 102 of the sterile elements F and / or T and / or of a flow of air coming out from one or more of the accesses 21 , 22 and 23, the actuator 200 rotates the rotatable wall 201 of the valves 25, 26 (126) and 27 to move it to the passage position.

[0124] From the above description it may be seen how the invention achieves the preset purpose and aims and in particular it should be noted that a container which can be sterilised by superheated steam is made, representing a valid alternative to isolators decontaminated with VHP generators or similar systems, which is simpler to control and easier to use.

[0125] In particular, the making of valves with integrated geometries for the sliding of bottles, syringes, carpules, caps and similar elements (that is to say, the shelves and the fastenings) creates the continuity of movement of the medical elements, in effect guaranteeing a “bridge” between the various parts of the movement guide and of the conveying track outside and inside the process chamber, limits considerably the escape of air from the chamber and gives the flow an optimum constancy.

[0126] In this way, a perfect and certain sterility of the machine and all its parts is ensured.

[0127] Another advantage of the invention is that it makes a container which can be sterilised by superheated steam which, whilst guaranteeing the maximum quality and sterility, is economically competitive.

[0128] Another advantage of the invention described herein is due to the fact that the use of these valves eliminates manual intervention from the outside and the quantity of automatic movements necessary to restore the continuity of the guide path is reduced to a single movement for each valve.

[0129] Moreover, the above-mentioned valve allows the internal pressure of the chamber to be easily controlled thanks to the reduced surface for passage of air between the process chamber and the adjacent chambers, since the passage of the sterile element and the integrated supporting elements is guaranteed, but the flow rate of air flowing out or entering the process chamber is minimised.

[0130] Another advantage of this regulating valve is that it allows the sterilisation of the elements of the container 1 necessary for moving the medical sterile elements, without any intervention by the operator and without the provision of gloves.

[0131] Moreover, the valve according to the invention allows the above-mentioned sterile medical elements to be moved, even through environments at different temperature, pressure, saturation conditions, etc., without the need for an external input during the operation of the process.

[0132] The invention described can be modified and adapted in several ways without thereby departing from the scope of the inventive concept.

[0133] Moreover, all the details of the invention may be substituted by other technically equivalent elements.

[0134] In practice, the materials used, as well as the dimensions, may be of any type, depending on requirements, provided that they are consistent with their production purposes.

Claims

CLAIMS1 ) A regulating valve (25, 26, 27, 126), preferably for the seal of process chambers (2, 102), comprising a wall (201 ) rotatable about an axis of rotation (R), between a blocked position and a position for passage of sterile elements (F, T) for parenteral drugs in the connecting path (81 , 86) between a process chamber (2, 102) and a zone adjacent to it; the rotatable wall (201 ) having, on at least a relative first side (201 a), a support (202, 212’, 212”) for at least one of the sterile elements (F, T) extending in a direction normal to the axis of rotation (R); in such a way that, in the blocked position, the rotatable wall (201 ) is substantially normal to a feed direction (D) of the sterile elements (F, T); and in the passage position, the rotatable wall (201 ) is parallel to the feed direction (D) and the support (202, 212’, 212”) is for connecting between two portions of the path (81 , 86).2) The valve (25, 26, 27, 126) according to claim 1 , wherein the support(202) comprises a bracket (202) having a supporting surface (202a) for at least one of the sterile elements (F).3) The valve (25, 26, 27, 126) according to claim 2, wherein the rotatable wall (201 ) has, on a second side (201 b) opposite the first side (201 a), a wing(203) protruding from the plane on which the rotatable wall (201 ) lies, for compensating relative to the shelf (202) and reducing the area of the passage section.4) The valve (25, 26, 27, 126) according to claim 1 , wherein the support (212’, 212”) comprises fastening elements (212’, 212”) for at least one of the sterile elements (T), positioned symmetrically on the first side (201 a) and on a second side (201 b) opposite the first side (201 a), relative to the axis of rotation (R).5) A container (1 , 101 ) which can be sterilised by superheated steam, preferably for filling and closing sterile elements (F, T) for parenteral drugs, comprising, on a load-bearing frame (15, 1 15): a process chamber (2, 102) designed to be sterilised by superheated steamusing a containment vaporisation duct (20, 120) for the apparatuses to be sterilised; a first compensation chamber (3, 103), at compensated pressure, for containing the instruments (10, 1 10) to be sterilised; a first partition (4, 104) hermetically interposed between the process chamber (2, 102) and the first compensation chamber (3, 103); and accesses (21 , 22, 23, 121 , 123) for connection between the process chamber (2, 102) and the zones adjacent to it, designed to be connected to the process chamber (2, 102), regulated when opening and closing by means of respective valves (25, 26, 27, 126); each of the valves (25, 26, 27, 126) comprising a wall (201 ) which is rotatable about an axis of rotation (R), between a blocked position and a position for passage of the sterile elements (F, T) in the connecting path (81 , 86) between the process chamber (2, 102) and one of the zones adjacent to it; the rotatable wall (201 ) having, on at least one relative side, a support (202, 212’, 212”) for a sterile element (F, T) and extending in a direction normal to the axis of rotation (R); in such a way that, in the blocked position, the rotatable wall (201 ) is substantially normal to a feed direction (D) of the sterile elements (F, T); and in the passage position, the rotatable wall (201 ) is parallel to the feed direction (D) and the support (202, 212’, 212”) is for connecting between two portions of the path (81 , 86).6) The container (1 ) according to claim 5, wherein the support (202) comprises a shelf (202) having a supporting surface for at least one of the sterile elements (F).7) The container (1 ) according to claim 6, wherein the rotatable wall (201 ) has, on a second side (201 b), opposite the first side (201 a), a wing (203) protruding from the plane on which the rotatable wall (201 ) lies, for compensating relative to the shelf (202) and reducing the passage section.8) The container (1 ) according to claim 6 or 7, wherein the accesses (21 ,22, 23) are defined in the walls of the process chamber (2) and comprise: an inlet opening (21 ) for the bottles (F) to be filled, regulated when opening and closing by means of an inlet valve (25); an access opening (22) for the caps (T) for closing the filled bottles (F), regulated when opening and closing by means of an access valve (26); an outlet opening (23) for the sealed bottles (F), positioned substantially on the opposite side of the process chamber (2) relative to the axis of symmetry of the container (1 ), regulated when opening and closing by means of an outlet valve (27); the path (81 , 86) comprising a movement guide (81 ) for transporting the bottles (F) between the inlet (21 ) and the outlet (23); or a transport track (86) for the caps (T) between the process chamber (102) of a second container (101 ) and the process chamber (2) of a first container (1 )-9) The container (1 ) according to claim 5, wherein the support (212’, 212”) comprises elements (212’, 212”) for fastening the sterile element (T), positioned symmetrically on the first side (201 a) and on a second side (201 b) opposite the first side (201 a), relative to the axis of rotation (R).10) A system (100) of at least two containers (1 , 101 ) which can be sterilised by superheated steam for filling and closing sterile elements (F, T) for parenteral drugs, according to any one of claims 5 to 9, wherein a first container (1 ) is used for filling bottles (F), syringes and carpules, designed to be filled and finished inside the relative process chamber (2), and a second container (101 ) is used for distributing caps (T) and covers for bottles (F), syringes and carpules, designed to be distributed to the first container (1 ); the first container (1 ) and the second container (101 ) being interconnected with each other by means of a pipe (14, 1 14) having the access valve (26) or the lower valve (126) interposed between the lower opening (123) of the process chamber (102) of the second container (101 ) and the access opening (22) of the process chamber (2) of the first container (1 );the access valve (26) or lower valve (126) being made according to any one of claims 1 to 4.11 ) A method for sterilising a container (1 , 101 ) according to any one of claims 5 to 9, comprising the steps of:- closing the accesses (21 , 22, 23, 121 , 123) between a process chamber (2, 102) of a container (1 , 101 ) under pressure and zones adjacent to it, rotating a rotatable wall (201 ) of a valve (25, 26, 27, 126) from a position for the passage of sterile elements (F, T) for parenteral drugs to a blocked position for the sterile elements (F, T), in such a way as to isolate the process chamber (2, 102); the valve (25, 26, 27, 126) being mounted in the connecting path (81 , 86) between the process chamber (2, 102) and said zones adjacent to it;- changing the isolated process chamber (2, 102) to a vacuum and, at the same time, a first compensation chamber (3, 103);- injecting saturated steam into the vacuum process chamber (2, 102) until the end of the validated sterilization cycle.12) The method according to claim 1 1 , comprising the step of rotating the rotatable wall (201 ) of the valves (25, 26, 27, 126) for moving it to the passage position, in such a way as to allow the transit into and out of the process chamber (2, 102) of the sterile elements (F, T) and / or a flow of air coming out from one or more of the accesses (21 , 22, 23); the flow of air being variable depending on the pressure difference between the inside of the process chamber (2, 102) and the zones adjacent to it.

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